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St. Lucie Press

Boca Raton London New York Washington, D.C.

Document DevelopmentCompliance Manual

A COMPLETE GUIDE and CD-ROM

ISO 9001:2000

Syed Imtiaz Haider, Ph.D.



This book contains information obtained from authentic and highly regarded sources. Reprinted material

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© 2001 by CRC Press LLC

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No claim to original U.S. Government works

International Standard Book Number 1-57444-308-9

Library of Congress Card Number 2001019637

Printed in the United States of America 1 2 3 4 5 6 7 8 9 0

Printed on acid-free paper

Library of Congress Cataloging-in-Publication Data

Haider, Syed Imtiaz.

ISO 9001:2000 document development compliance manual : a complete guide and

CD-ROM / Syed Imtiaz Haider.

p. cm.

Includes bibliographical references.

ISBN 1-57444-308-9 (alk. paper)

1. ISO 9000 Series Standards—Handbooks, manuals, etc. I. Title.

TS156.6 .H32 2001

658.5′62—dc21 2001019637



iii

PREFACE

The ISO 9001:2000 Document Development Compliance Manual: A Com-

plete Guide and CD-ROM provides guidelines to those involved in the

development of quality system manuals and applicable standard operating

procedures (SOPs) to comply with the requirements of international stan-

dard ISO 9001:2000 and proceed with the registration/certification process.

The quality manuals (models) and SOPs provided in the CD-ROM are also

a valuable tool for the companies to transform their existing ISO 9001,

ISO 9002, and ISO 9003 quality manuals and SOPs to meet the require-

ments of revised standards.

The text provides explicit documentation packages to the end users

globally, to develop documentation without spending a lot of money and

resources. The information provided will serve as the first milestone to

lead companies to ISO 9000 registration/certification.

The CD-ROM is user-friendly and provides meaningful understanding

of documentation requirements, which can be adopted by any company

after minor changes suitable to their operations. The contents of the quality

manuals and SOPs are written in simple and precise language to be incompliance with revised international standard ISO 9001:2000 and provide

readers and front-line management with all the information they need to

make a successfully documented quality system. The manual will ensure

the minimization of documents, to avoid the nightmare of management

representatives at the time of a registration/certification audit.

The text refers to the elements of the standards, however, specific

working formats are not included to ensure that the electronic package

can be used by a diversified range of industries and organizations.



v

ACKNOWLEDGMENTS

The author would like to thank his friends and colleagues for their helpand encouragement in this endeavor and for creating a professionalenvironment that demanded the development of this manual. He wouldalso like to thank the staff of CRC Press, particularly Drew Gierman, forhis patience and diligence in the production of this work.

Syed Imtiaz Haider



vii

THE AUTHOR

Syed Imtiaz Haider has a Ph.D. in chemistry and is a quality assurance specialist with over10 years of experience in aseptic and non-aseptic pharmaceutical processes and equip-ment validation, in-process control, and audit-ing. Dr. Haider is the author and co-author of more than 20 research publications in inter-

national journals dealing with products of pharmaceutical interest, their isolation, andstructure development. He is a professionaltechnical writer and author of more than 500standard operating procedures based on FDAregulations, ISO 9000, and ISO 14000 standard.

Dr. Haider is a certified auditor of IRCA and a registered provisionalenvironmental auditor of EARA.



ix

ABOUT THE MANUAL

This manual takes into account documentation of quality manuals andapplicable procedures based on quality elements described in internationalstandard ISO 9001:2000. No other manual in print deals exclusively withthe key elements of quality and provides hands-on templates to be tailoredto achieve ISO 9000 registration/certification.

ISO 9001:2000 quality manuals, together with 20 standard operating pro-cedures, provide explicit instructions on how to achieve the standard for

anyone responsible for writing and executing quality manuals and applicableprocedures. Included herein is the ready-to-use template on a CD-ROM thatone can immediately use as his own without “reinventing the wheel,” thussaving time and money without missing any critical quality elements.

This manual provides instant answers for quality professionals, quality assurance managers, auditors, and protocol writers regarding what shouldbe made part of quality manual standards and ISO 9000 standard operatingprocedures to enhance productivity.

INTRODUCTION

Objective What is Quality? Correspondence between ISO 9001:1994 and ISO 9001:2000 The Basic Changes Documentation and Registration/Certification

QUALITY SYSTEMS MANUALS

Model-1: Quality Manual ISO 9001:2000 Model-2: Quality Manual ISO 9001:2000



x ISO 9001:2000 Document Development Compliance Manual

Model-3: Quality Manual ISO 9001:2000 Model-4: Quality Manual ISO 9001:2000

STANDARD OPERATING PROCEDURES

Management Responsibility Quality Systems Contract Review Design Control Document and Data Control

Purchasing Customer-Supplied Product Product Identification and Traceability Process Control Inspection and Testing Inspection, Measuring, and Test Equipment Inspection and Test Status Control of Nonconforming Product Corrective Action

Handling, Storage, Packaging, and Delivery Quality Records Internal Quality Audits Training Servicing Statistical Techniques

APPENDICES

Recommended Readings

INDEX

The manual is designed especially for individuals involved in writingand executing quality manuals and applicable procedures. This manualprovides a complete, single-source reference which details quality manualsand over 20 explicit procedures based on quality elements described in

the ISO 9001:2000 international standard.



xi

CONTENTS

100.10 Objective100.10.1 What is Quality? ................................................................... 8100.10.2 Correspondence between ISO 9001:1994

and ISO 9001:2000............................................................. 12100.10.3 The Basic Changes ............................................................ 22100.10.4 Documentation and Registration/Certification................. 26

200.20 Quality Manuals

200.20.1 Model-1: Quality Manual ISO 9001:2000 ......................... 32200.20.2 Model-2: Quality Manual ISO 9001:2000 ....................... 122200.20.3 Model-3: Quality Manual ISO 9001:2000 ....................... 186200.20.4 Model-4: Quality Manual ISO 9001:2000 ....................... 248

300.30 Standard Operating Procedures300.30.1 Management Responsibility............................................. 308300.30.2 Quality Systems................................................................ 314300.30.3 Contract Review............................................................... 324300.30.4 Design Control ................................................................. 330

300.30.5 Document and Data Control .......................................... 340300.30.6 Purchasing ........................................................................ 348300.30.7 Control of Customer-Supplied Product.......................... 352300.30.8 Product Identification and Traceability .......................... 356300.30.9 Process Control ................................................................ 360300.30.10 Inspection and Testing .................................................... 366300.30.11 Inspection, Measuring, and Test Equipment ................. 372300.30.12 Inspection and Test Status .............................................. 376300.30.13 Control of Nonconforming Product ............................... 380300.30.14 Corrective Action ............................................................. 384

300.30.15 Handling, Storage, Packaging, and Delivery................. 388300.30.16 Quality Records................................................................ 392300.30.17 Internal Quality Audits .................................................... 396300.30.18 Training............................................................................. 402



xii ISO 9001:2000 Document Development Compliance Manual

300.30.19 Servicing ........................................................................... 406300.30.20 Statistical Techniques....................................................... 410



xiii

INTRODUCTION

The ISO 9001:2000 Document Development Compliance Manual: A Com-

plete Guide and CD-ROM is designed and written for the quality profes-sionals, auditors, managers, supervisors, and management representatives

who are responsible for writing and maintaining quality managementsystems for the successful operation of their companies. This documentprovides a set of three model ISO 9001:2000 quality manuals and appli-cable standard operating procedures (SOPs) revised on the basis of

ISO 9001:2000 international standard. These can be used to manage anddocument critical elements in an organization in order to build quality into the products and services provided by the company.

The numbering of the sections and the related quality manuals andSOPs begin with 100 and go through 300. In addition, the reader may add SOPs that are unique to his products and services. The term man-agement representative is used extensively throughout the SOPs. It refersto the person who has been delegated the authority by organizationalmanagement and deemed responsible for performing the duties associated

with management of the quality system.The ISO 9001:2000 Document Development Compliance Manual: A

Complete Guide and CD-ROM is comprised of the following three sections.

Objective: This section describes the meaning of quality corre-spondence between ISO 9001:1994 and international standardISO 9001:2000 and basic changes in ISO 9001:2000 internationalstandard. It also provides a time line chart and documentation,and describes the registration/certification process.

Quality Manuals: Four template quality manuals are provided asmodels. Quality manual Model-1 can be directly adopted by a com-pany planning for the first time for registration/certification to aninternational standard ISO 9001:2000. Model-2 will be useful for a



xiv ISO 9001:2000 Document Development Compliance Manual

company in possession of ISO 9001 registration/certification thatintends to revise its quality manual and quality system. Organizations

already holding the ISO 9002 and ISO 9003 quality manuals may referto Model-3 and Model-4, respectively, to incorporate changes in theexisting ISO 9002 and ISO 9003 quality manuals in order to be incompliance with the requirements of the ISO 9001:2000 standard.

Standard Operating Procedures: This provides 20 explicit tem-plate procedures that can be adopted after minor changes suitableto each company ’s operations.

QUALITY MANUAL FORMAT Your Company Name: At the top of each page of the quality manual space is provided to enter your company name.Quality System Manual: The quality manual is assigned a spaceto indicate the standard used to document the quality manage-ment system.Manual Serial Number: Each quality manual is assigned a uniquenumber that appears at the upper right hand corner of the page.

Revision Number: At the right hand corner of each page is therevision number box, which is provided to document the revisionnumber. Written by: The quality manual is assigned a space to provide theauthor name, title, and the department with signatures and the date.Checked by: The quality manual is assigned a space to providethe name of the person responsible for the verification of thecontents of the manual, the title, and the department with signa-tures and the date.

Approved by: Each page of the quality manual has a space toprovide the name, title, and department of the person in the quality assurance unit or the management representative approving themanual with signatures and the date.Date Supersedes: Each page of the quality manual is assigned aspace to indicate the issue date of the manual superseded.Date Issued: Each page of the quality manual is provided with aspace to provide the manual’s issue date.Distributed to: Each top page of the quality manual is assigned a

space to indicate the recipients of the manual.Controlled Copy Number: Each front page of the quality manualis assigned a space to provide the copy number assigned to themanual for distribution.



Introduction xv

Section, Clause: Each page of the quality manual has a box toindicate the section and the applicable clause.

Reasons for Revision: On the top page of the quality manual,space is provided to describe the reasons for revision of the proce-dure with the date.Reference SOP Number: On the last page of each clausedescribed in the quality manual, space is provided to write theapplicable SOP number.

SOP FORMAT

All SOPs have been designed and formatted to have the same look, andsimilar information is located in the same place on all SOPs. Informationcommon to all SOPs is described below.

Your Company Name: At the top of each page of an SOP, spaceis provided to enter your company name.Subject: The subject of each SOP appears at the upper left handcorner of the SOP and describes the quality element described inthe SOP.SOP Number: Each SOP is assigned a unique number that appearsat the upper right hand corner of the SOP, based on the referenceclause of the ISO 9000 series of standard.Corresponding Clause: All SOPs are provided with a space in thesecond line of the SOP’s header to provide reference to the corre-sponding clause of an international standard ISO 9001:2000.Distributed to: Each SOP is assigned a space to list the recipientsof the SOP.Based on: Each SOP is assigned a space to list the applicable ISO9000:1994 series of standard.Revision Number: At the right hand corner of each page is therevision number box. The box is provided to document the revisionnumber. Written by: Each SOP is assigned a space to provide the authorname, title, and department with signatures and the date.Checked by: Each SOP is assigned a space to provide the nameof the person responsible for the verification of the procedure, title,

and department with signatures and the date. Approved by: Each page of the SOP has a space to provide thename, title, and department of the person in the quality assuranceunit or the management representative approving the SOP withsignatures and the date.



xvi ISO 9001:2000 Document Development Compliance Manual

Date Supersedes: Each page of the SOP is assigned a space toindicate the issue date of the SOP superseded.

Date Issued: Each page of the SOP is provided with a space toprovide the SOP issue date.Page Number: Each SOP page is numbered.Purpose: Each SOP is supported with reasons, describing the pur-pose of that SOP.Responsibility: Each SOP is supported with responsibility, describ-ing the department and the employee responsible for implementingthe procedure.Definition: Where necessary, definitions are provided in the SOP

for better understanding.Procedure: Following the responsibility statement are the individualsteps of the SOP. These are arranged in logical order and numberedsequentially to make the SOP easy to perform, and they are basedon the ISO 9000:1994 series of standards.Reasons for Revision: At the end of each SOP, space is providedto describe the reasons for the revision of the procedure with the date.CD-ROM: An electronic copy of the quality manuals and SOPs areprovided. See pg. 413 of this manual for the CD-ROM instructions.



xvii

RECOMMENDED READINGS

1. ISO 9000-3:1997, Quality Management and Quality Assurance Standards —

Part 3: Guidelines for the Application of ISO 9001:1994 to the Development,Supply, Installation, and Maintenance of Computer Software.

2. ISO 9004: Quality Management Systems — Guidelines for PerformanceImprovements.

3. ISO 10005:1995, Quality Management — Guidelines for Quality Plans.4. ISO 10006:1997, Quality Management — Guidelines to Quality in Project

Management.5. ISO 10007:1995, Quality Management — Guidelines for Configuration Manage-

ment.6. ISO 10011-1:1990, Guidelines for Auditing Quality Systems — Part 1: Auditing.7. ISO 10011-2:1991, Guidelines for Auditing Quality Systems — Part 2: Qualifi-

cation Criteria for Quality Systems Auditing.8. ISO 10011-3:1991, Guidelines for Auditing Quality Systems — Part 3: Manage-

ment of Audit Programs.9. ISO 10012-1:1992, Quality Assurance Requirements for Measuring Equipment

— Part 1: Metrological Confirmation System for Measuring Equipment.10. ISO 10012-2:1997, Quality Assurance for Measuring Equipment — Part 2:

Guidelines for Control of Measurement Processes.11. ISO 10013:1995, Guidelines for Developing Quality Manuals.12. ISO/TR 10014:1998, Guidelines for Managing the Economics of Quality.13. ISO 10015, Quality Management — Guidelines for Training.14. ISO/TR 10017:1999, Guidance on Statistical Techniques for ISO 9001:1994.15. ISO/TC 178/SC 2/N 378, Quality Management Principles and Guidelines on

Their Application.16. ISO 9001:2000, Quality Management Systems Requirements.



100.10



2 ISO 9001:2000 Document Development Compliance Manual 100.10

OBJECTIVE

This manual is written in general terms so that it can be used as a

procedural guideline by the individual responsible for writing quality

manuals and applicable standard operating procedures and programs. The

format of this manual, these procedures, and the numbering system can

easily be used by small to large companies and are acceptable to ISO

certification bodies.

The CD-ROM consists of manuals and procedures that should be useful

to all companies. As the ISO 9000 series of quality standards becomes

more widely adopted by organizations, both in the United States and

elsewhere in the world, it is essential for compliant companies to createquality systems manuals and applicable standard operating procedures

(SOPs) for their employees. These SOPs enable both new and experienced

staff to understand the requirements of the ISO 9000 series of standards,

along with the principles and practices of the company, and comply with

these regulations to build the elements of quality into their products and

services with a particular reference to customer satisfaction.

For companies already in compliance with the ISO 9000 series of

standards, and who are registered, certified, and have long since developed

and adopted the quality manual and SOPs, this manual will help them havean easy transition to the new international standard ISO 9001:2000 require-

ments. This ISO 9001:2000 Document Development Compliance Manual: A

Complete Guide and CD-ROM will be of enormous value to recently emergedcompanies with a big investment in the slogan of quality. While thesecompanies are few, if any, they will have the expertise to fully understandthe elements of quality and achieve registration/certification.

The ISO 9001:2000 Document Development Compliance Manual: A

Complete Guide and CD-ROM with an included CD-ROM provides an

administrative solution for management both in text and software. Thequality manuals and standard operating procedures on the CD-ROM are valuable tools, especially for those companies in the process of applyingor planning to apply for registration in the future. The documentationpackage is especially relevant to quality management representatives,designers, internal auditors, and external auditors or to anyone interestedin developing a documented quality system.

The ISO 9000 series of standards (1994) was based on the “processapproach.” The management organizations that have adopted the 1994

edition of the standards had to describe their business processes anddevelop quality manuals and procedures needed to support them. Therevised ISO 9001:2000 international standard model is very clear; it encour-ages the adoption of the process approach as a means of readily identifyingand managing opportunities for improvement. The present family of 21standards in the ISO 9000 series is reduced to fi ve.



100.10 ISO 9001:2000 Document Development Compliance Manual 3

The development, implementation, and maintenance of a quality man-ual and key SOPs are essential for compliance with the ISO 9000 series

of standards and are a requirement of the international standardISO 9001:2000. Writing SOPs can be time consuming for those new to thesystem. Moreover, the standards do not specify how SOPs are to be written, what format they should be in, or how many procedures are enough.

Those new to international standard ISO 9001:2000 compliance may have dif ficulty knowing the best route to take. Generally, companiesnew to applying for registration are allowed an adequate amount of time for remedial action and demonstration of their commitment andcontinuous improvement. Documentation management can, however,

minimize the number of adverse findings for incomplete or missingSOPs and prevent repeated adverse findings by making the develop-ment of SOPs a top priority. The quality manuals and pr oceduresprovided in an electronic form can be easily adapted to any facility ’sneeds and style.

The text and CD-ROM provide end users with resource data to developand improve their quality system without spending a lot of money onconsultants or “reinventing the wheel.” The SOPs are made available insuch a form that end users can input them into their computer and use

their own Microsoft Word program to edit and print these documents.The contents of the quality manuals are written in simple, precise, andglobal text in order to be in compliance with the elements of internationalstandard ISO 9001:2000, which r eplaces the second edition of ISO 9001:1994 together with ISO 9002 (1994) and ISO 9003 (1994).

The quality manuals and procedures provide users and frontline man-agers with all the information they need to make a successful documentedquality system based on the international standard ISO 9001:2000 series

of standards.The contents of the manual are divided into three major sections:objectives, quality manuals, and standard operating procedures. The firstsection addresses the definition of quality, basic changes, correspondencebetween international standard ISO 9001 (1994) and ISO 9001:2000, andthe process of documentation development and application for registrationand certification.

The second section contains four template quality manuals writtenin compliance with international standard ISO 9001:2000 to provide

the statement of company approach and declaration of interest as tohow the requirements of the ISO 9001:2001 quality management stan-dard are to be addressed. This section is comprised of four samplequality manuals presented as Model-1, Model-2, Model-3, and Model-4,respectively.



4 ISO 9001:2000 Document Development Compliance Manual 100.10

Model-1

The quality manual is prepared and maintained in accordance with

ISO 9001:2000, without permissible exclusions.

Model-2

The ISO 9000 series of standards has been adopted by thousands of companies worldwide since the introduction of registration and certi-fication. Considering the fact that transition to the revised standardISO 9001:2000 will take time, Model-2 can be used wher e quality manual ISO 9001 already exists and needs to be revised in accordance with the requirements of ISO 9001:2000. Reference is made to theapplicable clauses of ISO 9001 and ISO 9001:2000. No exclusions arepermitted in Model-2.

Model-3

This model was developed for companies already holding ISO 9002registration/certification and intending to immediately comply with the

changes recommended in international standard ISO 9001:2000. Model-3represents the revision of the ISO 9002 quality manual in accordance withthe applicable clauses of the ISO 9001:2000 standard. Sub-clause 7.3 of design and/or development is excluded from the Model-2 quality manual.

Model-4

The last model is the quality manual for companies already registered,certified and in compliance with the ISO 9003 (1994) standard. The adoption

of Model-4 will facilitate effective transition to the requirements of interna-tional standard ISO 9001:2000. Following are the permissible exclusions:

Sub-clause 7.1: planning of product realizationSub-clause 7.2.3: customer communicationSub-clause 7.3: design and developmentSub-clause 7.4: purchasingSub-clause 7.5.1: control of production and service provisionSub-clause 7.5.2: validation of processes for production and service

provisionSub-clause 7.5.3: identification and traceability

The Model-1 quality manual can be directly adopted by companiesplanning to register/certify to international standard ISO 9001:2000 for thefirst time. Model-2 is useful for companies in possession of ISO 9001



100.10 ISO 9001:2000 Document Development Compliance Manual 5

registration/certification who intend to revise their quality manual andsystem. Organizations already holding ISO 9002 and ISO 9003 quality

manuals may refer to Model-3 and Model-4, respectively, to incorporatechanges into their existing ISO 9002 and ISO 9003 quality manuals in orderto be in compliance with the requirements of the ISO 9001:2000 standard.

The last section of this book provides a set of 20 explicit standardoperating procedures written in a global text to describe the elements of the revised standard. The contents of the procedures can be specifically tailored to an individual company ’s operations, and reference can be madeto specific documents and associated applicable procedures. Taking intoconsideration the fact that thousands of companies are already registered

and certified in compliance with the ISO 9001 (1994) or ISO 9002 (1994)or ISO 9003 (1994) international standards, reference is made to thecorresponding SOPs to indicate applicable clauses of both the second andthe third revisions of the ISO 9000 series of standards.



100.10.1



8 ISO 9001:2000 Document Development Compliance Manual 100.10.1

WHAT IS QUALITY?

The official definition of quality is, “the totality of features and character-istics of a product or service that bear upon its ability to satisfy stated orimplied needs” (ISO 8402). Well-planned design is one of the majorcontributing factors to achieving quality within a product or service. It istherefore necessary to carefully control critical elements of a company’sdocumentation system with particular reference to each phase of designin order to ensure that the effects on the end products or services arenot disastrous and are based on customer requirements.

To be successful, an organization must offer services and products that

meet a well-defined purpose or need. A company must satisfy its users,including delivery time scales. It should be ensured that applicable stan-dards, statuary requirements, and specifications are in compliance. Theoffered product or services should be within budget and provide value.Companies should ensure that their total operations are carefully reviewedbefore implementation to reduce the occurrence of error and quickly correct any error inadvertently made. Control should be demonstrated onchanges through proactive communication and feedback loops betweenthe company and external interfaces. Training needs must be identified

to promote efficiency and cost-effectiveness.Over the past decade, we have seen drastic changes in the worldaround us. There has been more competition in terms of quality, andcompanies have to do more work, accomplish targets, and be proactiverather than reactive. All this must be accomplished with fewer people. Inaddition, the quality must be better than ever, due to competitive forcesand consumer demands. Since the beginning of the new millennium, itis evident that we are working in a global village where it is impossiblefor a company to survive without offering quality products and services.

The quest to achieve excellence in products and services should beevery company’s mission, which can only be achieved with a vision toimplement a documented quality system based on a globally acceptedstandard (to overcome economic barriers). Compliance to global interna-tional standard ISO 9001:2000 will lead your company to:

Supply products that are totally fit for use

Satisfy its users’/customers’ expectations and contractual require-

ments

Yield profits on the invested resources Achieve and sustain defined levels of quality

Comply with applicable standards and specifications

Prevent defectives, rather than detect them

Provide value for money



100.10.1 ISO 9001:2000 Document Development Compliance Manual 9

Supply products within delivery time scales agreed upon/required

by the user/customer

Comply with environmental requirements

Work in harmony within an organization without productivity losses



100.10.2




CORRESPONDENCE BETWEEN ISO 9001:1994

AND ISO 9001:2000

A number of quality systems standards are in operation worldwide. Theirdivision into categories is based on the scope of their subject matter. ISO(International Standardization Organization) is a Geneva-based worldwidefederation of national bodies that normally work together to prepareinternational standards through technical committees (TC). Each memberbody interested in a subject for which a TC has been established has theright to be represented on that committee. International organizations,governmental and nongovernmental, in liaison with the ISO, also partic-

ipate in the work. The U.S. representative to the ISO is the AmericanNational Standards Institute (ANSI).The International ISO 9000:1994 series of standards has been estab-

lished and is based on the British Standard 5750:1987 series, EuropeanStandard EN 29000:1987 series, and Inter national Standard ISO9000:1987 series. The third edition of ISO 9001 cancels and replacesthe second edition (ISO 9000:1994) together with ISO 9002:1994 andISO 9003:1994. It constitutes a revision of these documents. Thoseorganizations that have used ISO 9002:1994 and ISO 9003:1994 in the

past may use this revised international standard by excluding certainrequirements in accordance with Clause 1.2 of ISO 9001:2000. It shouldbe noted that where the exclusives in sub-clause 1.2 of ISO/FDIS9001:2000 are exceeded, conformity to ISO/FDIS 9001:2000 shall notbe cleared. All requirements of the revised standard are generic andare applicable to all organizations, regardless of type, size, and productsoffered. If any requirements of this international standard cannot beapplied due to the nature of an organization, its products can beconsidered for exclusion.

The publication of BS EN ISO 9001:2000 has implications for CouncilDecision 93/465/EEC of July 22, 1993 concerning the modules for the

various phases of conformity assessment procedures and the rules foraffixing and using the CE conformity marking, which are intended to beused in the technical harmonization directives. It is important to note thatthe modules used in individual technical harmonization directives may

vary in some respects compared to those described in Council Decision93/465/ECC. In all cases, it is the annex of the applicable directive(s) thatis legally binding. The principles set out in this foreword remain valid

regardless of these variations.Three of the modules cited in the council decision, i.e., modules E,

D, and H, require that “the manufacturer must operate an approvedquality system.” The scope of the quality systems required by thesemodules addresses:




Final product inspection and testing (module E) Production, final inspection, and testing (module D)

Design manufacture, final product inspection, and testing (module H)

Council Decision 93/465/EEC specifies that conformity to the harmonizedstandards EN 29001, EN 29002, or EN 29003 provides a presumption of conformity to the relevant requirements of modules H, D, and E. EN29001, EN 29002, and EN 29003 were suspended by EN ISO 9001:1994,EN ISO 9002:1994, and EN ISO 9003:1994, respectively, which, in turn,are now superseded by EN ISO 9001:2000.

Where organizations wish to implement quality management systems

in conformance with modules E, D, or H, they may use EN ISO 9001:2000.In seeking compliance with modules D, E, or H, an organization may exclude specific requirements.

Only those requirements in clause 7 of ISO 9001:2000 pertaining tothe difference between modules E, D, and H may be excluded whileretaining the presumption of conformity. Refer to Table 1.

It should be noted that where the exclusions described in sub-clause1.2 of EN ISO 9001:2000 are exceeded, conformity to EN ISO 9001:2000shall not be claimed. Table 2 and Table 3 are provided below to help

companies identify similarities and differences between ISO 9001 (1994)and international standard ISO 9001:2000, respectively.

Table 2 is provided to help the readers of the manual understand thebasic changes and the correspondence between ISO 9001:1994 andISO 9001:2000.

Table 3 provides correspondence between the ISO 9001:2000 andISO 9001:1994.




Table 1

Module E

Permissible Exclusions

Module D

Permissible

Exclusions

Module H

Permissible

Exclusions

Sub-clause 7.1: planning ofproduct realization

Sub-clause 7.2.3: customercommunication

Sub-clause 7.3: design anddevelopment

Sub-clause 7.4: purchasingSub-clause 7.5.1: control ofproduction and serviceprovision

Sub-clause 7.5.2: validation ofprocesses for production andservice provision

Sub-clause 7.5.3: identificationand traceability

Sub-clause 7.3:design and/ordevelopment

No exclusionspermitted

It should be noted that no explicit requirements in modules H, D, and E relateto the concepts of “customer satisfaction” and “continual improvement.” As aconsequence, noncompliance with requirements of EN ISO 9001:2000, explicityrelated to these concepts, does not infringe upon the presumption of confor-mity to the appropriate module.

Extracts from BS EN ISO 9001:2000 reproduced with permission of BSI underlicence number 2001SK/0060. Complete standards can be obtained by post fromBSI Customer Services, 389 Chiswick High Road, London W 4 4AL. (Tel +44 (0)20 8996 9001).

Table 2

ISO 9001:1994 ISO 9001:2000

1.0 Scope 1.0

2.0 Normative reference 2.0

3.0 Definitions 3.0

4.0 Quality system requirements(title only)

4.1 Management responsibility(title only)

4.1.1 Quality policy 5.1 + 5.3 + 5.4.1

4.1.2 Organization (title only)




4.1.2.1 Responsibility and authority 5.5.1

4.1.2.2 Resources 5.1 + 6.1 + 6.2.1 + 6.3

4.1.2.3 Management representative 5.5.2

4.1.3 Management review 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1

4.2 Quality system (title)

4.2.1 General 4.1 + 4.2.1 + 4.2.2 + 5.1 +5.4.1

4.2.2 Quality system procedures 4.2.1

4.2.3 Quality planning 5.4.2 + 6.2.1 + 7.1 4.3 Contract review (title only)

4.3.1 General

4.3.2 Review 5.2 + 7.2.1 + 7.2.2 + 7.2.3

4.3.3 Amendment to a contract 7.2.2

4.3.4 Records 7.2.2

4.4 Design control (title only)

4.4.1 General

4.4.2 Design and development planning 7.3.1

4.4.3 Organizational and technicalinterfaces

7.3.1

4.4.4 Design input 7.2.1 + 7.3.2

4.4.5 Design output 7.3.3

4.4.6 Design review 7.3.1 + 7.3.4

4.4.7 Design verification 7.3.1 + 7.3.5

4.4.8 Design validation 7.3.1 + 7.3.6

4.4.9 Design changes 7.3.7

4.5 Document and data control(title only)

4.5.1 General 4.2.1 + 4.2.3

4.5.2 Document and data approval andissue

4.2.3

4.5.3 Document and data changes 4.2.3

4.6 Purchasing (title only)

4.6.1 General

4.6.2 Evaluation of subcontractors 7.4.1

4.6.3 Purchasing data 7.4.2

4.6.4 Verification of purchased product 7.4.3

4.7 Control of customer-suppliedproduct

7.5.4

Table 2 (Continued)

ISO 9001:1994 ISO 9001:2000




4.8 Product identification andtraceability

7.5.3

4.9 Process control 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2+ 8.2.3

4.10 Inspection and testing (title only)

4.10.1 General 7.1 + 8.1

4.10.2 Receiving inspection and testing 7.4.3 + 8.2.4

4.10.3 In-process inspection and testing 7.4.3 + 7.5.1 + 8.2.4

4.10.4 Final inspection and testing 7.4.3 + 8.2.4 4.10.5 Inspection and test records 7.5.3 + 8.2.4

4.11 Control of inspection, measuring,and test equipment (title only)

4.11.1 General 7.6

4.11.2 Control procedure 7.6

4.12 Inspection and test status 7.5.3

4.13 Control of nonconforming product(title only)

4.13.1 General 8.3 4.13.2 Review and dispositioning of

nonconforming product8.3

4.14 Corrective and preventive action(title only)

4.14.1 General 8.5.2 + 8.5.3

4.14.2 Corrective action 8.4 + 8.5.2

4.14.3 Preventive action 8.4 + 8.5.3

4.15 Handling, storage, packaging,

preservation, and delivery(title only)

4.15.1 General

4.15.2 Handling 7.5.5

4.15.3 Storage 7.5.5

4.15.4 Packaging 7.5.5

4.15.5 Preservation 7.5.5

4.15.6 Delivery 7.5.1 + 7.5.5

4.16 Control of quality records 4.2.4

4.17 Internal quality audits 8.2.2 + 8.2.3 4.18 Training 6.2.1 + 6.2.2

4.19 Servicing 7.1 + 7.5.1

4.20 Statistical techniques (title only)

Table 2 (Continued)

ISO 9001:1994 ISO 9001:2000




4.20.1 Identification of need 8.1 + 8.2.3 + 8.2.4 + 8.4

4.20.2 Procedures

Extracts from BS EN ISO 9001:2000 reproduced with permission of BSI underlicence number 2001SK/0060. Complete standards can be obtained by post fromBSI Customer Services, 389 Chiswick High Road, London W 4 4AL. (Tel +44 (0)20 8996 9001).

Table 3

ISO 9001:2000 ISO 9001:1994

1.0 Scope 1.0

1.1 General

1.2 Application

2.0 Normative reference 2.0

3.0 Terms and definitions 3.0

4.0 Quality management system

(title only) 4.1 General requirements 4.2.1

4.2 Documentation requirements(title only)

4.2.1 General 4.2.1 + 4.5.1

4.2.2 Quality manual 4.2.1

4.2.3 Control of documents 4.5.1 + 4.5.2 + 4.5.3

4.2.4 Control of quality records 4.16

5.0 Management responsibility

(title only)5.1 Management commitment 4.1 + 4.1.2.2 + 4.2.1

5.2 Customer focus 4.3.2

5.3 Quality policy 4.1.1

5.4 Planning (title only)

5.4.1 Quality objectives 4.1.1 + 4.2.1

5.4.2 Quality management systemplanning

4.2.3

5.5 Responsibility, authority, and

communication (title only)5.5.1 Responsibility and authority 4.1.2.1

5.5.2 Management representative 4.1.2.3

5.5.3 Internal communication

Table 2 (Continued)

ISO 9001:1994 ISO 9001:2000




5.6 Management review (title only) 4.1.3

5.6.1 General 4.1.3

5.6.2 Review input 4.1.3

5.6.3 Review output 4.1.3

6.0 Resource management (title only)

6.1 Provision of resources 4.1.2.2

6.2 Human resources (title only)

6.2.1 General 4.1.2.2 + 4.2.3 + 4.18

6.2.2 Competence, awareness, andtraining

4.18

6.3 Infrastructure 4.1.2.2 + 4.9

6.4 Work environment 4.9

7.0 Product realization (title only)

7.1 Planning of product realization 4.2.3 + 4.9 + 4.10.1

7.2 Customer-related processes(title only)

7.2.1 Determination of requirements

related to the product

4.3.2 + 4.3.3 + 4.3.4

7.2.2 Review of requirements related tothe product

4.3.2 + 4.3.3 + 4.3.4

7.2.3 Customer communication 4.3.2

7.3 Design and development (title only)

7.3.1 Design and development planning 4.4.2 + 4.4.3 + 4.4.6 + 4.4.7 + 4.4.8

7.3.2 Design and development inputs 4.4.4

7.3.3 Design and development outputs 4.4.5

7.3.4 Design and development review 4.4.67.3.5 Design and development verification 4.4.7

7.3.6 Design and development validation 4.4.8

7.3.7 Control of design and developmentchanges

4.4.9


7.4.1 Purchasing process 4.6.2

7.4.2 Purchasing information 4.6.3

7.4.3 Verification of purchased product 4.6.4 + 4.10.2 + 4.10.3 + 4.10.4

7.5 Production and service provision(title only)

7.5.1 Control of production and serviceprovision

4.9 + 4.10.3 + 4.15.6 + 4.19

Table 3 (Continued)

ISO 9001:2000 ISO 9001:1994




7.5.2 Validation of processes of productionand service provision

4.9

7.5.3 Identification and traceability 4.8 + 4.10.5 + 4.12

7.5.4 Customer property 4.7

7.5.5 Preservation of product 4.15.2 + 4.15.3 + 4.15.4 + 4.15.5 + 4.15.6

7.6 Control of monitoring and measuringdevices

4.11.1 + 4.11.2

8.0 Measurement, analysis, andimprovement (title only)

8.1 General 4.10 + 4.17 + 4.20.1

8.2 Monitoring and measurement(title only)

8.2.1 Customer satisfaction

8.2.2 Internal audit 4.17

8.2.3 Monitoring and measurement ofprocesses

4.9 + 4.17 + 4.20.1

8.3 Control of nonconforming product 4.13.1 + 4.13.28.4 Analysis of data 4.14.2 + 4.14.3 + 4.20

8.5 Improvement (title only)

8.5.1 Continual improvement 4.1.3

8.5.2 Corrective action 4.14.1 + 4.14.2

8.5.3 Preventive action 4.14.1 + 4.14.3

Extracts from BS EN ISO 9001:2000 reproduced with permission of BSI underlicence number 2001SK/0060. Complete standards can be obtained by post from

BSI Customer Services, 389 Chiswick High Road, London W 4 4AL. (Tel +44 (0)20 8996 9001).

Table 3 (Continued)

ISO 9001:2000 ISO 9001:1994



100.10.3




THE BASIC CHANGES

The third edition of ISO 9001 cancels and replaces the second edition of

ISO 9001:1994 together with ISO 9002:1994 and ISO 9003:1994. Those

organizations that have used ISO 9002:1994 and ISO 9003:1994 in the pastmay use this revised international standard by excluding certain require-

ments in accordance with clause 1.2.

The revised and adopted module ISO 9001:2000 makes the quality

system management requirements extremely clear. The review of Tables

1 and 2, under the heading “Correspondence between ISO 9001 (1994)

and ISO 9001:2000,” reveals that the same processes are specified inboth standards, even though they have dif ferent names and sub-

headings. The quality system requirements in ISO 9001:2000 are com-

prehensively grouped under clause 7 with additional emphasis on

customer satisfaction and internal communication. Where exclusions

are made, claims of conformity to this international standard are not

acceptable unless these exclusions are limited to the requirements within clause 7. Such exclusions do not affect the organization’s ability

or responsibility to provide products that fulfill customer and applicable

regulatory requirements.

The quality management principles stated in ISO 9004 were taken intoconsideration during the development of this international standard. This

standard promotes the adoption of a process appropriate when develop-ing, implementing, and improving the effectiveness of a quality manage-

ment system to enhance customer satisfaction by meeting customer

requirements. The following eight management principles are integrated

into the ISO 9001:1994 standard and revised as the third edition of

ISO 9001:2000.

Customer satisfaction Role of leadership Involvement of employees The business process approach Systematic approach to management Continual improvement A factual approach to decision making Mutually beneficial relationship with supplier

It is important for an organization to understand current and future needsand expectations, as well as quantify customer satisfaction and act on it.

Those in positions of leadership should deploy policies and verifiableobjectives, establish vision, and give direction to shared values. Man-agement should set challenging goals and implement strategies to




achieve those goals, as well as empower qualified employees with adocumented system.

The standards emphasize creating personal ownership of an orga-nization’s goals by using the experience and knowledge of qualifiedand trained personnel with identified authority and responsibility tocontinuously work toward process improvement. A system should beestablished for the identification of internal and external customers andsuppliers of processes. Process activities should be focused to ade-quately use the personnel, materials, machines, and methods to dem-onstrate control. All processes within a system should be identified andaligned for their interdependency with measurable organization goals

and objectives. Continuous improvement should be ensured with real-istic and challenging goals, and adequate resources should be providedto meet the company ’s needs in terms of people and equipment toaccomplish customer requirements. Continual improvement should beensured through management services, internal/external audits, andcorrective and preventive actions. The analysis of data and informationsuch as customer complaints, nonconforming products, and auditsshould be conducted on continuous basis to enhance productivity andminimize waste rework and rejections. Cost improvement projects

should be implemented.Efforts should be made to establish strategic alliances and to ensure

joint development and the continuous improvement of products, pro-cesses, and systems. The company should ensure thorough review andevaluation of the performance of subcontractors in order to meet cus-tomer requirements.

ISO 9000 defines system processes as activities that use resources totransform input into output. Inputs to a process are often outputs fromother processes. Any activity or operation that receives inputs and convertsthem to outputs can be considered a process. Almost all product and/orservice activities and operations are processes. For organizations to func-tion, they have to define and manage numerous linked processes. Often,the output from one process will directly form the input into the nextprocess. The systematic identification and management of the variousprocesses employed within an organization, and particularly the interac-tions between such processes, may be referred to as the “processapproach” to management.

The proposed new version of the international standard encourages theadoption of the process approach for both the management of the organi-zation and its processes and as a means of readily identifying and managingopportunities for customer satisfaction with continuous improvement.



100.10.4




DOCUMENTATION AND REGISTRATION/CERTIFICATION

ISO 9001:2000 registrants are familiar with the phrase “quality manual andstandard operating procedures.” A company cannot comply with registrationrequirements if there is no approved quality manual/standard operatingprocedures/working formats and records. The quality manual documenta-tion should be completed by the top management to ensure commitmentat all the appropriate levels within the organization. The quality policy,goals, and objectives defined in the quality manual must be verifiable. Theapplicable procedures should be established and documented by the com-pany prior to the certification process. Normally, the development of a

quality manual and applicable procedures is the most time-consuming factor,and the time may vary from small to large organizations. However, docu-mentation time can be greatly reduced using these sample quality manualsand standard operating procedures. Users should go through this text andreview their current systems in order to incorporate changes in theseelectronic files, which may take 4 to 12 weeks. It is expected that thedocumented quality standards will be in place and implemented at leastthree months prior to the registration audit.

For the documentation development process, refer to Figure 1.

Figure 2 provides guidelines for the registration/certification process, which is self-explanatory.Figure 3 provides an ISO 9001:2000 documentation and certification

time line.




Figure 1 The documentation development process.

Review international

standard ISO 9000 Series

Development Manual

Review ISO 9001:2000

international standard

Review customer and

statutory requirementsapplicable to your

operations

Amend electronic files

provided on CD-ROM to

incorporate change as per

the company ’s operations

Provide training

Systems implemented

minimum 3 months

Perform audit

Conduct management

review

Contact certification body,

local of fice




Figure 2 The assessment process.

Certification body

contacted

Questionnaire completed

and returned with

application forms

Pre-assessment

(optional)

Desk study

by certification body

Documentation amendment

if necessary

Recommended or approved

Recommended, approved

Surveillance every

six months

Corrective action

Reassessment

No

Yes




Figure 3 ISO 9001:2000 documentation and certification schedule.

Task Responsibility

Month

1st 2nd 3rd 4th 5th 6th 7 thCompany audit

questionerABC Company

Preparation of qualitymanual (QM)

ABC Company

Finalization of qualitymanual (QM)

ABC Company

Preparation of SOPs(20)

ABC Company

Training of staff ABC Company

Implementation ofprocedure

ABC Company

Management review ABC Company

Internal audit ABC Company

Training of leadauditors

ABC Company

Pre-inspectionby certification body

ABC Company

Final inspectionby certification body

ABC Company



200.20.1




YOUR COMPANY NAME HERE

QUALITY ASSURANCE DEPARTMENTQUALITY SYSTEMS MANUAL

MODEL - 1

PREPARED AND MAINTAINED IN ACCORDANCE WITHISO 9001:2000

Written by: Checked by: Approved by:

Date Supersedes

mm/dd/yyyy

Date Issued

mm/dd/yyyy

Manual Serial No.

QM-1

Revision No: 0

DISTRIBUTED TO CONTROLLED COPY NO.

1) Managing Director Copy-1

2) Quality Assurance Copy-2

3) Marketing Copy-3

4) ISO Management Representative Master

5)6)

Reasons for Revision:

mm/dd/yy 1) First time issued for (your company name).




TABLE OF CONTENTS

QUALITY SYSTEMS MANUAL REFERS TO ISO 9001:2000

Contents Clauses

Quality Management Systems Requirement (title only) . . . . . . . . . . . . . .Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.0

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.2Normative Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.0Quality Management System (title only) . . . . . . . . . . . . . . . . . . . . . . .4.0General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1Documentation Requirements (title only) . . . . . . . . . . . . . . . . . . . . . .4.2General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2.1Quality Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2.2

Control of Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2.3Control of Quality Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2.4Management Responsibility (title only) . . . . . . . . . . . . . . . . . . . . . . . .5.0Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1Customer Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.2Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.3Planning (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.4Quality Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4.1Quality Management System Planning . . . . . . . . . . . . . . . . . . . . . . 5.4.2Responsibility, Authority, and Communication (title only) . . . . . . . . . .5.5Responsibility and Authority. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.1Management Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.2Internal Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.3Management Review (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.6General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.1Review Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.2Review Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.3

Resource Management (title only). . . . . . . . . . . . . . . . . . . . . . . . . . . .6.0Provision of Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.1Human Resources (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.2General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.2.1Competence, Awareness, and Training . . . . . . . . . . . . . . . . . . . . . . 6.2.2




Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.3 Work Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6.4

Product Realization (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.0Planning of Product Realization . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.1Customer-Related Processes (title only). . . . . . . . . . . . . . . . . . . . . . . .7.2Determination of Requirements Related to the Product. . . . . . . . . . 7.2.1Review of Requirements Related to the Product . . . . . . . . . . . . . . . 7.2.2Customer Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2.3Design and Development (title only) . . . . . . . . . . . . . . . . . . . . . . . . .7.3Design and Development Planning . . . . . . . . . . . . . . . . . . . . . . . . 7.3.1Design and Development Inputs . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3.2

Design and Development Outputs . . . . . . . . . . . . . . . . . . . . . . . . . 7.3.3Design and Development Review. . . . . . . . . . . . . . . . . . . . . . . . . . 7.3.4Design and Development Verification. . . . . . . . . . . . . . . . . . . . . . . 7.3.5Design and Development Validation. . . . . . . . . . . . . . . . . . . . . . . . 7.3.6Control of Design and Development Changes . . . . . . . . . . . . . . . . 7.3.7Purchasing (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7.4Purchasing Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.4.1Purchasing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.4.2

Verification of Purchased Product. . . . . . . . . . . . . . . . . . . . . . . . . . 7.4.3

Production and Service Provision (title only) . . . . . . . . . . . . . . . . . . .7.5Control of Production and Service Provision . . . . . . . . . . . . . . . . . 7.5.1

Validation of Processes for Production and Service Provision . . . . . 7.5.2Identification and Tracebility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.5.3Customer Property . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.5.4Preservation of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.5.5Control of Monitoring and Measuring Devices . . . . . . . . . . . . . . . . . .7.6Measurement, Analysis, and Improvement (title only) . . . . . . . . . . . . .8.0General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.1Monitoring and Measurement (title only) . . . . . . . . . . . . . . . . . . . . . .8.2Customer Satisfaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.2.1Internal Audit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.2.2Monitoring and Measurement of Processes . . . . . . . . . . . . . . . . . . . 8.2.3Monitoring and Measurement of Product . . . . . . . . . . . . . . . . . . . . 8.2.4Control of Nonconforming Product . . . . . . . . . . . . . . . . . . . . . . . . . .8.3

Analysis of Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.4Improvement (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8.5Continual Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.5.1Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.5.2Preventive Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.5.3

Appendix I (Reference SOPs)





SCOPE

The quality system manual is applicable to (company name) products,activities, and services and includes design manufacture and final productinspection and testing.

GENERAL

The ISO 9001:2000 international standard adopted by (company name)specifies requirements for a quality management system to demonstratethe ability to consistently provide products that meet customer satisfactionand applicable regulatory requirements. The objective is to enhance cus-tomer satisfaction through the effective application of the system, includingprocesses for continual improvement of the system. In this quality systemmanual, the term “product” applies only to the product intended for, orrequired by, a customer. It should be noted that no exclusion is permitted

in the adopted model.

QUALITY SYSTEMS MANUALSCOPE Clause — 1.0ISO 9001:1994

Revision 0

Correspondence clause ofISO 9001:2000

1.0 + 1.1


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1





APPLICATION

The requirements of ISO 9001:2000 international standards are genericand are applicable to all the departments of (company name), their size,nature of their operation, and the product or product part manufactured.

Where any requirement (s) of this international standard cannot beapplied due to the operations of (company name), its products are excluded.

Claims of conformity to this international standard where exclusions

are made are not acceptable unless these exclusions are limited to require-ments within clause 7, and such exclusions do not affect the organization’sability or responsibility to provide products that fulfill our customers’ andapplicable regulatory requirements.

QUALITY SYSTEMS MANUALAPPLICATION Clause — 1.0ISO 9001:1994

Revision 0


1.2


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1





NORMATIVE REFERENCE

The quality system manual contains provisions of the international stan-dard ISO 9001:2000 and ISO 9001 (1994).

QUALITY SYSTEMS MANUALNORMATIVE REFERENCE Clause — 2.0ISO 9001:1994

Revision 0


2.0


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1





TERMS AND DEFINITIONS

The following terms, used in this edition of ISO 9001 to describe thesupply chain, have been changed in the quality system manual andapplicable standard operating procedure to reflect the vocabulary cur-rently used.

The term “organization” is replaced by the term “supplier” used inISO 9001:1994 and refers to the unit to which this international standard

applies. Also, the term “supplier” is replaced by the term “subcontractor.”Throughout the text of this quality system manual and applicable

procedure, the term “product” also means “service.”For the purposes of this international standard ISO 9001:2000, the terms

and definitions given in ISO 9000 are applicable.

QUALITY SYSTEMS MANUALTERMS AND DEFINITIONS Clause — 3.0ISO 9001:1994

Revision 0


3.0


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 8





Analysis Certificate

The analysis certificate is the document that gives the results of theinspection made on a representative sample taken from a product beforeits delivery. It must contain the results of all checks in a list approvedjointly by the client and the supplier.

Auditor A person who is qualified and authorized to perform all or any portionof a quality system audit is an auditor.

Audit

An audit is a systematic and independent examination to determine whether quality activities and related results comply with planned arrange-ments, and whether these arrangements are implemented effectively andare suitable to achieve objectives.

Audit Organization

An audit organization is an organization that regularly conducts quality assurance management system audits to a required standard.

Batch

A batch represents assignments of a batch of finished products to a clientas a function of that client’s requirements.


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Conformity

Conformity means the state of a product satisfying specified requirements.

Documentation

Documentation refers to any recorded or pictorial information describing,defining, specifying, reporting, or certifying activities, requirements, pro-

cedures, or results.

Documentation Level

The documentation level refers to the position of a quality document inthe quality assurance documentation system.

First Party Audits

Audits carried out internally by an organization are called first party audits.

Inspection

An inspection is an examination or measurement to verify whether anitem or activity conforms to a specified requirement.

Inspectors

Inspectors are appointed by the purchaser to provide advice on mattersrelating to products and inspection and to verify the achievement of thequality specified.


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Lead Auditor

An Auditor who is qualified and authorized to manage a quality systemaudit is called a lead auditor.

Management Review

Management review is a compulsory evaluation carried out by general

management on the state and suitability of the quality system with respectto quality policy and new objectives resulting from the changed situation.

Nonconformity

Nonconformity refers to the state of a product not satisfying specifiedrequirements.

Organization An organization is a unit to which this international standard applies.

Provisional Auditor

A provisional auditor is a person who meets all requirements for regis-tration except for audit experience.

QualityQuality means all properties and characteristics of a service that make itcapable of satisfying a client’s expressed or specified needs.


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Quality Audit

A quality audit is a methodical and independent examination in order todetermine if quality-related activities and results satisfy predeterminedrequirements, and if these requirements are implemented ef ficiently andare capable of achieving the objectives.

Quality AssuranceQuality assurance refers to all predetermined and systematic actions nec-essary to give appropriate confidence that a product or a service satisfiesgiven quality requirements.

Quality Control

Quality control is that part of good manufacturing practice concerned withsampling, specifications, and testing. Its organization, documentation, andrelease procedures ensure that the necessary and relevant tests are actually carried out, that materials are not released for use and products releasedfor sale or supply, until their quality has been judged to be satisfactory.

Quality Manual

The quality manual is a document describing general measures taken by the company to obtain quality in its products or services.


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Quality Planning

A document specifying the processes of the quality management system(including the product realization processes) and the resources to beapplied to a specific product, project, or contract can be referred to asquality plan.

Quality Policy A quality policy includes the overall quality intentions and direction of an organization as formally expressed by top management.

Quality (or Quality-Related) Record

The quality record refers to the filled-in documents proving that the quality assurance and quality control actions have been done.

Quality System

The organizational structure, responsibilities, procedures, processes, andresources for implementing quality management comprise the quality system.

Quality Surveillance

Quality surveillance refers to the continued monitoring and verification of the status of procedures, methods, conditions, processes, products andservices, and analysis of records in relation to stated references to ensurethat specified requirements for quality are being met.


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Representative Sample

A representative sample is a sample taken using a clearly defined proce-dure in order to obtain information about a batch.

Second Party Audits

Second party audits are audits of suppliers or potential suppliers under-

taken directly by a purchasing organization including the purchase of products by one company from another within the same group.

Specification

The specification is the document that specifies the requirements with which the product and/or material must comply.

SupplierThe organization or company is also called the supplier.

Subcontractor

Any organization offering goods or services to the supplier is known asa subcontractor.

Third Party Audits Audits of organizations undertaken by an independent certification body or similar organization are called third party audits.


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Traceability

Traceability is the capability of finding the history, use, or location of anarticle by means of a recorded identification.

Validation

Validation is the act of checking a calculation or design through its stages

to verify that the assumptions made, input data, and method used haveproduced a valid result.

Verification

The act of reviewing, inspecting, testing, checking, auditing, or otherwise verifying and documenting whether items, processes, services or docu-ments conform to specified requirements is known as verification.

This list is not conclusive as there are many other terms in general useor contained in various standards and quality documents.


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QUALITY MANAGEMENT SYSTEM

The quality management system is based on international standardISO 9001:2000, which can be effectively applied to (company name)products, activities, and processes.

QUALITY SYSTEMS MANUALQUALITY MANAGEMENT SYSTEM Clause — 4.2.1ISO 9001:1994

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GENERAL REQUIREMENTS

(Company name) has established, documented, implemented, and main-tained a quality management system and continually improved its effec-tiveness in accordance with the requirements of this international standard.

The organization has identified the process needed for the quality management system and its application throughout the organization, andhas determined the sequence and interaction of these processes as well

as criteria and methods needed to ensure that both the operation andcontrol of these processes are effective. The top management has ensuredthe availability of resources and information necessary to support theoperation and the monitoring of these processes, and has implementedthe actions necessary to achieve the desired results and continual improve-ment of these processes.

These processes, including management activities, provision of resources, product realization, and measurement, are managed by theorganization in accordance with the requirements of this internationalstandard.

Where an organization chooses to outsource any process that affectsproduct conformity with requirements, the organization ensures controlover such process. Control of such outsource processes is identified withinthe quality management system.

QUALITY SYSTEMS MANUALGENERAL REQUIREMENTS Clause — 4.2.1ISO 9001:1994

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DOCUMENTATION REQUIREMENTS

The documentation requirements are fulfilled in accordance with interna-tional standard ISO 9001:2000. The documentation includes informationdescribing, defining, specifying, reporting, or certifying activities, require-ments, procedures, or results.

QUALITY SYSTEMS MANUALDOCUMENTATIONREQUIREMENTS

Clause — 4.2.1 + 4.5.1ISO 9001:1994

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GENERAL

The documented quality management system is comprised of the followingkey documents, but is not limited to these components:

Quality policy and quality objectives Quality system manual Procedures required by this international standard Documents needed by the organization to ensure the effective

planning, operation, and control of its processes Quality records required by this international standard (see 4.2.4) Documentation maintained in both hardware and software form

as appropriate

QUALITY SYSTEMS MANUALGENERAL Clause — 4.2.1 + 4.5.1ISO 9001:1994

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QUALITY MANUAL

(Company name) has established and maintained a quality system manualto describe the scope of its quality management system, including detailsof and justification for any exclusions (see 1.2). The documented proce-dures established for the quality management system, or reference tothem, and a description of the interaction between the processes of thequality management system are included.

The need to achieve quality in activities, services, and products hasbeen recognized to ensure that the organization meets well-defined objec-tives, satisfies its users/customers expectations and contractual require-ments, complies with applicable standards and specifications, and provides

value for money.

QUALITY SYSTEMS MANUALQUALITY MANUAL Clause — 4.2.1ISO 9001:1994

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CONTROL OF DOCUMENTS

Procedures and documents required by the quality management system

are controlled. Quality records are a special type of document and are

controlled according to the requirements given in 4.2.4

The applicable documented procedure is established to define thecontrols needed, to approve documents for adequacy prior to issue, to

review and update as necessary and reapprove documents, and to ensurethat changes and the current revision status of documents are identified.

It is ensured that relevant versions of applicable documents are available

at points of use as appropriate, and remain legible and readily identifiable.

The documents of external origin are identified, and their distribution iscontrolled to prevent the unintended use of obsolete documents and to

apply suitable identification to them if they are withheld for any purpose.

QUALITY SYSTEMS MANUALCONTROL OF DOCUMENTS Clause — 4.5.1 + 4.5.2

+ 4.5.3ISO 9001:1994

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CONTROL OF QUALITY RECORDS

Quality records are identified, established, and maintained to provideevidence of conformity to requirements and of the effective operation of the quality management system. Quality records are legible, readily iden-tifiable, and retrievable for quality records. A procedure is established todefine the controls needed for the identification, storage, protection,retrieval, retention time, and disposition.

QUALITY SYSTEMS MANUALCONTROL OF QUALTY RECORDS Clause — 4.1.8

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MANAGEMENT RESPONSIBILITY

Management responsibilities are defined in correspondence with interna-tional standard ISO 9001:2000 to assist the management team in achievingits quality aims, promote a reputation in the marketplace through customersatisfaction, motivate staff toward pride in carrying out a job, and identify control training needs, improve communication, and produce historical

records to confirm the level of quality system effectiveness and activ-ity/service/product achievement. Management responsibilities are definedin the following quality matrix Table 1. Individual companies can tailorthis table according to their specific setup.

QUALITY SYSTEMS MANUALMANAGEMENT RESPONSIBILITY Clause — 4.1 + 4.1.2.2

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The quality planning matrix is described in Table 1.


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Table 1

Element in theQuality System

CorrespondingClause

ISO 9001:2000Function Concerned in the

Entity

ISO-9001:1994CLAUSE A D

M

Q U

A

P R D

Q C

D

S H

P

M A

I

P E R

P D

L

P U

R

P A C

M K

T

M P

M

4.1 Managementresponsibilities

5.1 + 5.3 + 5.4.1 +5.5.1

+ 6.1 + 6.2.1 + 6.35.5.25.6.1 + 5.6.2 +

5.6.3 + 8.5.1

X * * * * * * * * * * *

4.2 Quality system 4.1 + 4.2.1 + 4.2.2+ 5.1 + 5.4.1

5.4.2 + 6.2.1 + 7.1

* X * * * * * * * * * *

4.3 Contract review 5.2 + 7.2.1 + 7.2.2+ 7.2.3

* * * * * – – – – * X *

4.4 Design control 7.3.17.2.1 + 7.3.27.3.37.3.47.3.57.3.6

7.3.7

* * – * – – – X * – * –

4.5 Document anddata control

4.2.1 + 4.2.3 * * * * * * * X * * * *




4.6 Purchasing 7.4.17.4.27.4.3

* * – * * – – * X – – *

4.7 Control ofcustomer-suppliedproduct

7.5.4 – X – * – – – – – – – –

4.8 Productidentificationand traceability

7.5.3 * * X * * – – * * * * *

4.9 Process control 6.3 + 6.4 + 7.1 +7.5.1 + 7.5.2 +8.2.3

– * X * – – – * – * – –

4.10 Inspection andtesting

7.1 + 8.17.4.3 + 8.2.47.5.17.5.3

– X * * – – – – – * – –

4.11 Inspection,measurement,

and testequipment

7.6 – * * * – X – * – * – –

4.12 Inspection andtest status

7.5.3 – X * * – – – * – * – –

Table 1 (Continued)


CorrespondingClause


Entity

ISO-9001:1994CLAUSE A

D M

Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M



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4.13 Control ofnonconformingproduct

8.3 * * * X * * – * * * * *

4.14 Correctiveactions

8.5.2 + 8.5.38.4

* X * * * * * * * * * *

4.15 Handling, storage,packaging,preservation,and delivery

7.5.5 + 7.5.1

– * * * * – – – – * – X

4.16 Quality records 4.2.4 * * * X * * * * * * * * 4.17 Internal qualityaudits

8.2.2 + 8.2.3 * X * * * * – * * * * *

4.18 Training 6.2.1 + 6.2.2 * X * * * * X * * * * *

4.19 Servicing 7.1 + 7.5.1 * * * * * – – * * * X *

4.20 Statisticaltechniques

8.1 + 8.2.3 + 8.2.4+ 8.4

* X * * – – – – – * – –

X RESPONSIBLE FUNCTIONS, * FUNCTIONS CONCERNED, – NOT APPLICABLE

Key:ADM = Administration (Management) QUA = Quality AssurancePRD = Production QCD = Quality Control DepartmentSHP = Shipping PER = PersonnelPDL = Product Development Lab PUR = PurchasePAC = Packaging MKT = MarketingMPM = Materials Planning Manager MAI = Maintenance

Table 1 (Continued)


CorrespondingClause


Entity

ISO-9001:1994CLAUSE A

D M

Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M



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MANAGEMENT COMMITMENT

(Company name) has provided objective evidence of its commitment todeveloping and implementing the quality management system, continually improving its effectiveness through communicating to the organization theimportance of meeting customer as well as statutory and regulatory requirements, and establishing the quality policy and ensuring that quality

objectives are established. Adequate resources are provided and manage-ment reviews are conducted at specified frequencies.

QUALITY SYSTEMS MANUALMANAGEMENT COMMITMENT Clause — 4.1 + 4.1.2.2

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CUSTOMER FOCUS

The organization has ensured that customer requirements are identifiedand has met the acceptance criteria to achieve customer satisfaction (see7.2.1 and 8.2.1)

The documented quality system is maintained to ensure that theproduct conforms to the specified requirements and meets the expectationsand needs of the user, and that the product is continuously maintained

to the prescribed standard, specification, contract, and order agreement.

QUALITY SYSTEMS MANUALCUSTOMER FOCUS Clause — 4.3.2



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QUALITY POLICY

(Company name) has established the quality policy, which is appropriateto the purpose of the organization with a commitment to comply withrequirements and continually improve the effectiveness of the quality management system. The quality policy provides a management commit-ment for establishing and reviewing quality objectives. The policy iscommunicated and understood within the organization and is reviewed

on a periodic basis for its suitability.

(COMPANY NAME) POLICY

The organization will comply with the provisions of the current goodmanufacturing practice (CGMP) for the finished pharmaceutical asdescribed in Code 210 of the Federal Regulation — Current GoodManufacturing Practice in Manufacturing, Processing, Packaging, or Hold-

ing of Drugs. Signature and Date (Top Management)

ORGANIZATION CHART HERE

Describe a brief history of the company Key positions summary Location and number of employees Brief responsibility of key personnel Products, services, and activities offered Organization chart

QUALITY SYSTEMS MANUALQUALITY POLICY Clause — 4.1.1



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PLANNING

(Company name) has ensured customer satisfaction while meeting regu-latory requirements through effective planning at all levels.

QUALITY SYSTEMS MANUALPLANNING Clause — 4.1.1 + 4.2.1



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QUALITY OBJECTIVES

Our organization has established the quality objectives, including thoseneeded to meet requirements for the product (see 7.1 a), relevant func-tions, and levels within the company. The quality objectives are quanti-fiable and consistent with the quality policy.

QUALITY SYSTEMS MANUALQUALITY OBJECTIVES Clause — 4.1.1 + 4.2.1



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QUALITY MANAGEMENT SYSTEM PLANNING

Our organization has ensured that planning of the quality managementsystem is carried out to meet the requirements given in 4.1, as well asthe quality objectives, and the integrity of the quality management systemis maintained when changes to the quality management system areplanned and implemented.

QUALITY SYSTEMS MANUALQUALITY MANAGEMENT SYSTEMPLANNING

Clause — 4.2.3ISO 9001:1994

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RESPONSIBILITY, AUTHORITY, AND COMMUNICATION

Communication is conducted through identification of job responsibilities,training, and awareness.

QUALITY SYSTEMS MANUALRESPONSIBILITY, AUTHORITY,AND COMMUNICATION

Clause — 4.1.2.1ISO 9001:1994

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RESPONSIBILITY AND AUTHORITY

Top management has ensured that the responsibilities and authorities aredefined and communicated within the organization. The interrelations andoverlapping responsibilities are also communicated.

QUALITY SYSTEMS MANUALRESPONSIBILITY ANDAUTHORITY

Clause — 4.1.2.1ISO 9001:1994

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MANAGEMENT REPRESENTATIVE

(Company name) has exclusively appointed a management representative who, irrespective of other responsibilities, has the responsibility andauthority that includes:

Identifying processes and implementing and maintaining the quality management system needed for quality management

Evaluating and reporting the performance of the quality manage-ment system and the needs for improvement

Creating the promotion of awareness of customer requirementsthroughout the organization

QUALITY SYSTEMS MANUALMANAGEMENT REPRESENTATIVE Clause — 4.1.2.3



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INTERNAL COMMUNICATION

Appropriate communication procedures are established within the orga-nization and are communicated regarding the effectiveness of the quality management system.

QUALITY SYSTEMS MANUALINTERNAL COMMUNICATION Clause — 4.1.2.3



5.5.3


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MANAGEMENT REVIEW

Management review provides an effective tool for company managementto review the effectiveness of the existing quality system.

QUALITY SYSTEMS MANUALMANAGEMENT REVIEW Clause — 4.1.3



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GENERAL

Our top management reviews the organization’s quality managementsystem every quarter-year to ensure its continuing suitability, adequacy,and effectiveness. This review includes assessing opportunities forimprovement and the need for changes to the quality management system,including the quality policy and quality objectives. Records of the man-agement reviews are maintained (see 4.2.4).

QUALITY SYSTEMS MANUALGENERAL Clause — 4.1.3



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REVIEW INPUT

The input for the management review includes exorbitant informationincluding, but not limited to:

Recommendations for improvement

Planned changes that could affect the quality management system

Status of preventive and corrective action

Follow-up actions from previous management reviews Process performance and product conformity Customer feedback

Results of audits

QUALITY SYSTEMS MANUALREVIEW INPUT Clause — 4.1.3



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REVIEW OUTPUT

The output from the management reviews include decisions and actionsrelated to improvement of the effectiveness of the quality managementsystem and its processes, improvement of the product related to customerrequirements, and resource needs.

QUALITY SYSTEMS MANUALREVIEW OUTPUT Clause — 4.1.3



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RESOURCE MANAGEMENT

Adequate resources are managed to achieve the management objectives,customer satisfaction, and product compliance.

QUALITY SYSTEMS MANUALRESOURCE MANAGEMENT Clause — 4.1.1.2



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PROVISION OF RESOURCES

Our organization has determined and provided the necessary resourcesneeded to implement and maintain the quality management system andcontinually improve its effectiveness, and to enhance customer satisfactionby meeting customer requirements.

QUALITY SYSTEMS MANUALPROVISION OF RESOURCES Clause — 4.1.1.2



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HUMAN RESOURCES

The organization of planned human resources plays an important role inthe effectiveness of the quality system. The records of human resourcedevelopment are documented and maintained.

QUALITY SYSTEMS MANUALHUMAN RESOURCES Clause — 4.1.1.2 +

4.2.3 + 4.16ISO 9001:1994

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GENERAL

Employees performing work affecting product quality are competent onthe basis of appropriate education, training, skills, and background expe-rience.

QUALITY SYSTEMS MANUALGENERAL Clause — 4.1.1.2 +

4.2.3 + 4.16ISO 9001:1994

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COMPETENCE, AWARENESS, AND TRAINING

(Company name) has determined the necessary competence for personnelperforming work affecting product quality, has provided training, or hastaken other action to satisfy these needs. Effectiveness of the actions takenis evaluated, and it is ensured that the employees are aware of therelevance and importance of their activities and how they contribute tothe achievement of the quality objectives. Records of education, training,

skills, and experience are appropriately maintained (see 4.2.4).

QUALITY SYSTEMS MANUALCOMPETENCE, AWARENESS,AND TRAINING

Clause — 4.16ISO 9001:1994

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INFRASTRUCTURE

(Company name) has determined, established, and maintained the infra-structure needed to achieve conformity to product requirements. Infra-structure includes, but is not limited to, buildings, workspace, andassociated utilities. Process equipment, both hardware and software, andsupporting services such as transport or communication are reviewed andestablished on a continuous basis.

QUALITY SYSTEMS MANUALINFRASTRUCTURE Clause — 4.1.2.2 + 4.9



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WORK ENVIRONMENT

Top management has determined and managed the work environmentnecessary to achieve conformity to product requirements such as temper-ature, humidity, etc.

QUALITY SYSTEMS MANUALWORK ENVIRONMENT Clause — 4.9



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PRODUCT REALIZATION

Product realization is achieved through effective planning to achieveproduct requirements and quality objectives.

QUALITY SYSTEMS MANUALPRODUCT REALIZATION Clause — 4.2.3 + 4.9 +

4.10.1ISO 9001:1994

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PLANNING OF PRODUCT REALIZATION

Top management plans and develops the processes needed for productrealization. Planning of product realization is consistent with the require-ments of the other processes of the quality management system (see 4.1).In planning product realization, the following elements are determinedappropriate:

Quality objectives and product requirements Processes establishment, documents, and provision of resources

specific to the product Verification, validation, monitoring, inspection, and test activities

specific to the product to fulfill requirements (see 4.2.4) Records needed to provide evidence that the realization processes

and resulting product fulfill requirements (see 4.2.4)

The output of this planning is kept both in hardware and software form.

QUALITY SYSTEMS MANUALPLANNING OF PRODUCTREALIZATION

Clause — 4.2.3 + 4.9 + 4.10.1

ISO 9001:1994

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CUSTOMER-RELATED PROCESSES

The organization ensures the understanding of current and future customerneeds and expectations through leadership, the involvement of people,continual improvement, and a mutually beneficial relationship with thesupplier.

QUALITY SYSTEMS MANUALCUSTOMER-RELATED PROCESSES Clause — 4.3.2 + 4.4.4



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DETERMINATION OF REQUIREMENTS RELATEDTO THE PRODUCT

(Company name) has determined:

Customer-specified requirements, including delivery and postdeliv-ery activities

Requirements necessary for specified use or known and intendeduse but not stated by the customer

Regulatory and statutory requirements related to the product Additional requirements determined by the organization, if any

QUALITY SYSTEMS MANUALDETERMINATION OFREQUIREMENTS RELATED TO

THE PRODUCT

Clause — 4.3.2 + 4.4.4ISO 9001:1994

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REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

The organization reviews the requirements related to the product prior tothe organization’s commitment to supply a product to the customer (e.g.,submission of tenders, acceptance of contracts of orders, acceptance of changes to contracts or orders) to ensure that:

Product requirements are defined Contract or order requirements differing from those previously

expressed are resolved The organization has the ability to meet the defined requirements

Records of the results of the review and actions arising from the review are maintained (see 4.2.4).

The customer requirements are confirmed by the organization beforeacceptance when the customer provides no documented statement of requirement.

If product requirements are changed, the organization ensures thatrelevant documents are amended and that relevant personnel are madeaware of the changed requirements.

QUALITY SYSTEMS MANUALREVIEW OF REQUIREMENTSRELATED TO THE PRODUCT

Clause — 4.3.2 + 4.3.3+ 4.3.4

ISO 9001:1994

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CUSTOMER COMMUNICATION

(Company name) has established and implemented effective arrangementsfor communicating with customers in relation to:

Product information Inquiries, contracts, or order handling, including amendments Customer feedback, including customer complaints

QUALITY SYSTEMS MANUALCUSTOMER COMMUNICATION Clause — 4.3.2



7.2.3


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DESIGN AND DEVELOPMENT

Design and development are carried out through effective quality planning.Both products and services are considered, with particular reference tocustomer focus.

QUALITY SYSTEMS MANUALDESIGN AND DEVELOPMENT Clause — 4.4.2 + 4.4.3

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Page 1 of 1






DESIGN AND DEVELOPMENT PLANNING

The design and development of the product is controlled, and the designand development stages are defined. The review, verification, and valida-tion that are appropriate to each design and development stage, and theresponsibilities and authorities for design and development are clearly defined and assigned.

The interfaces between different groups involved in design and devel-opment are managed to ensure effective communication and clear assign-ment of responsibility.

Planning output is updated, as appropriate, as the design and devel-opment progress.

QUALITY SYSTEMS MANUALDESIGN AND DEVELOPMENTPLANNING

Clause — 4.4.2 + 4.4.3+ 4.4.6 + 4.4.7 + 4.4.8

ISO 9001:1994

Revision 0


7.3.1


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






DESIGN AND DEVELOPMENT INPUTS

Inputs related to product requirements are determined and records aremaintained (see 4.2.4) and include, but are not limited to, the following:

Functional and performance requirements Applicable statutory and regulatory requirements Information derived from previous similar designs where applicable Other requirements essential for design and development

These inputs are reviewed for adequacy. Requirements are completed toensure they are unambiguous and not in conflict with each other.

QUALITY SYSTEMS MANUALDESIGN AND DEVELOPMENTINPUTS

Clause — 4.4.4ISO 9001:1994

Revision 0


7.3.2


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






DESIGN AND DEVELOPMENT OUTPUTS

The outputs of design and development are provided in a form thatenables verification against the design and development input and areapproved prior to release.

Design and development outputs:

Meet the input requirements for design and development Provide appropriate information for purchasing, production, and

service provision Contain or reference product acceptance criteria Specify the characteristics of the product that are essential for its

safe and proper use

QUALITY SYSTEMS MANUALDESIGN AND DEVELOPMENTOUTPUTS

Clause — 4.4.5ISO 9001:1994

Revision 0


7.3.3


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






DESIGN AND DEVELOPMENT REVIEW

Systematic reviews of design and development are conducted at suit-able stages.

The ability of the results of design and development to fulfill require-ments is evaluated to identify any problems and propose necessary actions.

The representatives of functions concerned with the design and devel-opment stages participate in a review. They record the results of the

review and any necessary actions that are to be taken (see 4.2.4).

QUALITY SYSTEMS MANUALDESIGN AND DEVELOPMENTREVIEW

Clause — 4.4.6ISO 9001:1994

Revision 0


7.3.4


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






DESIGN AND DEVELOPMENT VERIFICATION

Verification is performed to ensure that the design and developmentoutputs have satisfied the design and development input requirements.Records of the results of the verification and any necessary actions thatare to be taken (see 4.2.4).

QUALITY SYSTEMS MANUALDESIGN AND DEVELOPMENTVERIFICATION

Clause — 4.4.7ISO 9001:1994

Revision 0


7.3.5


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






DESIGN AND DEVELOPMENT VALIDATION

Design and development validation is performed in accordance withplanned arrangements (see 7.3.1) to ensure that the resulting product iscapable of fulfilling the requirements for the specified or known intendeduse or application. Wherever practicable, validation is completed prior tothe delivery or implementation of the product. Records of the results of

validation and any necessary actions are maintained (see 4.2.4).

QUALITY SYSTEMS MANUALDESIGN AND DEVELOPMENTVALIDATION

Clause — 4.4.8ISO 9001:1994

Revision 0


7.3.6


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






CONTROL OF DESIGN AND DEVELOPMENT CHANGES

Design and development changes are identified, and records are main-tained. The changes are reviewed, verified, and validated as appropriate

and are approved before implementation. The review of design and

development changes includes evaluation of the effect of the changes on

constituent parts and the delivered product.

Records of the results of the review of changes and any necessary

actions are maintained (see 4.2.4).

QUALITY SYSTEMS MANUALCONTROL OF DESIGN AND

DEVELOPMENT CHANGES

Clause — 4.4.9ISO 9001:1994

Revision 0


7.3.7


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






PURCHASING

Quality purchasing is achieved through procurement from approved ven-dor sources.

QUALITY SYSTEMS MANUALPURCHASING Clause — 4.6.2



7.4


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






PURCHASING PROCESS

The company ensures that the purchased product conforms to specifiedpurchase requirements. The type and extent of control applied to thesupplier and the purchased product is dependent upon the effect of thepurchased product on subsequent product realization or the final product.

QUALITY SYSTEMS MANUALPURCHASING PROCESS Clause — 4.6.2



7.4.1


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






PURCHASING INFORMATION

Purchasing information is established to describe the product to be pur-chased, including, where appropriate:

Requirements for the approval of the product, procedures, pro-cesses, and equipment

Requirements for the qualification of personnel and quality man-agement system requirements

The organization ensures the adequacy of specified purchase require-ments prior to their communication to the supplier.

QUALITY SYSTEMS MANUALPURCHASING INFORMATION Clause — 4.6.3



7.4.2


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






VERIFICATION OF PURCHASED PRODUCT

(Company name) has established and implemented the inspection or otheractivities necessary for ensuring that the purchased product meets specifiedpurchase requirements.

Where the organization or its customer intends to perform verificationat the supplier premises, the organization states the intended verification

arrangements and method of product release in the purchasing information.

QUALITY SYSTEMS MANUALVERIFICATION OF PURCHASED

PRODUCT

Clause — 4.6.4 + 4.10.2+ 4.10.3 + 4.10.4

ISO 9001:1994

Revision 0


7.4.3


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






PRODUCTION AND SERVICE PROVISION

(Company name) carried out production and service provisions undercontrolled conditions as adequate.

QUALITY SYSTEMS MANUALPRODUCTION AND SERVICE

PROVISION

Clause — 4.9 + 4.103 + 4.15.6 + 4.19

ISO 9001:1994

Revision 0


7.5


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1

Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy]Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy]Reference Procedure — [Number ISO-4.15, dated mm-dd-yyyy]Reference Procedure — [Number ISO-4.19, dated mm-dd-yyyy]





CONTROL OF PRODUCTION AND SERVICE PROVISION

The company has planned and carried out production and service provi-sions under controlled conditions as applicable, including, but not limitedto, the availability of information that describes the characteristics of theproduct, the availability of work instructions, the use of suitable equip-ment, the availability and use of monitoring and measuring devices, and

the implementation of monitoring and measurement, and the implemen-tation of release, delivery, and postdelivery activities.

QUALITY SYSTEMS MANUALCONTROL OF PRODUCTION

AND SERVICE PROVISION

Clause — 4.9 + 4.10.3+ 4.15.6 + 4.19

ISO 9001:1994

Revision 0


7.5.1


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1

Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy]Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy]Reference Procedure — [Number ISO-4.15, dated mm-dd-yyyy]Reference Procedure — [Number ISO-4.19, dated mm-dd-yyyy]





VALIDATION OF PROCESSES FOR PRODUCTIONAND SERVICE PROVISION

Any process for production and service provision, where the resultingoutput cannot be verified by subsequent monitoring or measurement,

must be validated. Specific consideration is given to the processes wheredeficiencies become apparent only after the product is in use or the servicehas been delivered

The planned results are achieved through validation and, where appli-cable, through:

Defined criteria for review and approval of the processes Approval of equipment and qualifications of personnel Use of specific methods and procedures

Records (see 4.2.4) maintenance Planning and conducting revalidation

QUALITY SYSTEMS MANUAL

VALIDATION OF PROCESSES FOR

PRODUCTION AND SERVICE

PROVISION

Clause — 4.9ISO 9001:1994

Revision 0


7.5.2


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






IDENTIFICATION AND TRACEABILITY

Where appropriate, (company name) identifies the product by suitablemeans throughout product realization.

The product status with respect to monitoring and measurementrequirements is identified.

The unique identification of the product (see 4.2.4) is controlled and

recorded by assigning a specific batch number to each product.

QUALITY SYSTEMS MANUALIDENTIFICATION AND

TRACEABILITY

Clause — 4.8 + 4.10.5+ 4.12

ISO 9001:1994

Revision 0


7.5.3


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






CUSTOMER PROPERTY

The company identifies, verifies, protects, and safeguards customer prop-erty provided for use or incorporation into the product, including intel-lectual property. If any customer property is lost, damaged, or otherwisefound to be unsuitable for use, that is reported to the customer and recordsare maintained (see 4.2.4).

QUALITY SYSTEMS MANUALCUSTOMER PROPERTY Clause — 4.7



7.5.4


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






PRESERVATION OF PRODUCT

The conformity of the product and its constituents is preserved duringinternal processing and delivery to the intended destination. This preser-

vation includes identification, handling, packaging, storage, and protection.

QUALITY SYSTEMS MANUALPRESERVATION OF PRODUCT Clause — 4.15.2 +

4.15.3 + 4.15.4 + 4.15.5+ 4.15.6

ISO 9001:1994

Revision 0


7.5.5


Date Supersedesmm/dd/yyyy

Date Issuemm/dd/yyyy

Page 1 of 1






CONTROL OF MONITORING AND MEASURING DEVICES

The company has established processes to ensure that monitoring andmeasurement necessary to be undertaken to provide evidence of productconformity to its requirements is carried out in a manner consistent withthe monitoring and measurement requirements (see 7.2.1).

As appropriate, measuring equipment is:

Calibrated or verified at specified intervals, or prior to use, againstmeasurement standards traceable to international or national mea-surement standards; where no such standards exist, the basis usedfor calibration or verification is recorded.

Adjusted or re-adjusted where necessary Identified to enable the calibration status to be determined Protected from adjustments that would invalidate the measure-

ment result Protected to avoid damage and deterioration during handling,

maintenance, and storage

In addition, when the equipment is found not to conform to require-ments, the organization takes appropriate action regarding the equipmentand any product affected. Records of the results of calibration and veri-fication are maintained (see 4.2.4). The organization assesses and recordsthe validity of the previous measuring results.

The ability of computer software to satisfy the intended application isconfirmed prior to initial use when used in the monitoring and measure-ment of specified requirements.Note: See ISO 10012-1 and ISO 10012-2 for guidance.

QUALITY SYSTEMS MANUALCONTROL OF MONITORING

AND MEASURING DEVICES

Clause — 4.11.1 + 4.11.2

ISO 9001:1994

Revision 0


7.6


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






MEASUREMENT, ANALYSIS, AND IMPROVEMENT

The organization has ensured continual improvement in the effectivenessof the quality management system through management review (measure-ment and analysis), internal and external audits, and corrective actions.

QUALITY SYSTEMS MANUALMEASUREMENT, ANALYSIS, AND

IMPROVEMENT

Clause — 4.10 + 4.17 + 4.20.1

ISO 9001:1994

Revision 0


8.0


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






GENERAL

The company has planned and implemented the monitoring, measure-ment, analysis, and improvement processes needed to demonstrated con-formity of the product and has ensured conformity of the quality management system, continuity of improvement, and the effectiveness of the quality management system.

This includes determination of applicable methods and statistical tech-niques used.

QUALITY SYSTEMS MANUALGENERAL Clause — 4.10 + 4.17 +

4.20.1ISO 9001:1994

Revision 0


8.1


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






MONITORING AND MEASUREMENT

The adequate monitoring and measurements are conducted to ensurecustomer satisfaction and product specification compliance.

QUALITY SYSTEMS MANUALMONITORING AND

MEASUREMENT

Clause — 4.9 + 4.17 + 4.20.1

ISO 9001:1994

Revision 0


8.2


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1

Reference Procedure — [Number-ISO-4.9, dated mm-dd-yyyy]Reference Procedure — [Number-ISO-4.10, dated mm-dd-yyyy]Reference Procedure — [Number-ISO-4.17, dated mm-dd-yyyy]Reference Procedure — [Number-ISO-4.20, dated mm-dd-yyyy]





CUSTOMER SATISFACTION

Suitable methods are used for obtaining information regarding customerperception as to whether the company has fulfilled customer require-ments through:

Internal audits Monitoring and measurement of processes Monitoring and measurement of products

QUALITY SYSTEMS MANUAL

CUSTOMER SATISFACTION Clause — 4.9 + 4.17 + 4.10

ISO 9001:1994

Revision 0


8.2.1


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1

Reference Procedure — [Number-ISO-4.9, dated mm-dd-yyyy]Reference Procedure — [Number-ISO-4.10, dated mm-dd-yyyy]Reference Procedure — [Number-ISO-4.17, dated mm-dd-yyyy]





INTERNAL AUDIT

(Company name) conducts internal audits at specified intervals to deter-mine whether the quality management system:

Is effectively implemented and maintained Conforms to the planned arrangements (see 7.1), the requirements

of the international standards, and the quality management systemrequirements established by the organization

Programmed audits are conducted to consider the status and impor-tance of the processes and areas to be audited and the results of previousaudits. The audit criteria, scope, frequency, and methods are defined. Theselection of auditors and conduct of audits ensures objectivity and impar-tiality of the audit process. Auditors do not audit their own work.

The responsibilities and requirements for planning and conducting

audits and for reporting results and maintaining records (see 4.2.4) aredefined in a documented procedure.The management staff responsible for the area being audited ensures

that actions are taken without undue delay to eliminate detected noncon-formities and their causes. Follow-up activities include the verification of actions taken and the reporting of verification results (see 8.5.2).Note: See ISO 10011-1, ISO 10011-2, and ISO 10011-3 for guidance.

QUALITY SYSTEMS MANUALINTERNAL AUDIT Clause — 4.17



8.2.2


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






MONITORING AND MEASUREMENT OF PROCESSES

Suitable methods for monitoring and, where applicable, measurement of the quality management system processes are applied to demonstrate theability of the processes to achieve planned results. When planned resultsare not achieved, corrective action is taken, as appropriate, to ensureconformity of the product.


MEASUREMENT OF PROCESSES

Clause — 4.9 + 4.17 + 4.20.1

ISO 9001:1994

Revision 0


8.2.3


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






MONITORING AND MEASUREMENT OF PRODUCT

The product requirements are fulfilled through monitoring and measuringthe characteristics of the product.

Evidence of conformity with the acceptance criteria are maintained.Records indicate the person (s) authorizing release of the product (see 4.2.4).

Product release and service delivery do not proceed until all the plannedarrangements (see 7.1) have been satisfactorily completed, unless otherwiseapproved by a relevant authority and, where applicable, approved by thecustomer.


MEASUREMENT OF PRODUCT

Clause — 4.1.2 + 4.10.3+ 4.10.4 + 4.10.5 + 4.2.1

ISO 9001:1994

Revision 0


8.2.4


Date Supersedesmm/dd/yyyy

Date Issuemm/dd/yyyy

Page 1 of 1






CONTROL OF NONCONFORMING PRODUCT

A product that does not conform to product requirements is identifiedand controlled to prevent its unintended use or delivery. The controls andrelated responsibilities and authorities for dealing with a nonconformingproduct are defined in a documented procedure.

Records of the nature of nonconformities and any subsequent actions

taken, including concessions obtained, are maintained (see 4.2.4). When the nonconforming product is corrected, it is subjected to

reverification to demonstrate conformity to the requirements. When a nonconforming product is detected after delivery or use of

the product has begun, the organization takes action appropriate to theeffects of the nonconformity.

QUALITY SYSTEMS MANUALCONTROL OF

NONCONFORMING PRODUCT

Clause — 4.13.1 + 4.13.2

ISO 9001:1994

Revision 0


8.3


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






ANALYSIS OF DATA

The data generated as a result of monitoring and measurement and fromother relevant sources are analyzed to demonstrate the suitability and effec-tiveness of the quality management system and for continual improvement.

The data is broadly based and includes, but is not limited to:

Customer satisfaction (see 8.2.1) Conformance to product requirements (see 7.2.1) Characteristics and trends of processes and products, including

opportunities for preventive action, and suppliers

QUALITY SYSTEMS MANUALANALYSIS OF DATA Clause — 4.14.2 +

4.14.3 + 4.20ISO 9001:1994

Revision 0


8.4


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






IMPROVEMENT

The organization’s top management ensures continuous improvementthrough creating personal ownership of the organization’s goals, by usingits people’s knowledge and experience, and through education achieved asa result of involvement in operational decisions and process improvement.

QUALITY SYSTEMS MANUALIMPROVEMENT Clause — 4.1.3



8.5


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






CONTINUAL IMPROVEMENT

The organization intends to continually improve the effectiveness of thequality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions,and management review.

QUALITY SYSTEMS MANUALCONTINUAL IMPROVEMENT Clause — 4.1.3



8.5.1


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






CORRECTIVE ACTION

Actions are taken to eliminate the cause of nonconformities in order toprevent recurrence. Suitable corrective actions are initiated to counter theeffects of the nonconformities.

QUALITY SYSTEMS MANUALCORRECTIVE ACTION Clause — 4.14.1 +

4.14.2ISO 9001:1994

Revision 0


8.5.2


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1






PREVENTIVE ACTION

A documented procedure is established to define requirements for:

Determining potential nonconformities and their causes Evaluating the need for action to prevent the occurrence of

nonconformities Determining and implementing actions needed Records of results of actions taken (see 4.2.4) and reviewing any

preventive action taken

QUALITY SYSTEMS MANUALPREVENTIVE ACTION Clause — 4.14.1 +

4.14.3ISO 9001:1994

Revision 0


8.5.3


Date Supersedes

mm/dd/yyyy

Date Issue

mm/dd/yyyy

Page 1 of 1





APPENDIX I:Reference SOPs

Subject ClausesRef. SOP

No.Revision

No. Issued On

Quality management systemsrequirement (title only)

Scope 1.0 ISO-4.1 New mm/dd/yy

General 1.1 ISO-4.1 New mm/dd/yy

Application 1.2 ISO-4.1 New mm/dd/yy

Normative reference 2.0 ISO-4.1 New mm/dd/yy

Terms and definitions 3.0 ISO-4.1 New mm/dd/yyQuality management system

(title only) 4.0 ISO-4.1 New mm/dd/yy

General requirements 4.1 ISO-4.2 New mm/dd/yy

Documentationrequirements (title only)

4.2 ISO-4.2ISO-4.5

NewNew

mm/dd/yymm/dd/yy

General 4.2.1 ISO-4.2ISO-4.5

NewNew

mm/dd/yymm/dd/yy

Quality manual 4.2.2 ISO-4.2 New mm/dd/yy

Control of documents 4.2.3 ISO-4.5 New mm/dd/yyControl of quality records 4.2.4 ISO-4.1 New mm/dd/yy

Management responsibility(title only)

5.0 ISO-4.1ISO-4.2

NewNew

mm/dd/yymm/dd/yy

Management commitment 5.1 ISO-4.1ISO-4.2

NewNew

mm/dd/yymm/dd/yy

Customer focus 5.2 ISO-4.3 New mm/dd/yy

Quality policy 5.3 ISO-4.1 New mm/dd/yy

Planning (title only) 5.4 ISO-4.1

ISO-4.2

New

New

mm/dd/yy

mm/dd/yyQuality objectives 5.4.1 ISO-4.1

ISO-4.2NewNew

mm/dd/yymm/dd/yy

Quality management systemplanning

5.4.2 ISO-4.2 New mm/dd/yy

Responsibility, authority, andcommunication (title only)

5.5 ISO-4.1 New mm/dd/yy

Responsibility and authority 5.5.1 ISO-4.1 New mm/dd/yy

Management representative 5.5.2 ISO-4.1 New mm/dd/yy

Internal communication 5.5.3 ISO-4.1 New mm/dd/yyManagement review

(title only)5.6 ISO-4.1 New mm/dd/yy

General 5.6.1 ISO-4.1 New mm/dd/yy

Review input 5.6.2 ISO-4.1 New mm/dd/yy




Review output 5.6.3 ISO-4.1 New mm/dd/yy

Resource management(title only)


Provision of resources 6.1 ISO-4.1 New mm/dd/yy

Human resources (title only) 6.2 ISO-4.1ISO-4.2

ISO-4.16

NewNew

New

mm/dd/yymm/dd/yy

mm/dd/yyGeneral 6.2.1 ISO-4.1

ISO-4.2NewNew

mm/dd/yymm/dd/yy

Competence, awareness, andtraining


Infrastructure 6.3 ISO-4.9 New mm/dd/yy

Work environment 6.4 ISO-4.9 New mm/dd/yy

Product realization(title only)

7.0 ISO-4.2ISO-4.9

ISO-4.10

NewNew

New

mm/dd/yymm/dd/yy

mm/dd/yyPlanning of product

realization7.1 ISO-4.2

ISO-4.9ISO-4.10

NewNewNew

mm/dd/yymm/dd/yymm/dd/yy

Customer-related processes(title only)

7.2 ISO-4.3ISO-4.4

NewNew

mm/dd/yymm/dd/yy

Determination ofrequirements related to theproduct


Review of requirementsrelated to the product


Customer communication 7.2.3 ISO-4.3 New mm/dd/yy

Design and development(title only)


Design and developmentplanning


Design and developmentinputs


Design and developmentoutputs


Design and developmentreview


Design and developmentverification


APPENDIX I:Reference SOPs (Continued)


No.Revision

No. Issued On




Design and developmentvalidation


Control of design anddevelopment changes


Purchasing (title only) 7.4 ISO-4.6 New mm/dd/yy

Purchasing process 7.4.1 ISO-4.6 New mm/dd/yy

Purchasing information 7.4.2 ISO-4.6 New mm/dd/yyVerification of purchased

product7.4.3 ISO-4.6

ISO-4.10NewNew

mm/dd/yymm/dd/yy

Production and serviceprovision (title only)

7.5 ISO-4.9ISO-4.10ISO-4.15ISO-4.19

NewNewNewNew

mm/dd/yymm/dd/yymm/dd/yymm/dd/yy

Control of production andservice provision

7.5.1 ISO-4.9ISO-4.10

ISO-4.15ISO-4.19

NewNew

NewNew

mm/dd/yymm/dd/yy

mm/dd/yymm/dd/yy

Validation of processes ofproduction and serviceprovision


Preservation of product 7.5.5 ISO-4.15 New mm/dd/yy

Control of monitoring andmeasuring devices


Identification and traceability 7.5.3 ISO-4.8ISO-4.10ISO-4.12

NewNewNew


Customer property 7.5.4 ISO-4.7 New mm/dd/yy

Measurement, analysis, andimprovement (title only)

8.0 ISO-4.10ISO-4.17ISO-4.20

NewNewNew


General 8.1 ISO-4.10ISO-4.17ISO-4.20

NewNewNew


Monitoring and

measurement (title only)

8.2 ISO-4.9

ISO-4.10ISO-4.17ISO-4.20

New

NewNewNew

mm/dd/yy


Customer satisfaction 8.2.1 ISO-4.9ISO-4.10

NewNew

mm/dd/yymm/dd/yy



No.Revision

No. Issued On




Internal audit 8.2.2 ISO-4.17 New mm/dd/yy

Monitoring andmeasurement of processes

8.2.3 ISO-4.9ISO-4.17ISO-4.20

NewNewNew


Monitoring andmeasurement of products

8.2.4 ISO-4.1ISO-4.2

ISO-4.10

NewNew

New

mm/dd/yymm/dd/yy

mm/dd/yyControl of nonconforming

product8.3 ISO-4.13 New mm/dd/yy

Analysis of data 8.4 ISO-4.14ISO-4.20

NewNew

mm/dd/yymm/dd/yy

Improvement (title only) 8.5 ISO-4.1 New mm/dd/yy

Continual improvement 8.5.1 ISO-4.1 New mm/dd/yy

Corrective action 8.5.2 ISO-4.14 New mm/dd/yy

Preventive action 8.5.3 ISO-4.14 New mm/dd/yy



No.Revision

No. Issued On



200.20.2






MODEL - 2

ISO 9001:2000

PREPARED AFTER INCORPORATION OF CHANGES INISO 9001 MANUAL


Date Supersedes

mm/dd/yyyy

Date Issued

mm/dd/yyyy

Manual Serial No.

QM-2

Revision No: 0




3) Marketing Copy-3 4) ISO Management Representative Master

5)

6)


mm/dd/yy 1) First time issued for (your company name)




TABLE OF CONTENTS

QUALITY SYSTEMS MANUAL REFERS TO ISO 9001:2000PREPARED AFTER INCORPORATION OF CHANGES

IN ISO 9001 QUALITY MANUAL

Contents Clauses

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.0Scope and Field of Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.0Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.0Quality Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.0Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.1Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2Responsibility and Authority. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.1Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.2Management Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.3Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.3Quality System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.2Contract Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.3Design Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.4Document and Data Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.5Purchasing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6Customer-Supplied Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.7

Product Identification and Traceability . . . . . . . . . . . . . . . . . . . . . . . . 4.8Process Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.9Inspection and Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.10Inspection, Measuring, and Test Equipment . . . . . . . . . . . . . . . . . . . 4.11Inspection and Test Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.12Control of Nonconforming Product . . . . . . . . . . . . . . . . . . . . . . . . . 4.13Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.14Handling, Storage, Packing, and Delivery . . . . . . . . . . . . . . . . . . . . . 4.15Quality Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.16

Internal Quality Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.17Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.18Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.19Statistical Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.20

Appendix II (Reference SOPs)





INTRODUCTION

It is in the interest of (company name) to ensure that a managementsystem describing its total operations is carefully thought out and imple-mented so that the likelihood of error is reduced. This can only be achievedby implementing a quality system specific to the company ’s requirementsor the standard, which has global recognition in general.

This manual provides references to the organizational structure,

responsibilities, procedures, work instructions, and resources that havebeen established to affect to the company policy and documentedquality objectives.

The requirements of this manual are aimed at the prevention of quality failures and the maintenance of a system that provides the most effectiveand ef ficient means of achieving the documented objectives.

The company has revised the existing ISO 9001 quality manual, andthe contents of this manual refer to international standard ISO 9001:2000.No exclusions of the quality system requirements are permitted.

QUALITY SYSTEMS MANUALINTRODUCTION Clause — 0.0,ISO 9001:1994

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SCOPE AND FIELD OF APPLICATION

Worldwide, there are a number of quality systems standards in operation.Their division into categories is based on the scope of their subject matter.

ISO (International Standardization Organization) is a Geneva-based, worldwide federation of national bodies that normally work together toprepare international standards through technical committees (TC). Eachmember body interested in a subject for which a TC has been established

has the right to be represented on that committee. International organi-zations, governmental and nongovernmental, in liaison with the ISO, alsoparticipate in the work. The U.S. representative to the ISO is the AmericanNational Standards Institute (ANSI)

The international standard ISO 9001:1994 was established by TechnicalCommittee ISO/TC 178, and is based on the British standard 5750:1987series, European standard EN 29000:1987 series, and international standardISO 9000:1987 series.

This third edition of ISO 9001 cancels and replaces the second edition(ISO 9001:1994) together with ISO 9002:1994 and ISO 9003:1994. It con-stitutes a technical revision of these documents. The quality manual QM-2 is revised in accordance with the corresponding changes specified inthe third edition of ISO 9001:2000.

The international standard ISO 9001:2000 specifies quality systemrequirements for use where a contract between the company and customersrequires demonstration of the capability to design and supply the productin compliance with the applicable regulatory requirements and customer

satisfaction. The contents of the adopted standard refer to design, manu-facture, and final product inspection and testing. No exclusions permitted.

QUALITY SYSTEMS MANUALSCOPE AND FIELD OFAPPLICATION

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REFERENCES

ANSI/ASQCA3, Quality Systems Terminology ISO 8402-1986, Quality Vocabulary ANSI/ASQCQ 90-1987, Quality Management and Quality Assurance

Standards Guidelines for Selection and Use ISO 9000-1987, Quality Management and Quality Assurance Stan-

dard - Guides for Selection and Use ISO 9001:1994, Quality System — Model for Quality Assurance in

Design, Development, Production, Installation, and Servicing ISO 9001:2000, Quality Management System Requirements. Design,

Manufacture, and Final Product Inspection and Testing.

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DEFINITIONS

For the purpose of standard ISO/FDIS 9001:2000E, the terms and defini-tions given in ISO 9000 apply.


The analysis certificate is a document that gives the results of the inspection

made on a representative sample taken from a product before its delivery.It must contain the results of all checks in a list approved jointly by theclient and the supplier.

Auditor

A person who is qualified and authorized to perform all or any portionof a quality system audit is called an auditor.

Audit


Audit Organization

An organization that regularly conducts quality assurance managementsystem audits to a required standard is known as an audit organization.

QUALITY SYSTEMS MANUALDEFINITIONS Clause — 3.0,ISO 9001:1994

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Batch

A batch refers to assignments of a batch of finished products to a clientas a function of that client’s requirements.

Conformity

Conformity refers to the state of a product satisfying specified require-

ments.

Documentation

Documentation means any recorded or pictorial information describing,defining, specifying, reporting, or certifying activities, requirements, pro-cedures, or results.

Documentation LevelThe position of a quality document in the quality assurance documentationsystem is its documentation level.

First Party Audits

Audits carried out internally by an organization are known as first party audits.

Inspection

Inspection refers to examination or measurement to verify whether anitem or activity conforms to a specified requirement.


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Inspectors

Inspectors are appointed by the purchaser to provide advice on mattersrelating to product and inspection and to verify the achievement of thequality specified.

Lead Auditor

An auditor who is qualified and authorized to manage a quality systemaudit is known as a lead auditor.

Management Review

The management review is a compulsory evaluation carried out by generalmanagement on the state and suitability of the quality system with respectto quality policy and new objectives resulting from the changed situation.

Nonconformity


Organization

An organization is a unit to which this international standard applies.

Provisional Auditor

A person who meets all requirements for registration except for auditexperience is known as a provisional auditor.


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Quality

Quality refers to all properties and characteristics of a service that makeit capable of satisfying a client’s expressed or specified needs.

Quality Audit

A quality audit is a methodical and independent examination in order to

determine if quality-related activities and results satisfy predeterminedrequirements, and if these requirements are implemented ef ficiently andare capable of achieving the objectives.

Quality Assurance

Quality assurance refers to all predetermined and systematic actions nec-essary to give appropriate confidence that a product or a service satisfiesgiven quality requirements.

Quality Control

Quality control is that part of good manufacturing practice which isconcerned with sampling, specifications, and testing. Organization, docu-mentation, and release procedures ensure that the necessary and relevanttests are actually carried out, and that materials are not released for use,and that products are not released for sale or supply, until their quality has been judged to be satisfactory.

Quality Manual

The quality manual is a document describing general measures taken by the company to ensure that quality of its products or services.


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Quality Planning


Quality PolicyThe overall quality intentions and direction of an organization formally expressed by top management is called the quality policy.


The quality record refers to the filled-in record documents proving thatthe quality assurance and quality control actions have been done.

Quality System

The quality system consists of the organizational structure, responsibil-ities, procedures, processes, and resources for implementing quality management.




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The representative sample is a sample taken using a clearly definedprocedure in order to obtain information about a batch.

Second Party Audits



Specification

Specification refers to a document that specifies the requirements with which the product and/or material must comply.

Third Party Audits Audits of organizations undertaken by an independent certification body or similar organization are known as third party audits.

Traceability

Traceability is the capability of finding the history, use, or location of anarticle by means of a recorded identification.

Validation

The act of checking a calculation or design through its stages to verify that the assumptions made, input data, and method used have produceda valid result is known as validation.


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Verification

Verification refers to the act of reviewing, inspecting, testing, checking,auditing, or otherwise verifying and documenting whether items, pro-cesses, services, or documents conform to specified requirements.


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The contents of the ISO 9001:1994 international standards are describedbelow in correspondence with ISO 9001:2001 to define quality systemrequirements and management responsibilities.

QUALITY SYSTEMS MANUALQUALITY MANAGEMENT SYSTEM Clause — 4.0,ISO 9001:1994

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Correspondence between ISO 9001:1994 and ISO 9001:2000

Clause ISO 9001:1994 ISO 9001:2000

1.0 Scope 1.0

2.0 Normative reference 2.03.0 Definitions 3.0



4.1.1 Quality policy 5.1 + 5.3 + 5.4.1



4.1.2.2 Resources 5.1 + 6.1 + 6.2.1 + 6.3 4.1.2.3 Management representative 5.5.2



4.2.1 General 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1


4.2.3 Quality planning 5.4.2 + 6.2.1 + 7.1

4.3 Contract review (title only)

4.3.1 General

4.3.2 Review 5.2 + 7.2.1 + 7.2.2 + 7.2.3 4.3.3 Amendment to a contract 7.2.2

4.3.4 Records 7.2.2

4.4 Design control (title only)

4.4.1 General




4.4.2 Design and development planning 7.3.1

4.4.3 Organizational and technicalinterfaces

7.3.1

4.4.4 Design input 7.2.1 + 7.3.2

4.4.5 Design output 7.3.3 4.4.6 Design review 7.3.1 + 7.3.4

4.4.7 Design verification 7.3.1 + 7.3.5

4.4.8 Design validation 7.3.1 + 7.3.6

4.4.9 Design changes 7.3.7


4.5.1 General 4.2.1 + 4.2.3

4.5.2 Document and data approval and

issue

4.2.3



4.6.1 General





7.5.4

4.8 Product identification andtraceability 7.5.3

4.9 Process control 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 +8.2.3


Correspondence between ISO 9001:1994 and ISO 9001:2000 (Continued)

Clause ISO 9001:1994 ISO 9001:2000


QUALITY SYSTEMS MANUALQUALITY MANAGEMENT SYSTEM Clause — 4.0,



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4.10.1 General 7.1 + 8.1

4.10.2 Receiving inspection and testing 7.4.3 + 8.2.4

4.10.3 In-process inspection and testing 7.4.3 + 7.5.1 + 8.2.4

4.10.4 Final inspection and testing 7.4.3 + 8.2.4

4.10.5 Inspection and test records 7.5.3 + 8.2.4 4.11 Control of inspection, measuring,

and test equipment (title only)

4.11.1 General 7.6


4.12 Inspection and test status 7.5.3

4.13 Control of nonconformingproduct (title only)

4.13.1 General 8.3

4.13.2 Review and dispositioning ofnonconforming product

8.3


4.14.1 General 8.5.2 + 8.5.3



4.15 Handling, storage, packaging,preservation, and delivery

(title only) 4.15.1 General

4.15.2 Handling 7.5.5

4.15.3 Storage 7.5.5



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4.15.6 Delivery 7.5.1 + 7.5.5


4.17 Internal quality audits 8.2.2 + 8.2.3

4.18 Training 6.2.1 + 6.2.2 4.19 Servicing 7.1 + 7.5.1



4.20.2 Procedures


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QUALITY POLICY

[Quality policy statement here][Should be by top management]

Top management has provided evidence of its commitment to the devel-opment and implementation of the quality management system and con-tinually improving its effectiveness by

1. Ensuring the availability of resources2. Conducting management reviews and ensuring that quality objec-

tives are established3. Establishing the quality policy 4. Communicating to the organization the importance of meeting

customer as well as statutory and regulatory requirements

Quality Policy

Our immediate and long-term success is dependent on the followingelements:

Compling with customer’s provided specifications Following standard operating procedures Meeting the registration requirements of the regulatory bodies

QUALITY SYSTEMS MANUALQUALITY POLICY Clause — 4.1.1,ISO 9001:1994

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The “quality ” path, to which we have all been firmly committed for many years, will lead us to maintain the ISO 9001: 2000 certification. Our quality objective is ambitious but realistic. It involves teamwork and is a challengethat we accept together. Our future depends on it.

It is ensured that the quality policy is appropriate to the purpose of the organization and includes a commitment to comply with requirementsand continually improve the effectiveness of the quality managementsystem. The policy provides a framework for establishing and reviewing

quality objectives, communicated and understood within the organization,and is reviewed for continuing suitability.

Quality Objectives

It is ensured that quality objectives, including those needed to meetrequirements for product compliance, are established at relevant functionsand levels within the organization. The quality objectives are measurableand consistent with the quality policy.

SignatureDesignation of the Head of the Company


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Describe the site organization chart of your company and the number of employees. Describe departments involved, field of activity, interrelation-ships, definitions, and terminologies used within the company.

The (company name) head of fice is located at (address), and iscurrently involved in the manufacturing of the following products/services.

Provide list of products. Provide list of services.

The company specializes in the production of (provide details).The plant organization is shown in the chart on the following page.The key functions of the departments are as follows.The common quality associated terms used in the company are describedbelow.

QUALITY SYSTEMS MANUALORGANIZATION Clause — 4.1.2,ISO 9001:1994

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ORGANIZATIONAL RESPONSIBILITY AND AUTHORITY

Every employee whose work may ultimately affect product quality andservice has the responsibility, authority, and organizational freedom to:

1. Identify and record product- or service-related problems2. Recommend, initiate, or provide solutions through systemic review

and approvals3. Initiate corrective action to prevent the occurrence of product

nonconformity 4. Verify the implementation of solutions5. Monitor and control further processing, delivery, or installation of

a nonconforming product or service until the deficiency or unsat-isfactory condition has been corrected

The management has ensured that the responsibilities, authorities, and

their interrelation are defined and communicated within the organization.


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RESOURCES

Personnel performing work affecting product quality are competent andare selected on the basis of appropriate education, training, skills, andexperience.

INFRASTRUCTURE

The organiztion has determined, provided, and maintained the infrastruc-ture needed to achieve conformity to product requirements. The basicinfrastructure includes buildings, workspace and associated utilities, pro-cess equipment, both hardware and software, and supporting servicessuch as transport or communication.


The top management of (company name) is committed to the developmentand implementation of the quality management system and continually improving its effectiveness by:

1. Ensuring the availability of resources2. Conducting management reviews3. Ensuring that quality objectives are established4. Establishing the quality policy 5. Communicating to the organization the importance of meeting

customer as well as statutory and regulatory requirements

QUALITY SYSTEMS MANUALRESOURCES Clause — 4.1.2.2,ISO 9001:1994

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PROVISION OF RESOURCES

The management has determined and provided the resources needed toimplement and maintain the quality management system, continually improve its effectiveness, and enhance customer satisfaction by meetingcustomer requirements.


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The [quality assurance manager] is appointed as the management repre-sentative and has the defined authority and responsibility, irrespective of other responsibilities, to ensure that the requirements of all pertinentstandards are implemented and maintained.

The management representative has the full responsibility for:

1. Ensuring that processes needed for the quality management systemare established, implemented, and maintained

2. Reporting to top management on the performance of the quality management system and any need for improvement

3. Ensuring the promotion of awareness of customer requirementsthroughout the organization

4. Forming a liaison with external parties on matters relating to thequality management system

QUALITY SYSTEMS MANUALMANAGEMENT REPRESENTATIVE Clause — 4.1.2.3,ISO 9001:1994

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MANAGEMENT REVIEW

The quality system is reviewed on a quarterly basis through managementreviews to ensure continuing suitability and effectiveness. The data andresults of the input and output reviews are recorded and maintained.

This review includes assessing opportunities for improvement and theneed for changes to the quality management system, including the quality policy and quality objectives.

REVIEW INPUT

The input to the management review includes information on:

1. Results of audits2. Customer feedback3. Process performance and product conformity

4. Status of preventive and corrective action5. Follow-up actions from previous management reviews6. Planned changes that could affect the quality management system7. Recommendations for improvement

QUALITY SYSTEMS MANUALMANAGEMENT REVIEW Clause — 4.1.3,ISO 9001:1994

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REVIEW OUTPUT

The output from the management review includes decisions and actionsrelated to:

1. Improvement of the effectiveness of the quality management sys-tem and its processes

2. Improvement of the product related to customer requirements3. Resource needs


The organization continually improves the effectiveness of the quality management system through the use of the quality policy, quality objec-tives, audit results, analysis of data, corrective and preventive actions, andmanagement reviews.


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GENERAL

A quality management system is established, maintained, and documentedas a means to ensure that products and services conform to specifiedrequirements. This quality system is designed to comply with theISO 9001:2000 standard. The quality systems responsibilities are tabulatedin Table 1 (amend the table as relevant to your company).


QUALITY SYSTEMS MANUALQUALITY SYSTEM Clause — 4.2,ISO 9001:1994

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Table 1


CorrespondenceClause

ISO 9001:2000 Function Concerned in the Entity

ISO-9001 CLAUSE A D M

Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M

4.1 Managementresponsibilities 5.1 + 5.3 + 5.4.1+ 5.5.1+ 6.1 + 6.2.1 +

6.35.5.25.6.1 + 5.6.2 +

5.6.3 + 8.5.1

X * * * * * * * * * * *

4.2 Quality system 4.1 + 4.2.1 + 4.2.2 + 5.1 +5.4.1

5.4.2 + 6.2.1 +7.1

* X * * * * * * * * * *

4.3 Contract review 5.2 + 7.2.1 +7.2.2 + 7.2.3

* * * * * – – – – * X *




4.4 Design control 7.3.17.2.1 + 7.3.27.3.37.3.47.3.57.3.67.3.7

* * – * – – – X * – * –


4.2.1 + 4.2.3 * * * * * * * X * * * *

4.6 Purchasing 7.4.17.4.27.4.3

* * – * * – – * X – – *


7.5.4 – X – * – – – – – – – –


7.5.3 * * X * * – – * * * * *

4.9 Process control 6.3 + 6.4 + 7.1 +7.5.1 + 7.5.2 +8.2.3

– * X * – – – * – * – –

Table 1 (Continued)





Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M


QUALITY SYSTEMS MANUALQUALITY SYSTEM Clause — 4.2,



4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1+ 7.1


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4.10 Inspection andtesting 7.1 + 8.17.4.3 + 8.2.47.5.17.5.3

– X * * – – – – – * – –

4.11 Inspection,measurement,and testequipment

7.6 – * * * – X – * – * – –


7.5.3 – X * * – – – * – * – –


8.3 * * * X * * – * * * * *


8.5.2 + 8.5.38.4

* X * * * * * * * * * *

4.15 Handling, storage,packaging,preservation,and delivery

7.5.5 + 7.5.1

– * * * * – – – – * – X

4.16 Quality records 4.2.4 * * * X * * * * * * * * 4.17 Internal quality

audits8.2.2 + 8.2.3 * X * * * * – * * * * *

4.18 Training 6.2.1 + 6.2.2 * X * * * * X * * * * *

Table 1 (Continued)





Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M





4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2+ 6.2.1 + 7.1


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QUALITY SYSTEM PROCEDURES

The organization has identified the processes needed for the quality management system and their application throughout the organization.

These processes are managed by the organization in accordance with

the requirements of these international standards. The quality managementsystem documentation is reviewed, updated, and maintained both inhardware and software form.

4.19 Servicing 7.1 + 7.5.1 * * * * * – – * * * X * 4.20 Statistical

techniques8.1 + 8.2.3 +

8.2.4 + 8.4* X * * – – – – – * – –


Key:ADM = Administration (Management) QUA = Quality AssurancePRD = Production QCD = Quality Control DepartmentSHP = Shipping PER = Personnel

PDL = Product Development Lab PUR = PurchasePAC = Packaging MKT = MarketingMPM = Materials Planning Manager MAI = Maintenance

Table 1 (Continued)





Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M





4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2+ 6.2.1 + 7.1


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CONTROL MANUAL

The scope of the quality management system includes details of andjustification for any exclusions, the documented procedures established forthe quality management system, or reference to them, and a description of the interaction between the processes of the quality management system.

MANAGEMENT COMMITMENTThe organization has committed to the development and implementation of the quality management system and continually improving its effectiveness.

QUALITY OBJECTIVES

(Company name) has ensured that quality objectives, including thoseneeded to meet requirements for products, are established at relevant

functions and levels within the organization. The quality objectives aremeasurable and consistent with the quality policy.

DOCUMENTATION

Documented quality system procedures and instructions are prepared tomeet the requirements of all pertinent standards.

This manual is reviewed, revised (as required), and reapproved annually.Quality planning is performed by the quality assurance department to

fully meet specified requirements. Procedures and instructions for quality are kept current to conform to specified requirements.

Quality records are properly prepared and identified and can be inany form or medium.


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IMPLEMENTATION

[Quality assurance system] procedures and instructions are updated as needed. When needed to achieve the required standard of quality, quality control,

inspection techniques, and instrumentation are updated. As needed toachieve the required quality, any controls, processes, inspection equipment,fixtures, total production resources, and skills are identified and acquired.

Standards of acceptability for all features and requirements are clear,

complete, and understood (including those that contain a subjective ele-ment). The production process, product installation, inspection, and testprocedures are compatible with the design and requirements.

All quality system procedures and instruction changes are properly documented.

QUALITY PLANNING

The planning of the quality management system is carried out in orderto meet the requirements given in 4.1 as well as the quality objectives,and the integrity of the quality management system is maintained whenchanges to the quality management system are planned and implemented.

It is ensured that personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills, andexperience.

PLANNING OF PRODUCTION REALIZATION

The organization has planned and developed the processes needed forproduct realization. Planning of product realization is consistent with therequirements of the other processes of the quality management system.


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CONTRACT REVIEW

Procedures for contract review are established and maintained.The [order entry department] ensures that our customers’ requirements

are adequately defined and documented.[Production control planners] ensure that the plant has the capability

to meet contractual requirements.[Customer service] ensures that a method for solving contractual dif-

ferences has been developed and is in use.

CUSTOMER FOCUS

It is ensured that the product shall meet the customer requirements.


The organization determines requirements specified by the customer,requirements not stated by the customer but necessary for specifieduse or known and intended use, regulatory requirements, and any additional requirements.


The organization determines and implements effective arrangements for

communicating with customers.

QUALITY SYSTEMS MANUALCONTRACT REVIEW Clause — 4.3,ISO 9001:1994

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Reference Procedure — [Number- ISO-4.3, dated mm-dd-yyyy]





GENERAL

Procedures are established and maintained to control and verify the designof the product and service in order to ensure the specified requirementsare met.


The [design department] identifies the responsibility for each design anddevelopment activity.

Design and verification activities are planned and assigned to qualifiedstaff equipped with adequate resources.

Organizational and technical interfaces between different groups areidentified, and the necessary information is documented, transmitted, andregularly reviewed.

The organization plans and controls the design and development of

the product.

DESIGN INPUT

The [design department] and [plant product engineering] ensure thatthe design input requirements relating to the product are identified,documented, and their selection is reviewed to ensure adequacy. Incom-plete, ambiguous, or conflicting requirements are resolved when defin-ing these requirements.

QUALITY SYSTEMS MANUALDESIGN CONTROL Clause — 4.4,ISO 9001:1994

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DESIGN OUTPUT

The [design department] and [plant product engineering] ensure that thedesign output meets the design input requirements.

Design output is documented and expressed in terms of requirements,calculations, and analysis.

Engineering drawings and/or specifications contain or refer to accep-tance criteria.

Design output conforms to appropriate regulatory requirements [e.g.,put names of agencies here], whether or not these have been stated inthe input information.

Engineering drawings and/or specifications identify those characteris-tics of the design that are crucial to the safe and proper functioning of the product.

DESIGN REVIEW

The organization plans and controls the design and development of theproduct. During the design and development planning, the organizationdetermines the design and development stages, the review, verification,and validation that are appropriate to each design and development stage,and the responsibilities and authorities for design and development.


At suitable stages, systematic reviews of design and development areconducted.


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DESIGN VERIFICATION

Design verification is assigned to the [research and development depart-ment] and is planned, established, and documented.

[Engineering standard practice instructions] ensure that design outputmeets the design input requirements by means of designing controlmeasures such as:

1. Holding and recording design reviews2. Undertaking qualification tests and demonstrations3. Carrying out alternative calculations4. Comparing the new design with a similar proven design, if available

Design verification is performed to ensure that the design and devel-opment outputs have satisfied the design and development input require-ments. Records of the results of the verification and any necessary actions

are maintained.

DESIGN VALIDATION

Design and development validation is performed in accordance withplanned arrangement to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use orapplication. Wherever practicable, validation is completed prior to thedelivery or implementation of the product. Records of the results of

validation and any necessary actions are maintained.


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DESIGN CHANGES

[Engineering standard practice instructions] are established and maintainedfor the identification, documentation, and appropriate review and approvalof all changes and modifications.


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GENERAL

The quality management system documentation includes quality policy, aquality manual, and documented procedures required by this internationalstandard and quality standards.

DOCUMENT, DATA APPROVAL, AND ISSUES

[Engineering standard practice instructions] are established and maintainedto control all documents and data that relate to the standard’s requirements.These documents are reviewed and approved for adequacy by authorizedpersonnel prior to being issued.

Current revisions of documents are identified by the [master list] onthe computer system.

The [master list] and the [manufacturing plant procedures] ensure thatthe pertinent issues of appropriate documents are available at all locations

where operations essential to the effective functioning of the quality systemare performed.The [manufacturing plant procedures] ensure that obsolete documents

are promptly removed from all points of issue or use.

QUALITY SYSTEMS MANUALDOCUMENT AND DATACONTROL

Clause — 4.5,ISO 9001:1994

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DOCUMENT AND DATA CHANGES

Document changes/modifications are reviewed and approved by the[design department], which has access to all pertinent background infor-mation upon which to base its review and approval.

The change and the nature of the change are identified on the docu-ment or on an appropriate attachment, unless it is not practicable.

Documents are reissued promptly after changes are made.

Documents required by the quality management system are controlled. A documented procedure is established to define the controls needed.


Clause — 4.5,ISO 9001:1994

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GENERAL

The [purchasing] and [quality assurance departments] ensure that pur-chased products conform to specified requirements.

VENDOR ASSESSMENT

Vendors are selected on the basis of their ability to meet quality require-ments. An approved vendor list is established and maintained. Only approved vendors are used.

Vendors are approved based on [parts qualification report] and perfor-mance as to the type of product and service being purchased. Vendorevaluation ensures that the vendor has effective quality system controls.

PURCHASING DATA

The [buyers] review and approve purchase orders for adequacy of specifiedrequirements prior to release. Purchasing documents contain data clearly describing the product ordered, including, where applicable:

1. The type, class, style, grade, or other precise identification2. The title or other positive identification, applicable issue of spec-

ifications, drawings, process requirements, inspection instructions,and other relevant technical data, including requirements forapproval or qualification of product, procedures, process equip-

ment, and personnel3. The title, number, and issue date of the specification to be applied

to the product

QUALITY SYSTEMS MANUALPURCHASING Clause — 4.6,ISO 9001:1994

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Our customer or our customer’s representatives are afforded the right to verify at the source or upon receipt that the purchased product conformsto the specified requirements. Product verification by the customer doesnot absolve our operation of the responsibility to provide a fully acceptableproduct, nor does it preclude subsequent rejection. When our customercarries out product verification at a vendor’s plant, such verification is

used as evidence of effective quality control of the vendor.


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Reference Procedure — [Number ISO-4.6 dated mm-dd-yyyy]





CUSTOMER-SUPPLIED PRODUCT

Customer-supplied products are verified, stored, and maintained to prevent

deterioration or loss. It is ensured that:

A customer-supplied product is prevented from deterioration or loss.

The nonconforming customer-supplied product is segregated from

the production streams recorded and reported to the customer.

The contract describes the conditions of handling the customer-

supplied product (or by other documented specification). Customer property includes intellectual property rights.

QUALITY SYSTEMS MANUALCUSTOMER-SUPPLIED PRODUCT Clause — 4.7,



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PRODUCT IDENTIFICATION

The identification of the product is established and maintained for allproducts to all applicable drawings, specifications, or other documentsduring all stages of production, delivery, and installation.

PRODUCT TRACEABILITY

Where traceability is specified, the product and subassemblies of theproduct have unique recorded identification.

QUALITY SYSTEMS MANUALPRODUCT IDENTIFICATIONAND TRACEABILITY

Clause — 4.8,ISO 9001:1994

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PROCESS CONTROL

Production operations, which directly affect quality, are identified andplanned to ensure that these processes are carried out under controlledconditions. Controlled conditions shall include the following:

1. Documented work instructions defining the manner of productionand installation, where the absence of instructions would adversely affect quality

2. Use of suitable production and installation equipment, a suitable working environment, compliance with reference standards, codes,and quality plans

3. Monitoring and control of suitable process and product character-istics during production and installation

4. The approval of processes and equipment, as appropriate5. Engineering drawings and inspection plans stipulating the accep-

tance and rejection criteria6. Availability of suitable buildings and workplaces

SPECIAL PROCESSES

These are processes, the results of which cannot be fully verified by subsequent inspection and testing of the product and where, for exam-ple, process deficiencies may become apparent only after the productis in use. Accordingly, continuous monitoring and/or compliance with

documented procedures are required to ensure that the specified require-ments are met. Records are maintained for all qualified process equip-ment and personnel.

QUALITY SYSTEMS MANUALPROCESS CONTROL Clause — 4.9,ISO 9001:1994

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Planning of product realization is consistent with the requirements of theother processes of the quality management system, and the organizationdetermines the elements as appropriate.


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GENERAL

The organization has planned and developed the processes needed forproduct realization. Planning of product realization is consistent with therequirements of the other processes of the quality management systemand considers monitoring, measurement, analysis, and improvement pro-cesses needed.

RECEIVING INSPECTION AND TEST

Consideration is given to the control exercised at the source and doc-umented evidence of quality conformance provided. All incoming mate-rials are inspected or otherwise verified as to conforming to specifiedrequirements before being released for use to production. This verifica-tion is in accordance with the quality plan or documented procedures.

All incoming materials released for urgent production purposes are

positively identified and recorded in order to permit immediate recallin the event of nonconformance.The organization monitors and measures the characteristics of the

product to verify that product requirements are fulfilled. This is carriedout at appropriate stages of the product realization process in accordance

with the planned arrangements.

QUALITY SYSTEMS MANUALINSPECTION AND TESTING Clause — 4.10,ISO 9001:1994

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IN-PROCESS INSPECTION AND TESTING

All in-process inspection and test requirements, as specified by contract,are controlled by these means:

1. Inspecting, testing, and identifying the product as required by thequality plan or documented procedures

2. Establishing product conformance to specified requirements by useof process monitoring and control methods

3. Holding the product until the required inspection and tests havebeen completed or necessary reports have been received and

verified (except when the product is released under positive recallprocedures); release under positive recall procedures does notpreclude the activities of (1) above.

4. Identifying a nonconforming product5. Considering controlled conditions, as applicable

FINAL INSPECTION AND TESTING

The [quality plan] ensures that all specified inspections and tests, includingthose specified either upon receipt of the product or in process, havebeen carried out and that all data meet the specified requirements.

All final inspections and testing are performed in accordance with the[quality plan and specifications] to complete the evidence of productconformance to the specified requirements.

No product is shipped until all specified requirements have beensatisfactorily completed and the associated data and documentation arecomplete and authorized.


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INSPECTION AND TEST RECORDS

[Inspection records] are maintained in order to provide evidence that theproduct has passed an inspection and/or test with defined acceptancecriteria.


Where appropriate, the organization identifies the product by suitablemeans throughout product realization.


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INSPECTION, MEASURING, AND TEST EQUIPMENT

The [calibration system] controls, calibrates, and maintains inspection,measuring, and test equipment to demonstrate the conformance of theproduct to the specified requirements. Equipment is used in such a mannerso as to ensure that measurement uncertainty is known and is consistent

with the required measurement capability. The measurements made areidentified, the accuracy is stated, and the appropriate inspection, measur-

ing, and test equipment is used.[Calibration procedures] are established and maintained to include

details of equipment type, identification number, location, frequency of checks, check method, acceptance criteria, and the action to be taken

when check results are unsatisfactory. Calibration records are maintained,and calibration environmental conditions are controlled.

All inspection, measuring, and test equipment is capable of the accuracy and precision necessary. Prior to use, all inspection, measuring, and testequipment is identified, calibrated, and adjusted as required. Calibrationand adjustments are made are against standards of certified equipment,traceable to the National Institute of Standards and Technology (NIST, whereno such standard exists, the basis used for calibration is documented).Inspection, measuring, and test equipment is identified with a suitableindicator or approved identification record to show the calibration status.

When inspection, measuring, and test equipment is found to be outof calibration, an assessment of the validity of previous inspections andtests are made and documented.

The accuracy and fitness for use of inspection, measuring, and testequipment are maintained by controlling the handling, preservation, andstorage of the equipment.

Inspection, measuring, and test equipment and test facilities, includingboth test hardware and test software, are safeguarded from adjustmentsthat would invalidate the calibration setting.

QUALITY SYSTEMS MANUALINSPECTION, MEASURING, ANDTEST EQUIPMENT

Clause — 4.11,ISO 9001:1994

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Test hardware (e.g., jigs, fixtures, templates, and patterns) or testsoftware is checked to ensure capability of verifying the acceptability of the product, prior to release, for use during production or installation.Such hardware and software is controlled by periodic checks. Recordsare maintained.

In addition, the organization assesses and records the validity of theprevious measuring results when the equipment is found not to conformto requirements. The organization takes appropriate action on the equip-

ment and any product affected. Records of the results of calibration and verification are maintained.Note: See ISO 10012-1 and ISO 10012-2 for guidance.


Clause — 4.11,ISO 9001:1994

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Reference Procedure — [Number ISO-4.11, dated mm-dd-yyyyy]





INSPECTION AND TEST STATUS

The inspection and test status of the product is identified by markings,authorized tags, labels, routing cards, inspection records, test software,and physical location, which indicate the conformance or nonconformanceof the product with regard to inspection and tests performed.

The identification of inspection and test status is maintained, as nec-essary, throughout production and installation of the product to ensure

that only product that has passed the required inspection and test isshipped, used, or installed.

Records identify the inspection authority responsible for the release of conforming product.

QUALITY SYSTEMS MANUALINSPECTION AND TEST STATUS Clause — 4.12,ISO 9001:1994

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Nonconforming product is controlled to ensure that any product that doesnot conform to specified requirements is prevented from inadvertent useor installation.

The [procedures] provide for identification, documentation, evaluation,and segregation when practical, as well as disposition of nonconformingproduct and notification to the functions concerned.

NONCONFORMITY REVIEW AND DISPOSITION

The responsibility for review and authority for the disposition of noncon-forming product is assigned to a [material review board]. Nonconformingproduct is reviewed in accordance with [material review board procedures].

Disposition of nonconforming product may be:

1. Rework to meet the specified requirements2. Accept with repair by concession3. Accept without repair by concession4. Regrade for alternative applications5. Scrap

Where required by contract, the proposed use or repair of any productthat does not conform to specified requirements is reported for concessionto the customer or the customer’s representative. The description of

nonconformity that has been accepted, as well as repairs, is recorded todenote the actual condition.

Repaired and reworked products are reinspected in accordance withthe [quality plan].

QUALITY SYSTEMS MANUALCONTROL OFNONCONFORMING PRODUCT

Clause — 4.13,ISO 9001:1994

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When nonconforming product is detected after delivery or use hasbegun, the organization takes action appropriate to the effects of thenonconformity.


Clause — 4.13,ISO 9001:1994

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CORRECTIVE ACTION

[Corrective action procedures] are established, documented, and main-tained. They include:

1. Investigating the cause of nonconforming product and the correc-tive action needed to prevent recurrence

2. Analyzing all processes, work operations, concessions, quality records, service reports, and customer complaints to detect andeliminate potential causes of nonconforming product

3. Initiating preventive actions to deal with problems to a levelcorresponding to the risk encountered

4. Applying controls to ensure corrective actions are taken and thatthey are effective

5. Implementing and recording changes in procedures resulting fromcorrective action

The organization initiates actions to eliminate the causes of potentialnonconformities in order to prevent their occurrence. Preventive actionsappropriate to the effects of the potential problem are initiated asappropriate.

QUALITY SYSTEMS MANUALCORRECTIVE ACTION Clause — 4.14,ISO 9001:1994

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HANDLING, STORAGE, PACKING, AND DELIVERY

[Warehouse procedures] are established, documented, and maintained forthe handling, storage, packaging, and delivery of the product.

[Warehouse procedures] establish the methods and means of handlingto prevent damage or deterioration.

[Storage areas] or stock rooms are provided to prevent damage ordeterioration of the product, pending use or delivery. Appropriate methods

for authorizing receipt and dispatch to and from such areas are stipulated.The condition of any product in stock is assessed at appropriate intervals.

[Packing system] establishes the processes of packing, preserving, andmarking, to the extent necessary, to ensure conformance to specifiedrequirements and identifies, preserves, and segregates all product fromthe time of receipt until the plant’s responsibility ceases.

[Shipping system] provides for the protection of the product throughthe delivery of the product to its final destination.

QUALITY SYSTEMS MANUALHANDLING, STORAGE,PACKING, AND DELIVERY

Clause — 4.15,ISO 9001:1994

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QUALITY RECORDS

Quality records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

Quality records are made available for evaluation by the customer orthe customer’s representative for an agreed period.

All quality records are legible and identifiable to the product involved.

Quality records are stored and maintained in such a way that they arereadily retrievable in storage facilities, which minimizes deterioration andprevents loss.

Quality records are maintained to demonstrate achievement of therequired quality and the effective operation of the quality system.

The retention time of quality records is according to the recordretention policy.

[Record procedures] are established and maintained for the identify-ing, collecting, indexing, filing, storing, maintaining, and disposing of quality records.

QUALITY SYSTEMS MANUALQUALITY RECORDS Clause — 4.16,ISO 9001:1994

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INTERNAL QUALITY AUDITS

A comprehensive system of planned and documented internal quality auditsis established to verify whether quality activities comply with plannedarrangements and to determine the effectiveness of the quality system.

Audits are scheduled on the basis of the status and importance of the activity.

The audits and the follow-up actions are carried out in accordance

with ANSI/ASQC Q1-1986 or ISO 10011-1, ISO 11-1, and ISO 10011-3.The results of the audit are documented and brought to the attention

of the personnel with responsibility in the area audited. The managementpersonnel responsible for that area take timely corrective action for thedeficiencies found by the audit.

The selection of auditors and conduct of audits ensure the objectivity and impartiality of the audit process.

QUALITY SYSTEMS MANUALINTERNAL QUALITY AUDITS Clause — 4.17,ISO 9001:1994

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TRAINING

Procedures are established and maintained for identifying the trainingneeds and providing for the training of all personnel performing activitiesaffecting quality. Personnel performing specific assigned tasks are qualifiedon the basis of appropriate education, training, and/or experience, asrequired. Training records are maintained.

QUALITY SYSTEMS MANUALTRAINING Clause — 4.18,ISO 9001:1994

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SERVICING

Where servicing is specified in the contract, procedures are establishedand maintained for performing and verifying that service meets the spec-ified requirements.

The organization plans and carries out production and service provi-sions under controlled conditions as applicable.

QUALITY SYSTEMS MANUALSERVICING Clause — 4.19,ISO 9001:1994

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STATISTICAL TECHNIQUES

Where appropriate, procedures are established for identifying adequatestatistical techniques required for verifying the acceptability of processcapability and product characteristics.

The organization determines, collects, and analyses appropriate datato demonstrate the suitability and effectiveness of the quality managementsystem and to evaluate where continual improvement to the quality

management system can be made.

QUALITY SYSTEMS MANUALSTATISTICAL TECHNIQUES Clause — 4.20,ISO 9001:1994

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Appendix IIReference SOPs

Subject

ClausesISO 9001

:2000Ref. SOP

NoRevision

No. Issued On





Normative reference 2.0 ISO-4.1 New mm/dd/yyTerms and definitions 3.0 ISO-4.1 New mm/dd/yy

Quality management system(title only)




4.2 ISO-4.2ISO-4.5

NewNew

mm/dd/yymm/dd/yy


NewNew

mm/dd/yymm/dd/yy

Quality manual 4.2.2 ISO-4.2 New mm/dd/yyControl of documents 4.2.3 ISO-4.5 New mm/dd/yy

Control of quality records 4.2.4 ISO-4.1 New mm/dd/yy


5.0 ISO-4.1ISO-4.2

NewNew

mm/dd/yymm/dd/yy


NewNew

mm/dd/yymm/dd/yy



Planning (title only) 5.4 ISO-4.1ISO-4.2

NewNew

mm/dd/yymm/dd/yy

Quality objectives 5.4.1 ISO-4.1ISO-4.2

NewNew

mm/dd/yymm/dd/yy






Management representative 5.5.2 ISO-4.1 New mm/dd/yyInternal communication 5.5.3 ISO-4.1 New mm/dd/yy

Management review(title only)











Human resources (title only) 6.2 ISO-4.1ISO-4.2ISO-4.16

NewNewNew



NewNew

mm/dd/yymm/dd/yy




Work environment 6.4 ISO-4.9 New mm/dd/yy

Product realization(title only)

7.0 ISO-4.2ISO-4.9ISO-4.10

NewNewNew


Planning of productrealization

7.1 ISO-4.2ISO-4.9ISO-4.10

NewNewNew



7.2 ISO-4.3ISO-4.4

NewNew

mm/dd/yymm/dd/yy

Determination ofrequirements related to theproduct




Customer communication 7.2.3 ISO-4.3 New mm/dd/yy











Appendix IIReference SOPs (Continued)

Subject

ClausesISO 9001

:2000Ref. SOP

NoRevision

No. Issued On






Design and developmentvalidation


Control of design and

development changes


Purchasing (title only) 7.4 ISO-4.6 New mm/dd/yy

Purchasing process 7.4.1 ISO-4.6 New mm/dd/yy

Purchasing information 7.4.2 ISO-4.6 New mm/dd/yy

Verification of purchasedproduct

7.4.3 ISO-4.6ISO-4.10

NewNew

mm/dd/yymm/dd/yy

Production and serviceprovision (title only)

7.5 ISO-4.9ISO-4.10ISO-4.15

ISO-4.19

NewNewNew

New


mm/dd/yyControl of production andservice provision

7.5.1 ISO-4.9ISO-4.10ISO-4.15ISO-4.19

NewNewNewNew




Identification and traceability 7.5.3 ISO-4.8ISO-4.10

ISO-4.12

NewNew

New

mm/dd/yymm/dd/yy

mm/dd/yyCustomer property 7.5.4 ISO-4.7 New mm/dd/yy





8.0 ISO-4.10ISO-4.17ISO-4.20

NewNewNew


General 8.1 ISO-4.10

ISO-4.17ISO-4.20

New

NewNew

mm/dd/yy

mm/dd/yymm/dd/yy


Subject

ClausesISO 9001

:2000Ref. SOP

NoRevision

No. Issued On




Monitoring andmeasurement (title only)

8.2 ISO-4.9ISO-4.10ISO-4.17ISO-4.20

NewNewNewNew


Customer satisfaction 8.2.1 ISO-4.9

ISO-4.10

New

New

mm/dd/yy

mm/dd/yyInternal audit 8.2.2 ISO-4.17 New mm/dd/yy


8.2.3 ISO-4.9ISO-4.17ISO-4.20

NewNewNew


Monitoring andmeasurement of products

8.2.4 ISO-4.1ISO-4.2ISO-4.10

NewNewNew


Control of nonconformingproduct



NewNew

mm/dd/yymm/dd/yy


Continual improvement 8.5.1 ISO-4.1 New mm/dd/yy




Subject

ClausesISO 9001

:2000Ref. SOP

NoRevision

No. Issued On



200.20.3






MODEL - 3

ISO 9001:2000

PREPARED AFTER INCORPORATION OF CHANGES INISO 9002 MANUAL


Date Supersedes

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Date Issued

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Manual Serial No.

QM-3

Revision No: 0




3) Marketing Copy-3

4) ISO Management Representative Master5)

6)


mm/dd/yy 1) First time issued for (your company name)




TABLE OF CONTENTS



Contents Clauses

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.0Scope and Field of Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.0Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.0Quality Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.0Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.1Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2Responsibility and Authority. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.1Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.2Management Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.3Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.3Quality System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.2Contract Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.3Design Control (not applicable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.4Document and Data Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.5Purchasing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6Customer-Supplied Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.7

Product Identification and Traceability . . . . . . . . . . . . . . . . . . . . . . . . 4.8Process Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.9Inspection and Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.10Inspection, Measuring, and Test Equipment . . . . . . . . . . . . . . . . . . . 4.11Inspection and Test Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.12Control of Nonconforming Product . . . . . . . . . . . . . . . . . . . . . . . . . 4.13Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.14Handling, Storage, Packing, and Delivery . . . . . . . . . . . . . . . . . . . . . 4.15Quality Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.16

Internal Quality Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.17Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.18Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.19Statistical Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.20

Appendix III (Reference SOPs)





INTRODUCTION

This manual provides a written description of the organization and policiesof the quality system.

Changes may be made to this manual only after being approved by the manager of quality assurance or an authorized representative.

The system is designed to provide controls to assure that productquality meets or exceeds the quality requirements and expectations of our

customers. The system is designed to provide controls for the preventionof nonconforming parts, early detection of discrepancies, and correctiveaction to ensure consistent delivery of a quality product.

The contents of this manual r efer to international standardISO 9001:2000 prepared after incorporation of corresponding changes inquality manual ISO 9002 (1994).

The manual provides customer-focused leadership with continualimprovement through involvement of employees within a strong commu-nication matrix.


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(Company name) is in compliance with the requirements of an interna-tional standard ISO 9002:1994 quality system — model for quality assur-ance in production and installation. However, the second edition (ISO9002:1994), together with ISO 9001:1994 and ISO 9003:1994, is cancelledand replaced by a third edition of the ISO 9001:2000 module. It constitutesa technical revision of these documents. The quality manual QM-3 is

prepared in accordance with the corresponding changes specified in thethird edition of ISO 9001:2000.

The international standard ISO 9001:2000 specifies quality systemrequirements for use where a contract between the company and cus-tomers requires the demonstration of capability to produce and supply the product in compliance with the applicable regulatory requirements.The sub-clause 7.3, design and/or development, is excluded.

The contents and the elements of this ISO 9002 quality system manualare revised in accordance with the requirements of international standardISO 9001:2000.


Clause — 1.0,ISO 9002:1994

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REFERENCES



dard — Guides for Selection and Use ISO 9002: 1994, Quality System — Model for Quality Assurance in

Production and Installation ISO 9001:2000, Quality Management System Requirements


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DEFINITIONS

For the purpose of standard ISO 9001:2000, the terms and definitions givenin ISO 9000 apply.


An analysis certificate is a document that gives the results of the inspection

made on a representative sample taken from a product before its delivery.It must contain the results of all checks in a list approved jointly by theclient and the supplier.

Auditor

An auditor is a person who is qualified and authorized to perform all orany portion of a quality system audit.

Audit


Audit Organization

An audit organization is an organization that regularly conducts quality assurance management system audits to a required standard.


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Batch

A batch refers to assignments of a batch of finished products to a clientas a function of that client’s requirements.

Conformity

Conformity refers to the state of a product satisfying specified requirements.

Documentation

Documentation means any recorded or pictorial information describing,defining, specifying, reporting, or certifying activities, requirements, pro-cedures or results.

Documentation Level

The position of a quality document in the quality assurance documentationsystem is its documentation level.

First Party Audits

Audits carried out internally by an organization are known as first party audits.

Inspection An inspection is an examination or measurement to verify whether anitem or activity conforms to a specified requirement.


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Inspectors

Inspectors are appointed by the purchaser to provide advice on mattersrelating to the product and inspection and to verify the achievement of the quality specified.

Lead Auditor

An auditor who is qualified and authorized to manage a quality systemaudit is a lead auditor.

Management Review

A management review is a compulsory evaluation carried out by generalmanagement on the state and suitability of the quality system with respectto quality policy and new objectives resulting from the changed situation.

Nonconformity


Organization


Provisional Auditor

A provisional auditor is a person who meets all requirements for regis-tration except for audit experience.


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Quality Planning


Quality PolicyThe overall quality intentions and direction of an organization formally expressed by top management are its quality policy.


The quality record is the filled-in record documents proving that the quality assurance and quality control actions have been done.

Quality System

The quality systems refers to the organizational structure, responsibili-ties, procedures, processes, and resources for implementing quality management.


Quality surveillance means the continued monitoring and verification of the status of procedures, methods, conditions, processes, products andservices, and analysis of records in relation to stated references to ensurethat specified requirements for quality are being met.


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A representative sample is a sample taken using a clearly defined proce-dure in order to obtain information about a batch.

Second Party Audits



Specification

A specification is a document that specifies the requirements with whichthe product and/or material must comply.

Third Party Audits Audits of organizations undertaken by an independent certification body or similar organization are called third party audits.

Traceability

Traceability refers to the capability of finding the history, use, or locationof an article by means of a recorded identification.

Validation

The act of checking a calculation or design through its stages to verify that the assumptions made, input data, and method used have produceda valid result is known as validation.


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Verification

Verification is the act of reviewing, inspecting, testing, checking, auditing,or otherwise verifying and documenting whether items, processes, ser-

vices, or documents conform to specified requirements.

The list is not conclusive as there are many others terms in general useor contained in various standards and quality documents.


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The contents of the ISO 9002:1994 international standards are describedbelow in correspondence with ISO 9001:2001 standards to define quality system requirements and management responsibilities.

QUALITY SYSTEMS MANUALQUALITY MANAGEMENTSYSTEM

Clause — 4.0,ISO 9002:1994

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Correspondence between ISO 9002:1994 and ISO 9001:2000

Clause ISO 9002:1994 ISO 9001:2000

1.0 Scope 1.0

2.0 Normative reference 2.03.0 Definitions 3.0



4.1.1 Quality policy 5.1 + 5.3 + 5.4.1



4.1.2.2 Resources 5.1 + 6.1 + 6.2.1 + 6.3 4.1.2.3 Management representative 5.5.2



4.2.1 General 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1


4.2.3 Quality planning 5.4.2 + 6.2.1 + 7.1

4.3 Contract review (title only)

4.3.1 General

4.3.2 Review 5.2 + 7.2.1 + 7.2.2 + 7.2.3 4.3.3 Amendment to a contract 7.2.2

4.3.4 Records 7.2.2

4.4 Design control (not applicable)

4.4.1 General (not applicable)




4.4.2 Design and development planning(not applicable)

7.3.1 (not applicable)

4.4.3 Organizational and technicalinterfaces (not applicable)

7.3.1 (not applicable)

4.4.4 Design input (not applicable) 7.2.1 + 7.3.2 (not applicable)

4.4.5 Design output (not applicable) 7.3.3 (not applicable)

4.4.6 Design review (not applicable) 7.3.1 + 7.3.4 (not applicable)

4.4.7 Design verification (notapplicable)

7.3.1 + 7.3.5 (not applicable)

4.4.8 Design validation (not applicable) 7.3.1 + 7.3.6 (not applicable)

4.4.9 Design changes (not applicable) 7.3.7 (not applicable)


4.5.1 General 4.2.1 + 4.2.3 4.5.2 Document and data approval andissue

4.2.3



4.6.1 General




4.7 Control of customer-suppliedproduct 7.5.4


7.5.3


Clause ISO 9002:1994 ISO 9001:2000



Clause — 4.0,ISO 9002:1994

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4.15.2 Handling 7.5.5

4.15.3 Storage 7.5.5



4.15.6 Delivery 7.5.1 + 7.5.5. 4.16 Control of quality records 4.2.4


4.18 Training 6.2.1 + 6.2.2

4.19 Servicing 7.1 + 7.5.1



4.20.2 Procedures


Clause ISO 9002:1994 ISO 9001:2000



Clause — 4.0,ISO 9002:1994

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QUALITY OBJECTIVES

The quality objectives defined are measurable and consistent with thequality policy and are based on:

Customer satisfaction The role of leadership The involvement of people The business process approach A systematic approach to management Continual improvement A factual approach to decision making Mutually beneficial supplier relationship



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Provide an organization chart of your company. Describe departmentsinvolved, field of activity, interrelationships, definitions, and terminology used within the company. Provide information as relevant:

Company introduction Nature of products manufactured Key departments and functions Organization chart List of quality-related definitions


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RESOURCES

The quality assurance department is assigned the management of verifi-cation of product quality.

All relevant departments are provided with adequate resources andtrained personnel for the activities related to product realization includinginspection, test, monitoring of the design, production, installation, andservicing of the process and/or product. Verification and audit activities

are carried out by personnel independent of those having direct respon-sibility for the work being performed.

GENERAL

The areas to maintain and enhance the product quality are identified, andfor necessary competence of the employees, adequate in-house, outsidetraining programs are conducted to satisfy these needs. The records of

actions initiated are maintained.

INFRASTRUCTURE

(Company name) ensures the conformity of product requirements by thecustomers and provides adequate infrastructure in terms of workplace, area,utilities, processing equipment, computers, and means of transportation.


The management has ensured its commitment by providing availability of skilled resources and communication of quality policies and objectives tothe employees to meet customer and regulatory requirements. Efforts aremade for continual improvement to ensure customer satisfaction.


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MANAGEMENT REVIEW

The entire quality system is reviewed every quarter-year through manage-ment reviews to ensure continuing suitability and effectiveness. The dataand results of the reviews are recorded and maintained.

(Company name) has appointed an ISO-9002 system coordinator (man-agement representative) who is independent and has defined authority to

verify the product quality.

The periodic management reviews ensure continuing suitability, ade-quacy, and effectiveness of the overall quality system, including assessmentof areas for improvement, changes in existing policies, and objectives forfurther improvement.

REVIEW INPUT

The agenda of the management review meetings is based on follow-up

actions from previous reviews, proposed and planned changes to inculcatefurther improvement, customer feedback resulted through effective com-munication and results of the previous audits, and the corrective andpreventive action taken.


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REVIEW OUTPUT

The decisions made lead to provide adequate resources in terms of buildings, equipment, utilities, and communication means to ensure cus-tomer requirements are met on a continuous basis.


The application of an effective quality system supported with quality policies, objectives, reviews, and corrective action ensures continualimprovement and adds value to the customer product. The product offeredmeets the expectations and needs of the “user” and “the product” iscontinuously maintained to the prescribed standard/specification/con-tact/order agreement.


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GENERAL

This manual documents the quality system, which is based on the exclu-sion of clause 7.3, revised in accordance with international standardISO 9001:2000. It is implemented throughout the company and understoodat all levels. The entire system is reviewed at least once a year by management reviews to ensure that the system is effective. The system isdesigned to ensure that:

Products meet or exceed customer expectations. Emphasis is placed on problem presentation rather than dependent

on detection after occurrence. Causes of the problem are found and comprehensive corrections

are made. Feedback is generated to be used for product and process design. Constant improvement of the product and process is enhanced.


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The quality system responsibilities are tabulated in Table 1. Amend thetable as relevant your company.


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Table 1


Correspondenceclause

ISO 9001:2000

Function Concerned in the Entity

ISO-9002 Clause* A D M

Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M


5.1 + 5.3 + 5.4.1+ 5.5.1

+ 6.1 + 6.2.1 +6.3

5.5.2 + 5.6.1 +5.6.2 + 5.6.3 +8.5.1

X * * * * * * * * * * *

4.2 Quality system 4.1 + 4.2.1 +

4.2.2 + 5.1 +5.4.15.4.2 + 6.2.1 +

7.1

* X * * * * * * * * * *

4.3 Contract review 5.2 + 7.2.1 +7.2.2 + 7.2.3

* * * * * – – – – * X *

4.4 Design control(not applicable)

7.2.1, (7.3.1 +

7.3.2, 7.3.3, 7.3.4,

7.3.5, 7.3.6, 7.3.7) (not

applicable)

– – – – – – – – – – – –


4.2.1 + 4.2.3 * * * * * * * X * * * *




4.6 Purchasing 7.4.1, 7.4.2,

7.4.3

* * – * * – – * X – – *


7.5.4 – X – * – – – – – – – –


7.5.3 * * X * * – – * * * * *

4.9 Process control 6.3 + 6.4 + 7.1 +

7.5.1 + 7.5.2 +8.2.3

– * X * – – – * – * – –


7.1 + 8.1 + .4.3+ 8.2.4 + 7.5.1+ 7.5.3

– X * * – – – – – * – –


7.6 – * * * – X – * – * – –

4.12 Inspection and

test status

7.5.3 – X * * – – – * – * – –


8.3 * * * X * * – * * * * *

Table 1 (Continued)



ISO 9001:2000



Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M





4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1+ 7.1


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4.14 Corrective

actions

8.5.2 + 8.5.3

8.4

* X * * * * * * * * * *

4.15 Handling storage,packaging,preservation,and delivery

7.5.5 + 7.5.1

– * * * * – – – – * – X

4.16 Quality records 4.2.4 * * * X * * * * * * * *

4.17 Internal qualityaudits

8.2.2 + 8.2.3 * X * * * * – * * * * *

4.18 Training 6.2.1 + 6.2.2 * X * * * * X * * * * *

4.19 Servicing (notapplicable) 7.1 + 7.5.1 * * * * * – – * * * X *

4.20 Statisticaltechniques

8.1 + 8.2.3 +8.2.4 + 8.4

* X * * – – – – – * – –


Key:ADM = Administration (Management) QUA = Quality AssurancePRD = Production QCD = Quality Control Department

SHP = Shipping PER = PersonnelPDL = Product Development Lab PUR = PurchasePAC = Packaging MKT = MarketingMPM = Materials Planning Manager MAI = Maintenance

The elements not relevant are described as “not applicable."

Table 1 (Continued)



ISO 9001:2000



Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M





4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1+ 7.1


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DOCUMENTATION

An adequate documentation level is established to ensure compliance tothis international standard. The documentation includes:

Quality policy/manual Standard operating procedures Applicable formats used for planning, operations, and in-process

control Product technical dossier Electronic records

IMPLEMENTATION

All quality system procedures and instructions are implemented to ensureeffectiveness of the quality management system. To ensure continual

improvement, facilities, equipment, and documents are reviewed andapproved for implementation. The compatibility of the process with theproduction facilities and infrastructure is ensured to achieve productrealization in compliance with the customer requirements. The implemen-tation is achieved through:

Planning of product realization Determination of requirements related to the product Communication


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QUALITY PLANNING

The elements of quality planning are based on quality objectives. Thechanges to the management system are maintained proactively.

PLANNING OF PRODUCT REALIZATION

Planning of product realization exclusively addresses requirements of thequality management system (see 4.1). The company has determined thefollowing as appropriate:

Customer-related processes Determination of requirements related to product Review of requirements related to the product Customer communication Design and development (if applicable)

Design and development planning (if applicable) Design and development inputs (if applicable) Design and development outputs (if applicable) Design and development review (if applicable) Design and development verification (if applicable) Design and development validation (if applicable) Control of design and development changes (if applicable)

Module D: Permissable exclusions

Sub-clause 7.3: design and/or development


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CONTRACT REVIEW

Every order, when received, is checked to ensure that the specifics of theorder are the same as what was specified at the time of quotation.

When there is any discrepancy or the order is not the same as thetender, the discrepancy will be reconciled before any work is done.

Before production begins, every order is checked to ensure that allpertinent information is available to the production.

CUSTOMER FOCUS

(Company name) ensures to identify, determine, and meet the customerrequirements.


The product requirements are defined and resolved if different from thosepreviously ordered. The records of reviews are maintained. The changesmade are communicated and reconfirmed.


(Company name) has determined and implemented effective communi-cation procedures regarding product information and feedback regarding

customer complaints.


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GENERAL

Not applicable/justify.



DESIGN INPUT


DESIGN OUTPUT



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DESIGN REVIEW




DESIGN VERIFICATION


DESIGN VALIDATION


DESIGN CHANGESNot applicable/justify.


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GENERAL

The organization has defined, documented, and implemented the proce-dures needed to ensure effective planning, operational controls, and theassociated processes. The key elements include quality policy, objectives,and the applicable procedures.

DOCUMENT AND DATA APPROVAL AND ISSUESThe documents are reviewed for their adequacy before approval. Thedocument control system is designed to ensure that the information usedin the production of the product or parts is clear, complete, correct, andcurrent. No changes can be made without authorization. The systemoperates within a contractual constraint that requires all products or partsto be built to blueprints, drawings, or other specifications. All personnelare required to immediately report any discrepancy to the proper super-

visor so that corrective action can be taken. Documentation shall includeone or more of the following, but is not limited to:

Drawings Blueprints Inspection instructions Work instructions Operation sheets Test procedures

Operational procedures Quality assurance procedures Formulations Common practices


Clause — 4.5,ISO 9002:1994

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Product and document changes are reviewed to verify that there is nodegradation of quality. Document changes are distributed at the propertime to the appropriate point in the system to ensure that work andfunctions are accomplished in accordance with requirements.


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GENERAL

The purchasing system is designed to ensure that purchased materialconforms to specified requirements.

VENDOR ASSESSMENT

Vendors are approved based on their performance as to the type of productand service being purchased. An approved vendor’s list is kept. One ormore of the following data are used for basis of approval:

Demonstrated capability Demonstrated performance Documented quality system Test reports or certifications

PURCHASING DATAPurchasing documents are reviewed for adequacy of specified require-ments prior to release. Purchasing documents contain data clearly describ-ing the product ordered, including, where applicable:

The verification requirements and reports on the material forrelease and shipment

The type, class, grade, or other precise identification

The title or other positive identification and applicable issues of specifications, drawings, process requirements, inspection instruc-tions, or other relevant technical data

The title, number, and issue date of the quality system standardto be applied to the product


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Strict control of nonconforming purchased material is maintained andinformation is fed back to purchasing and the vendor for corrective action.

The customer or our customer representative is afforded the right to verify at the source or upon receipt that the purchased product conformsto the specified requirements. At any stage of production, the customeror our customer representative is afforded access to our location to verify

product conformance and, when necessary, is accommodated with veri-fication personnel and equipment.


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The products received from the customers are verified, stored, and main-

tained to prevent deterioration or loss. The conditions of handling and

use of customer-supplied product are spelled out in the contract or by

other documented specifications. Any customer-supplied product that

becomes nonconforming is segregated from the production stream,

recorded, and reported to the customer.

QUALITY SYSTEMS MANUALCUSTOMER-SUPPLIED PRODUCT Clause — 4.7,



7.5.4


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Products and parts are identified to all applicable drawings, specifications,or other documents throughout all stages of production and delivery. Foridentification, suitable means are used throughout the product realizationand with reference to monitoring and measurement requirements.

PRODUCT TRACEABILITY When traceability is specified, the product or parts have unique identification.


Clause — 4.8,ISO 9002:1994

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PROCESS CONTROL

Production operations are planned and verified to ensure that they areproceeding under controlled conditions in the specified manner andsequence.

Before production begins, all tooling, filtering, programming, inspec-tion equipment, and procedures are verified.

Production operations are controlled by blueprints, drawings, docu-

mented work instructions, specifications, formulations, or proven numer-ical controlled software.

Work instructions are suf ficiently detailed to accomplish the task. Whereapplicable, they include one or more of the following:

Function to be performed Sequence of operations Inspection points

Equipment and tools, their set-up, speeds, feed, and processes Raw material types and size Blueprints, drawing number and revision number Sketches or working drawings Specifications Formulations

The above must be explicit, clear, accurate, and to the current revisionlevel.

Common practices that apply during production are documented andcontrolled.


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GENERAL

Inspection is used at appropriate points in the production process toensure conformity of the product or parts.

A receiving inspection is performed on incoming material, whereapplicable, to ensure that the incoming material conforms to require-ments. Inspection is performed to the degree and extent needed todetermine acceptability.

In-process inspection is employed at appropriate points in the pro-cess. The quality plan or an inspection plan specifies the type of inspection. Inspection points may include, but are not limited to one ormore of the following:

Setup and first piece inspection Inspection by machine operator Inspection by automatic gages or automatic test equipment

Fixed inspection stations at intervals throughout the process Patrol inspection by an inspector following an established proce-dure or inspection plan

Inspections after specified production operations have beenperformed

Final inspection and test, as appropriate, are performed to ensureproduct and part requirements. Final inspection may be one or more of the following:

First article inspection Acceptance sampling According to a quality plan 100% inspection


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RECEIVING INSPECTION AND TEST

The incoming materials are inspected to ensure compliance with thematerials specification. The nonconforming materials are rejected. Thefacility is provided to the customers to perform specific verification testat the company premises.

IN-PROCESS INSPECTION AND TESTINGThe in-process inspection and testing is carried out in accordance withthe approved test methods, work instructions, and qualified equipment.For in-process control, statistical sampling techniques are used as appro-priate.


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The finished product compliance is ensured in accordance with customerspecifications. Where possible, quality plans are used and records aremaintained.


The records of inspection and testing are maintained to ensure that thefinished product meets the customer specifications.


Throughout product realization, the product identification and traceability are ensured using appropriate means.


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Measuring tools and gages are of the type, range accuracy, and precisionappropriate to the product, parts, and process.

The calibration system ensures that the measuring and test equipmentis calibrated, adjusted, repaired, or replaced prior to becoming inaccurate.

Procedures are in place to ensure that the measurement and inspectionprocesses are in a state of control, and that the uncertainties associated

with the measurement are suitably small, so as to have a negligible effecton decisions or actions based on inspection results or measurements.

Measuring and test equipment, tooling masters, gages, jigs, and fixturesused to control manufacturing or as a media of inspection are:

Proven accurate prior to use Calibrated periodically or prior to use to master standards traceable

to the NIST (National Institute for Standards and Technology)

Uniquely identified and, where practical, marked with calibra-tion status

Stored in a restricted area with appropriate control of environment,issuance, and recall

Segregated and identified when out of adjustment, calibration,or obsolete

When inspection, measuring, or test equipment is found to be out of calibration, an evaluation is made to determine the validity of previous

inspection or test results and a decision is made as to the need for re-inspection or retest.


Clause — 4.11,ISO 9002:1994

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The inspection and test status of the product or parts are clearly identifiedby marking, tags, labels, inspection records, test reports, shop travelers,physical location, or other suitable means that indicate the conformanceor nonconformance of the product. Records show the inspection authority that determined the status.


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Nonconforming material is positively identified and controlled.Nonconforming material is:

Identified with a clear mark such as a “hold” or “reject” tag or stamp Segregated from the work stream or placed in a designated holding

area; when practical, the access is restricted to those with authority to make disposition

NONCONFORMITY REVIEW AND DISPOSITION

Nonconforming product is reviewed by authorized personnel to makedisposition and request corrective action. The product is resubmittedthrough the regular inspection channels for acceptance, if approved forrelease because of “rework” or a “use as is with waiver” disposition.


Clause — 4.13,ISO 9002:1994

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CORRECTIVE ACTION

When nonconformances occur, the corrective action plan is activated. Anyone seeing the need for corrective action is responsible for reportingthe problem to the proper supervisor or manager. Merely correcting theparticular unsatisfactory product does not achieve corrective action. If possible, the root cause of the unsatisfactory condition is determined, anda proposed remedy is put in place. The effectiveness of the corrective

action is verified.Corrective actions may include any or all of the following, according

to the situation:

Investigating the cause of the nonconforming product or serviceand the remedy needed to prevent recurrence

Analyzing all processes, work operations, concessions, quality records, and customer complaints to detect and eliminate potential

causes of nonconforming product or service Taking preventive actions to deal with problems to the levelcorresponding to the risk encountered

Applying controls to ensure that corrective actions are taken andthat they are effective

Recording changes in procedures resulting in the remedy


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HANDLING, STORAGE, PACKING, AND DELIVERY

The product is handled, stored, packaged, preserved, and delivered insuch a way to prevent damage or deterioration through all processesincluding delivery of the product to the final destination.


Clause — 4.15,ISO 9002:1994

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QUALITY RECORDS

Quality records are maintained to demonstrate achievement of the requiredquality and the effectiveness of the quality system.

Quality records are:

Legible and identifiable to the product involved Stored and maintained in such a way that they are readily retriev-

able Stored in facilities that minimize deterioration and prevent loss Made available for evaluation to the customer’s representative for

an agreed upon period Retained for a period of three (3) years after the work is completed,

or such a period as agreed on by the customer Stored as electronic data where practical.


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Quality audits are performed to evaluate the effectiveness of the quality system as well as the level of product conformance.

Quality audits are:

Scheduled on the basis of the status and importance of the activity Used to determine the effectiveness of the quality system or activity. Planned, to be sure that the audit itself is effective Documented and reviewed with the personnel responsible for the

area being audited Not complete until adequate corrective action is taken, when

necessary Conducted using ISO 10011 as guidelines


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TRAINING

Consistent training is used to meet the needs of and provide training forall personnel-performed activities affecting quality. All personnel are pro-

vided with training on good quality performance and are aware of theconsequences of poor quality.


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SERVICING

Where servicing is specified in the contract, procedures are establishedand maintained for performing and verifying that the service meets thespecified requirements.


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The need for the use of statistical techniques is determined for each job. When statistics are needed, instructions are made available at the worklocation. Good quality engineering practices are in place before statisticaltechniques are started.

QUALITY SYSTEMS MANUALSTATISTICAL TECHNIQUES Clause — 4.20,ISO 9002:1994

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Appendix IIIReference SOPs

Subject Clauses

ISO 9001:2000Ref. SOP

No.Revision

No. Issued On

Quality managementsystems requirement(title only)





Quality managementsystem (title only)



Documentationrequirements(title only)

4.2 ISO-4.2ISO-4.5

NewNew

mm/dd/yymm/dd/yy

General 4.2.1 ISO-4.2

ISO-4.5

New

New

mm/dd/yy

mm/dd/yyQuality manual 4.2.2 ISO-4.2 New mm/dd/yy

Control of documents 4.2.3 ISO-4.5 New mm/dd/yy

Control of qualityrecords


Managementresponsibility(title only)

5.0 ISO-4.1ISO-4.2

NewNew

mm/dd/yymm/dd/yy

Management

commitment

5.1 ISO-4.1

ISO-4.2

New

New

mm/dd/yy

mm/dd/yyCustomer focus 5.2 ISO-4.3 New mm/dd/yy



NewNew

mm/dd/yymm/dd/yy


NewNew

mm/dd/yymm/dd/yy

Quality managementsystem planning


Responsibility,authority, andcommunication(title only)





Responsibility andauthority


Managementrepresentative


Internalcommunication







Resourcemanagement(title only)



Human resources(title only)

6.2 ISO-4.1ISO-4.2ISO-4.16

NewNewNew



NewNew

mm/dd/yymm/dd/yy

Competence,awareness, andtraining



Work environment 6.4 ISO-4.9 New mm/dd/yyProduct realization(title only)

7.0 ISO-4.2ISO-4.9ISO-4.10

NewNewNew



7.1 ISO-4.2ISO-4.9ISO-4.10

NewNewNew


Customer-relatedprocesses (title only)

7.2 ISO-4.3ISO-4.4

NewNew

mm/dd/yymm/dd/yy

Determination ofrequirements relatedto the product


Appendix IIIReference SOPs (Continued)

Subject Clauses


No.Revision

No. Issued On




Review ofrequirements relatedto the product


Customercommunication


Design and

development(title only)


Design anddevelopmentplanning (notapplicable)

7.3.1 EP EP EP

Design anddevelopment inputs(not applicable)

7.3.2 EP EP EP

Design anddevelopmentoutputs (notapplicable)

7.3.3 EP EP EP

Design anddevelopment review(not applicable)

7.3.4 EP EP EP

Design anddevelopmentverification (not

applicable)

7.3.5 EP EP EP

Design anddevelopmentvalidation (notapplicable)

7.3.6 EP EP EP

Control of design anddevelopmentchanges (notapplicable)

7.3.7 EP EP EP

Purchasing (title only) 7.4 ISO-4.6 New mm/dd/yyPurchasing process 7.4.1 ISO-4.6 New mm/dd/yy

EP = Exclusion Permitted


Subject Clauses


No.Revision

No. Issued On




Purchasinginformation


Verification ofpurchased product

7.4.3 ISO-4.6ISO-4.10

NewNew

mm/dd/yymm/dd/yy

Production andservice provision

(title only)

7.5 ISO-4.9ISO-4.10

ISO-4.15ISO-4.19

NewNew

NewNew

mm/dd/yymm/dd/yy

mm/dd/yymm/dd/yy

Control of productionand service provision

7.5.1 ISO-4.9ISO-4.10ISO-4.15ISO-4.19

NewNewNewNew


Validation ofprocesses ofproduction andservice provision


Identification andtraceability

7.5.3 ISO-4.8ISO-4.10ISO-4.12

NewNewNew



Preservation ofproduct


Control of monitoringand measuringdevices


Measurement,analysis, andimprovement(title only)

8.0 ISO-4.10ISO-4.17ISO-4.20

NewNewNew



NewNewNew


Monitoring andmeasurement

(title only)

8.2 ISO-4.9ISO-4.10

ISO-4.17ISO-4.20

NewNew

NewNew

mm/dd/yymm/dd/yy

mm/dd/yymm/dd/yy


NewNew

mm/dd/yymm/dd/yy


Subject Clauses


No.Revision

No. Issued On





Monitoring andmeasurement ofprocesses

8.2.3 ISO-4.9ISO-4.17ISO-4.20

NewNewNew


Monitoring andmeasurement of

products

8.2.4 ISO-4.1ISO-4.2

ISO-4.10

NewNew

New

mm/dd/yymm/dd/yy

mm/dd/yyControl of

nonconformingproduct



NewNew

mm/dd/yymm/dd/yy

Improvement(title only)


Continual

improvement





Subject Clauses


No.Revision

No. Issued On



200.20.4




TABLE OF CONTENTS



Contents Clauses

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.0Scope and Field of Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.0Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.0Quality Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.0Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.1Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.1.2Responsibility and Authority. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.1Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.2Management Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.3Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.3Quality System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.2Contract Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.3Design Control (not applicable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.4Document and Data Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.5Purchasing (not applicable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.6Customer-Supplied Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.7

Product Identification and Traceability . . . . . . . . . . . . . . . . . . . . . . . . 4.8Process Control (not applicable) . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.9Inspection and Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.10Inspection, Measuring, and Test Equipment . . . . . . . . . . . . . . . . . . . 4.11Inspection and Test Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.12Control of Nonconforming Product . . . . . . . . . . . . . . . . . . . . . . . . . 4.13Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.14Handling, Storage, Packing, and Delivery . . . . . . . . . . . . . . . . . . . . . 4.15Quality Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.16

Internal Quality Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.17Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.18Servicing (not applicable). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.19Statistical Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.20

Appendix IV (Reference SOPs)





INTRODUCTION

This manual provides reference to the organizational quality managementsystem to ensure consistency, reproduceability, and continuous improve-ment in the company ’s operations with a particular reference to customersatisfaction and to meet regulatory requirements as appropriate. Themanual refers to the elements of international standard ISO 9001:2000incorporated in the already existing ISO 9003 (1994) quality manual.


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The international standard ISO 9003:1994 was established by TechnicalCommittee ISO/TC 178, and is based on British standard 5750:1987 series,European standard EN 29000: 1987 series, and international standards ISO9000:1987 series. The standard was adopted by the company to provideobjective evidence that the company ’s operations of final product inspec-tion and testing are in compliance with the requirement of this standard.

However, this third edition canceled and replaced the second edition (ISO9003:1994). The quality manual QM-4 is revised in accordance with thecorresponding changes specified in the third edition of ISO 9001:2000 tospecify quality system requirements for use where a contract between thecompany and customer requires the demonstration of capability of finalproduct inspection and testing with customer satisfaction. The permissibleexclusions are made to:

Sub-clause 7.1Sub-clause 7.2.3Sub-clause 7.3Sub-clause 7.4Sub-clause 7.5.1Sub-clause 7.5.2Sub-clause 7.5.3


Clause — 1.0,ISO 9003:1994

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REFERENCES



dard — Guides for Selection and Use ISO 9003:1994, Quality System — Model for Quality Assurance in

Final Inspection and Test ISO 9001:2000 module, Quality Management System Requirements


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DEFINITIONS

For the purpose of standard ISO 9001:2000, the terms and definitions givenin ISO 9000 apply.

The following terms, used in this edition of ISO 9001 to describe thesupply chain, have been changed in the quality systems manual and applicablestandard operating procedure to reflect the vocabulary currently used.

The term “organization” is replaced by the term “supplier” used in

ISO 9001:1994, and refers to the unit to which this international standardapplies. Also, the term “supplier” is replaced by the term “subcontractor.”

Throughout the text of this quality systems manual and applicableprocedures the term “product” also means “service.”

ANALYSIS CERTIFICATE

An analysis certificate is a document that gives the results of the inspectionmade on a representative sample taken from a product before its delivery.It must contain the results of all checks in a list approved jointly by theclient and the supplier.

AUDITOR

An auditor is a person who is qualified and authorized to perform all orany portion of a quality system audit.

Audit

An audit is a systematic and independent examination to determine whether quality activities and related results comply with planned arrange-ments and whether these arrangements are implemented effectively andare suitable to achieve objectives.


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Audit Organization

An organization that regularly conducts quality assurance managementsystem audits to a required standard is known as an audit organization.

Batch

Batch refers to assignments of a batch of finished products to a client as

a function of that client’s requirements.

Conformity

Conformity refers to the state of a product satisfying specified requirements.

Documentation

Documentation is any recorded or pictorial information describing, defin-

ing, specifying, reporting, or certifying activities, requirements, procedures,or results.

Documentation Level

The position of a quality document in the quality assurance documentationsystem is its documentation level.

First Party Audits Audits carried out internally by an organization are called first party audits.


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Inspection

An inspection is an examination or measurement to verify whether anitem or activity conforms to a specified requirement.

Inspectors

Inspectors are appointed by the purchaser to provide advice on matters

relating to the product and inspection and to verify the achievement of the quality specified.

Lead Auditor

A lead auditor is an auditor who is qualified and authorized to managea quality system audit.

Management ReviewManagement review is a compulsory evaluation carried out by generalmanagement on the state and suitability of the quality system with respectto quality policy and new objectives resulting from the changed situation.

Nonconformity


Organization



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Provisional Auditor

A person who meets all requirements for registration except for auditexperience is a provisional auditor.

Quality

Quality refers to all properties and characteristics of a service that make

it capable of satisfying a client’s expressed or specified needs.

Quality Audit

A quality audit is a methodical and independent examination in order todetermine if quality-related activities and results satisfy predeterminedrequirements, and if these requirements are implemented ef ficiently andare capable of achieving the objectives.

Quality Assurance

Quality assurance refers to all predetermined and systematic actions nec-essary to give appropriate confidence that a product or a service satisfiesgiven quality requirements.

Quality Control

Quality control is that part of good manufacturing practice concerned with sampling, specifications, and testing. Its organization, documenta-tion, and release procedures ensure that the necessary and relevant testsare actually carried out and that materials are not released for use, norproducts released for sale or supply, until their quality has been judgedto be satisfactory.


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Quality Manual

A quality manual is a document describing general measures taken by the company to obtain quality in its products or services.

Quality Planning

A document specifying the processes of the quality management system

(including the product realization processes) and the resources to beapplied to a specific product, project, or contract can be referred to asquality plan.

Quality Policy

The overall quality intentions and direction of an organization formally expressed by top management are its quality policy.


The quality record refers to the filled-in record documents proving thatthe quality assurance and quality control actions have been done.

Quality System

The organizational structure, responsibilities, procedures, processes,and resources for implementing quality management comprise thequality system.


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Representative Sample A representative sample is a sample taken using a clearly defined proce-dure in order to obtain information about a batch.

Second Party Audits

Second party audits are audits of suppliers or potential suppliers under-taken directly by a purchasing organization including the purchase of products by one company from another within the same group.

Specification

The specification is a document that specifies the requirements with whichthe product and/or material must comply.

Supplier

The supplier is the organization or company.

Subcontractor

Any organization offering goods or services to the supplier is called asubcontractor.


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Third Party Audits

Third party audits are audits of organizations undertaken by an indepen-dent certification body or similar organization.

Traceability

Traceability is the capability of finding the history, use, or location of an

article by means of a recorded identification.

Validation

Validation is the act of checking a calculation or design through its stagesto verify that the assumptions made, input data, and method used haveproduced a valid result.

Verification Verification is the act of reviewing, inspecting, testing, checking, auditing,or otherwise verifying and documenting whether items, processes, ser-

vices, or documents conform to specified requirements.

The list is not conclusive as there are many other definitions in generaluse or contained in various standards and quality documents.


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The contents of the ISO 9003:1994 international standards are describedbelow in correspondence with ISO 9001:2001 to define quality systemrequirements and management responsibilities. The permissible exclusionsare grouped in a bracket and indicated as “not applicable.”

QUALITY SYSTEMS MANUALQUALITY MANAGEMENT SYSTEM Clause — 4.0,ISO 9003:1994

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Correspondence between ISO 9003:1994 and ISO 9001: 2000

Clause ISO 9003:1994 ISO 9001:2000

1.0 Scope 1.02.0 Normative reference 2.0

3.0 Definitions 3.0



4.1.1 Quality policy 5.1 + 5.3 + 5.4.1


4.1.2.1 Responsibility and authority 5.5.1 4.1.2.2 Resources 5.1 + 6.1 + 6.2.1 + 6.3

4.1.2.3 Management representative 5.5.2



4.2.1 General 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1


4.2.3 Quality planning 5.4.2 + 6.2.1 + (7.1, notapplicable)

4.3 Contract review (title only) 4.3.1 General

4.3.2 Review 5.2 + 7.2.1 + 7.2.2 + (7.2.3, notapplicable)

4.3.3 Amendment to a contract 7.2.2




4.3.4 Records 7.2.2

4.4 Design control (not applicable)


4.4.2 Design and development planning

(not applicable)

(7.3.1, not applicable)

4.4.3 Organizational and technicalinterfaces (not applicable)


4.4.4 Design input (not applicable) 7.2.1 + (7.3.2, not applicable)

4.4.5 Design output (not applicable) (7.3.3, not applicable)

4.4.6 Design review (not applicable) (7.3.1 + 7.3.4, not applicable)

4.4.7 Design verification (notapplicable)

(7.3.1 + 7.3.5, not applicable)

4.4.8 Design validation (not applicable) (7.3.1 + 7.3.6, not applicable)

4.4.9 Design changes (not applicable) (7.3.7, not applicable) 4.5 Document and data control(title only)

4.5.1 General 4.2.1 + 4.2.3

4.5.2 Document and data approval andissue

4.2.3


4.6 Purchasing (not applicable)


4.6.2 Evaluation of subcontractors (notapplicable) (7.4.1, not applicable)

4.6.3 Purchasing data (not applicable) (7.4.2, not applicable)

4.6.4 Verification of purchased product(not applicable)



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7.5.4


7.5.3

4.9 Process control (not applicable) 8.2.3 + 6.3 + 6.4 + (7.1 + 7.5.1+ 7.5.2, not applicable)


4.10.1 General 8.1 + (7.1, not applicable)

4.10.2 Receiving inspection and testing (7.4.3, not applicable) + 8.2.4

4.10.3 In-process inspection and testing (7.4.3 + 7.5.1, not applicable)+ 8.2.4

4.10.4 Final inspection and testing 7.4.3 + 8.2.4

4.10.5 Inspection and test records 7.5.3 + 8.2.4

4.11 Control of inspection, measuring,and test equipment (title only)

4.11.1 General 7.6


4.12 Inspection and test status (7.5.3, not applicable)

4.13 Control of nonconformingproduct (title only)

4.13.1 General 8.3

4.13.2 Review and dispositioning of

nonconforming product

8.3


4.14.1 General 8.5.2 + 8.5.3



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4.15 Handling, storage, packaging,preservation, and delivery(title only)

4.15.1 General

4.15.2 Handling 7.5.5

4.15.3 Storage 7.5.5



4.15.6 Delivery 7.5.5 + (7.5.1, not applicable)



4.18 Training 6.2.1 + 6.2.2

4.19 Servicing (not applicable) (7.1 + 7.5.1, not applicable) 4.20 Statistical techniques (title only)


4.20.2 Procedures


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QUALITY POLICY

(Company name) management has defined and documented its policy and objectives for, and commitment to, quality. (Company name) hasensured that this policy is understood, implemented, and maintained atall levels in the organization.

We believe that this approach is essential for the company in the longterm. Moreover, with the support of trained and motivated personnel, this

objective will enable us to continue making progress.The management believes in the effectiveness of a quality assurance

system based on complying with the provisions of ISO 9003 and ourprinciple of continual progress through defect prevention and improve-ment. This system is managed by our quality assurance department, whoserole is to implement and maintain a structure and control its evolution inorder to:

Adapt our organization to satisfy existing standards and modify it whenever necessary Write the necessary procedures and manuals, then keep them up

to date Perform personnel qualification and keep it updated with time Ensure that personnel are qualified and provide further training

according to our plan Correct omissions by corrective and preventive actions and monitor

their effectiveness


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Quality Objectives

It is ensured that quality objectives, including those needed to meetrequirements for product compliance, are established at relevant functionsand levels within the organization. The quality objectives are measurableand consistent with the quality policy.



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Provide an organogram of your company. Provide a brief history of thecompany, the products and services offered by the company, and thedepartments responsible.

Provide a brief history of the company. Provide a summary of services and products provided by the

company. Describe the key departments involved and their functions in brief. Provide an organogram. Provide definitions of quality-related terms used in the manual and

applicable procedures.


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ORGANIZATIONAL RESPONSIBILITY AND AUTHORITY

The responsibility, authority, and the interrelation of all personnel whomanage, perform, and verify work affecting quality are defined in theapplicable standard operating procedures.

The quality has been defined, particularly for personnel who need theorganizational freedom and authority to:

Verify the implementation of solutions through audits Identify and record products or services associated quality prob-

lems Provide solutions through designated channels Initiate and recommend corrective action to prevent the occurrence

of product nonconformity

Demonstrate control over further processing, delivery, or installation

of nonconforming product until the deficiency or unsatisfactory conditionhas been corrected.


Clause — 4.1.2.1,ISO 9003:1994

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RESOURCES

(Company name) has identified in-house verification requirements, provided adequate resources, and assigned trained personnel for verificationactivities (see 4.18). Verification activities include inspection, test, andmonitoring of the design production, installation, and servicing of theprocess and/or product; and design reviews and audits of the quality system, process, and/or products to be carried out by personnel indepen-

dent of those having direct responsibility for the work being performed.For verification activities, the organization critically follows the require-

ments specified for the competence, awareness, and training for personnelperforming quality-related work who may affect the end results. Theactions taken are reviewed for their effectiveness.

INFRASTRUCTURE

The provisions for buildings, equipment, and personnel are determinedand provided as appropriate to the company ’s operations.


Top management is committed to meeting the customer and regulatory requirements. Systematic and structured planning ensures identificationand availability of resources, implementation of quality policy throughoutthe organization, and achievement of management objectives in a timely

manner without compromising customer requirements.


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(Company name) has appointed a management representative who,irrespective of other responsibilities, has defined authority and respon-sibility for ensuring that the requirements of this standard are imple-mented and maintained.

QUALITY SYSTEMS MANUALMANAGEMENT REPRESENTATIVE Clause — 4.1.2.3,ISO 9003:1994

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MANAGEMENT REVIEW

The quality system in place is reviewed annually and, when necessary,is subject to management reviews to ensure continuing suitability andeffectiveness. The data and results of the reviews are recorded andmaintained.

REVIEW INPUTThe management reviews are conducted with a planned agenda toprovide direction for the company ’s quality operations. Input fromoutside and inside sources are welcome to ensure continuous improve-ment. The audit findings and areas of quality concern are discussed. Itis ensured that corrective and preventive measures are taken on time.The review input includes statistical evaluation of process performanceand product conformity.


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REVIEW OUTPUT

The decisions made in the management review committee meetings arefollowed to ensure:

Infrastructure and resources availability Review of customer requirements Continuous improvement and effectiveness of the documented

system


The quality policies, objectives, and documented pr ocedures arereviewed at specified frequency, and corrective actions are initiated toensure continual improvement based on audit findings and review of analytical data.


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GENERAL

(Company name) has established and maintained a documented quality system as a means of ensuring that the product conforms to specifiedrequirements. This includes:

The clarification of standards of acceptability for all features andrequirements, including those that contain a subjective element

The identification of any measurement requirement involving capa-bility that exceeds the known state-of-the-art in suf ficient time forthe needed capability to be developed

The identification and acquisition of any controls, processes,inspection equipment, fixtures, total production resources, andskills that may be needed to achieve the required quality

The preparation of documented quality system procedures andinstructions in accordance with the requirements of this standard

The preparation of quality plans and a quality manual in accor-dance with the specified requirements The updating, as necessary, of quality control, inspection, and

testing techniques, including the development of new instru-mentation

The effective implementation of the documented quality systemprocedures and instructions

The responsibilities in the quality system are described in Table 1.

Amend the table as relevant to your company. Permissible exclusions aremarked as “not applicable.”


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Table 1

Element in theQuality System Correspondence

ClauseISO 9001:2000


ISO 9001 Clause A D M

Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M

4.1 Management

responsibilities

5.1 + 5.3 + 5.4.1

+ 5.5.1+ 6.1 + 6.2.1 +

6.3 + 5.5.25.6.1 + 5.6.2 +

5.6.3 + 8.5.1

X * * * * * * * * * * *

4.2 Quality system 4.1 + 4.2.1 + 4.2.2 + 5.1 +5.4.1

5.4.2 + 6.2.1 +

(7.1, notapplicable)

* X * * * * * * * * * *

4.3 Contract review 5.2 + 7.2.1 +7.2.2 + (7.2.3,notapplicable)

* * * * * – – – – * X *

4.4 Design control(not applicable)

7.2.1, (7.3.1 +7.3.2 + 7.3.3 +7.3.4

7.3.5 + 7.3.6 +7.3.7, notapplicable)

– – – – – – – – – – – –


4.2.1 + 4.2.3 * * * * * * * X * * * *




4.6 Purchasing 7.4.1 (not

applicable)7.4.2 (notapplicable)

7.4.3 (notapplicable)

* * – * * – – * X – – *

4.7 Control ofcustomer-supplied product

7.5.4 – X – * – – – – – – – –

4.8 Productidentification and

traceability


* * X * * – – * * * * *

4.9 Process control(not applicable)

6.3 + 6.4 + 7.1+ (7.5.1, notapplicable) +7.5.2 + 8.2.3

– * X * – – – * – * – –


7.1 + 8.1 (notapplicable)

7.4.3. + (notapplicable)



8.2.4

– X * * – – – – – * – –

Table 1 (Continued)


ClauseISO 9001:2000



Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M





4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2+ 6.2.1 + 7.1


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7.6 – * * * – X – * – * – –



– X * * – – – * – * – –


8.3 * * * X * * – * * * * *

4.14 Corrective actions 8.5.2 + 8.5.38.4

* X * * * * * * * * * *

4.15 Handling, storage,packaging,preservation, anddelivery

7.5.5 + 7.5.1(notapplicable)

– * * * * – – – – * – X

4.16 Quality records 4.2.4 * * * X * * * * * * * *

4.17 Internal qualityaudits

8.2.2 + 8.2.3 * X * * * * – * * * * *

4.18 Training 6.2.1 + 6.2.2 * X * * * * X * * * * *

4.19 Servicing (notapplicable)

7.1 + 7.5.1 (notapplicable)

* * * * * – – * * * X *

Table 1 (Continued)


ClauseISO 9001:2000



Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M





4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2+ 6.2.1 + 7.1


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CONTROL MANUAL

The quality system manual provides descriptions of management efforts

and initiatives to ensure customer requirements are met with continuous

improvement in the final product inspection and testing activities. The

quality system manual and procedures:

Provide a documented system that controls the activity/ser-

vice/product Produce written procedures that define authority, responsibility,

and interfaces Ensure that the activity/service/product meets all specified cus-

tomer requirements

4.20 Statistical

techniques

8.1 + 8.2.3 +

8.2.4 + 8.4

* X * * – – – – – * – –


Key:ADM = Administration (Management) QUA = Quality AssurancePRD = Production QCD = Quality Control DepartmentSHP = Shipping PER = PersonnelPDL = Product Development Lab PUR = PurchasePAC = Packaging MKT = MarketingMPM = Materials Planning Manager MAI = Maintenance

Table 1 (Continued)


ClauseISO 9001:2000



Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M





4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2+ 6.2.1 + 7.1


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Promote a reputation in the marketplace through customer satisfaction Provide a system to ensure that all nonconformities, errors, defi-

ciencies, complaints, and quality problems are immediately iden-tified, controlled, and dealt with through feedback loops

Promote ef ficiency and cost effectiveness Motivate staff toward pride in carrying out their jobs Promote improved industrial relations through interfaces and inter-

departmental cooperation and input

Control all activity/service/product performance data through feed-back analysis Provide activity/service/product performance data through feed-

back analysis Identify and control training needs Show commitment to quality through maintaining constant quality

levels Improve communications Produce historical records to confirm levels of quality system

effectiveness and activity/service/product achievement Provide information for employee induction


(Company name) has identified and assigned a management representativeto ensure quality policies are established with due consideration to cus-tomer focus. Management reviews are conducted to ensure that the definedobjectives are met.

QUALITY OBJECTIVES

The quality objectives are well defined to prevent defects or errors occurringduring the whole process and to prevent failure of the end product.


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DOCUMENTATION

Documentation plays an important role in the effective control and imple-mentation of quality management system requirements. The quality policy,objective, and applicable procedures ensure to meet:

Mark a well-defined purpose or need Comply with applicable standards and specifications Meet regulatory requirements Satisfy users’/customers’ expectations Supply a product that is totally fit for use

Documents that need to be controlled are:

The quality manual Control procedures

Work instructions, including work orders and route cards Quality plans Drawings — including “as built” Specifications Inspection and test plans or requirements (usually included in work

instructions and quality plans) Records (inspection, quality, training, document control, calibra-

tion, and goods accepted and dispatched) Purchasing specifications, orders, and acknowledgments

Quotes, tenders, contracts, and contract reviews Audit plans and records Management reviews

The quality records are identified, established, and maintained.


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IMPLEMENTATION

Top management takes all necessary actions to implement the requirementof this international standard with a particular focus on customer require-ments.

The processes needed to achieve excellence are implemented. Interaction and interfaces are identified. Training needs are fulfilled. Actions resulting from the management reviews are communicated

and implemented. Sequences of interaction affecting the product quality are defined

and documented.

QUALITY PLANNING

The quality system requirements specified in clause 4.1 are achievedthrough proactive planning. Changes made to the system are documentedand controlled.


Quality plans are made specific to the product, project, or contract asappropriate to the company ’s operations. The records of quality plans aremaintained and include:

Determination of requirements related to the product Review of requirements related to the product


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CONTRACT REVIEW

(Company name) has established and maintained procedures for contractreview and for the coordination of these activities.

Each contract is reviewed to ensure that:

The requirements are adequately defined and documented. Any requirements differing from those in the tender are resolved. The ability of the supplier to meet contractual requirements is ensured.

The contract review activities, interfaces, and communication withinthe supplier’s organization are coordinated with the purchaser’s (clients)organization, as appropriate.

CUSTOMER FOCUS

Appropriate methods including statistical techniques are used to monitorthe customer requirements and their fulfillment.


The product requirements are reviewed before the contract or tender isaccepted. Product requirements are defined and communicated to thepersonnel responsible for the quality production. The unresolved and

ambiguous issues are resolved and documented. The changes made inthe product specifications are approved before execution of the order.Provisions are made for removing absolute drawings, procedures, workinstructions, and specifications from all work areas to ensure that they are correctly authorized versions. Provisions are made for emergency changes necessary to prevent the production of nonconforming material.


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CUSTOMER COMMUNICATON

The product information is determined and communicated at all levelsas appropriate, including customer complaints, changes, revisions, andfinal approvals.


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GENERAL




DESIGN INPUT


DESIGN OUTPUT



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DESIGN REVIEW




DESIGN VERIFICATION


DESIGN VALIDATION


DESIGN CHANGESNot applicable/justify.


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OUR COMPANY NAME HERE

DOCUMENT, DATA APPROVAL, AND ISSUES

The procedure is established and maintained to control all documents anddata that relate to the requirements of this standard. These documents arereviewed and approved for adequacy by authorized personnel prior toissue. This control ensures that:

Obsolete documents are promptly removed from all points of issueor use.

The pertinent issues of appropriate documents are available at alllocations where operations essential to the effective functioning of the quality system are performed.


Changes to documents are reviewed and approved by the same func-

tions/organizations that performed the original review and approval,unless specifically designated otherwise. The designated organizationshave access to pertinent background information upon which to basetheir review and approval.

Where practicable, the nature of the changes is identified in thedocument or the appropriate attachments.

A master list is established to identify the current revision of documentsin order to preclude the use of nonapplicable documents.

Documents are reissued after a practical number of changes have been

made.


Clause — 4.5,ISO 9003:1994

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GENERAL


VENDOR ASSESSMENT


PURCHASING DATA





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(Company name) has established and maintained procedures for verifica-tion, storage, and maintenance of purchaser (client) supplied productprovided for incorporation into the supply. Any such product that is lost,damaged, or is otherwise unsuitable for use is recorded and reported tothe purchaser (see 4.16).

Verification by the supplier does not absolve the purchaser of the

responsibility to provide an acceptable product.

QUALITY SYSTEMS MANUALCUSTOMER SUPPLIED PRODUCT Clause — 4.7,



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The procedure has been established and maintained for identifying theproduct from applicable drawing specifications, or other documents, dur-ing all stages of production, delivery, and installation.

PRODUCT TRACEABILITY

Where, and to the extent that, traceability is a specified requirement,individual products or batches have a unique identification. This identifi-cation is recorded (see 4.16).


Clause — 4.8,ISO 9003:1994

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PROCESS CONTROL


SPECIAL PROCESSES





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GENERALRECEIVING INSPECTION AND TESTING

The incoming products are not used or processed (except in the circum-stances described in 4.10.2.3) until they have been inspected or otherwise

verified as conforming to specified requirements. Verification is performedin accordance with the quality plan or documented procedures.

Where incoming product is released for urgent production purposes,it is positively identified and recorded (see 4.16) in order to permitimmediate recall and replacement in the event of nonconformance tospecified requirements.

In determining the amount and nature of the receiving inspection,consideration is given to the control exercised at the source, and docu-mented evidence of quality conformance is provided.

IN-PROCESS INSPECTION AND TESTING

Nonconforming product is identified. Hold the product until the required inspection and tests have been

completed or necessary reports have been received and verified,except when the product is released under positive recall proce-dures (see 4.10.1). Release under positive recall procedures doesnot preclude the inspection, testing, and identification of the prod-uct as required by the quality plan or documented procedures.

Product conformance is established to specified requirements by use of process monitoring and control methods.

(Company name) inspects, tests, and identifies the product asrequired by the quality plan or documented procedures.


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The quality plan or documented procedures for final inspection and testingrequire that all specified inspection and tests, including those specifiedeither on receipt of product or in-process, have been carried out and thatthe data meet specified requirements.

(Company name) carries out all final inspection and testing in accordance with the quality plan or documented procedures to complete the evidence

of conformance of the finished product to the specified requirements.No product is dispatched until all the activities specified in the quality

plan or documented procedures have been satisfactorily completed andthe associated data and documentation are available and authorized.


(Company name) establishes and maintains records that give evidence

that the product has passed inspection and/or test with defined acceptancecriteria (see 4.16).


The identification and traceability is maintained to ensure product recallin the event of nonconformity or for rework.


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(Company name) controls, calibrates, and maintain inspection, measur-ing, and test equipment, whether owned, on loan, or provided by theclient, to demonstrate the conformance of the product to the specifiedrequirements. Equipment is used in a manner that ensures that mea-surement uncertainty is known and is consistent with the r equiredmeasurement capability.

(Company name):

Assesses and documents the validity of previous inspection andtest results when inspection, measuring, and test equipment isfound to be out of calibration

Maintains calibration records for inspection, measuring, and testequipment (see 4.16)

Identifies inspection, measuring, and test equipment with a suit-

able indicator or approved identification record to show thecalibration status

Ensures that the inspection, measuring, and test equipment iscapable of the accuracy and precision necessary

Establishes, documents, and maintains calibration procedures,including details of equipment type, identification number, location,frequency of checks, check method, acceptance criteria, and theaction to be taken when results are unsatisfactory

Identifies, calibrates, and adjusts all inspection, measuring, and

test equipment and devices that can affect product quality atprescribed intervals or, prior to use, against certified equipmenthaving a known valid relationship to nationally recognized stan-dards. Where no such standards exist, the basis used for calibra-tion is documented.


Clause — 4.11,ISO 9003:1994

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Identifies the measurements to be made and the accuracy required,and selects the appropriate inspection, measuring, and test equipment

Ensures that the environmental conditions are suitable for thecalibrations, measurements, and tests being carried out

Ensures that the handling, preservation, and storage of inspection,measuring, and test equipment is such that the accuracy and fitnessfor use is maintained

Safeguards inspection, measuring, and test facilities, including both

test hardware and test software, from adjustments that wouldinvalidate the calibration setting.

Where test hardware (e.g., jigs, fixtures, templates, patterns) or testsoftware are used as suitable forms of inspection, they are checked toprove that they are capable of verifying the acceptability of the productprior to release for use during production and installation and arerechecked at prescribed intervals. The extent and frequency of such checksis established, and records are maintained as evidence of control (see

4.16). Measurement design data are made available when required by thepurchaser (client) or his/her representative for verification that the productis functionally adequate.


Clause — 4.11,ISO 9003:1994

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The inspection and test status of products is identified by using markings,authorized stamps, tags, labels, routing cards, inspection records, testsoftware, physical location, or other suitable means to indicate the con-formance or nonconformance of the product with regard to inspectionand tests performed. The identification of inspection and test status ismaintained, as necessary, throughout production and installation of the

product to ensure that only product that has passed the required inspec-tions and tests is dispatched, used, or installed.

Records identify the inspection authority responsible for the release of conforming product (see 4.16).


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(Company name) has established and maintained procedures to ensurethat product that does not conform to specified requirements is preventedfrom inadvertent use or installation, evaluated, segregated when practical,disposed of, and the functions concerned are notified.

NONCONFORMITY REVIEW AND DISPOSITIONThe responsibility for review and authority for the disposition of noncon-forming product is defined.

Nonconforming product is reviewed in accordance with documentedprocedures. It may be:

Reworked to meet the specified requirements Accepted with or without repair by concession

Regraded for alternative application Rejected or scrapped

Where required by the contract, the proposed use or repair of product(see 4.13.1b) that does not conform to specified requirements is reportedfor concession to the purchaser or the purchaser’s (client) representative.The description of nonconformity or repairs that have been accepted isrecorded to denote that actual conditions do not, in fact, conform to theacceptable standard (see 4.16).

Repaired and reworked product is reinspected in accordance withdocumented procedures.


Clause — 4.13,ISO 9003:1994

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CORRECTIVE ACTION

The procedure is established, documented, and maintained for:

Implementing and recording changes in procedures resulting fromcorrective action

Applying controls to ensure that corrective actions are taken andthat they are effective

Initiating preventive actions to deal with problems to a levelcorresponding to the risks encountered

Analyzing all processes, work operations, concessions, quality records, service reports, and customer complaints to detect andeliminate potential causes of nonconforming product

Investigating the cause of nonconforming product and the correc-tive action needed to prevent recurrence


Revision 0


8.4 + 8.5.2 + 8.5.3


Date Supersedes

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Date Issue

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HANDLING, STORAGE, PACKAGING, AND DELIVERY

General

The procedure is established, documented, and maintained for handling,storage, packaging, and delivery of the product.

Handling

The methods and means of handling that prevent damage or deteriorationare provided for the product.

Storage

The secured storage areas or stock rooms are provided to prevent damageor deterioration of the product pending use or delivery. Appropriate

methods for authorizing receipt and the dispatch to and from such areasis stipulated. In order to detect deterioration, the condition of the productis assessed at appropriate intervals.

Packing

The packing, preservation, and marking processes (including materialsused) are controlled to the extent necessary to ensure that conformanceto specified requirements is identified, preserved, and segregated for all

products from the time of receipt until the responsibility ceases.


Clause — 4.15,ISO 9003:1994

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7.5.1 + 7.5.5


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Delivery

The arrangements are made for the protection of the quality of the productafter final inspection and test. Where contractually specified, this protectionis extended to include delivery to destination.


Clause — 4.15,ISO 9003:1994

Revision 0


7.5.1 + 7.5.5


Date Supersedes

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Date Issue

mm/dd/yyyy

Page 2 of 2






QUALITY RECORDS

Quality records are maintained to demonstrate achievement of the requiredquality and the effective operation of the quality system. Pertinent sub-contractor quality records are an element of these data.

The procedure is established and maintained for identification, collection,indexing, filing, storage, maintenance, and disposition of quality records.

All quality records are legible and identifiable to the product involved.

Quality records are stored and maintained in such a way that they arereadily retrievable in facilities that provide a suitable environment tominimize deterioration or damage and to prevent loss. Retention times of quality records have been established and recorded. Where agreed con-tractually, quality records are made available for evaluation by the pur-chaser (client) or the purchaser’s representative for an agreed upon period.


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4.2.4


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The comprehensive system of planned and documented internal quality audits is carried out to verify whether quality activities comply with plannedarrangements and to determine the effectiveness of the quality system.

The audits and follow-up actions are carried out in accordance withdocumented procedures.

Audits are scheduled on the basis of the status and importance of

the activity.The results of the audits are documented and brought to the attention

of the personnel having responsibility in the area audited. The manage-ment personnel responsible for the area takes timely corrective action forthe deficiencies found by the audits (see 4.1.3).


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TRAINING

The procedure is established for identifying the training needs and toprovide for the training of all personnel performing activities affectingquality. Personnel performing specific assigned tasks are qualified on thebasis of appropriate education, training, and/or experience, as required.

Appropriate records of training are maintained (see 4.16).


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6.2.1 + 6.2.2


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SERVICING



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7.1 + 7.5.1


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Where appropriate, the procedure is established for identifying adequatestatistical techniques required for verifying the acceptability of processcapability and product characteristics.

QUALITY SYSTEMS MANUALSTATISTICAL TECHNIQUES Clause — 4.20, ISO9003:1994

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8.1 + 8.2.3 + 8.4


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Appendix IVReference SOPs

Subject

ClausesISO 9001

:2000Ref. SOP

No.Revision

No. Issued On






Quality management system(title only)




4.2 ISO-4.2ISO-4.5

NewNew

mm/dd/yymm/dd/yy


NewNew

mm/dd/yymm/dd/yy

Quality manual 4.2.2 ISO-4.2 New mm/dd/yyControl of documents 4.2.3 ISO-4.5 New mm/dd/yy

Control of quality records 4.2.4 ISO-4.1 New mm/dd/yy


5.0 ISO-4.1ISO-4.2

NewNew

mm/dd/yymm/dd/yy


NewNew

mm/dd/yymm/dd/yy




NewNew

mm/dd/yymm/dd/yy


NewNew

mm/dd/yymm/dd/yy






Management representative 5.5.2 ISO-4.1 New mm/dd/yyInternal communication 5.5.3 ISO-4.1 New mm/dd/yy











Provision of resources 6.1 ISO-4.1 New mm/dd/yyHuman resources (title only) 6.2 ISO-4.1

ISO-4.2ISO-4.16

NewNewNew



ISO-4.2 New mm/dd/yy




Work environment 6.4 ISO-4.9 New mm/dd/yyProduct realization

(title only)7.0 ISO-4.2

ISO-4.9ISO-4.10

NewNewNew



7.1 EP EP EP


7.2 ISO-4.3ISO-4.4

NewNew

mm/dd/yymm/dd/yy

Determination of

requirements related to theproduct




Customer communication 7.2.3 EP EP EP


7.3 EP EP EP


7.3.1 EP EP EP


7.3.2 EP EP EP


7.3.3 EP EP EP


Appendix IVReference SOPs (Continued)

Subject

ClausesISO 9001

:2000Ref. SOP

No.Revision

No. Issued On





7.3.4 EP EP EP


7.3.5 EP EP EP

Design and development

validation

7.3.6 EP EP EP

Control of design anddevelopment changes

7.3.7 EP EP EP

Purchasing (title only) 7.4 EP EP EP

Purchasing process 7.4.1 EP EP EP

Purchasing information 7.4.2 EP EP EP

Verification of purchasedproduct

7.4.3 EP EP EP

Production and service

provision (title only)

7.5 ISO-4.9

ISO-4.10ISO-4.15ISO-4.19

New

NewNewNew

mm/dd/yy


Control of production andservice provision

7.5.1 EP EP EP


7.5.2 EP EP EP

Identification and traceability 7.5.3 EP EP EP






8.0 ISO-4.10ISO-4.17ISO-4.20

NewNewNew



NewNewNew


Monitoring andmeasurement (title only)

8.2 ISO-4.9ISO-4.10ISO-4.17ISO-4.20

NewNewNewNew




Subject

ClausesISO 9001

:2000Ref. SOP

No.Revision

No. Issued On





NewNew

mm/dd/yymm/dd/yy



8.2.3 ISO-4.9ISO-4.17

ISO-4.20

NewNew

New

mm/dd/yymm/dd/yy

mm/dd/yyMonitoring and

measurement of products8.2.4 ISO-4.1

ISO-4.2ISO-4.10

NewNewNew


Control of nonconformingproduct



NewNew

mm/dd/yymm/dd/yy


Continual improvement 8.5.1 ISO-4.1 New mm/dd/yyCorrective action 8.5.2 ISO-4.14 New mm/dd/yy



Subject

ClausesISO 9001

:2000Ref. SOP

No.Revision

No. Issued On



300.30.1




STANDARD OPERATING PROCEDURE


PURPOSE

To describe the elements of management responsibility in accordance withclause 4.1 of ISO 9001 and the corresponding clauses of internationalstandard ISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers or supervisors tounderstand and implement management responsibilities described in theprocedure. The ISO 9000 systems coordinator (management representa-tive) is responsible for SOP compliance.

PROCEDUREMANAGEMENT RESPONSIBILITY

1. The quality management policies and objectives are stated anddefined in the quality manual, numbers QM-1, QM-2, QM-3, andQM-4, respectively (select any one of these as a model). Thecontents described in the quality manual and applicable proceduresare relevant to the size of the departments within the organization,the types of activities, the complexity of the process, and the

interactions and competence of the personnel.2. The quality policy defines measurable quality goals and relates

needs/expectations, which include: Meet contractual requirements/satisfy users Comply with applicable standards and specifications Comply with the company ’s standard operating procedures

SUBJECT: MANAGEMENT RESPONSIBILITY SOP NO: ISO – 4.1

Corresponding Clause: ISO 9001:2000 5.1 + 5.3 + 5.4.1 + 5.5.1 + 5.5.2+ 5.5.3 + 5.6 + 5.6.1 + 5.6.2 +5.6.3 + 6.1 + 6.2.1 + 6.3 + 7.1

Distributed To: Based on:ANSI/ASQC Q 9001-1994

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3. The senior company management representative authorizes thequality policy statement.

4. The responsibilities, authorities, and interrelationships of personnelare fully described (provide your company organization chart) forall quality activities in the quality manual as well as in the applicableprocedures described in the quality manual appendix and otherprocedures applicable to your company ’s operations.

5. Each procedure fully describes the purpose, responsibility, author-ity, and interrelationships of personnel for all quality activities.

6. The responsibilities for personnel related to quality assurance func-tions are defined in the job description file.

7. The responsible personnel allocated for the management and ver-ification of the following work activities are suitably qualified: Contract review Design review System auditing/corrective action Materials control

8. The quality manual is reviewed and revised at least once a year.The master quality manual is kept with the ISO 9000 coordinator.The distribution copies are stamped with a copy number Therecipients acknowledge the receipt and replacement.

9. Documents needed by the organization to ensure effective plan-ning, operations, and control of processes are established.

10. Processes needed for the quality management system are referred to

in the manual and in the applicable procedures, including processesfor management activities, provision of resources, product realization,and measurement. Where an organization chooses to outsource any process that affects product conformity with requirements, the orga-nization ensures control over that process. Control of such outsourcedprocesses is identified within the quality management system.




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11. There is an appointed management representative quality assur-ance manager (ISO 9000 system coordinator), independent of other functions, with the necessary authority and responsibility to ensure that the requirements of the standard are implementedand maintained.

12. The management representative provides information to the topmanagement relating to the performance of the quality manage-ment system.

13. The management representative is responsible for organizing themanagement reviews of the quality systems, e.g., every threemonths.

14. The management reviews are undertaken against defined/measur-able goals and objectives, which incorporate: Internal audit

Customer complaints Nonconformance Training Contract review

15. Records of the management reviews are maintained.16. The management reviews take into consideration customer needs

and expectations.17. The distribution of the quality manual and standard operating

procedures is controlled.

18. The terms and definitions used in the development, demonstration,and implementation of the quality system refer to standardISO 9000.




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Date Issue:

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DOCUMENTATION

1. Quality manual and applicable procedures/policy/objectives2. Organization chart

3. Personnel qualification file (document describing the qualificationand experience required for each specific quality-related job)4. Job description file5. Internal audit reports (system)6. Management review minutes7. Management action plans

REASONS FOR REVISION

mm-dd-yy 1) First time issued for (your company name).




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300.30.2




STANDARD OPERATING PROCEDUREYOUR COMPANY NAME HERE

PURPOSE

To describe the elements of the quality system in accordance with clause4.2 of ISO 9001 and the corresponding clauses of international standardISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers or supervisors tounderstand and implement management responsibilities described in theprocedure. The ISO 9000 systems coordinator (management representa-tive) is responsible for SOP compliance.

PROCEDURE

The company has established and maintained the following documentedquality system as a means of ensuring that the product/services conformto specified requirements of this international standard.

QUALITY SYSTEMS

1. Top management is committed to the development and implemen-tation of the quality management system and to continually improv-ing its effectiveness by: Communicating to the organization the importance of meeting

customer, statutory, and regulatory requirements Establishing the quality policy Ensuring that quality objectives are established Conducting management reviews and ensuring the availability

of resources

SUBJECT: QUALITY SYSTEMS SOP NO: ISO – 4.2

Corresponding Clause: ISO 9001:2000 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1+ 5.4.2 + 6.2.1 + 7.1

Distributed To: Based on:ANSI/ASQC Q 9001-

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2. The quality objectives, including those needed to meet require-ments for the product, are established at relevant functions andlevels within the organization. The quality objectives are measur-able and consistent with the quality policy.

3. The key quality management system documentation includes: Documented statements of the quality policy and quality objectives A quality manual Documented procedures required by this international standard Documents needed by the organization to ensure the effective

planning, operation, and control of its processes Quality records required by this international standard

4. The distribution of quality management system documentation iscontrolled. The documented quality management system gives dueconsideration to the following elements:

All resources and skills needed to achieve the required quality The compatibility of procedures and applicable documentation Updating of verification techniques and equipment Identification and development of measurement requirements

that exceed present capabilities Verification during product development Defining levels of acceptable quality, including subjective

standards Identification, preparation, and retention of quality records

Identifying the processes needed for the quality managementsystem and their application throughout the organization

Determination of the sequence and interaction of these processes Determination of criteria and methods needed to ensure that

both the operation and control of these processes are effective

SUBJECT: QUALITY SYSTEM SOP NO: ISO – 4.2



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Ensuring the availability of resources and information necessary to support the operation and monitoring of these processes

Monitoring, measurement, and analysis of these processes andimplementation of actions necessary to achieve planned resultsand continual improvement of these processes.

5. The quality manual outlines the structure of the quality manage-ment system and reference procedures.

6. The contents of the quality manual include: The scope of the quality management system, including details

of and justification for any exclusions The documented procedures established for the quality man-

agement system or reference to them A description of the interaction between the processes of the

quality management system

7. The contents of the quality management system documentationdiffer from one department to another due to: The size of the department and type of activities The complexity of processes and their interactions The competence of personnel

8. The procedures/work instructions are documented, describing allquality-related activities and authorities (provide details in a sepa-rate work instruction manual).

9. The processes needed for the quality management system referred

to above include processes for management activities, provisionof resources, product realization, and measurement.

10. Concerning the outsourced processes that affect product conformity with requirements, the organization ensures their control and iden-tification within the quality management system.




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11. The documentation is maintained both in hardware and softwareform as appropriate to the company ’s operations.

12. Personnel performing work affecting product quality are competenton the basis of appropriate education, training, skills, and experience.

13. The planning of the quality management system is carried out inorder to meet the quality objectives, maintain the system integrity

when changes to the quality management system are planned andimplemented, and develop the processes needed for product real-ization. Planning of product realization is consistent with the require-ments of the other processes of the quality management system.

14. In planning product realization, the organization determines thefollowing, as appropriate: Quality objectives and requirements for the product The need to establish processes and documents and provide

resources specific to the product Required verification, validation, monitoring, inspection, and test

activities specific to fulfill the product requirements Records needed to provide evidence that the realization pro-

cesses and resulting product fulfill requirements15. Quality plans are prepared in accordance with the requirements

of the standard where applicable (provide details).16. The output of this planning is maintained in a suitable form

according to the organization’s method of operations.

17. The responsibilities and authorities are defined in the followingquality matrix in Table 1, based on the ISO 9001, ISO 9002, andISO 9003 series of standards with a corresponding clause of inter-national standard ISO 9001:2000. Amend the matrix to suit yourcompany ’s operations.




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RESPONSIBILITIES AND AUTHORITY IN THE QUALITY SYSTEM





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Date Issue:

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Table 1

Elements in the QualitySystem ISO 9001:1994

Clauses

REF.ISO

9002

REF.ISO

9003

CorrespondingClause

ISO 9001:2000


A D M

Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M


APP APP 5.1 + 5.3 + 5.4.1+ 5.5.1

+ 6.1 + 6.2.1 +6.3

5.5.25.6.1 + 5.6.2 +

5.6.3 + 8.5.1

X * * * * * * * * * * *

4.2 Quality system APP APP 4.1 + 4.2.1 + 4.2.2 + 5.1 +5.4.1

5.4.2 + 6.2.1 +7.1

* X * * * * * * * **

*

4.3 Contract review APP APP 5.2 + 7.2.1 +7.2.2 + 7.2.3

* * * * * – – – – * X *

4.4 Design control NA NA 7.3.17.2.1 + 7.3.27.3.37.3.47.3.57.3.67.3.7

* * – * – – – X * – * –





APP APP 4.2.1 + 4.2.3

* * * * * * * X * * * * 4.6 Purchasing APP NA 7.4.1

7.4.27.4.3

* * – * * – – * X – – *


APP APP 7.5.4 – X – * – – – – – – – –

4.8 Productidentification

and traceability

APP APP 7.5.3 * * X * * – – * * * * *

4.9 Process control APP NA 6.3 + 6.4 + 7.1 +7.5.1 + 7.5.2 +8.2.3

– * X * – – – * – * – –


APP APP 7.1 + 8.17.4.3 + 8.2.47.5.17.5.3

– X * * – – – – – * – –

4.11 Inspection,measurement,and test

equipment

APP APP 7.6 – * * * – X – * – * – –


APP APP 7.5.3 – X * * – – – * – * – –


APP APP 8.3 * * * X * * – * * * * *

Table 1 (Continued)


Clauses

REF.ISO

9002

REF.ISO

9003

CorrespondingClause

ISO 9001:2000


A D M

Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M





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mm-dd-yy

Date Issue:

mm-dd-yy

Page 6 of 8





APP APP 8.5.2 + 8.5.38.4

* X * * * * * * * * * *

4.15 Handling,storage,packaging,preservation,and delivery

APP APP 7.5.5 + 7.5.1

– * * * * – – – – * – X

4.16 Quality records APP APP 4.2.4 * * * X * * * * * * * * 4.17 Internal quality

auditsAPP APP 8.2.2 + 8.2.3 * X * * * * – * * * * *

4.18 Training APP APP 6.2.1 + 6.2.2 * X * * * * X * * * * * 4.19 Servicing NA NA 7.1 + 7.5.1 * * * * * – – * * * X * 4.20 Statistical

techniquesAPP APP 8.1 + 8.2.3 +

8.2.4 + 8.4* X * * – – – – – * – –

X RESPONSIBLE FUNCTIONS * FUNCTIONS CONCERNED – NOT APPLICABLE

Key:ADM = Administration (Management) QUA = Quality AssurancePRD = Production QCD = Quality Control DepartmentSHP = Shipping PER = PersonnelPDL = Product Development Lab PUR = PurchasePAC = Packaging MKT = MarketingMPM = Materials Planning Manager APP = ApplicableNA = Not Applicable MAI = Maintenance

Table 1 (Continued)


Clauses

REF.ISO

9002

REF.ISO

9003

CorrespondingClause

ISO 9001:2000


A D M

Q U A

P R D

Q C D

S H P

M A I

P E R

P D L

P U R

P A C

M K T

M P M





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mm-dd-yy

Date Issue:

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Page 7 of 8





DOCUMENTATION

1. Quality manual2. Standard operating procedures/training records

3. Work instructions manual/training records4. Training manual/training records5. Equipment manual/training records






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300.30.3






PURPOSE

To describe the elements of contract review in accordance with clause

4.3 of ISO 9001 standard and corresponding clauses of an international

standard ISO 9001:2000.

RESPONSIBILITYIt is the responsibility of the particular departmental managers and supervisors

concerned (marketing and sales) to understand and implement management

responsibilities described in the procedure. The ISO systems coordinator

(management representative) is responsible for SOP compliance.

PROCEDURE

1. The company has established and maintained a procedure forcontract review and for the coordination of these activities. Thecompany ensures that the following customer requirements are

determined and fulfilled with the aim of enhancing customer

satisfaction. A designated and authorized staff is responsible for

reviewing each contract to ensure:

The requirements are adequately defined and documented. The tender, contract, order/delivery dates, and penalties are

agreed upon and accepted. Verbal orders from the clients are documented and confirmed

before processing. Any requirements differing from those in the tender are resolved. The capacity to meet contractual requirements is reviewed and

documented.

SUBJECT: CONTRACT REVIEW SOP NO: ISO – 4.3

Corresponding Clause: ISO 9001:2000 5.2 + 7.2.1 + 7.2.2 + 7.2.3


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The appropriate departments are notified in writing of any variations in the client’s contract.

Requirements specified by the customer, including the require-ments for delivery and postdelivery activities, are fulfilled.

Requirements not stated by the customer but necessary forspecified use or known and intended use are fulfilled.

2. The company reviews the requirements related to the product.

This review is conducted prior to the organization’s commitmentto supply a product to the customer (e.g., submission of tenders,acceptance of contracts of orders, acceptance of changes to con-tracts or orders) to ensure that: Product requirements are defined. Contract or order requirements differing from those previously

expressed are resolved. The organization has the ability to meet the defined require-

ments.

Records of the results of the review and actions arising fromthe review are maintained.

3. The review and approval arrangements include consideration of (if applicable): Program Internal resources External resources Risk factors Statutory/regulatory requirements related to the contract

Project stages and reviews Documentation of project details Record of contract review Statutory and regulatory requirements related to the product




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4. The work plan identifies the following elements: The client brief Principal personnel, responsibilities, and authority Other parties associated with the job Principal stages of the project, including reviews and approvals Arrangements for communication and consultation between the

parties

Specific project procedures, where needed The job record/filing system Final review and approval

5. The review includes any additional requirements determined by the organization.

6. Where the customer provides no documented statement of require-ments, the customer requirements are confirmed by the organiza-tion before acceptance.

7. Where product requirements are changed, the organization ensures

that relevant documents are amended and that relevant personnelare made aware of the changed requirements.

8. In situations such as Internet sales, a formal review is impracticalfor each order. Instead, the review covers product informationprovided in the catalogues of advertising material.

9. Effective arrangements for communicating with customers aremaintained, with particular reference to: Product information Inquiries, contracts, or order handling, including amendments

Customer feedback, including customer complaints




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DOCUMENTATION

Purchase requisition from the clients Quotation/agreement/contract Approved purchase order Material release certificate of analysis

Client acknowledgment of the goods Customer’s goods receiving reports (clients)






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300.30.4






PURPOSE

To describe the design control procedure in accordance with clause 4.4 of

ISO 9001 and corresponding clauses of international standard ISO 9001:2000.

RESPONSIBILITYIt is the responsibility of the particular departmental managers or supervisors

concerned (product development) to understand and implement manage-

ment responsibilities described in the procedure. The ISO systems coordi-

nator (management representative) is responsible for SOP compliance.

PROCEDURE

The procedure has been established and maintained to control and verify

the design of the product services in order to ensure that the specified

requirements are met. Control of design is achieved through design,

planning, identification of design input, verification of design, stage output,control of changes, and validation of the eventual product or service. Each

phase of design is carefully controlled to ensure that it achieves the

purchaser’s or product brief requirements.

1. The designing and development of the product is controlled.

2. During the design and development planning, the organizationdetermines the following:

The design and development stages The review, verification, and validation that are appropriate to

each design and development stage The responsibilities and authorities for design and development

SUBJECT: DESIGN CONTROL SOP NO: ISO – 4.4

Corresponding Clause: ISO 9001:2000 7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1+ 7.3.3 + 7.3.6 + 7.3.7


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3. The personnel supervising the design development are suitably qualified/experienced.

4. The design scheme is traceable to the basis against which thedesign has been prepared (if applicable). The design route starts with the input of information to the

design team. This input is usually referred to as the design brief.

The brief may consist of information from simple verbal instruc-tions to very detailed drawings and specifications. Information for the brief comes from marketing, sales, and

customer requirements. It is very important to ensure that the brief given to the design

team is transmitted formally to ensure that the design personnelare aware of the requirements. This may require several meetings

with the customer to ensure that the requirements are perfectly clear prior to starting any design work.

Changes to the design brief must be carefully controlled to assesstheir cost and effect on work completed up to the point of change.

5. The design scheme is reviewed to give due consideration tocontract review actions.

6. The design and development are reviewed at regular intervals inaccordance with the planned program.

7. Requirements for product development are determined and recordsare maintained, including functional and performance require-

ments, applicable statutory and regulatory requirements, whereapplicable, information derived from previous similar designs, andother requirements essential for design and development.

8. The requirements are complete, unambiguous, and clear.9. The operability, maintainability, reliability, safety, interchangeabil-

ity, and spare parts aspects are suitably addressed.




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10. The design and development responsibilities are clearly assigned.11. The design function or team is responsible for translating the design

brief into drawings and technical specifications for materials, prod-ucts, processes, and services that satisfy the customer’s expectationsat an acceptable cost, which reflects a return on capital invested.

12. Design tasks may be either subcontracted or carried out in-house.

Whichever is chosen, management is responsible for specifically assigning tasks and responsibilities that shall include the require-ments for achieving quality.

13. External design is controlled to the same extent as internal design.Design staff have the necessary qualifications, experience, training,and expertise to carry out the tasks assigned to them. This requires

verification prior to assigning tasks and responsibilities.14. Design management establishes design programs with time-phased

checkpoints, which are relative to the product or service and

translate the customer’s needs and marketing information into clearspecifications.15. The design program is determined by the product or service

application, complexity, technology, standardization, and pastproven designs compared to the risks involved. Safety, environ-mental, and other regulations shall be taken into account.

16. The following design factors are taken into consideration: Product application Design complexity

Technology being used Degree of standardization Compatibility with proven designs Customer needs Consideration of safety requirements




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Environmental and other regulations The quality policy Statutory requirements

17. The calculations, design, and drawings are rechecked.18. The quality assurance quality requirements are unambiguous and

define the quality characteristics. Special requirements including

safeguards against misuse, reliability, maintainability, and service-ability throughout reasonable life expectancy will also be consid-ered.

19. Product testing and measurement are specified and include: Performance target values and tolerances Acceptance/rejection criteria Test and measurement methods and equipment Computer software considerations (if used)

20. All relevant personnel are involved with the design review of the

design/functions.21. Participants in such reviews include representatives of functionsconcerned with the design and development stage(s) beingreviewed. Records of the results of the reviews and any necessary actions are maintained.

22. The design reviews clearly indicate the scope of the review andactions decided.

23. The actions completed are recorded.24. Changes to the design are documented for proposing, reviewing,

approving, and implementing.25. At suitable stages, systematic reviews of design and development

are conducted to evaluate the ability of the results of design anddevelopment to fulfill requirements, identify any problems, andpropose necessary actions.




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26. Changes to the design include review of interfaces.27. The interfaces between different groups involved in design and

development are managed to ensure effective communication andclear assignment of responsibility. Documentation is updated, asappropriate, as the design and development progress.

28. Participants at each design review include representatives of all

functions affecting quality as appropriate to the phase beingreviewed.29. The aim of each review is to ensure that the design is proceeding

according to plan and is meeting the specification or customerrequirements. The review may also identify and anticipate problemareas or inadequacies and initiate corrective actions. It may alsoreview the adequacy of any corrective actions taken since the lastreview took place.

30. It is prudent to raise an agenda for design reviews to ensure that

nothing is missed and that reviews do not overrun the timeallocated to them.31. Elements of design plans and reviews include items pertaining to

customer needs and satisfaction. Comparison of purchase needs expressed in the product brief

with technical specifications for materials, products, and processes Verification of design through data and calculation checks and

validation of design through prototype tests, where applicable Ability to perform under expected conditions of use and

environment Considerations of unintended uses and misuses Safety and environmental compatibility Compliance with regulatory requirements, national and interna-

tional standards, and corporate practices




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32. The technical data of the design are used to provide instruction,maintenance, and spare documentation at the production phase.

33. The materials used are standardized.34. The information (reference literature) adequate for the scope of

work is maintained.35. After completion of design, verification is performed to ensure that

the design and development outputs have satisfied the design anddevelopment input requirements. Records of the results of the verification and any necessary actions are maintained.

36. Design verification is carried out at suf ficient planned stages by applying analytical evaluation or other methods to ascertain thatthe design stage output is achieving the design stage input require-ment parameters. Methods of verification are: FMEA, failure mode and effects analysis Fault tree analysis

Risk audit Inspection and test of prototypes or production samples Independent evaluation to verify original calculations or to pro-

vide alternatives and/or perform tests to produce results forcomparison

Adequate numbers of samples are tested to ensure statistical con-fidence in the results.

37. Design evaluation of performance, reliability, durability, maintain-ability, and safety under expected operational and storage condi-

tions is carried out.38. Quality control techniques are applied to ensure and verify that

all design features are as intended and that any changes to thedesign have been authorized, distributed, accomplished, andrecorded.




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39. The results of verification, evaluation, and tests are recorded anddocumented to provide evidence of conformance of the actualdesign to the planned design. This allows for comparison of thedesign input against the design output.

40. After completion, designs are validated/tested to ensure that they meet customer needs/requirements. The design outputs are

approved prior to release to ensure that they: Satisfy customer requirements Meet the input requirements for design and development Provide appropriate information for purchasing, production, and

service provision Contain or reference product acceptance criteria Specify the characteristics of the product that are essential for

its safe and proper use41. The validation is performed in accordance with a planned arrange-

ment to ensure that the resulting product is capable of fulfillingthe requirements for the specified or known intended use orapplication. Wherever practicable, validation is completed priorto the delivery or implementation of the product. Records of theresults of validation and any necessary actions are maintained.

42. The quality system provides for a review to determine whetherproduction capability and field support are adequate for the new or redesigned product. Depending upon the type of product, thereview may cover the following points:

Availability and adequacy of installation, commissioning, oper-ation, maintenance, and repair manuals

Existence of an adequate distribution and customer serviceorganization

Training of field personnel




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Field trials (validation) Certification of satisfactory completion of qualification tests Physical inspection of early production units and their packaging

and labelling Evidence of process capability to meet the specification produc-

tion requirements

43. The feedback obtained from the clients is used effectively in thedevelopment of future designs.

DOCUMENTATION

1. Design input (request)2. Design development data3. Design reference material4. Design change control form5. Design output form data6. Design verification data7. Product development file






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300.30.5






PURPOSE

To describe the document and data control in accordance with clause 4.5 of ISO 9001 and corresponding clauses of international standard ISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers to understand andimplement management responsibilities described in the procedure. TheISO systems coordinator (management representative) is responsible forSOP compliance.

PROCEDURE

1. The management has defined and documented its policy andobjectives for, and commitment to, quality. This policy is relevantto the organizational goals and the expectations and needs of customers. It is ensured that this policy is understood, implemented,and maintained at all levels in the organization.

2. This requirement is achieved by raising and using the followingquality documentation.a. Quality Assurance Manual: A statement of company quality

policy (signed by the chief executive) and a declaration of intent

as to how the requirements of the nominated quality manage-ment standards are addressed. The quality assurance manualprovides a description of senior and quality assurance manage-ment responsibilities and the scope of the service offered by the organization. The manual contains organization charts (orga-nograms) and key responsibilities of senior management.

SUBJECT: DOCUMENT AND DATA CONTROL SOP NO: ISO – 4.5

Corresponding Clause: ISO 9001:2000 4.2.1 + 4.2.3


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b. Detailed Procedures: Provides a listing of the authorized prac-tices, responsibilities, and interfaces to be adopted in pursuit of the company ’s activities, in particular those that relate to, orfollow on from, different departments. Responsibilities of middleand junior management are described.

c. Work Instructions: Written instructions are used within depart-ments and contain specific details of how particular tasks are

to be carried out. These are the backbone of the quality systemas they describe in great detail how “the task” is to be carried out.d. Additional Contract Procedures: These are additional proce-

dures for specific contracts and include precise purchaserrequirements, procedural matters in relation to outside organi-zations involved, and any additional controls required due tothe nature of the task or risk factor involved.

e. Quality Plans: Quality plans describe the strategy to assure therequired quality at each stage of the task without disproportionate

effort to produce the plan. Plans are made available early on inthe project, rather than a “ wallpapering” exercise at the end tosuit the purchaser’s quality assurance representative. Quality plansare used in contract situations where the purchaser or his/hernominated representative wishes to control various phases of thetask. They nominate hold, stop, report, and documentation pointsbeyond which the supplier may not progress until given permissionto do so. The plans are drawn up by either the purchaser or thesupplier, depending on the contract or quality, and then approved.

3. Documents issued to casual users who will only use them forreference, e.g., a purchaser, client, or customer, are clearly distin-guished from those issued for the controlled copy circulation asthey need not be kept up to date. They are marked: “uncontrolledcopy ” (will not be maintained), “this copy will not be kept up todate,” or “check for latest issue before use.”




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4. The documentation can be in any form or type of medium asappropriate to the company ’s operations.

5. Documents required by the quality management system are con-trolled. Quality records are a special type of document and arecontrolled according to the requirements given in this interna-tional standard.

6. The status of documents is indicated in the current registers. The

documents are identified by a specific number and are availableat the appropriate workplaces.7. The documents are legible and readily identifiable.8. All of these documents are controlled, issued, and recorded. Special

attention must be paid to any changes to controlled documents aslack of control can have disastrous effects at the point of use of the document.

9. A clear definition of the controls is applied and included in theprocedures that govern the use of documents. This includes:

Responsibility for the creation, authorization, revision, and issu-ing of controlled documents

Formats to be used Identification of issue, revision, or amendment status Indentification of the reason for the change Instructions for removal of superseded and obsolete documents

from the point of use How marking up of superseded documents if retained in use

or on file is to be carried out

Record keeping requirements Where computerized documents are held, procedures should

specify which is the master document — the magnetic media(diskette, hard disc, or tape) or the hard copy.




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For most documents, these objectives are met by designating themas controlled documents, which are: Properly authorized by approved signatories Serial numbered for identification Issue/revision referenced and dated Issued within a registered circulation Subject to control of all changes

Updated to same distribution10. Documents received from external organizations are recorded toensure traceability.

11. The documents affecting the product quality/services are ade-quately drafted, checked, and approved for adequacy prior to use. Specifications/reports QMS documents (manual and SOPs)

12. Methods or checklists in use are adequate and complete andare referenced to the procedure number, revision number, and

issue date.13. The same authorities that originally approved the documents

review the changes to in-house documents.14. The changes made in the documents are documented.15. The reasons for changes are suitably recorded.16. The documents are formally issued to recipients to track their

purpose and status.17. All recipients are kept posted with updated documents18. The superseded documents are withdrawn from the workplace.

19. Master lists of documents applicable to each job are maintainedby the management representative.

20. The handling and storing of master documents is consistent with: Traceability Their preservation




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21. The classified documents are kept secured.22. The discrepancies discovered at the workplace in the documents

are resolved and documented.23. The documents are reviewed according to the specified frequency

(e.g., once per year) for verification, updated as necessary, and re-approved.

24. The changes relating to subcontract materials are approved by the

company.25. The company evaluates the consequences of changes relating tosubcontract materials.

26. The consequences of alterations to interchangeability and spareparts are made known to the customer.

27. The changes are reflected in: User instruction literature Spare parts lists

28. The incoming and outgoing correspondence is promptly handled

and the documents are traceable.29. The standards and customer drawings/specifications are included

in the document control system.30. To prevent the unidentified use of obsolete documents, suitable

identification is assigned if they are retained for any purpose.31. The management representative is responsible for the production,

issue, and holding of documents. Table 1 provides the level andtypes of documents implemented in the company.

32. The documents identified as quality records are kept secured

according to the shelf life determined and are easily retrievable.




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T a b l e 1

Q u a l i t y D o c u m e n t a t i o n

D e s c r i p t i o n

Q u a l i t y

M a n u a

l

L e v e l 1

S t a t e m e n t o f

P o l i c y ,

C o m m i t m e n t ,

O r g a n i z a t i o n ,

a n d

R e s p o n s i b l i t i e s

C o m p a n y

P r o c e d u r e s

L e v e l 2

C o m p a n y

P r a c t i c e s ,

R e s p o n s i b i l i t i e s ,

a n d I n t e r f a c e s

W o r k

I n s t r u c t i o

n /

P l a n s o f W

o r k

L e v e l 3

W r i t t e n

I n s t r u c t i o n s T o

C o n t r o l T a k s

F o r m s ,

R e c o r d s ,

D o c u m e n t s ,

F i l e s

L e v e l 4

Q u a l i t y R e c o r d s

M a r k e t i n g

S a l e s a n d

C o n t r a c t s

D e s i g n a n d

D e v e l o p m e n

t

M a t e r i a l

C o n t r o l

M a n u f a c t u r e ,

E n g i n e e r i n g ,

P l a n n i n g

A c c o u n t s

C o s t i n g

P e r s o n n e l

T r a i n i n g

S e r v i c e a n d

A

f t e r - S a l e s

S u p p o r t






DOCUMENTATION

1. SOPs distribution register2. External and internal documents distribution register3. Documents change control form






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300.30.6






PURPOSE

To describe the purchasing requirement in accordance with clause 4.6of ISO 9001 and corresponding clauses of international standardISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers or supervisors (pur-chasing) to understand and implement management responsibilitiesdescribed in the procedure. The ISO systems coordinator (managementrepresentative) is responsible for SOP compliance.

PROCEDURE

1. The procedure has been established and implemented to ensurethat purchased product conforms to specified requirements.

2. The quality-related material requisitions are raised with materialspecification, describing code number, and subjective and quanti-tative details. Purchasing information describes the product to bepurchased, including, where appropriate, requirements forapproval of product, procedures, processes and equipment,requirements for qualification of personnel, and quality manage-

ment system requirements.3. The company ensures the adequacy of specified purchase require-ments prior to their communication to the supplier.

4. The supplies and subcontractors are evaluated based on: Quality certificate from the country of origin Material certificate of analysis

SUBJECT: PURCHASING SOP NO: ISO – 4.6

Corresponding Clause: ISO 9001:2000 7.4.1 + 7.4.2 + 7.4.3


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In-house checking or sample sent from the supplier or sub-contractor

Second party audit Formal visit to the site Audit by mail (quality questioner)

5. It is ensured that purchased product conforms to specified purchaserequirements. Criteria for selection, evaluation, and reevaluation

are established. Records of the results of evaluations and any necessary actions arising from the evaluation are maintained.6. The procedure for the audit of suppliers and subcontractors is

maintained (checklist suitable to the activity).7. The approved list of suppliers for products affecting quality is

maintained (refer to the purchase manual).8. The purchase orders are issued formally and recorded.9. The purchase materials are listed according to class (classify as

appropriate):

Materials affecting the product quality Materials not affecting the product quality

10. The type and extent of control applied to the supplier and thepurchased product depends upon the effect of the purchasedproduct on subsequent product realization or the final product.Records of the results of the review of changes in specificationsand any necessary actions are maintained.

11. The purchased products are checked against the purchase orderfor their identification and suitability (as appropriate).

12. All orders identify numbers and quality of materials.13. The purchasing documents are reviewed for their adequacy prior

to release.14. The materials received are inspected, verified, and documented.15. The products supplied by the subcontractor are verified (describe

the procedure suitable for your company).




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16. Where the organization or customer intends to perform verificationat the supplier’s premises, the organization states the intended

verification arrangements and method of product release in thepurchasing information.

DOCUMENTATION

1. Purchase requisition2. Purchase order3. Certificate of analysis (from the supplier or manufacturer)4. Vendor approval records5. Approved vendor list6. Materials receiving reports






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300.30.7






PURPOSE

To describe the control of customer-supplied product in accordance with

clause 4.7 of ISO 9001 and the corresponding clause of internationalstandard ISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers or supervisors (stores

and quality control) to understand and implement management respon-

sibilities described in the procedure. The ISO systems coordinator (man-agement representative) is responsible for SOP compliance.

PROCEDURE

1. The goods supplied by the customer are adequately examined

upon receipt (refer to the specification manual).

2. The purchaser-supplied products are kept segregated from other

similar goods in storage.

3. All goods are adequately identified using a code numbering system

(choose a method suitable to your company).4. The responsibilities and duties of the customer’s personnel (coordi-

nator) engaged in activities under company supervision relating to

the contract are clearly defined (establish procedures suitable to yourcompany and refer to the customer-supplied product manual).

5. The defects in customer-supplied product unsuitable for use in the

intended product are reported to the customer and records aremaintained.

SUBJECT: CONTROL OF CUSTOMER-SUPPLIED

PRODUCT

SOP NO: ISO – 4.7

Corresponding Clause: ISO 9001:2000 7.5.4

Distributed To: Based on:ANSI/ASQC Q 9001 -

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6. The customer-supplied product (while it is under company controlor being used by the company) is identified, verified, protected,and safeguarded. Any customer property lost, damaged, or other-

wise found to be unsuitable for use is reported to the customerand records are maintained.

7. The lost and damaged customer-supplied products are reported to

the customer and records are maintained. Customer property includes the intellectual property.

DOCUMENTATION

1. Customer-supplied product list2. Customer-supplied product notification form3. Test records4. Maintenance records5. Storage records6. Specification manual for customer-supplied products.

Note: Verification by the supplier does not absolve the purchaser of theresponsibility to provide acceptable product.



SUBJECT: CONTROL OF CUSTOMER-SUPPLIED

PRODUCT

SOP NO: ISO – 4.7


Distributed To: Based on:ANSI/ASQC Q 9001 -

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PURPOSE

To describe the product identification and traceability in accordance with

clause 4.8 of ISO 9001 and the corresponding clause of internationalstandard ISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers or supervisors tounderstand and implement management responsibilities described in theprocedure. The ISO systems coordinator (management representative) isresponsible for SOP compliance.

PROCEDURE

1. The materials in the stores are identified by code number and,upon receipt, are assigned specific lot number.

2. The materials are issued to the production line with specific lotnumbers against a particular batch number to be manufactured.

3. Each production batch is assigned a specific batch number.4. The identification is carried throughout the production line with a

specific batch number.5. The materials are clearly identified at dispatch and during produc-

tion, processing, and installation.6. The product status is identified with respect to monitoring and

measurement requirements.7. The customer supplied materials are controlled using specific code

numbers that are traceable.

SUBJECT: PRODUCT IDENTIFICATION AND

TRACEABILITY

SOP NO: ISO – 4.8



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8. The organization identifies, verifies, protects, and safeguards cus-tomer property provided for use or incorporation into the productby maintaining its unique identity.

9. The customer property lost, damaged, or otherwise found to beunsuitable for use is reported to the customer and records aremaintained.

10. The customer property includes intellectual property.11. The quality records are identified and are traceable with theirunique identity according to SOP ISO-4.5 and ISO-4.16.

DOCUMENTATION

1. Materials code list2. Product code list3. Batch number4. Batch processing documents5. Materials test reports6. In-process test reports7. Finished product test reports



SUBJECT: PRODUCT IDENTIFICATION AND

TRACEABILITY

SOP NO: ISO – 4.8



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300.30.9






PURPOSE

To describe the process control in accordance with clause 4.9 of ISO 9001standard and the corresponding clauses of international standardISO 9001:2000.

RESPONSIBILITY

This is the responsibility of all departmental managers or supervisors(production) to understand and implement management responsibilitiesdescribed in the procedure. The ISO systems coordinator (managementrepresentative) is responsible for SOP compliance.

PROCEDURE

1. The company has determined, provided, and maintained the infra-structure needed to achieve conformity to product requirements.Infrastructure includes, for example: Buildings, workspace, and associated utilities Process equipment, both hardware and software Supporting services such as transport or communication

2. The company plans and develops the processes needed for productrealization. Planning of product realization is consistent with the

requirements of the other processes of the quality managementsystem. In planning product realization, the organization deter-mines the following as adequate: Quality objectives and requirements for the product The need to establish processes and documents and provide

resources specific to the product

SUBJECT: PROCESS CONTROL SOP NO: ISO – 4.9

Corresponding Clause: ISO 9001:2000 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 +8.2.3


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Required verification, validation, monitoring, inspection, and testactivities specific to fulfill product requirements.

Records needed to provide evidence that the realization pro-cesses and resulting product fulfill requirements

3. The manufacturing operations are carried out under controlledconditions as follows:

Production planning is made on a monthly basis. Written procedures are followed for manufacturing. Manufacturing is performed on suitable equipment. Calibrated monitoring and measuring devices are available. The production environment is controlled if necessary, e.g.,

temperature and humidity. The manufacturing process is controlled using suitable, accept-

able quality plans. Release, delivery, and postdelivery activities are implemented.

4. The output of planning is maintained in a suitable form.5. The organization validates the process for production and service

provision where the resulting output cannot be verified by subse-quent monitoring or measurement (for processes where deficien-cies become apparent only after the product is in use or the servicehas been delivered).

6. The changes made during processing are suitably identified andrecords are maintained. The changes are reviewed, verified, and

revalidated, as appropriate, and approved before further imple-mentation. The review of design and development changesincludes evaluation of the effect of the changes on constituentparts and the delivered product. Records of the results of the review of changes and any necessary actions are maintained.




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7. The validation of these processes includes, as applicable: Defined criteria for review and approval of the processes Approval of equipment and qualifications of personnel Use of specific methods and procedures Requirements for records and revalidation

8. The materials are used for process evaluation and records are

maintained.9. The production manual includes: Manufacturing direction Compliance with reference standards (specifications) Compliance with codes of practice (specifications) Photographs or representative samples (if applicable) Sampling procedures

10. The inspection is performed after each work operation that affectsquality, and corrective actions are initiated, as appropriate, to

ensure conformity of the product.11. Alternatively, several steps are controlled by: Monitoring process methods Equipment control Personnel involvement

12. The inspection methods and controls are corrected whenever theirunsuitability is demonstrated.

13. The special processes that form a part of production or inspectionare controlled.

14. The critical equipment affecting the product quality and processcapability is effectively maintained.




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DOCUMENTATION

Production manual.






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300.30.10






PURPOSE

To describe the inspection and testing in accordance with clause 4.10 of

ISO 9001 and the corresponding clauses of international standardISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers or supervisors (receiv-

ing inspection), in-process control, and quality control to understand and

implement management responsibilities described in the procedures. TheISO systems coordinator (management representative) is responsible for

SOP compliance.

PROCEDURE

1. The materials received from the vendors are identified, assigned a

unique lot number, and documented.

2. The incoming goods and materials are checked against the

purchase order (or original specified requirement). If the com-

pany or its customer intends to perform verification at thesupplier premises, the company states the intended verification

arrangements and method of product release in the purchasing

information.3. The company identifies the product by suitable means throughout

product realization. The product status with respect to monitoring

and measurement is identified. The finished product identificationand traceability are maintained and recorded.

SUBJECT: INSPECTION AND TESTING SOP NO: ISO – 4.10

Corresponding Clause: ISO 9001:2000 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1+ 8.2.4


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4. The incoming goods are inspected or tested and recorded againstthe approved specifications.

5. The nonconforming goods or materials are marked, segregated,and subsequently issued against a concession or returned forreplacement.

6. In addition to product realization, the company determines the

following as appropriate to their activities: Quality objectives and requirements for the product The need to establish processes and documents and provide

resources specific to the product Required verification, validation, monitoring, inspection, and test

activities specific to fulfill product requirements Records needed to provide evidence that the realization processes

and resulting product fulfill requirements in any suitable form7. At each workstation, the documented procedures and/or work

instructions are available for in-process inspection.8. The in-process inspection is carried out according to the approvedstatistical sampling plans and acceptance criterias to: Demonstrate conformity of the product Ensure conformity of the quality management system and

continually improve the effectiveness of the quality manage-ment system

9. The company plans and carries out production and service provi-sion under controlled conditions. Controlled conditions include, as

applicable: The availability of information that describes the characteristics

of the product The availability of work instructions


Corresponding Clause: ISO 9001:2000 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1,8.2.4


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The use of suitable equipment The availability and use of monitoring and measuring devices The implementation of monitoring and measurement and the

implementation of release, delivery, and postdelivery activities10. The nonconforming items are suitably identified by labels and

removed from the work area.

11. The nonconformances are immediately reported to the authority responsible for their review.12. The nonconformances brought about by machine malfunctions or

faulty machinery/test instruments are systematically rechecked,upon rectification of such malfunctions or faults, and documented.

13. The control documents include a provision to initiate correctiveaction in case of noncompliance.

14. The finished product is subject to final inspection/test to ensurethat the inspection/test requirements are met (refer to finished

product specifications).15. The finished tests include (as relevant): Procedure qualification tests Equipment qualification tests Prototype qualification tests Proof tests Commissioning test Operational tests

16. The inspections/tests are performed in accordance with written

inspection/test procedures (as relevant): Incorporate inspection/test requirements Specify acceptance limits Specify environmental conditions The instruments used for inspection and testing are properly

calibrated (if applicable).




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The calibration procedures are based on the manufacturer’smanual or made in-house.

The calibration records are maintained. After calibration, theinstruments are labeled to indicate status (calibration performedon, by, date of calibration, and next calibration due on).

The instruments that are out of calibration are labeled to indicate

their status. The results of the products tested on the instrumentsthat are out of calibration are reevaluated after the calibration.17. The documented inspection/test results are evaluated by authorized

personnel prior to the release of the products.18. The hold points are described in inspection/test procedures and

are verified by an authorized staff if necessary.19. The inspection/test personnel are either suitably qualified, have

suf ficient relevant experience, or are trained to perform the task.

DOCUMENTATION

1. Production manual2. In-process control records3. Calibration records (as relevant)4. Materials receiving reports5. Materials specification manual6. Materials nonconforming records

7. Final inspection records8. Equipment manual






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300.30.11






PURPOSE

To describe the inspection, measuring, and test equipment in accordance

with clause 4.11 of ISO 9001 and the corresponding clause of internationalstandard ISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers and supervisors

(maintenance) to understand and implement management responsibilities

described in the procedure. The ISO systems coordinator (managementrepresentative) is responsible for SOP compliance.

PROCEDURE

1. The monitoring and measurement activities and devices needed

to provide evidence of conformity are defined to ensure consis-

tency with the requirements.

2. The measuring and test equipment and test software used for the

verification of product quality are selected based on: Range Type Accuracy

Precision

SUBJECT: INSPECTION, MEASURING, AND TEST

EQUIPMENT

SOP NO: ISO – 4.11

Corresponding Clause: ISO 9001:2000 7.6


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3. The equipment used for inspection and measurement/test equip-ment is identified by number or serial number (as necessary).

4. The following instruments affecting the product quality are on acalibration and maintenance program (location and frequency isdescribed): List (as relevant)

5. The initial and periodic calibration is performed against standardsthat are traceable to national standards or another defined calibra-tion basis.

6. Records are maintained in order to provide evidence of calibrationand maintenance status.

7. Any equipment that is found to be out of calibration is rectified.8. In the event that any equipment is found to be out of calibration,

the results of the finished products released prior to that determi-nation are reviewed for disposition.

9. The equipment is: Adjusted or readjusted as necessary Identified to enable the calibration status to be determined Safeguarded from adjustments that would invalidate the mea-

surement result Protected from damage and deterioration during handling, main-

tenance, and storage10. The ability of computer software to satisfy the intended application

is confirmed prior to initial use and reconfirmed as necessary, using

adequate means as appropriate.


EQUIPMENT




1994

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Date Issue:mm-dd-yy

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DOCUMENATION

1. Equipment preventive maintenance manual/records2. Equipment calibration manual/records3. Out of calibration/materials disposition form

Note: See ISO 10012-1 and ISO 10012-2 for guidance.




EQUIPMENT




1994

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Date Issue:mm-dd-yy

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300.30.12






PURPOSE

To describe the inspection and test status in accordance with clause 4.12

of ISO 9001 standard and the corresponding clause of international stan-

dard ISO 9001:2000.

RESPONSIBILITYIt is the responsibility of all departmental managers or supervisors (pro-

duction and shipping) to understand and implement management respon-

sibilities described in the procedure. The ISO systems coordinator

(management representative) is responsible for SOP compliance.

PROCEDURE

1. The company identifies the product by suitable means throughoutproduct realization using a specific batch number.

2. The product status with respect to monitoring and measurement

is identified using the same batch number.

3. The inspection and test status of the product is identified by using

markings, authorized stamps, tags, labels, routing cards, inspection

records, test software, physical location, or other suitable means

to indicate the conformance or nonconformance of the product with regard to inspection and tests performed.

4. The identification of the inspection and test status is maintained,as necessary, throughout the production and installation of the

product to ensure that only product that has passed the required

inspections and tests is dispatched, used, or installed.

SUBJECT: INSPECTION AND TEST STATUS SOP NO: ISO – 4.12



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5. The following measures are used for checking status: Physical identification marks Transfer of identification marks Other methods (as relevant)

6. The markings are clearly applied.7. When physical identification is not possible, other suitable methods

are used and recorded (provide details).

8. The production or manufacturing documents are maintained as theproduct passes through various stages with specific identification,i.e., batch number.

9. The marking are posted on the finished product to indicate thepositions that affect the function of the item or cause stress in thematerial.

10. The manufacturing records identifying the inspections and teststatus are maintained with a specific batch number.

11. The nonconforming items are identified by labels with a specific

batch number.12. The authorized personnel responsible for the application and

removal of status markings are clearly identified.13. The manufacturing direction is provided with literature indicating

the operating status of structures, systems, and components toprevent inadvertent operation and mix-up.

14. Before the release system, all inspection and test operations areensured to have been satisfactorily completed, and all documentary evidence is reviewed and completed with product identification

and traceability.15. The system allows for release of the product by authorized per-

sonnel under the cover of a concession with complete identificationand traceability. Authorized personnel may release the products if the finished product results are satisfactory.




1994

Revision No.: New


Date Supersedes:

mm-dd-yy

Date Issue:

mm-dd-yy

Page 2 of 3






DOCUMENTATION

1. Labeling system manual/records2. Production manual/records3. Product manual4. Quality control manual






1994

Revision No.: New


Date Supersedes:

mm-dd-yy

Date Issue:

mm-dd-yy

Page 3 of 3



300.30.13






PURPOSE

To describe the control of nonconforming product in accordance with

clause 4.13 of ISO 9001 standard and the corresponding clause of inter-national standard ISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers or supervisors (pro-

duction and quality control) to understand and implement management

responsibilities described in the procedure. The ISO systems coordinator(management representative) is responsible for SOP compliance.

PROCEDURE

1. The nonconforming products are identified and segregated by

labels to indicate their pending disposition.

2. The organization ensures that product that does not conform to

product requirements is identified and controlled to prevent its

unintended use or delivery. The controls and related responsibilities

and authorities for dealing with nonconforming product are definedin a documented procedure.

3. The organization deals with nonconforming product in one or

more of the following ways: By taking action to eliminate the detected nonconformity By authorizing its use, release, or acceptance under concession

by a relevant authority and, where applicable, by the customer By taking action to preclude its original intended use or application

SUBJECT: CONTROL OF NONCONFORMING

PRODUCT




1994

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Date Issue:mm-dd-yy

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4. All nonconformities have to be dealt with regardless of how important an impact they may have on the established system. Itis common practice to categorize nonconformities into groups toenable the speed of reaction to their rectification to be assessed.

5. They are categorized into the following groups:5.1 Serious: A complete system element (standard requirement)

or a significant part of an element is missing or ineffective.5.2 Requires attention: A minor lapse within the system hasoccurred (the human element), which can quickly be put right.

Several minor lapses of the same content (incorrect issue of doc-umentation in use in several areas) show a system breakdown andare therefore regarded as serious and upgraded as such.

6. Records of the nature of nonconformities and any subsequentactions taken, including concessions obtained, are maintained.

7. The products not meeting the specification are indicated to the

relevant personnel or customers in a timely manner.8. The nonconformance report incorporates recommendations forremedial action as appropriate.

9. The measures initiated ensure timely response to the nonconfor-mance report by authorized personnel.

10. The agreed remedial actions are promptly implemented. Rework Disposal (rejection or release with notification)

11. The documented procedures/quality plans applicable to reworked

products are reviewed and approved by authorized personnel.12. Adequate records are kept of the actions taken and the quality

compliance of the item upon completion of repair/rework.13. The reworked items are issued after adequate verification review

and approval.

SUBJECT: CONTROL OF NONCONFORMING

PRODUCT




1994

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Date Issue:mm-dd-yy

Page 2 of 3



300.30.14






PURPOSE

To describe the elements of corrective action in accordance with clause4.14 of ISO 9001 and corresponding clauses of international standardISO 9001:2000.

RESPONSIBILITYIt is the responsibility of all departmental managers or supervisors (mostly production and quality control) to understand and implement managementresponsibilities described in the procedure. The ISO systems coordinator(management representative) is responsible for SOP compliance.

PROCEDURE

1. The organization continually improves the effectiveness of thequality management system through the use of the quality policy,quality objectives, audit results, analysis of data, corrective andpreventive actions, and management review

2. The company determines, collects, and analyzes appropriate data todemonstrate the suitability and effectiveness of the quality manage-ment system and to evaluate where continual improvement of thequality management system can be made. This includes data gener-ated as a result of monitoring and measurement and from other

relevant sources. The analysis of data provides information relating to: Customer satisfaction Conformance to product requirements

SUBJECT: CORRECTIVE ACTION SOP NO: ISO – 4.14



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Date Supersedes:

mm-dd-yy

Date Issue:

mm-dd-yy

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Characteristics and trends of processes and products includingopportunities for preventive action

Suppliers3. The records of product and system defects are analyzed to identify

and eliminate potential areas of nonconformance. Nonconformancehandling programs are made and followed.

4. In the event of noncompliance, the effective corrective and pre-

ventive actions are established and documented.5. The company initiates actions to eliminate the causes of noncon-formities in order to prevent recurrence. Corrective actions appro-priate to the effects of the nonconformities encountered are taken.The nonconformity investigations include: Reviewing nonconformities (including customer complaints) Determining the causes of nonconformities Evaluating the need for action to ensure that nonconformities

do not recur

Determining and implementing actions needed Records of the results of actions taken Reviewing any corrective actions taken

6. The noncompliance detected is extended for investigation andcorrective action (as relevant): Within the process Within work operation/instructions Via service reports Via customer complaints

7. The major, minor, and critical defectives that may adversely affectquality are identified and checked.




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Date Supersedes:

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Date Issue:

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8. The corrective action causes and resolutions taken are recorded

(as appropriate).

Documented evidence of individual occurrence

Minutes of management meetings

Changes to procedures (reason for revision)

9. The preventive actions are established to prevent recurrence and

are recorded.

Determining potential nonconformities and their causes Evaluating the need for action to prevent the occurrence of

nonconformities

Determining and implementing actions needed

Records of results of actions taken and reviewing any preventive

actions taken

10. The changes to procedures and other results of preventive actions

are presented at management review meetings.

DOCUMENTATION

1. Nonconformance reports

2. Minutes of management reviews

3. Change control records






1994

Revision No.: New


Date Supersedes:

mm-dd-yy

Date Issue:

mm-dd-yy

Page 3 of 3



300.30.15






PURPOSE

To describe the handling, storage, packaging, and delivery in accordance

with clause 4.15 of ISO 9001 and corresponding clauses of internationalstandard ISO 9001:2001.

RESPONSIBILITY

It is the responsibility of all departmental managers and supervisors

(production, stores, and shipping) to understand and implement manage-

ment responsibilities described in the procedure. The ISO systems coor-dinator (management representative) is responsible for SOP compliance.

PROCEDURE

1. The materials received and finished products are kept in a secured

store to prevent damage, deterioration, and loss.

Forklifts are used for transportation within the company (asrelevant).

The storage area is segregated, secured, temperature and humid-ity controlled, and provided with numbered shelves.

Transport between locations and to the site is carried out insecured temperature and humidity-controlled trucks (as rele-

vant).2. The material’s lot number or finished product batch number is

clearly identified with shelf number (location) at all times duringhandling, storage, and shipping, as appropriate.

SUBJECT: HANDLING, STORAGE, PACKAGING,

PRESERVATION, AND DELIVERY




1994

Revision No.: New



Date Issue:mm-dd-yy

Page 1 of 3






3. The conformity of the product during internal processing anddelivery to the intended destination is ensured. This preservationincludes identification, handling, packaging, storage, and protectionincluding constituent parts of a product.

4. The production and service provisions are carried out undercontrolled conditions. Controlled conditions include, as appli-

cable: The availability of information that describes the characteristicsof the product

The availability of work instructions The use of suitable equipment The availability and use of monitoring and measuring devices The implementation of monitoring and measurement, and the

implementation of release, delivery, and postdelivery activities5. The equipment used for lifting and special handling is inspected,

tested, identified, and recorded. Records are kept of materials and equipment received. Storage conditions of materials and equipment are maintained

where special cleanliness or environments are necessary.6. The environmental conditions inside and outside storage areas and

around equipment are periodically monitored.7. For transportation, a temperature-controlled national delivery sys-

tem is used.8. Alternatively, companies owning temperature-controlled trucks are

also used.






1994

Revision No.: New



Date Issue:mm-dd-yy

Page 2 of 3






DOCUMENTATION

1. Materials receiving records2. Materials status/location records3. Environmental monitoring records of stores








1994

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Date Issue:mm-dd-yy

Page 3 of 3



300.30.16






PURPOSE

To describe the quality records in accordance with clause 4.16 of ISO 9001and the corresponding clause of international standard ISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers and supervisors tounderstand and implement management responsibilities described in theprocedure. The ISO systems coordinator (management representative) isresponsible for SOP compliance.

PROCEDURE

1. The quality-related records are identified and kept according tothe specified shelf life and disposition procedure established.

Provide a list of quality records with shelf life (as relevant).2. The quality record may include the following (as appropriate to

the company ’s operations): Design records Design reviews Procurement records Commissioning and operation records Manufacturing records Inspect and test records Calibration records Control procedures Management reviews Stability records of products Material certificates

SUBJECT: QUALITY RECORDS SOP NO: ISO – 4.16



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Date Issue:

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Nonconformance reports and concessions Corrective actions Audit plans and records Quotes, tenders, contracts, and contract review Purchasing specification Drawings Quality plans

3. The records are traceable with the plant/material to which they

relate.4. The records are systematically filed and are readily retrievable.5. The records are stored in a segregated and secured room to ensure

there will be no deterioration or loss of records.6. The records on computers are subject to:

Periodic backup Recoverable (backup is placed in a fireproof cabinet away from

the workplace) The records are handled by authorized personnel to ensure

security and control possible contamination with viruses7. Quality records are kept legible, readily identifiable, and retriev-

able.8. The records furnished are consistent with relevant codes, standards,

and regulatory requirements.9. The records that are shipped with equipment are suitably protected.

10. The contractual record requirements are identified and passed toappropriate organizations.

DOCUMENTATION

1. Quality records list2. Records retrieval audit reports3. Computer system verification records




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Date Supersedes:

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Date Issue:

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Revision No.: New


Date Supersedes:

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300.30.17






PURPOSE

To describe the internal quality audits in accordance with clause 4.17of ISO 9001 and corresponding clauses of international standard

ISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers to understand and

implement management responsibilities described in the procedure. The

ISO systems coordinator (management representative) is responsible for

SOP compliance.

PROCEDURE

1. The internal audits at planned intervals determine whether the

quality management system conforms to the planned arrangements

of the requirements of this international standard and to the quality

management system requirements established by the organization,and are effectively implemented and maintained.

2. Follow-up activities include the verification of actions taken and

the reporting of verification results. The organization also applies

suitable methods for monitoring and, where applicable, measure-

ment of the quality management system processes to demonstrate

the ability of the processes to achieve planned results. Whenplanned results are not achieved, correction and corrective action

are taken, as appropriate, to ensure conformity of the product.

3. The company quality system is audited once every year to:

Demonstrate conformity of the product Ensure conformity of the quality management system

SUBJECT: INTERNAL QUALITY AUDITS SOP NO: ISO – 4.17



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Date Supersedes:

mm-dd-yy

Date Issue:

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Continually improve the effectiveness of the quality manage-ment system

Where applicable, statistical techniques are also used.4. The main requirement of the audit team is to collect objective

evidence throughout the audit task by means of interviews withthe staff, examination of documents, and observation of activitiesand conditions at the work or site. The following methods may be used as a guideline or as appropriate to your company ’s

operations to achieve the “audit aim”:4.1 Seek objective evidence that the system is functioning asprescribed. Samples taken of the system allow the audit teamto obtain the required evidence.

4.2 Establish absolute proof to substantiate each nonconformity found; therefore, always seek objective evidence when non-conformity is apparent. The occurrence discovered may bethe effect and not the cause. Objective evidence helps findthe proof of nonconformity.

4.3 Ensure that the responsibility, authority, and interrelation-ships of all personnel who manage, perform, and verify workaffecting quality are defined.

4.4 Ensure that each requirement (element) of the quality systemis documented to demonstrate that the system covers every element/requirement and that each one is effective.

4.5 Review procedures and work instructions for completeness,adequacy, and issue levels against a master list.

4.6 Verify evidence of implementation of procedures and instruc-

tions in the work areas. The procedures and instructions areof required issue (revision), and their distribution is controlled.

4.7 Management, specialist, technician, evident staff, employee,and operator training and qualification records are evident,particularly when specialist skills are required, to ensure allemployees are adequately qualified.




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4.8 Corrective actions undertaken to clear any previous noncon-formities are followed up.

4.9 Work, which has been accepted, is selected at random andexamined, and the findings are compared with the appro-priate requirements, basis for acceptance, and applicableissue status.

4.10 Where processes are involved, the audit team should examineprocess controls and records to establish conformance with

the specification.4.11 Information gathered during interviews is checked by acquir-ing the same information from other independent sourcesand checking the samples against each other for accuracy.

5. Throughout the entire audit, all the evidence collected in the formof observations should be documented on the checklist. Thisevidence is then examined to determine if there are any noncon-formities that need to be reported.

6. An audit program is planned, taking into consideration the status

and importance of the processes and areas to be audited, as wellas the results of previous audits. The audit criteria, scope, fre-quency, and methods are defined. The standard operating proce-dures are also audited according to the plan.

7. Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. Auditors do not audittheir own work.

8. The responsibilities and requirements for planning and conductingaudits and for reporting results and maintaining records are defined

in a documented procedure.9. The audits are conducted according to the checklist. The audit pro-

gram includes time frame, area, and concerned responsible parties.10. The findings of the audit are reported, and any noncompliance

found is attached to the report to initiate corrective actions andpreventive measures.




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11. The follow-up audit is made to close the audit findings.12. The general audit of the housekeeping is performed every six

months. The findings are documented and the responsible partiesare informed to initiate corrective actions.

13. The audit performed is reviewed with senior manage-ment/involved parties.

14. Recommendations are made for the resolution of problems andfollow-up actions are delegated.

15. The corrective actions are closed out.16. The results of audits are discussed during a management review meeting.

17. The management responsible for the area being audited ensuresthat actions are taken without undue delay to eliminate detectednonconformities and their causes.

DOCUMENTATION

1. SOPs audit records2. Corrective action reports3. Management review records






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300.30.18






PURPOSE

To describe the training in accordance with clause 4.18 of ISO 9001 and

corresponding clauses of international standard ISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers to understand andimplement management responsibilities described in the procedure. The

ISO systems coordinator (management representative) is responsible for

SOP compliance.

PROCEDURE

1. All personnel are adequately trained for the functions they perform.

Personnel performing work affecting product quality are competenton the basis of appropriate education, training, skills, and experi-ence.

2. The training needs are effectively identified for personnel perform-

ing work affecting product quality.

Qualification Previous experience Training to be provided by the equipment supplier or in-house

senior staff Procedure reading is part of the training records

3. The required level of qualification and experience is defined foreach quality-related job in the personnel qualification file.

4. The in-house training program is made every year and followed.

SUBJECT: TRAINING SOP NO: ISO – 4.18



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5. The employees are sent for outside training (if necessary or asneeded).

6. The training program ensures to: Provide training or take other action to satisfy these needs Evaluate the effectiveness of the action taken Ensure that its personnel are aware of the relevance and impor-

tance of their activities and how they contribute to the achieve-

ment of the quality objectives, and maintain appropriate recordsof education, training, skills, and experience7. The training and experience records are archived systematically

and are retrievable.

DOCUMENTATION

1. Personnel qualification file2. Employee training record3. Annual training program



SUBJECT: TRAINING SOP NO: ISO – 4.18



1994

Revision No.: New


Date Supersedes:

mm-dd-yy

Date Issue:

mm-dd-yy

Page 2 of 2



300.30.19






PURPOSE

To describe the servicing in accordance with clause 4.19 of ISO 9001 and

the corresponding clauses of international standard ISO 9001:2000.

RESPONSIBILITY

It is the responsibility of all departmental managers and supervisors tounderstand and implement management responsibilities described in the

procedure. The ISO systems coordinator (management representative) is

responsible for SOP compliance.

PROCEDURE

1. The safety aspects of the product or service quality are identified.

2. For each product, the safety standards are identified and serviceprovisions are made under controlled conditions. Controlled con-ditions include, as applicable:

The availability of information that describes the characteristicsof the product

The availability of work instructions The use of suitable equipment The availability and use of monitoring and measuring devices The implementation of monitoring and measurement and the

implementation of release, delivery, and postdelivery activities.3. The products are subject to safety testing as per in-house procedure

(refer to the relevant procedure).

SUBJECT: SERVICING SOP NO: ISO – 4.19

Corresponding Clause: ISO 9001:2000 7.5.1 + 7.1


1994

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4. Safety warnings are issued to the customer. Labeling the product Within promotional literature Within maintenance or operations manuals

5. The products found to be unsafe in use are investigated by anauthorized person.

6. The products are traceable by batch number and can be recalled.

7. The services provided are documented (refer to the servicingmanual).8. The service records are maintained.9. The servicing requirements are clearly defined, reviewed, and

approved by authorized personnel to ensure they have been con-ducted successfully.

10. The company plans and develops processes needed for productrealization as appropriate to ensure customer satisfaction. Quality objectives

Resources and documents required for each specific product Validation, verification, monitoring, inspection, and test activities

critical for product characteristics. Documented records (for details, refer to SOP ISO-4.4).

DOCUMENTATION

Servicing manual/records.



SUBJECT: SERVICING SOP NO: ISO – 4.19

Corresponding Clause: ISO 9001:2000 7.5.1 + 7.1


1994

Revision No.: New


Date Supersedes:

mm-dd-yy

Date Issue:

mm-dd-yy

Page 2 of 2



300.30.20






PURPOSE

To describe the elements of statistical technique in accordance with clause4.20 of ISO 9001 and the corresponding clauses of international standardISO 9001:2000.

RESPONSIBILITYIt is the responsibility of all departmental managers or supervisors (pro-duction and in-process control) to understand and implement managementresponsibilities described in the procedure. The ISO systems coordinator(management representative) is responsible for SOP compliance.

PROCEDURE

1. The statistical analysis is performed to: Demonstrate the conformity of the product Ensure conformity of the quality management system Continually improve the effectiveness of the quality manage-

ment system2. Suitable statistical techniques are used to demonstrate the ability

of the process to achieve planned results. When planned resultsare not achieved, correction and corrective actions are taken, asappropriate, to ensure conformity of the product.

3. The statistical analysis provides information relating to: Customer satisfaction Conformance to product requirements Characteristics and trends of processes and products including

opportunities for preventive action and suppliers

SUBJECT: STATISTICAL TECHNIQUES SOP NO: ISO – 4.20

Corresponding Clause: ISO 9001:2000 8.1 + 8.2.3 + 8.4 + 8.2.4


1994

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4. The areas where statistical techniques are employed are: Raw material sampling Market analysis Product design, including experiment analysis Reliability and life testing In-process control and finished product testing

5. For in-process control and determination of quality levels, inspection

plans and quality control charts are used (as relevant). For samplingplans and acceptance criteria, Military Standard 105E is used.6. The statistical analysis performed during the in-process control and

finished product test is verified by other authorized personnel priorto release.

7. Product performance assessment is carried out using suitable sta-tistical techniques as applicable.

8. The company collects and analyzes data to demonstrate the suitability and effectiveness of the system on a continuous basis to ensure:

Effective internal and external communication Customer satisfaction

Product meets the customer and regulatory requirements

DOCUMENTATION

1. In-process control manual/statistical analysis records

2. Statistical sampling plans

3. Product assessment records



SUBJECT: STATISTICAL TECHNIQUES SOP NO: ISO – 4.20

Corresponding Clause: ISO 9001:2000 8.1 + 8.2.3 + 8.4 + 8.2.4


1994

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Page 2 of 2



SYSTEM REQUIREMENTS:

Windows 95, 98, or NT 4.0Minimum Video: 640×480 256 color display Recommended Video: 800×600 16-bit or higher color display Free Disk Space: 12 MbMinimum Memory: 16 Mb of RAM

Recommended Memory: 32 Mb of RAM

INSTALLATION INSTRUCTION:

1. Place the CD-ROM into the CD-ROM drive.2. Using My Computer or Windows Explorer, locate the “letter” that

designates the CD-ROM drive.3. Double-click on the CD-ROM drive icon and select the folder of

choice

NOTE: This product requires that Microsoft Word 97 or higher be

installed on your computer.



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