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Your Company Name

(YOUR COMPANY NAME) PROPRIETARY INFORMATION of 18

PMA and 14 CFR 21

QUALITY MANUAL

Origination Date: XXXX Document

Identifier: QMS-00 Quality Manual

Date: Latest Revision Date Document

Status: Draft, Redline, Released, Obsolete

Document Link:

Location on Server (if used)

Abstract: This document describes the quality management system for 14 CFR 21.

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QMS-00 Quality Manual

PAH/PMA (…)

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Rev: Orig

of 18 This document may not be disclosed or reproduced in whole or in part without prior written

permission from a representative of the Company with the authority to grant such permission.

REVISION LOG Issue Date Comment Author

Orig

DOCUMENT CHANGE RECORD

Issue Item Reason for Change

Changes to the Quality System are approved by the FAA Manufacturing Inspection District Office (MIDO) prior to implementation. The Company immediately notifies the FAA MIDO, in writing, of changes that affect inspection, conformity or airworthiness of approved articles.

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TABLE OF CONTENTS 1.0 ............................................................................................................................................................4 SCOPE

1.1 ............................................................................................................................. 4 Overview of Responsibility and Authority

1.2 .................................................................................................................................................. 5 Management Representative

1.3 ......................................................................................................................................................... 5 Internal Communication

1.4 .............................................................................................................................................................. 5 Management Review

Section A: Design Data Control ....................................................................................................................................5

Section B: Document Control........................................................................................................................................6 B1 .................................................................................................................................................... 6 Configuration Management

Section C: Supplier Control...........................................................................................................................................6

Section D: Manufacturing Control ................................................................................................................................8

Section E: Inspecting & Testing ..................................................................................................................................12

Section F: Inspection, Measuring and Test Equipment Control ..................................................................................13

Section G: Inspection and Test Status .........................................................................................................................14

Section H: Nonconforming Product and Article Control.............................................................................................14

Section I: Corrective and Preventive Action ...............................................................................................................14

Section J: Handling & Storage ....................................................................................................................................15

Section K: Control of Quality Records........................................................................................................................16

Section L: Internal Audits............................................................................................................................................16

Section M: In-Service Feedback..................................................................................................................................16

Section N: Quality Escapes .........................................................................................................................................17

Section O: Issuing Authorized Release Documents ....................................................................................................17

Section P: PMA Article Part Marking .........................................................................................................................18

Section Q: Shipping / Export of Completed Articles...................................................................................................18

Section R: Supplemental Requirements ......................................................................................................................18

Appendix 1: Organization ...........................................................................................................................................18

Appendix 2: Facility Layout........................................................................................................................................18

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1.0 SCOPE This quality assurance manual is submitted to the Federal Aviation Administration (FAA) for information and conformance according to Regulatory Compliance requirements. This manual includes verification policies and procedures and instructions for the design, development and manufacture of Parts Manufacturer Approval (PMA) articles for various model aircraft under the authority of Title 14 Code of Federal Regulations (14 CFR).

This manual establishes and maintains a quality assurance system to ensure compliance and conformance with FAA-PMA Articles manufactured for use on certified aircraft or as detail components of an aircraft assembly.

Changes that impact inspection, conformity and airworthiness are only implemented into this manual with prior FAA approval.

The Company notifies the FAA in writing, in advance, when the manufacturing facility is relocated or expanded to other locations. Prior to shipping FAA-PMA parts from a new location, the new facility is evaluated and approved by the FAA.

The Company is committed to the ongoing maintenance and improvement of the quality management system; to ensure this, management focuses on deploying practical steps that positively support quality and environmental policies.

CUSTOMER FOCUS:

EMPOWERMENT:

INTELLIGENT MANAGEMENT:

WORKPLACE EXCELLENCE:

1.1 Overview of Responsibility and Authority The organizational chart in Appendix 1 is an overview of the management structure of the Company. See personnel roster for the name of the Responsible Authority (RA) in each branch of management that includes multiple assignments. In all cases, the appropriate person has

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1.2 Management Representative The Accountable Manager of the Company has been assigned the role of Quality System Management Representative. The Accountable Manager is responsible for

The Accountable Manager is responsible for

In addition, the Accountable Manager

1.3 Internal Communication To ensure proper communication between and throughout all levels of employees within the Company, internal communication is

This system requires management to

1.4 Management Review Management Review meetings are conducted according to the QMS-04 Management Process Procedure. This procedure defines

Section A: Design Data Control A1 Copies of all drawings for FAA Approved articles are

A2 Design data is filed by Drawing Number and the latest revision is

A3 Minor design changes to the PMA Articles are

A4 Major design changes are

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These design changes may require amendments or additions to:

A5 Material Review Board (MRB) is

Section B: Document Control Documents are controlled to ensure information is

The controls for documents are defined in the QMS-01

Control of Documented Information Procedure.

Paper records are controlled to provide evidence of conformity to requirements. The Company has established a documented procedure for control of electronic records. Electronic records are

B1 Configuration Management The configuration of products is controlled through advanced configuration management techniques that have been built upon the requirements of Configuration management is conducted according to the QMS-02 Configuration Management Procedure.

Section C: Supplier Control C1 Materials received are required to

Supplied items that support manufacturing and or assembly of FAA-PMA articles are inspected for

a. Reports of unsatisfactory conditions are

b. Review of documented unsatisfactory conditions increases An on-site visit may be required that verifies:

C2 Material is labeled to

C3 Materials are stored

C4 Vendors supply

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Note: As part of the receiving inspection process, a comparison is made between the Supplier's packing sheet and the purchase order then each shipment is inspected for:

After acceptance of incoming shipments, the Responsible Authority

C5 When discrepancies are encountered during inspections, the material or shipment is according to the QMS-

14 Control of Nonconformities Procedure.

C8 Rejected articles are

C9 Requirements

Purchasing is treated as a process within the Company's quality system.

The Company does not The process is fully defined in the QMS-08 Purchasing Procedure.

C9.1 Purchasing Process

The purchasing process

C9.2 Purchasing Information

Purchase orders are used to transmit the Company's requirements to Suppliers.

C9.3 Verification of Purchased Product

Incoming materials are The process is defined in the QMS-09 Receiving Procedure.

C10 Identification and Traceability

All products are identified throughout product life cycle. This is fully defined in QMS-10 Production Process. Other identification and traceability requirements are

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C11 Preservation of Product

The Accountable Manager

The instructions are detailed in the applicable job documentation and general rules are defined in the QMS-11 Shipping Procedure.

Section D: Manufacturing Control The Design and Development process ensures that design activities are conducted in a controlled manner, which is defined in the QMS-17 Design and Development Procedure. Instructions for Continued Airworthiness (ICA) are kept current with design changes.

D1 Materials received are required to

D2 A Shop Routing Sheet is used to document the number of pieces at each step of the manufacturing process and is used to annotate any losses. A shop routing sheet is used for

D3 The Company uses a folder for

D4 Parts are inspected to

D5 Small parts (sub-assemblies) are marked according to FAR 45.15(b) with a tag attached to the part or the packaging for the part.

D6 Parts are permanently marked or tagged with:

D7 Requirements:

The Company plans and carries out processes for product realization. In general, this includes assurances that:

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In-process inspection is conducted according to

These activities are fully defined in the QMS-10 Production Procedure. All products are identified throughout product life cycle. Other identification and traceability requirements are

D7.1 Production Documentation

Production operations are performed according to

In addition, the Company may utilize

These activities are fully defined in the QMS-10 Production Procedure and the QMS-17 Design and Development Procedure.

D7.2 Control of Production Process Changes

Only the Configuration Control Board may approve changes to production processes. The Company identifies and obtains Customer and/or regulatory authority approval for changes when

These activities are fully

defined in the QMS-10 Production Procedure and the QMS-17 Design and Development Procedure.

D7.3 Control of Production Equipment & Tools

Production equipment, tools and programs are

D7.4 Control of Work Transferred on a Temporary Basis Outside the Organization's Facilities

When the Company provides supplies for outside processing, such as acceptance testing, it is done under the following controls:

D7.5 Control of Service Operations

The Company services supplies returned to it for warranty work or repair - field servicing is(is not) performed. For such product work,

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D8 Customer Property

Where Customer property is provided to the Company for processing or use, it is

Damaged or missing Customer property is

Government and Customer property is controlled according to the QMS-10 Production Procedure, specified contractual requirements and

D9 Preservation of Product

The Accountable Manager specifies, where required and according to contractual directives, instructions for

The instructions are detailed in the applicable job documentation and general rules are defined in the QMS-11 Shipping Procedure.

D10 Identification and Traceability

All products are identified throughout product life cycle. This is fully defined in the QMS-10 Production Procedure. Other identification and traceability requirements are

D11 Monitoring and Measurement of Product

To ensure the conformance of product to requirements, monitoring and measurement is conducted

The Quality Group is responsible for

Inspection methods may include but are not limited to:

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The inspection includes verification of compliance to:

Inspection by statistical sampling is applied, as appropriate and when specified, in

Authorized sampling plans for product acceptance are based on SAE ARP9013, Statistical Product Acceptance Requirements and documented in work instructions. The specified sampling plan for a designated application is

In the event supplies are needed prior to receipt of Certified Test Data, Certificate of Compliance or Analysis, approved Request for Deviation or Waiver or other limited risk condition, at least two applicable MRB members may

D11.1 Inspection Documentation

The engineering drawing, FAA-approved design data and/or other technical documentation provide the requirements for all deliverable supplies. In all cases, this includes

D11.2 First Article Inspection (FAI)

When required by purchase order or Customer specification, a First Article Inspection (FAI) is performed. The FAI is

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D12 Competence, Training and Awareness

All Company personnel are hired on the basis of their ability to

The Company has implemented a training program that:

Management conducts periodic reviews of employee performance. Appropriate records of education, training, skills and experience are

The training program is defined in the QMS-06 Training

Procedure.

Section E: Inspecting & Testing E1 Request For Service Inspectors (RFS) determine that each completed part conforms to the design

data and is Inspectors perform the following:

E2 RFS Inspectors have access to FAA approved data and specifications when inspecting FAA-PMA articles. When witnessing acceptance tests, the Inspectors

E3 All inspection records described above and the record of disposition are

E4 Requirements

Inspection methods may include but are not limited to:

E4.1 In-Process Inspection

In-process inspections are conducted during production to

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E4.2 Final Inspection

Once all operations are complete, the lot is submitted to Quality for a final inspection. This is performed according to an accepted sampling plan, The sampling plan is

Section F: Inspection, Measuring and Test Equipment Control F1 Tools, gauges and test equipment are

F2 Tools, gauges and test equipment that become inaccurate are

F3 Special tools, shop aids, master gauges or molds manufactured by RFS that are contracted with or purchased from a vendor are

F4 Inaccuracy of tools, gauges, test equipment and molds identified during periodic inspections are

a) The Company notifies MIDO of any quality escape. b) The Company processes actions according to Section N herein.

F5 Scales, shop aids and measuring devices used for inspection are

All inaccuracies are

Serviceable certifications are

Unserviceable tools are

F6 Requirements

All measuring and test equipment instruments and devices used to determine an article's conformance to specified requirements are

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Section G: Inspection and Test Status G1 The inspector affixes an initial on the Inspection Record indicating

G2 Rejected components are

Section H: Nonconforming Product and Article Control H1 Nonconforming and rejected materials are

H2 Nonconforming parts may

H4 Major Change incorporation to FAA-PMA articles are first approved by FAA ACO and MIDO with PMA addition.

H5 Requirements

All supplies found to be nonconforming against specified requirements are

Procedures are available for receiving and processing feedback for in-service failures, malfunctions and defects. The procedures include

Procedures are available that establish a system for receiving, processing and tracking in-service failures. The procedures include provisions to Service problems, unairworthy conditions, unsafe features and unsafe characteristics are reported to the FAA according to FAR §21.3 (§21.9) and are

See the QMS-14 Control of Nonconformities Procedure.

Section I: Corrective and Preventive Action I1 Corrective actions review non-conformities of manufactured articles to:

cur

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I2 Action is taken to:

I3 Preventive Action is taken to:

A ons

I4 Requirements

I4.1 Corrective Action

The Company has implemented and maintains a robust system for identifying and reporting nonconformities requiring corrective action. These nonconformities can

This process is defined in QMS-13 Corrective Action Procedure.

I4.2 Preventive Action

In addition to the preventive measures taken for corrective action requests (used to prevent recurrence of an existing problem) the Corrective and Preventive Action process is used to

This process is defined in the QMS-13 Corrective Action Procedure.

Section J: Handling & Storage J1 All materials are

J2 Acceptable finished products are

J3 Parts are

J4 Parts are

J5 Parts are

J6 Requirements: Preservation of Product

The Responsible Authority specifies, where required and according to contractual directives, instructions for

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general rules are defined in the QMS-11 Shipping Procedure.

Section K: Control of Quality Records K1 The Company controls and distributes

approved changes are made available to:

And manage records as:

K2 The Company retains files for

Note: The Company ensures that only FAA approved data is used for manufacturing, instruction and support.

K3 Requirements: Control of Records

Paper records are

defined in procedure QMS-01 Control of Documented Information Procedure.

Section L: Internal Audits L1 Request For Service Inspectors conduct Internal Audits according to

See Internal Audit control log:

L2 Requirements: Internal Audit

Internal quality audits are conducted to ensure ongoing compliance with requirements of the Company's policies and procedures. This is accomplished by

The internal audit process is fully defined in the QMS-12 Internal Auditing Procedure.

Section M: In-Service Feedback Service Difficulty Reports (SDRs)

M1 When in service difficulties are discovered, they are reported to the FAA ACO and MIDO.

Note: The Company reports 14 CFR 21.3 conditions to the FAA ACO and MIDO within 24 hours, with the exceptions of weekends and recognized holidays.

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Self Disclosure Reporting

M2 When in-service difficulties are found for an article, they are reported to the FAA's geographic MIDO.

Airworthiness Directives (ADs)

M3 In the event that an Airworthiness Directive is issued by the FAA, the Company immediately implements applicable changes, if any, to articles affected by the AD.

- When appropriate, changes related to an AD are

Section N: Quality Escapes A quality escape is defined as any article that has been released from the quality system that does not conform to the applicable design data or quality system requirements.

N1 The Company notifies the FAA of any apparent quality escape by contacting the FAA MIDO office. Initial notice of a voluntary disclosure may be submitted orally, by electronic means or by written hardcopy.

N2 Notification is made in a timely manner, normally within 24 hours of the discovery of the apparent quality escape, with the exception of weekends and recognized holidays.

N3 Quality escape notifications include the following information:

Section O: Issuing Authorized Release Documents The Company may issue authorized release documents for

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O1 The Company ensures that only qualified personnel issue authorized release documents. Evaluation of persons responsible for authorizing release documents includes

O2 FAA Form 8130-3.

The Company’s authorized personnel issue release documents using FAA Form 8130-3.

O3 Conditional Requirement.

When applicable, the Company may obtain airworthiness approvals from the FAA.

Section P: PMA Article Part Marking P1 PMA articles: Responsible Authorities permanently and legibly mark all FAA PMA articles with

the following:

P2 Sample of marking used on all PMA articles:

Your Sample Markings

P3

Section Q: Shipping / Export of Completed Articles Q1 All required documents are

Q2 Before exporting products to other Countries, FAA AC21-2 and Bilateral Agreements are reviewed for applicable requirements.

Q3 All shipping documents are followed and completed according to

Section R: Supplemental Requirements Supplemental FAA policies are defined in QMS-18 Supplemental Policies.

Appendix 1: Organization INSERT ORG CHART

Appendix 2: Facility Layout INSERT FACILITY MAP

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PROPRIETARY INFORMATION This document expires 30 days after printing unless marked "Released".

Date Printed: Form Rev: Orig

ISO 9001 PMA and 14 CFR 21 QUALITY POLICIES HANDBOOK


Identifier: QMS-00 QMS Quality Policies Handbook


Revision: Orig

Abstract: This quality handbook describes the quality management system policies and procedures that achieve conformance with ISO 9001, FAA AC 21-43, FAA Order 8120.22 and 14 CFR Part 21.137.

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QMS-00 Policies Handbook

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NOTE: Company policies herein are expressed from the perspective of "As-a-Matter-of-Fact". To apply this perspective, mentally add the phrase to the beginning of each paragraph herein. Delete this note prior to release of quality handbook.

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TABLE OF CONTENTS

Section 1: ...................................................................................................................................................................... 5 Scope

Section 2: .............................................................................................................................................. 5 Normative references

Section 3: ............................................................................................................................................ 5 Terms and Definitions

Section 4: ................................................................................................................................... 5 Context of the Organization

4.1 ..................................................................................................................................................5 Understanding the organization and its context

4.2 ........................................................................................................................5 Understanding the needs and expectations of interested parties

4.3 ................................................................................................................................5 Determining the scope of the quality management systemNon-Applicable Provisions of the QMS.............................................................................................................................................................................................5

4.4 ...................................................................................................................................................6 Quality management system and its processes4.4.1 .......................................................................................................................................................................................7 Vision and governing policies

4.4.2 ...........................................................................................................................................................................................8 Overview of documentation

4.4.3 ......................................................................................................................................................................9 Overall process sequence and interaction

Section 5: .............................................................................................................................................................. 9 Leadership5.1 ...............................................................................................................................................................................9 Leadership and commitment

5.1.1 ...........................................................................................................................................................................................................................9 General

5.1.2 ..............................................................................................................................................................................................................9 Customer focus

5.2 .................................................................................................................................................................................................................10 Policy5.2.1 .....................................................................................................................................................................................10 Establishing the quality policy

5.2.2 ...............................................................................................................................................................................10 Communicating the quality policy

5.3 .......................................................................................................................................10 Organizational roles, responsibilities and authorities

Section 6: ................................................................................................................................................................ 10 Planning6.1 ........................................................................................................................................................10 Actions to address risks and opportunities

6.1.1 ..................................................................................................................................................................................................10 Planning for the QMS

6.1.2 .................................................................................................................................................................................................10 Planning requirements

6.2 .............................................................................................................................................11 Quality objectives and planning to achieve them6.2.1 ....................................................................................................................................................................................11 Establishing quality objectives

6.2.2 .......................................................................................................................................................................................11 Achieving quality objectives

6.3 ..........................................................................................................................................................................................11 Planning of changes

Section 7: ................................................................................................................................................................. 11 Support7.1 ...........................................................................................................................................................................................................11 Resources

7.1.1 General .........................................................................................................................................................................................................................11 7.1.2 People ...........................................................................................................................................................................................................................11 7.1.3 ................................................................................................................................................................................................................12 Infrastructure

7.1.4 ................................................................................................................................................................13 Environment for the operation of processes

7.1.5 ...........................................................................................................................................................................13 Monitoring and measuring resources

7.1.5.1 .........................................................................................................................................................................................................................13 General

7.1.5.2 .............................................................................................................................................................................................13 Measurement traceability

7.1.6 ...........................................................................................................................................................................................13 Organizational knowledge

7.2 .......................................................................................................................................................................................................13 Competence

7.3 .........................................................................................................................................................................................................14 Awareness

7.4 .................................................................................................................................................................................................14 Communication

7.5 ..................................................................................................................................................................................14 Documented information7.5.1 .........................................................................................................................................................................................................................14 General

7.5.2 ..................................................................................................................................................................................................15 Creating and updating

7.5.3 ............................................................................................................................................................................15 Control of documented information

7.5.3.1 ..........................................................................................................................................15 Documents required by QMS and International Standard

7.5.3.2 .......................................................................................................................................................16 Activities for control of documented information

Section 8: .............................................................................................................................................................. 16 Operation

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8.1 .................................................................................................................................................................16 Organizational planning and control

8.2 ...........................................................................................................................................................16 Requirements for products and services8.2.1 ............................................................................................................................................................................................16 Customer communication

8.2.2 ..................................................................................................................................17 Determining the requirements related to products and services

8.2.3 ...........................................................................................................................................17 Review of requirements related to products and services

8.2.3.1 .......................................................................................................................................................................................17 Ability to meet requirements

8.2.3.2 ..................................................................................................................................................................17 Retain documented information of review

8.2.4 ....................................................................................................................................................17 Changes to requirements for products and services

8.3 ...........................................................................................................................................17 Design and development of products and services8.3.1 ...........................................................................................................................................17 General through 8.3.6 Design and development changes

8.4 .....................................................................................................................18 Control of externally provided processes, products and services8.4.1 .........................................................................................................................................................................................................................18 General

8.4.2 ...........................................................................................................................................................................................18 Type and extent of control

8.4.3 ...............................................................................................................................................................................19 Information for external providers

8.5 ......................................................................................................................................................................20 Production and service provision8.5.1 ...............................................................................................................................................................20 Control of production and service provision

8.5.2 ......................................................................................................................................................................................21 Identification and traceability

8.5.3 ..............................................................................................................................................22 Property belonging to Customers or external providers

8.5.4 ..................................................................................................................................................................................................................22 Preservation

8.5.5 .................................................................................................................................................................................................22 Post-delivery activities

8.5.6 .......................................................................................................................................................................................................23 Control of changes

8.6 ......................................................................................................................................................................23 Release of products and services

8.7 ....................................................................................................................................................................23 Control of nonconforming outputs8.7.1 ...............................................................................................................................................................23 Identify and control nonconforming outputs

8.7.2 .................................................................................................................................................25 Retain documented information for nonconformities

Section 9: ........................................................................................................................................ 25 Performance evaluation

9.1 .........................................................................................................................................25 Monitoring, measurement, analysis and evaluation9.1.1 .........................................................................................................................................................................................................................25 General

9.1.2 ...................................................................................................................................................................................................25 Customer satisfaction

9.1.3 ...............................................................................................................................................................................................26 Analysis and evaluation

9.2 ......................................................................................................................................................................................................26 Internal audit9.2.1 ................................................................................................................................................................26 Conduct internal audits at planned intervals

9.2.2 ......................................................................................................................................................................................................26 Audit requirements

9.3 ..........................................................................................................................................................................................26 Management review9.3.1 .........................................................................................................................................................................................................................26 General

9.3.2 ..........................................................................................................................................................................................27 Management review inputs

9.3.3 ........................................................................................................................................................................................27 Management review outputs

Section 10: ........................................................................................................................................................ 27 Improvement10.1 ........................................................................................................................................................................................................27 General

10.2 .........................................................................................................................................................27 Nonconformity and corrective action10.2.1 .........................................................................................................................................................................27 Required actions for nonconformities

10.2.2 .........................................................................................................................................................................28 Required records for nonconformities

10.3 ..............................................................................................................................................................................28 Continual improvement

Section 11: ............................................................................................................ 28 PMA Article Part Marking 14 CFR 45.15

Appendix A: Cross-Reference Matrix to ISO 9001 and AC 21-43................................................................................................. 29 Appendix B: Company Process Cross Reference Matrix to ISO 9001 ........................................................................................... 30 Appendix C: Company Processes and Applicable Documents ....................................................................................................... 31 Appendix D: Outsourced Processes................................................................................................................................................ 32 Appendix E: Quality Objectives ..................................................................................................................................................... 33 Appendix F: Identification of Key Product Realization Processes ................................................................................................. 34 Appendix G: Facility Layout .......................................................................................................................................................... 35

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Section 1: Scope (Your Company's) quality management system (QMS) policies and procedures summarize top management's stategic view to improve the QMS, enhance Customer satisfaction and assure consistent delivery of products and services that achieve conformance with Customer and applicable statutory and regulatory requirements.

Section 2: Normative references Documents that are referenced herein are indispensable and their title's are displayed in Bold Italics.

Section 3: Terms and Definitions Unless otherwise noted, the Company applies the definitions of key terms according to ISO 9001, FAA AC 21-43, FAA Order 8120.22, 14 CFR Part 21.137 and the QMS-16 Definitions and Abbreviations Procedure.

Section 4: Context of the Organization

4.1 Understanding the organization and its context The Company determines, monitors and reviews internal and external issues that affect its ability to achieve intended results according to the QMS-04 Management Process Procedure.

4.2 Understanding the needs and expectations of interested parties The Company considers the needs and expectations of interested parties that affect its ability to achieve intended results according to the QMS-04 Management Process Procedure.

4.3 Determining the scope of the quality management system The Company's quality management system applies to all employees within all functional areas of the business operation.

The Company provides the following products and/or services:

Producer/Provider of [Your text]

NAICS code: [Your code(s)]

SIC code: [Your code(s)]

QMS policies and/or procedures outline responsibilities, methods, measurements and related performance indicators to ensure effective operation and control of the quality management system.

Non-Applicable Provisions of the QMS

The Company cites no exclusions to requirements of ISO 9001, FAA AC 21-43, FAA Order 8120.22 or 14 CFR Part 21.137.

(User Info: If your Company strictly builds-to-print or performs a service and doesn't design tools for the job, then take exception to "design" and other features herein and report exclusion in other paragraphs, such as paragraph 8.3. Delete this "User Info" prior to release of quality manual.)

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4.4 Quality management system and its processes The Company's quality management system is fully documented and implemented and is maintained as needed to meet the requirements of the Company's vision and governing policies.

The Company uses a process-oriented method of management, which emphasizes the importance of:

During Management Review (see 9.3), process resources are discussed and allocated as applicable. Corrective action is taken to ensure processes achieve the desired results and continuously improve.

Every process has at least one QMS Procedure that defines it in greater detail that may include a process map.

For each process identified in use by the Company, the sequence and interaction of processes has been determined (see Process Orientation Checklist) and the process controlled by way of criteria and methods specific to that process, such as

Process maps define the details of each process, which includes The relationship between QMS procedures and

their applicable FAA AC 21-43 and ISO 9001 clauses is shown in Appendix A. See Appendix B for applicable Company processes and documents. Outsourced processes and their controls are defined in Appendix C. See Appendix E for identification of key realization processes.

The Company maintains all required documentation to effectively sustain its quality management system and to

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4.4.1 Vision and governing policies

QUALITY POLICY The Company is committed to providing high

quality and high value products to its Customers,

ENVIRONMENTAL POLICY To prevent production and distribution of

products or waste materials that

PRACTICAL STEPS TO SUPPORT POLICIES

Customer Focus:

Workplace Excellence:

Empowerment:

Intelligent Management:

SEE SECTION 5 FOR DETAILS ON THESE PRACTICAL STEPS

COMPANY VISION To continually improve our processes, products and services to


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4.4.2 Overview of documentation

The quality system documentation is comprised of a hierarchy of documents that flow from this Quality Handbook.

Corporate Vision and Governing

Policy

Quality Handbook Defines overall

Company policies and procedures

QMS Procedures Defines quality system

related processes in greater detail.

Work instructions and other job specific documentation

Forms Used to record data; once complete, they

become records.


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4.4.3 Overall process sequence and interaction

MANAGEMENT PROCESS MANAGEMENT INTERNAL AUDITING CORRECTIVE ACTION

Product Realization Processes Proposal Development and

Contract Review

Section 5: Leadership

5.1 Leadership and commitment The Company's Management is committed to

5.1.1 General

The Company uses the quality management system to guide and validate its decisions and to encourage the discovery of new areas of improvement. Management participation in the QMS is described in the QMS-04 Management Process Procedure.

5.1.2 Customer focus

The Company demonstrates leadership and commitment with respect to Customer focus by ensuring the maintenance and enhancement of Customer satisfaction through

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according to the QMS-04 Management Process Procedure.

5.2 Policy

5.2.1 Establishing the quality policy

The Company's quality policy defines the purpose and context of the organization and its strategic direction, which includes a framework for

5.2.2 Communicating the quality policy

The Company's quality policy is available to interested parties and is maintained as documented information that is

5.3 Organizational roles, responsibilities and authorities Assignment of responsibilities and authorities for relevant roles are communicated and understood throughout the organization according to the QMS-05 Responsibilities and Authorities Procedure to ensure the quality management system conforms to the requirements of ISO 9001. Responsible authorities confirm processes are

Section 6: Planning

6.1 Actions to address risks and opportunities

6.1.1 Planning for the QMS

Planning for the quality management system includes consideration of the context of the organization and the needs and expectations of interested parties. QMS-04 Management Process Procedure is used to address associated risks and opportunities to achieve

Supplemental FAA policies are defined in QMS-18, Supplemental Policies.

6.1.2 Planning requirements

Proportionate actions are taken to address risks and opportunities that could impact requirements that are applicable to products and services according to the QMS-13 Corrective Action Procedure. The Company integrates and implements these actions into quality management system processes (see 4.4) and evaluates their effectiveness.


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6.2 Quality objectives and planning to achieve them

6.2.1 Establishing quality objectives

The Company establishes and maintains documented information for quality objectives at relevant functions, levels and processes according to the QMS-04 Management Process Procedure. Quality objectives are measurable and consistent with the quality policy and are

6.2.2 Achieving quality objectives

The Company determines how to achieve its quality objectives according to

6.3 Planning of changes Changes to the quality management system are performed according to the QMS-02 Configuration Management Procedure, which considers the purpose of changes and potential consequences and

IMPORTANT:

The quality management system is maintained at its authorized revision level until planned changes are implemented.

Section 7: Support

7.1 Resources

7.1.1 General

The Company determines and provides the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system according to the QMS-04 Management Process Procedure, which considers

7.1.2 People

The Company determines and provides the people necessary for the effective implementation of its quality management system and operation and control of its processes according to the QMS-04 Management Process Procedure and QMS-06 Training Procedure.


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ORGANIZATION CHART

PRESIDENT

7.1.3 Infrastructure

The Company determines, provides and maintains the infrastructure necessary for the operation of its processes to achieve according to the QMS-04 Management Process Procedure.

The Company has determined and provides the basic infrastructure needed to achieve conformity to product requirements. Infrastructure requirements are regularly reviewed during Management Review and include a review of:

The Company utilizes corrective maintenance and skilled maintenance personnel to

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7.1.4 Environment for the operation of processes

The Company determines, provides and maintains the environment necessary for the operation of its processes to achieve


7.1.5 Monitoring and measuring resources

7.1.5.1 General

When monitoring or measuring is used to verify the conformity of products and services, the Company determines and provides resources needed to

7.1.5.2 Measurement traceability

All measuring and test equipment instruments and devices used to determine an item's conformance to specified requirements are

according to the QMS-15 Calibration Procedure.

7.1.6 Organizational knowledge

The Company determines, maintains, uses and internally shares knowledge that is required to operate its processes. The Company considers the need for

7.2 Competence The Company determines and periodically reviews the necessary competence for Employees whose work affects the performance and effectiveness of the quality management system. The Company affirms Employee competence according to

the QMS-04

Management Process Procedure, QMS-06 Training Procedure and QMS-01 Control of Documented Information Procedure.

All Company personnel are hired on the basis of their ability to

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The Company has implemented a training program that:

Management conducts periodic reviews of employee performance. Appropriate records of education, training, skills and experience are maintained.

The internal auditing process evaluates the effectiveness of training and

7.3 Awareness The Company affirms Employees and Contractors are made aware of the Company's quality policy and applicable quality objectives. In addition, Employees and Contractors are made aware of their

according

to the QMS-06 Training Procedure.

7.4 Communication Internal and external communications that are relevant to the QMS are determined, which includes


To ensure proper communication between and throughout all levels of Employees within the Company, internal communication is

Management periodically communicates with employees to discuss Company policies and the status and effectiveness of the quality system and other information.

Employees are encouraged to

7.5 Documented information

7.5.1 General

The Company's quality management system includes

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The order of precedence of order-specific documentation is as follows unless otherwise directed by Customer requirements:

7.5.2 Creating and updating

During creation and update of documented information, the Company reviews and approves documents prior to release for

The Company controls documented information to ensure it is according

to the QMS-01 Control of Documented Information Procedure.

7.5.3 Control of documented information

7.5.3.1 Documents required by QMS and International Standard

Documents are controlled so that the information on them is

For details, see QMS-01 Control of Documented Information Procedure and QMS-02 Configuration Management Procedure.

The Company controls and distributes design data and changes. Release and distribution of new (or revised) FAA approved drawings and/or (major) process specifications and latest approved changes are made available to:

And manage records as:

The Company retains files for

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Note: The Company ensures that only FAA approved data is

7.5.3.2 Activities for control of documented information

The Company controls the content, change disposition, revision level, access, use, retention, distribution and retrieval, preservation of legibility and storage of documented information that is maintained as evidence of conformity to

Section 8: Operation

8.1 Organizational planning and control Processes that are used to achieve compliance with requirements for deliverable products and services are monitored, measured and analyzed, suitable for their purpose and are planned according to Section 6 herein (including special processes and airborne software) that have been identified and defined by FAA-approved design data. In planning the processes for product realization, management affirms

The Company applies the QMS-07 Proposal Development and Contract Review Procedure to engage Responsible Authorities and

The Company applies QMS-02 Configuration Management Procedure to approve processes and control changes. Consequences of unintended changes are

Suppliers used for outsourced processes are approved according to 8.4 herein and the QMS-08 Purchasing Procedure.

8.2 Requirements for products and services

8.2.1 Customer communication

The Company communicates with its Customers by providing information relative to its products and services according to the QMS-07 Proposal Development and Contract Review Procedure and by obtaining

Additional Customer communication channels include

according to the QMS-10 Production Procedure.


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8.2.2 Determining the requirements related to products and services

The Company determines that it can meet the claims for products and services it offers and ensures requirements for products and services are defined, which includes

according to the QMS-07 Proposal Development and Contract Review Procedure.

8.2.3 Review of requirements related to products and services

8.2.3.1 Ability to meet requirements

The Company reviews Customer requirements according to the QMS-07 Proposal Development and Contract Review Procedure before accepting a contract, which includes

8.2.3.2 Retain documented information of review

The Company establishes and maintains a record for each contract review that includes

8.2.4 Changes to requirements for products and services

When the requirements for products and services are changed, the Company

8.3 Design and development of products and services

8.3.1 General through 8.3.6 Design and development changes

The Company's design and development process is conducted in a controlled manner according to the nature, duration and complexity of design and development activities, stages and controls, which are defined in the QMS-17 Design and Development Procedure that includes policies for:

8.3.2 Design and development planning 8.3.3 Design and development inputs 8.3.4 Design and development controls 8.3.5 Design and development outputs 8.3.6 Design and development changes

Instructions for Continued Airworthiness (ICA) are kept current with design changes.

8.3.7 Copies of all drawings for FAA Approved articles are

8.3.8 Design data is filed by Drawing Number and the latest revision is

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8.3.9 Minor design changes to the PMA Articles are

8.3.10 Major design changes are

These design changes may require amendments or additions to:

8.4 Control of externally provided processes, products and services The Company accepts responsibility for

8.4.1 General

The Company affirms externally provided processes, products and services conform to requirements according to the QMS-08 Purchasing Procedure and QMS-09 Receiving Procedure. The Company determines the controls to be applied to externally provided processes, products and services when

The Company determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers that is based upon

according to requirements and QMS-08 Purchasing Procedure. The Company retains documented information of these activities and any necessary actions arising from the evaluations, which includes

8.4.2 Type and extent of control

The Company affirms externally provided processes, products and services do not adversely affect the Company's ability according to the QMS-08 Purchasing Procedure and QMS-09 Receiving Procedure. The Company takes into consideration

The Company plans, implements and controls processes to prevent counterfeit or suspect counterfeit parts according to the QMS-03 Counterfeit Parts Prevention Procedure and QMS-04 Management Process Procedure.

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Material received is accompanied by a certification record and verified as noted on the Approved Supplier List. Supplied items that support production and or assembly of FAA-PMA articles are

a. Reports of unsatisfactory conditions are documented and nonconforming parts are segregated. All affected Suppliers are informed of possible FAA audit.

b. Review of documented unsatisfactory conditions increases Supplier surveillance to a more frequent basis. An on-site visit may be required that verifies:

c.

d.

e.

Note: As part of the receiving inspection process, a comparison is made between the Supplier's packing sheet and the purchase order then each shipment is inspected for:

f.

g.

h.

8.4.3 Information for external providers

The Company ensures that mandatory requirements are adequately documented prior to communicating with Suppliers according to the QMS-08 Purchasing Procedure. When the Company provides supplies for outside processing, such as acceptance testing, the work is performed under the following conditions:

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8.5 Production and service provision

8.5.1 Control of production and service provision

The Company implements production and services under controlled conditions according to the QMS-04 Management Process Procedure and QMS-10 Production Procedure. The engineering drawing, FAA-approved design data and/or other technical documentation provides the requirements for all deliverable supplies.

A Shop Routing Sheet is used to

The Company services supplies returned to it for warranty work or repair - field servicing is(is not) performed. For such product work,

Inspection methods may include

The Company plans and carries out processes for product realization. In general, this includes assurances that:

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In-process inspection and nondestructive testing (NDT) is conducted according to work instruction or other controlled document to

"Request for Service Inspectors" (RFS) determine that each completed part conforms to the design data and is safe for installation on type certificated products. Inspectors perform the following:

RFS Inspectors have access to FAA approved data and specifications when

When witnessing acceptance tests, the Inspectors have access to FAA approved data used to verify and validate any test.

All inspection records described above and the record of disposition are

The Responsible Authority completes the required inspection form, and by signing off, is

The Company does not perform work operations where the resulting quality of the work cannot be ascertained prior to delivery. When the Responsible Authority determines that a latent deficiency is discovered,

8.5.2 Identification and traceability

The Company uses suitable means to identify outputs when it is necessary to ensure

The inspector affixes an initial on the Inspection Record indicating

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Rejected components are

8.5.3 Property belonging to Customers or external providers

When outside sources provide property for processing or use, it is

Property is controlled according to the QMS-10 Production Procedure, specified contractual requirements, and

8.5.4 Preservation

According to contractual directives, instructions are detailed in the applicable job documentation for

The Company preserves production and service outputs to ensure conformity to requirements according to the QMS-10 Production Procedure and QMS-11 Shipping Procedure.

8.5.5 Post-delivery activities

The Company meets requirements for post-delivery activities associated with the products and services according to

The Company provides as applicable:

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8.5.6 Control of changes

To ensure continuing conformity with requirements, the Company according to the QMS-02 Configuration

Management Procedure, QMS-10 Production Procedure and QMS-17 Design and Development Procedure. The Company identifies and obtains Customer and/or regulatory authority approval for changes when

8.6 Release of products and services In-process inspections are conducted during production and service activities

according to the QMS-10 Production Procedure. Products and services are released for delivery to Customers only after

The Company is responsible for issuing FAA Form 8130-3 for new, rebuilt and altered articles. Authorized Responsible Authority(s) that issue Form 8130-3 are

The Company retains and maintains records for the release of products and services that includes

8.7 Control of nonconforming outputs

8.7.1 Identify and control nonconforming outputs

The Company affirms outputs that do not conform to requirements are according to the QMS-14 Control of Nonconformities Procedure.

Nonconforming outputs may be identified by the Customer and internal and external sources. The Company takes appropriate actions based on

Procedures are available that establish a system for receiving, processing and tracking in-service failures, malfunctions and defects. The procedures include

Service problems, unairworthy conditions, unsafe features and unsafe characteristics are reported to the FAA according to FAR §21.3 (§21.9) and are

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Nonconforming and rejected materials are

Nonconforming parts may be reworked to achieve conformity, provided

Major Change incorporation to FAA-PMA articles are first approved by FAA ACO and MIDO with PMA addition.

Service Difficulty Reports (SDRs)

When in service difficulties are discovered, they are reported to the FAA ACO and MIDO.

Note: The Company reports 14 CFR 21.3 conditions to the FAA ACO and MIDO within

Self Disclosure Reporting

When in-service difficulties are found for an article, they are reported to the FAA's geographic MIDO.

Airworthiness Directives (ADs)

In the event that an Airworthiness Directive is issued by the FAA, the Company

When appropriate, changes related to an AD are

A quality escape is defined as

The Company notifies the FAA of any apparent quality escape by contacting the FAA MIDO office. Initial notice of a voluntary disclosure may

Quality escape notifications include the following information:

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8.7.2 Retain documented information for nonconformities

Records used to disposition nonconformities clearly describe each nonconformance and include

according to the QMS-14 Control of Nonconformities Procedure. The Company retains and maintains records according to the QMS-01 Control of Documented Information Procedure.

Section 9: Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

The Company's determines methods for monitoring, measurement, analysis and evaluation to

according to the QMS-04 Management Process Procedure, QMS-12 Internal Auditing Procedure and QMS-01 Control of Documented Information Procedure.

Documented information that is used for determining the acceptability of this quality management system may include, but are not limited to:

ports

9.1.2 Customer satisfaction

To monitor and measure Customer satisfaction and fulfillment of expectations, the Company collects information about: (adjust "your list" as required - keep mandatory items - delete this note prior to release of quality handbook)

(mandatory)

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ance (mandatory) (mandatory)

The Company continuously improves Customer satisfaction according to the QMS-04 Management Process Procedure.

9.1.3 Analysis and evaluation

The Company evaluates according to the QMS-04 Management Process Procedure.

9.2 Internal audit

9.2.1 Conduct internal audits at planned intervals

The Company conducts internal audits at planned intervals to provide information according

to the QMS-12 Internal Auditing Procedure and QMS-04 Management Process Procedure

Request for Service Inspectors conduct Internal Audits according to

See Internal Audit Control Log:

(Log headings: )

9.2.2 Audit requirements

The Company assigns Responsible Authorities to

9.3 Management review

9.3.1 General

Top management reviews the Company's quality management system at planned intervals to ensure

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9.3.2 Management review inputs

Management review is planned and carried out according to the QMS-04 Management Process Procedure, which takes into consideration

9.3.3 Management review outputs

Results from management reviews include


Section 10: Improvement It is the goal of all employees to continually improve the effectiveness of the quality management system through the use of

10.1 General The Company determines and selects according to the QMS-04 Management Process Procedure.

10.2 Nonconformity and corrective action

10.2.1 Required actions for nonconformities

When a nonconformity occurs in products and processes, including according to the QMS-13 Corrective Action Procedure and QMS-14

Control of Nonconformities Procedure. The Company evaluates the need for action to review, analyze, control, correct and eliminate the root cause of nonconformities, including

Corrective actions are reviewed for nonconformities of produced articles to:

Action is taken to:

The Company affirms corrective actions are appropriate to the effects of nonconformities, and:

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10.2.2 Required records for nonconformities

The Company retains and maintains records regarding according to the QMS-14 Control of Nonconformities Procedure and

QMS-01 Control of Documented Information Procedure.

10.3 Continual improvement The Company continually improves

according to the QMS-04 Management Process Procedure using

Section 11: PMA Article Part Marking 14 CFR 45.15 Responsible Authorities permanently and legibly mark all FAA PMA articles with the following:

1. 2. 3. 4.

If a part is too small or is impractical to mark,

Sample of marking used on all PMA articles:

Your Sample Markings

Shipping / Export of Completed Articles

All required documents are

Before exporting products to other Countries, FAA AC 21-2 and Bilateral Agreements are reviewed for applicable requirements.

All shipping documents


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Appendix A: Cross-Reference Matrix to ISO 9001 and AC 21-43

FAA AC 21-43A 10/01/15 Quality System (a – o)

Federal Aviation

Regulation

Quality Manual and ISO 9001 Paragraph Numbers

Procedure Number

2.3 Design Data Control: 21.137(a) 7.5.3 Control of documented info 8.3.6 Design changes

QMS-01 Control of Documented Info QMS-17 Design and Development

2.4 Document Control: 21.137(b) 7.5.3 Control of documented info QMS-01 Control of Documented Info

2.5 Supplier Control: 21.137(c)

8.4 Purchasing 8.4.1 Supplier evaluation 8.4.2 Purchasing information 8.6 Verification of purchased product 8.5.2 Identification & traceability 8.5.4 Preservation 8.7 Control of nonconformities

QMS-08 Purchasing QMS-09 Receiving QMS-10 Production QMS-14 Control of Nonconformities

2.6 Manufacturing Process Control:

2.7 Inspection and Testing:

21.137(d) 21.137(e)

7.5.3 Control of documented info 8.1 Planning of product realization 8.3.6 Design changes 8.5.1 Control of production 8.5.2 Identification & traceability 8.5.3 Customer property 8.5.4 Preservation 7.1.5 Control of measuring equipment 8.6, 9.1.1 Monitoring & measurement of product 8.7 Control of nonconformities

QMS-01 Control of Documented Info QMS-10 Production QMS-14 Control of Nonconformities QMS-15 Calibration

2.8 Inspection, Measuring and Test Equipment Control:

2.9 Inspection and Test Status:

21.137(f) 21.137(g)

7.1.5 Control of measuring equipment 8.5.2 Identification & traceability 8.6, 9.1.1 Monitoring & measurement of product

QMS-10 Production QMS-15 Calibration

2.10 Nonconforming Product and Article Control:

21.137(h) 8.7 Control of nonconformities QMS-14 Control of Nonconformities

2.11 Corrective and Preventive Actions:

21.137(i) 10.2 Corrective action QMS-13 Corrective Action

2.12 Handling and Storage: 21.137(j) 8.5.4 Preservation QMS-10 Production 2.13 Control of Quality Records: 21.137(k) 7.5.3 Control of documented info QMS-01 Control of Documented Info

2.14 Internal Audits: 21.137(l) 9.2 Internal audit QMS-12 Internal Auditing

2.15 In-Service Feedback: 21.137(m)

5.1.2 Customer focus 8.3.6 Design changes 8.7 Control of nonconformities 10.2 Corrective action

QMS-00 Quality Manual QMS-13 Corrective Action QMS-14 Control of Nonconformities QMS-17 Design and Development

2.16 Quality Escapes: 21.137(n) 8.7 Control of nonconformities 10.2 Corrective action

QMS-13 Corrective Action QMS-14 Control of Nonconformities

2.17 Authorized Release 21.137(o) 8.6 Release of products QMS-06 Training


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Appendix B: Company Process Cross Reference Matrix to ISO 9001

Process Applicable ISO 9001 Clauses

Configuration Management See 8.3.1 for 8.3.6, 8.5.6 Design and Development Changes, Control of Changes (was

) Control of Documents 7.5.2, 7.5.3 Creating and Updating, Control of Documented Information (was ) Control of Records 7.5.2, 7.5.3 Creating and Updating, Control of Documented Information (was ) Control of Nonconformities 8.7 Control of Nonconforming Outputs (was nformances) Corrective Action 10.2 Nonconformity and Corrective Action (was ) Internal Auditing 9.2 Internal Audit (was )

Management

4.4 Quality Management System and its Processes (was rements) 7.5 Documented Information (was ) 5.1, 5.1.1 Leadership and Commitment, General (was ) 5.1.2 Customer Focus (was ) 5.2, 5.2.1, 5.2.2 Policy, Developing the Quality Policy, Communicating the Quality Policy (was

) 6.0 Planning (was ) 5.3 Organizational Roles, Responsibilities and Authorities (was thority) 5.3 Organizational Roles, Responsibilities and Authorities (was ) 7.4 Communication (was munication) 9.3 Management Review (was ) 7.1.1, 7.1.2 General, People (was ) 7.2 Competence (was sources) 7.1.3 Infrastructure (was ) 7.1.4 Environment for the Operation of Processes (was ) See 8.3.1 for 8.3.6, 8.5.6 Design and Development Changes, Control of Changes (was

) 8.2.1 Customer Communication (was ) 8.5.1, 8.5.5 Control of Production & Service Provision, Post Delivery Support (was ) 7.1.5 Monitoring and Measuring Resources (was ) 9.1.1 Measurement, Analysis & Improvement: General (was ) 9.1.2 (was ) Customer Satisfaction 9.1.1 General (was ) 9.1.3 Analysis and Evaluation (was ) 10.1 General, Continual Improvement (was )

Production

8.1 Operational Planning and Control (was ) 8.5.1, 8.5.5 Control of Production and Service Provision, Post Delivery Support (was ) 8.5.2 Identification & Traceability (was ) 8.5.3 Property Belonging to Customers or External Providers (was ) 8.5.4 Preservation (was ) 8.6 Release of Products and Services (was ) 8.7 Control of Nonconforming Outputs (was )

Proposal Development & Contract Review

8.2.2 Determining the Requirements Related to Products and Services (was )

8.2.3 Review of Requirements Related to Products and Services (was irements)

Purchasing 8.4.1, 8.4.2 General, Type and Extent of Control (was process) 8.4.3 Information for External Providers (was )

Receiving

8.6 Release of Products and Services (was product) 8.5.2 Identification & Traceability (was ) 8.5.3 Property Belonging to Customers or External Providers (was ) 8.5.4 Preservation (was ) 8.6 Release of Products and Services (was ) 8.7 Control of Nonconforming Outputs (was )

Shipping

8.2.2 Determining Requirements Related to Products and Services (was )

8.5.1, 8.5.5 Control of Production and Service Provision, Post Delivery Support (was ) 8.5.2 Identification & Traceability (was ) 8.5.4 Preservation (was ) 8.7 Control of Nonconforming Outputs (was )


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Appendix C: Company Processes and Applicable Documents

Process Applicable Company Procedures Applicable Company Records Corrective Action QMS-13 Corrective Action Corrective action records 10.2 (was )

Design & Development

QMS-17 Design & Development

Realization processes and resulting product meet requirements 8.1 (was ) Design and development planning 8.3.2 (was ) Design inputs records 8.3.3 (was ) Design review records 8.3.4 (was ) Design verification records 8.3.4 (was ) Design validation records 8.3.4 (was ) Design and development outputs 8.3.5 (was ) Design change records see 8.3.1 for 8.3.6 (was

) Internal Auditing QMS-12 Internal Auditing Internal audits 9.2 (was )

Management

QMS-00 Quality Handbook QMS-01 Control of Documented Info QMS-02 Configuration Management QMS-04 Management Process Procedure QMS-05 Responsibilities & Authorities QMS-06 Training QMS-15 Calibration QMS-16 Definitions and Abbreviation

Management review minutes 9.3.1 (was ) Training records 7.2, 7.3 (was ) Calibration records 7.1.5 (was )

Production QMS-10 Production QMS-14 Control of Nonconformities

Traceability records (if required) 8.5.2 (was ) Records of loss, damage or nonconformances 8.5.3 (was ) Records of release authority of inspected product 8.6 (was ) Records of first article inspection 8.6 (was ) Control of nonconformities 8.7 (was )


QMS-07 Proposal Development & Contract Review

Contract review records 8.2.3 (was )

Purchasing QMS-08 Purchasing Supplier evaluation records 8.4.1, 8.4.2 (was )

Receiving QMS-09 Receiving QMS-14 Control of Nonconformities

Records of loss, damage or nonconformances 8.5.3 (was ) Control of nonconformities 8.7 (was )

Shipping QMS-11 Shipping QMS-14 Control of Nonconformities

Records of loss, damage or nonconformances 8.5.3 (was ) Control of nonconformities 8.7 (was )


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Appendix D: Outsourced Processes The following processes are outsourced and controlled as indicated:

Direct shipment may be performed according to the latest revision of SAE ARP9114, Direct Ship Guidance for Aerospace Companies.

The following restrictions apply:

(1)

(2) (3)

(4)

(5) The Buyer obligates the Supplier to: (a) (b) (c) (d) (e) (f)

(g) (h)

(i)

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Appendix E: Quality Objectives

Process Quality Objective Metric

Corrective Action

Design & Development

Internal Auditing

Management

Production


Purchasing

Receiving

Shipping

User Info: (Delete the following User Info prior to release of quality manual)

The quantity of quality objectives listed above should be evaluated and adjusted to meet actual value-added goals of the business operation. The objectives that are listed above are


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Appendix F: Identification of Key Product Realization Processes

C

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T

O

M

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Market Research

Sales

Business Plan and Objective

Management Responsibility

Key Product Realization Processes

Quote

RFQ

Management Review

R

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c

e

Production

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Appendix G: Facility Layout (Insert your facility map)

8 Mandatory Procedures

(delete this table prior to release of quality handbook)

22 Mandatory Forms

(delete this table prior to release of quality handbook)

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MANAGEMENT PROCESS PROCEDURE


Identifier: Management Process Procedure

Date: Latest Revision Date Project: Customer, Unique ID, Part Number

Document Status:

Draft, Redline, Released, Obsolete

Document Link:


Abstract: This document describes the management review process.

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Management Process Procedure

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TABLE OF CONTENTS

1.0 ................................................................................................................................................... 4 PURPOSE

2.0 .................................................................................................................................................... 4 THEORY

3.0 .................................................................................................................. 4 MANAGING AS A PROCESS

4.0 ............................................................................................. 4 PROCEDURE: MANAGEMENT REVIEW

5.0 .................................... 6 PROCEDURE: MEASURING AND MONITORING PROCESS OBJECTIVES

6.0 ...................................................... 7 PROCEDURE: INTERNAL and EXTERNAL COMMUNICATION

7.0 ........................................................................................ 8 PROCEDURE: RESOURCE MANAGEMENT

Appendix A: PROCESS MAP.............................................................................................................................. 10

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1.0 PURPOSE This document defines the Management process, including or making reference to procedures for the various activities within the Management process.

2.0 THEORY The Company believes in “intelligent management,” which enables the Company to make decisions based on

3.0 MANAGING AS A PROCESS The Company recognizes that it has to manage processes identified in the Quality Management Policies and Procedures Handbook; however, management itself must also be treated as a process. This means

Management is responsible for implementation and application of the following QMS requirements:

4.0 PROCEDURE: MANAGEMENT REVIEW 4.1 The management of the Company performs formal management review of the Quality Management System a minimum of

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4.2 This review shall include

4.3 Minutes of the meetings are taken and maintained. The Management Review Report Template may be used as a guide for the records or may be completed and retained as the record.

4.4 The Management Review meeting should include analysis of the following inputs:

4.5 Management shall use action items or the corrective action system to take recorded actions as a result of review topics in an effort to

See the QMS-13 Corrective Action Procedure.

4.6 Management shall determine internal issues that affect its ability to achieve intended results, which may include, but are not limited to:

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4.7 Management shall determine external issues that affect its ability to achieve intended results, which may include, but are not limited to:

5.0 PROCEDURE: MEASURING AND MONITORING PROCESS OBJECTIVES 5.1 Each process identified in the Quality Management System has at least one objective. The objective is

5.2 Each process objective

5.3 Top management will

5.4 Throughout the year, assigned managers and staff will

5.5 During Management Review

5.6 When a process does not meet a goal,

5.7 The current metrics, standings, previous goal and revised goals shall be (See Section 4.0)

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5.8 Over time, management shall assess performance of each process against the goals according to the

QMS-13 Corrective Action Procedure.

6.0 PROCEDURE: INTERNAL and EXTERNAL COMMUNICATION 6.1 Internal communication is an important facet of the way the Company does business. By this we mean that information must be able to flow in all directions, from

The following methods are used for internal communications:

6.2 External communications that are relevant to the quality management system must

6.2.1 Confidential Company Information

Company Employees must not reveal Confidential Company Information to External Parties except to the extent such disclosures are necessary

6.2.1.1 Basic Company Information

Company Employees must not communicate Basic Company Information to External Parties except to the extent that such communication is part of their normal responsibilities. For example,

Only Authorized Responsible Authorities may communicate about the Company or its business, or communicate as a representative of the Company, with any of the following External Parties:

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Only Authorized Responsible Authorities may communicate about the Company or its business or communicate as a representative of the Company on

6.2.1.2 Written Company Information

All Written Company Information must conform to guidelines established from time to time.

All Written Company Information must be approved by the appropriate Responsible Authority before it is communicated to any External Party.

With respect to any Written Company Information regarding new business, clients, or other contract counterparties, or other Third Parties with a business relationship with the Company, care must be exercised to

Written Company Information regarding must also be

approved by the appropriate Responsible Authority.

7.0 PROCEDURE: RESOURCE MANAGEMENT 7.1 The management of resources is a critical component to the management activities of the Company.

Resources requiring such management includes:

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7.2 Like other management activities, resource management must

7.3 To manage resources, top management must

7.4 During Management Review, managers shall

7.5 From that data, top management can


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Appendix A: PROCESS MAP

Objective:

INPUT from other processes

INPUT from other processes

Conduct Management Review Meeting according to Section 4.0. Review all agenda items and current data against most current internal and external issues.

Management must research why goal is not being met.

continued next page…

Objective met?

MANAGEMENT

Owner:

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from previous page…


NO

YES

OUT

ALL other processes

Planning, resources or controls needed?

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Footnote:

1 Counterfeit part prevention processes should consider:


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(YOUR COMPANY NAME) PROPRIETARY INFORMATION Page 1 of 7

MANAGEMENT REVIEW REPORT


Identifier: Name, Number, Unique ID


Status: Draft, Redline, Released, Obsolete

Document Link:


Abstract: This document provides the management review report.

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Page 2 of 7 This document may not be disclosed or reproduced in whole or in part without prior written


CREATION LOG Issue Date Comment Author

0-0

REVISION RECORD


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Please complete each section - this form may used as the final report or used as a template to type and publish more formal Management Review Meeting records. At all stages, management must consider proper, proactive measures to take to improve the Company and determine where it is necessary to apply corrective action. Record corrective actions (NCR’s) filed in last section of this template.

Date of Review: Recorded by:

In Attendance:

NAME TITLE

Absent:

NAME TITLE

ITEM 1: Review of the Quality Policy for current adequacy and the need for changes to it. Review the Quality Policy to ensure it still represents the Company’s goals.

ITEM 2: Internal audit results. Report on the status of

ITEM 3: Status of MR System corrective actions. Review

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ITEM 4: Review of resources needed to maintain and improve the effectiveness of the quality management system. Discuss

ITEM 5: Review the effectiveness of current training programs and the effectiveness of additional training for designated individuals. Include

ITEM 6: Review of Suppliers and Subcontractors. Discuss

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ITEM 7: Review of quality objectives, data and goals. Review

Process Quality Objective Data Metric Current Standing

Goal

Management

Corrective Action

Internal Auditing

Proposal

Development and Contract Review

Purchasing

Receiving

ITEM 8: Discuss Customer feedback and complaints not already discussed as part of the NCR system review.

ITEM 9: Discuss the overall performance of the quality system, any changes to the Company that may affect the quality system or vice-versa. Include

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ITEM 10: Note other recommendations for management to

ITEM 11. Note follow-up activities from prior Management Review issues.

ITEM 12. Set date for next Management Review:

ITEM 13. NCR’s FILED AT THIS MEETING:

Line Item Corrective? Nature of Issue

1

2

3

4

5

6

ITEM 14. OTHER ACTION ITEMS ASSIGNED:

Action Item Assigned to: Required Response Date

ITEM 15. ITEMS FOR FOLLOW-UP AT NEXT MEETING:

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ACTION ITEM

Date: Action Item Number: Meeting: Due Date:

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ACTION PLAN Page: _____ of _____ Date: _____________

Department: Responsible Authority:

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Page 1 of 3

This document expires 30 days after printing unless marked "Released". Date Printed:

Work Instruction

CHANGES TO ISO 9001:2015CAGE: Your#

The main changes in ISO 9001:2015 are:

i. The adoption of a Higher Level Structure (HLS) as set out in Annex SL of ISO Directives Part 1. 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation

10. Improvement ii.

iii. iv. v.

vi. vii.

viii. ix.

ISO 9001:2008 certifications will not be valid after three years from publication of ISO 9001:2015, which was September 15, 2015.

Organizations using ISO 9001:2008 are recommended to take the following actions:

i. ii.

iii.

iv.

v.

Here's how ISO 9001:2015 aligns with the format for "Plan - Do - Check - Act":

PLAN

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Work Instruction


DO

CHECK

ACT

Mandatory and recommended procedures and forms:

8 Mandatory Procedures

1. Determining the scope of the QMS (4.3) 2. Support operation of processes (4.4.2.a) 3. Quality policy (5.2.1, 5.2.2.a) 4. Quality objectives (6.2.1) 5. Control of documented information from external providers (7.5.3.2) 6. Plan, implement and control processes (8.1) 7. Determine controls to be applied and criteria for evaluation, selection, monitoring and re-

evaluation of external providers (8.4.1) 8. Implement audit program (paragraph 9.2.2)

Recommended Procedures (when applicable)

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Work Instruction


22 Mandatory Forms

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.

14. 15. 16. 17. 18. 19. 20. 21. 22.

Now that the ISO 9001 standard is a little more complex, are you wondering how to begin a quality control plan? We'll help you facilitate the changes in ISO 9001 as quickly and efficiently as possible with our "as-a-matter-of-fact" approach and with our no charge/no-expiration support by phone and email.

Purchase the updated ISO 9001:2015 standard at:

ANSI.org Webstore

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http://www.quality-control-plan.com/quality-control-plan-basics/how-to-begin-a-quality-control-plan/

http://www.quality-control-plan.com/quality-control-plan-basics/how-to-begin-a-quality-control-plan/

http://webstore.ansi.org/RecordDetail.aspx?sku=ISO+9001%3a2015

IMPACT ANALYSIS REPORT

Form Rev: Orig

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PROPRIETARY INFORMATION PAGE 1 of 6


Form Rev: Orig

PROCESS ORIENTATION CHECKLIST


Identifier: Name, Number, Unique ID

Date: Latest Revision Date Project: Customer, Unique ID, Part Number

Document Status:

Draft, Redline, Released, Obsolete

Document Link:


Abstract: This document describes an orientation checklist to understand a process.

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Form Rev: Orig


0-0



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Form Rev: Orig

Defined properly, a quality management system is viewed as a system of processes. After identifying organizational support and process realization processes or departments that affect quality, a documented procedure or process map is

The traditional approach to quality management has confused practitioners that are used to “compliance to requirements”. The traditional standards-based approach will prevent proper application of the quality system and diminish the return on investment in the PDCA cycle to continuously improve the QMS and its processes. Once processes are properly identified and defined, the PDCA cycle can then be effectively applied to drive improvement in the processes and in the QMS.

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Form Rev: Orig

Process Name:

Question Answer

(N/A if not applicable) Process Characteristics Who owns the process? Who is responsible for performing and overseeing the process?

Support Process Question With Who - training, knowledge, skills What criteria have been established for Operator competency?

Support Process Questions With What - equipment, installations What machines, materials, safety equipment, test equipment, computer systems and software are used in the process?

Support Process Questions With What Key Criteria - measurements, assessments What in-process/final verification criteria are associated with the output?

Input - what should be received Upon what inputs does the process operate, e.g., document(s), materials, tooling, schedule, etc?

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Form Rev: Orig

Process Name:

Question Answer

(N/A if not applicable)

Output - what should be delivered What output does the process produce?

Support Process Questions Performance indicators How is the process identified throughout the process? How is inspection status identified throughout the process?

Support Process Question How - instructions, procedures, methods What instructions are available to Operators? Are documents/work instructions approved?

Workmanship Process Map Step 1: (name) Is this a key characteristic in the process?

Process Map Step 2: (name) Is this a key characteristic in the process?

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Form Rev: Orig

Process Name:

Question Answer

(N/A if not applicable)

Process Map Step 3: (name) Is this a key characteristic in the process? If so, what happens to the defectives?

Process Map Step 4: (name) Is this a key characteristic in the process? If so, what happens to the defectives?

Repeat questions listed above for each remaining Steps in the process map ------------------ Improvement Resources

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