pe 6421 chapter 3 iso 9000 quality system oct 13 2014

The ISO 9000Quality System

CHAPTER THREE (3)

1

PE 6421 Quality Engineering

PROF. CHARLTON S. INAODefence University

College of Engineering, Bishoftu ,Ethiopia

Topics

I. The ISO 9000 Family of Standards

II. Quality System Documentation and

Auditing

III. ISO : 9000 Related Aspects

ISO 9001:2008

Course Objectives:

Appreciate the significance of ISO 9001:2008 to organizational performance and to business development;

Understand the requirements of ISO 9001:2008;

Implement ISO 9001:2008 requirements, for certification purposes.

At the end of the seminar, the participants will be able to:

Course Outline:

What is ISO?History of ISO 9000Benefits of Quality Management SystemRelated Management SystemsEight Quality Mangement Principles

Part I:

Understanding the Requirements of ISO 9001:2008

Part II:

Steps to ISO 9001:2008 Certification

Part III:

Part I: What is ISO? History of ISO 9000 Benefits of Quality Management

System Related Management Systems Eight Quality Management Principles

ISO 9001:2008

Because "International Organization for Standardization"

would have different acronyms in different languages

"IOS" in English

"OIN" in French for Organisation Internationale de Normalisation)

its founders decided to give it also a short, all-purpose name.

Short name (ISO) was derived from the Greek word,

“ISOS” meaning equal.

WHAT IS ISO???WHAT IS ISO???

WHAT IS ISO???WHAT IS ISO???

• An International Standard and a Set of Guidance Documents Intended for Organizations in all Types of Industries

HISTORY OF ISO

HISTORY OF ISO

ISO was founded in 1947 as anon-governmental organization withthe goal of facilitating internationaltrade and developing international

cooperation in scientific, technological,

and economic arenas.

FOUNDER - Worldwide federation of national standard bodies, based in Geneva, Switzerland.

Now comprises 162 members, one in each member country out of 203 total countries in the world.

THE INTERNATIONAL ORGANIZATION FOR

STANDARDIZATION (ISO)

ISO 9001:2008 – Quality Management Systems

ISO 14001:2004 – Environmental Management Systems

ISO/IEC 17025:2005 – Testing & Calibration Laboratories

THE INTERNATIONAL ORGANIZATION FOR

STANDARDIZATION (ISO)

ISO 9001:2008 – Quality Management

ISO 14001:2004 – Environmental Management

OHSAS 18001 – Occupational Health & Safety

INTEGRATED MANAGEMENT SYSTEMS

ISO 9000 is a set of

standards for

Quality Management

System that

is accepted around the

world

The ISO 9000 Family

of Standards

WHAT IS THE ISO 9000 FAMILY?The 4 primary standards of ISO 9000 family:

ISO 9000:2005Quality

Management Systems- Fundamentals and

Vocabulary

ISO 19011:2011Guidelines for Quality and/or

Environmental Systems Auditing


Management Systems- Requirements

The ONLY standardwhich third-party

certification can be carried.


Management Systems- Guidelines for Performance Improvements

contains the fundamentals and vocabulary,which are vital information for an organization that wishes to establish a quality management system.

ISO 9000:2005Quality Management Systems: Fundamentals and Vocabulary

consists of the requirements, laying down the groundwork for building a QMS according tointernationally accepted standards.

The standard is the only standard in the ISO family which an organization’s quality management system can be certified by an external certifying body.

ISO 9001:2008

Quality Management Systems: Requirements

provides guidelines into continually improving the established system and extending the benefits of ISO 9001:2008 to business stakeholders such as the organization’s employees, owners, suppliers and the society.

ISO 9004:2009

Quality Management Systems: Guidelines for Performance Improvements

Contains guidelines on how to audit QMS or EMS (Quality or Environmental Management

Systems)

ISO 19011:2011

Guidelines on Quality and /or Environmental Management Auditing

The Development of theISO 9000 Family of Standards

1987 Initial release

1994 First revision

2000 Second revision

2008 Third revision

ISO 9001, like other management system standards is subject to periodic

review to determine whether it is still relevant, whether it needs to be updated or whether it is to be

discontinued.

The Development of theISO 9000 Family of Standards

Why should an organization needs to set up a QMS?Why should an organization needs to set up a QMS?

For internal purposes For certification purposes Contractual purposes

Our Customers

Quality Service Increased Confidence in Service Less number of non-compliance's. Improved Supply/Consistent Quality Helps in Planning Activity Competitive Pricing/Lead Time Reduction

The benefits of ISO to ……..The benefits of ISO to ……..

Our Company Reduced Number of defects Increased Customer Satisfaction Consistency in Output Assured Customer/Market Share Reduction in costs due to reduction of defects Involvement of Personnel and consequent Higher

Productivity


Our Employees Defined Directions Improved Performance Better and improved relation. Increases Motivation Job Satisfaction Involvement Pride of working in an ISO 9001 Certified company.


Stability

Growth

Partnership and mutual understanding

Our Suppliers


Fulfillment of legal and regulatory requirements

Improved health and society

Reduced environmental impact

Increased security

Our Society


EXPECTED QUALITY

by the Customer

PLANNED QUALITY

by the Company

PRODUCED QUALITY

by the Company

PERCEIVEDQUALITY

by the Customer

Measurement of the Performance of the Company

Measurement of theClient’s satisfaction

The ISO 9001:2008 requirements

A quality management principle is a

comprehensive and fundamental rule or

belief, to lead and operate an

organization successfully designed to

continually improve performance over

the long term by focusing on

customers while addressing the needs

of all other interested parties.

Quality Management Principles: Definition

EIGHT ( ) QUALITYMANAGEMENT PRINCIPLESEIGHT ( ) QUALITYMANAGEMENT PRINCIPLES

ISO 9001:2008

Mutually beneficial supplier relationship

Customer focus Leadership

Involvement of people Process approach

System approach to Mgt. Continual improvement

Factual approach to decision making

Principle 1: Customer Focus

Organizations depend on customer

Determine customer needs & expectations

Requirements

Customer Satisfaction

Create unity of purpose, common goals, one direction.

Principle 2: Leadership


They create and maintain the internal environment in which people become effectively involved in achieving the organization’s objectives

Leaders must be people thatHave the ability to think in time spans of years instead of months Visualize life in 5 years--what do you want it to beStresses corporate “big picture”LeadersDevelop a participative climate

PartnershipsMake others responsibleEmployee participation

“Walk what you talk”“Say what you mean, mean what you say”

Customer

requirements

determined

and met


People at all levels are the

essence of an organization

and their full involvement

enables their abilities to be

used for the organization’s

benefit.

Principle 3: Involvement of People

A desired result is

achieved more efficiently

when related resources

and activities are

managed as a process.

Principle 4: Process Approach

PROCESS

“set of interrelated or

interacting activities

which transforms inputs

into outputs.”

Input OutputPROCESS

Customers

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

Clause 5

Clause 6 Clause 8

Clause 7

Service/Product

realization

Value adding activitiesInformation flow

InputRequirement

s

Output

Customers

Satisfaction

Service

Product

Resource

Management

Measurement, analysis and improvement

Management responsibility

Process Approach

“Identifying,

understanding and

managing interrelated

processes as a system

contributes to the

organization’s

effectiveness and

efficiency in achieving

its objectives.”

Principle 5: Systematic Approach to Management

Organizational Structure

Responsibilities

ProcessesProcedures

ResourcesSYSTEM

SYSTEM APPROACH

“Continual improvement of the

organization’s overall performance should

be a permanent objective of the organization.”

Principle 6: Continual Improvement

PDCA CYCLE

“Effective decisions

are based on the

analysis

of data and

information.”

Principle 7: Factual Approach to Decision Making

“An organization and

its suppliers are

interdependent and a

mutually beneficial

relationships enhances

the ability of both

to create value.”

Principle 8: Mutually Beneficial Supplier Relationships

Summary

Implementing the Eight Principles is not easyTakes a good leaderTakes vision/perseveranceAn infrastructure must be establishedCommunication needs to be done Much planning should start immediatelyGoes along well with ISO 9000 implementation

Quality Systems Documentation and Auditing

Part II: Understanding the

Requirements of ISO 9001:2008

ISO 9001:2008

1. Control of Documents

2. Control of Records

3. Control of Nonconforming Products

4. Internal Audit

5. Corrective Action

6. Preventive Action

• Administrative and Explanatory Notes Section 1 – Scope Section 2 – Normative Reference Section 3 – Terms & Definition

• Core Requirements Section 4 – Quality Management System Section 5 – Management Responsibility Section 6 – Resource Management Section 7 – Product Realization Section 8 – Measurement, Analysis & Improvement

1. SCOPE

The Scope of the Quality Management System

Those parts of the business that are included within the system for certification (inspection services, product being inspected, report, etc.)

51

ISO 9001:2008 StandardISO 9001:2008 Standard

CUSTOMER

CUSTOMER

Customer Supplied Materials

CustomerComplaints/Satisfaction

Internal Audit & Analysis of Data

C & P Action

Measurement, Analysis & Improvement

Control of NC Product

QMS Performance Data

Planning & Objectives

Mgt. Review

Mg

t R

espo

nsib

ility P

rocesses

Continual Improvement

Policies &Directions

Policies &Directions

Resource Mgt Processes

Personnel Competence

& Skills

Facilities, Eqpt & Work Environment

Financial Require-

ments

Resource NeedsResources

Purchasing

Receiving & Inspection

Operation

Warehousing Delivery

Operations Planning

Work Order Requirements

Processing

SAMPLE BUSINESS PROCESS MAP

SCOPE OF ACTIVITIES

CERTIFICATE OF REGISTRATION

This is to certify that

XYC CompanyDebre Zeit, Oromia

operates a Quality Management System which has been assessed as conforming to

ISO 9001:2008

for the scope of activities

Design, Machining, Casting, and Fabrication

CERT NO.: ___________ Issue Date: 14 October 2014

Valid until 14 October 2017 subject to the adherence of the ongoing audit programme, successful endorsement of certification, following each audit and compliance with the certifying body regulations.

2. NORMATIVE REFERENCES

Make references to:Applicable: Standards, Directives, Codes, etc.

appropriate to the Scope

55


In this instance, the only reference is:

“ISO 9000:2005, Quality Management Systems

– Fundamentals and Vocabulary”

3. TERMS & DEFINITIONS

The business terms defined within the trade As understood by the organization

56


This third section explains wherever the term

“product” occurs, it can also mean “service”

throughout the text of the International

Standard.

CODE

4 Quality Management

System 5 Management Responsibility 6 Resource Management 7 Product and/or Service

Realization 8 Measurement, Analysis and

Improvement

MAIN GROUPING OF QMS REQUIREMENTS

CLAUSES

4 – Quality Management System

5 – Management Responsibility

6 – Resource Management

7 – Product Realization

8 – Measurement, Analysis and Improvement

4.1 General Requirements

4.2 Documentation Requirements

4.2.2 Quality Manual4.2.3 Control of

Documents4.2.4 Control of

Records

Clause 4 – Quality Management System (Structure and Components)

4.1 General requirements

• Processes needed for QMS includes 4 areas corresponding to QMS clauses 5 to 8.

• Ensure control over outsourced process

• Factors that can affect type and extent of control

- potential impact to organization’s products/ service

- degree to which the control for the process is shared

- application of Purchasing (7.4)

CLAUSE 4: QUALITY MANAGEMENTCLAUSE 4: QUALITY MANAGEMENT

Processes, interaction, improvement The focus is on looking at:

What we do.

Who we are doing it for.

Improving how we provide

service.


4.1 General requirements

4.2 Documentation requirements• Develop a quality system and a manual that

describes it.

• Quality system procedures are consistent with your quality policy.

• Develop quality plans for products, processes, projects, and customer contracts.


Level 2

Level 3

Level 4

Hierarchy of QMS DocumentationHierarchy of QMS Documentation

4.2 Quality Manual

• Describes intent to establish a quality management system with an emphasis on continual improvement.

• Specifies the scope of QMS

• Includes the policies and targets, process description, process instructions and process responsibility.

• States the justification for exclusions, if any


- Approve documents for adequacy prior to issue

- Review, update as necessary and re-approve documents

- Changes and current revision status of documents are identified

4.2 Document control


- Relevant versions of applicable documents are available at points of use

- Documents remain legible and readily identifiable

- External documents are identified and their distribution controlled



- Prevent the unintended use of obsolete documents, and identify them if they are retained for any purpose

- Documented procedure required




The procedure of Control of Document comprises,

• the creation, the determination of marking, storage, protection /data security, retrievability, safekeeping periods and responsibilities of who possesses the document or has access.

For example: • Where and how long are the documents stored?• Which documents are useful?• How are outdated documents marked?


Certain records need to be kept to demonstrate how the

QMS is operating effectively.

- Records must be legible, readily identifiable, accessible, protected, retained within prescribed period and disposed properly.

- Documented procedure must describe how they are identified, stored, protected, retrievable, and define their retention and disposal time.

4.3 Control of Records


MANAGEMENT RESPONSIBILITYMANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.2 Customer Focus5.3 Quality Policy5.4 Planning5.5 Responsibility,

Authority & Communication

5.6 Management Review






5.1 Management Commitment

• A QM system is a matter for the Management

• It is no longer possible to delegate the responsibility

• Communicate the requirement to your staff

• Make Quality policy and quality objectives at relevant functions

• Management reviews conducted

• Resources made available

CLAUSE 5: MANAGEMENT RESPONSIBILITYCLAUSE 5: MANAGEMENT RESPONSIBILITY

5.2 Customer focus

• Quality is what the customer requires.

• The top most aim must be to meet your customers’ requirements and win, retain and further increase their confidence and satisfaction.

• Identify your customers’ desires and expectations

• Clarify product-related obligations e.g. legal requirements


5.3 Quality policy

• Should be written down in your QM manual.

Aims: • Customer satisfaction, development of staff, future improvement• Which resources do you provide• Customer requirements should be at the centre of attention. • Mandatory: The commitment to continual improvement

• On-going review of the quality policies and its adequacy for the company

• Formulate the guidelines concerning the planned business position and development very clearly, and underpin them with quantifiable aims, so that they can be put into practice.


What is Quality Policy?

"The overall intentions and direction of an organization related to quality as formally expressed by top management."

This policy is meant to be an outward statement of its commitment to its customers and to the provision of quality products.

It should be in line with the purpose and mission of the organization.

It should be practical and aligned with measurable expression in the Quality Objectives.

It also should be understandable by all members of the organization, employees, managers as well as other stakeholders.

What is Quality Policy?

VISION

"To become the most successful and respected lift truck company in

the U.S.”

Toyota Vision Statement

MISSION

"To sustain profitable growth by providing the best customer

experience and dealer support."

Toyota Mission Statement

QUALITY POLICY• Total Quality Control based on mutual trust among

ourselves and involvement of every single member of our organization is our Company Lifestyle. We cannot compromise for quality in anything we do.

• We are committed to continuous improvement (Kaizen) in all our activities and practices.

• We shall cooperate with and assist our suppliers for continuous improvement in their products, services and practices.

• Our quality target is to be always better than competitors

and also to be better than other Toyota Motor Corporation plants, producing CS No. 1 vehicles.

5.4 Quality objectives and planning

• Quality policies are the orientation frame for the formulation of measurable quality targets and means that are necessary to achieve these targets.

• Identify the procedures that have a direct impact on company success and customer satisfaction.

• Determine measurable targets that concretely state what you intend to achieve in a defined period.


5.4 Quality objectives and planning

• Define the activities necessary for achieving the targets.

• Communicate these targets and measures and provide the necessary resources.

• Moreover, you have to plan changes in your QM system in such a way that the system can seamlessly continue to function.


QUALITY OBJECTIVES

CORPORATE OBJECTIVE:To attain a “very satisfactory” customer satisfaction rating through the continual improvement of our QMS.

FUNCTIONAL OBJECTIVES:Human Resource

To provide requested manpower within 5 days upon receipt of personnel request.

FUNCTIONAL OBJECTIVES

Operations

To ensure not to exceed 0.5% rejects.

Maintenance To ensure that 98% machine availability”

5.5 Responsibility, authority and communications• Delegate responsibilities and authorities to employees in

the whole company, you will achieve that quality becomes the concern of employees at all level.

• By systematically promoting internal communication you can make sure that quality policies become well-known, your staff feels included.

• Define responsibilities and authorities of those employees who will have to take decisions that are relevant to quality.

• Identify a QMR who is a member of the topmost management..


must be a member of the organization’s management

ensures processes of QMS are established, maintained, and implemented

reports on the performance of QMS and any need for improvement

promotes awareness of customer requirements throughout the organization


5.5.2 Management Representative

set up an effective system of communication to ensure effective operation of the QMS


5.5 .3 Internal Communication

5.6 Management review

• Required inputs and outputs

• Evaluates suitability, adequacy and effectiveness of QMS

• Involves TOP Management


CLAUSE 5.6: MANAGEMENT REVIEWCLAUSE 5.6: MANAGEMENT REVIEW

5.6 .3 Review Input

The input to management review shall include information on:

a) results of audits,b) customer feedback,c) process performance and product conformity,d) status of preventive and corrective actions,e) follow-up actions from previous management

reviews,f) changes that could affect the QMS, andg) recommendations for improvement.

CLAUSE 5.6: MANAGEMENT REVIEWCLAUSE 5.6: MANAGEMENT REVIEW

5.6 .2 Review Output

The output to management review shall include any decisions and actions related to:

a) improvement of the effectiveness of the QMS and its processes,

b) improvement of product related to customer requirements, and

c) resource needs.

RESOURCE MANAGEMENTRESOURCE MANAGEMENT

6.1 Provision of Resources

6.2 Human Resources

6.3 Infrastructure6.4 Work

Environment






to improve processes and

enhance customer satisfaction

to improve processes and

enhance customer satisfaction

Human Resource

InfrastructureWork

Environment

CLAUSE 6: RESOURCE MANAGEMENTCLAUSE 6: RESOURCE MANAGEMENT

6.1 Provision of Resources

Human Resource

InfrastructureWork

Environment

Determine competence on the basis of education, training, skills and experience

Provide training or other action.

Evaluate effectiveness of action.

6.2 Human Resources


Human Resource

Infrastructure Work Environment

Buildings, workspace, utilities.

Materials, plant and process equipment.

Computer system and information technology

Support services (i.e. transport and communication)

6.3 Infrastructure


Human Resource

Infrastructure Work Environment

Human Resource

Infrastructure

Must be the right

work environment to

achieve conformity

to product

requirements Physical,

environmental and

other factors (i.e.

noise, temperature,

lighting, humidity,

etc.)

6.4 Work Environment


MANAGEMENT RESPONSIBILITYMANAGEMENT RESPONSIBILITY

7.1 Planning of Product Realization

7.2 Customer-related Processes

7.3 Design and Development

7.4 Purchasing7.5 Product &

Service Provision7.6 Control of

Monitoring & Measuring Eqpt.






• Quality objectives and requirements for product need to be determined

• Processes and documents shall be established

• Resources specific to the product

• Required verification, validation, monitoring, measurement, inspection and test activities

• Records of effective implementation

CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION

7.1 Planning of Product or Service Realization

• Customer and regulatory requirements related to the product

• Additional requirements considered by the organization

• Post delivery activities

• Review of requirements related to the product

• Customer communication

- Product information

- Contracts including amendments

- Customer feedback/complaint


7.2 Customer-related Processes

• Design and development planning

• Design and development inputs

• Design and development outputs

• Design and development review

• Design and development verification

• Design and development validation

• Control of design and development change


7.3 Design and Development

Make a clearly defined order which contains quantities, price and date of delivery, clear quality statements with technical details.

Make a list of suitable suppliers.

Assess your suppliers. Document the assessment.

Is your supplier certified?

Make goods inward test to ensure that requirements are met.


7.4 Purchasing

Provide the adequate manufacturing facilities, auxiliary means, documents, staff and their qualification.

State the requirements in e.g. QM process instructions, work instructions, process descriptions, workflows, hiring plans and shop floor papers.


7.5 Production and Service Provision

• Appropriate production facilities have to be selected.

• Measurement equipment is available.

• The staff needs to be qualified by training and instructions

• Has to document the measurement.


7.5.1 Control of Product and Service Provision

• Processes performed under controlled conditions if inspection/testing can not be done before release of product to customer

• Required where destructive testing is involved


7.5.2 Validation of Processes of Production and Service Provision

Identify what the product is throughout product realization

Trace where the product/service has gone or come from

Important for monitoring and measurement purposes

In case of non-conformity the product must be traceable all over product lifetime.


7.5.3 Identification and Traceability

Includes customer’s information/data and/or hardware, used to produce customer’s product/ service

Has to be carefully handled

Make a goods inward inspection (completeness, identity and transport damages) and ensure correct storage

Subject to protection and other controls while at organization’s custody

Report to customer if lost or damaged


7.5.4 Customer Property

In-house treatment of products

Attention when shipping the product: Possibility of corrosion on ships

Needed time for transport, sensitivity to shock and vibration, other environmental conditions and the means of travel and transportation required by the customer.

Consistency with the shipping documents and legal requirements (for example military goods).


7.5.5 Preservation of Product

• Ensure that any equipment used for measurement is accurate, precise

• Calibration needed for measurements with direct impact on product conformity

• Measurement equipment shall be calibrated or verified or both, adjusted or re-adjusted, have calibration status, safeguarded and protected

• With records of calibration and/or verification

• Verification and configuration of computer software


7.6 Control of Monitoring & Measuring Equipment

Measurement, Analysis and ImprovementMeasurement, Analysis and Improvement

8.1 General8.2 Monitoring and

Measurement8.3 Control of

Nonconforming Product

8.4 Analysis of Data8.5 Improvement






Monitoring and measurement of:

Customer satisfactionInternal (quality system) auditingProcess performance / improvementProduct conformity / non-

conformance

106

MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT

“When you can measure what you are speaking about and express it in numbers, you know something about it. When you cannot express it in numbers, your knowledge is of a meager and unsatisfactory kind”.

Lord Kelvin — Physicist

107


Definitions of procedures to ensure product conformity.


8.1 General

8.2 Measurement and Monitoring

Continual adaption to new requirements of market and customers.

Adapt also effectiveness and efficiency of the processes and the QM system.

On the basis of data, facts and information analyses have to be made and the foundation for making decisions has to be prepared.

Customer feedback, complaints and surveys, sales information, field studies, etc.

The information should be analyzed systematically in order to obtain statements on developments, e.g. by means of a defined process of complaints.


8.2.1 Customer Satisfaction

Plan internal quality audit systematically.

Define responsibilities and frequency as well as the areas to be audited.

Process auditors should be independent of their own work.

Make sure in a system audit that your QM system is effective and complete.

Carry out process audits by checking the effectiveness of your instructions and processes.


8.2.2 Internal Audits

Define the time frame for the internal audits. You can commission a customer of yours or an external auditor.

Make sure that the results summarized in an audit report are discussed with the persons concerned

Results of quality audits are an integral part of the management assessment.


8.2.2 Internal Audits

Demonstrate achievement of planned results.

• The basis of improvement of processes is controlling and measuring them.With regard to serial production, fulfil the requirements by examining machine capabilities.


8.2.3 Monitoring and Measurement of Processes

• It is possible to conclude whether the customers’ requirements are met by means of testing the product.

• Documented tests serve as a proof that your product has left your factory flawlessly.

Monitor and measure characteristics. Conformity with acceptance criteria. Waivers / concessions.


8.2.4 Monitoring and Measurement of Product

Elimination or correction of nonconforming processes.

Defective products must not be processed further or delivered.

Mark defective parts and products, write down defects which were discovered.

Parts which were reworked will be tested once again with regard to the concerned characteristics before releasing them.


8.3 Control of Nonconforming Product

Decisions should be made based on data.

Suitable data has to be determined which will support in assessing the effectiveness of the QMS.

The data analysis has to present evidence on Customer Satisfaction particularly on:- meeting the product requirements,- process and product characteristics and their further development


8.4 Analysis of Data

• Analysis of the results of internal audits, data analyses, preventive and corrective measures as well as management assessments help you to improve your QM-system.

• Measures to stop the following problems:

• - Customer complaints: Show your customers that you take their complaints seriously.

• - Being open towards mistakes and giving and receiving constructive criticism, not only with regard to the employees, but also the management and direction are essential.

• The employees’ motivation to take part in the process of constant improvement will be destroyed if no measures are following the proposals.


8.5 Improvement

8.5.1 Continual improvement

• Continually improve the effectiveness of QMS

through the use of the quality policy, quality

objectives, audit results, analysis of data,

corrective and preventive action and

management review.

8.5.2 Corrective Action

• Take action to eliminate the cause of

nonconformities in order to prevent recurrence

• Corrective Action is appropriate to the effects of

nonconformities encountered

8.5.2 Corrective Action• A documented procedure is established to

define requirements for

- reviewing nonconformities

- determining the causes of nonconformities

- determining required action to ensure that

NC does not recur

- implementing, monitoring and evaluating

effectiveness of corrective action• Maintaining records

8.5.3 Preventive Action

A documented procedure is established to define

requirements for• Determining potential nonconformities and their

causes• Evaluating the need for action to prevent

occurrence of nonconformities• Determining and implementing action needed• Recording results of action taken• Reviewing effectiveness of preventive action taken

What’s the difference between corrective and preventive action?

CORRECTIVE ACTIONS are steps that are taken to

remove the causes of existing nonconformities.

PREVENTIVE ACTIONS are steps that are taken to

remove the causes of potential nonconformities.

CORRECTIVE ACTIONS addresses actual problems,

ones that have already occurred, while PREVENTIVE

ACTIONS addresses potential problems, ones that

haven’t occurred yet.

Registration Procedures

• Awareness Seminar on ISO 9001:2008• Compares Company Operations to

9001:2008 Requirements• Prepares Gap Analysis• Drafts Custom Quality & Procedure

Manuals • Company Reviews and Approves Manuals• Trains Internal Auditors

----

---A

ssess

men

t Ph

ase

----

-

Registration Procedures (Cont.)

• Auditor Seeks Documented Evidence of ISO System Implementation

• Implementation Verified• Issuance of the ISO Registration

Certificate• Mandatory Annual Renewals --

--au

dit

Ph

ase

--

Certification audit

• adequacy audit– evaluation whether the documented

procedures comply with the standard’s requirements

• compliance audit– evaluation whether the documented

procedures are followed by the employees

Time Line - Zero to Certification

Generate Documented Evidence

Assessment & Implementation

Milestone

Audit & Registration

September OctoberAugust DecemberNovember

to ISO 9001:2008

QUALITY MANAGEMENT SYSTEMQUALITY MANAGEMENT SYSTEM

To meet the requirements you must:

Document Write down what you do.

Document Write down what you do.

Continually Improve EffectivenessUse corrective/preventive action to improve your service to your customers.

Continually Improve EffectivenessUse corrective/preventive action to improve your service to your customers.

ImplementDo what you wrote down.

ImplementDo what you wrote down.

MaintainShow evidence that you are doing what you said you were doing.

MaintainShow evidence that you are doing what you said you were doing.

CERTIFICATION

Procedure by which a third party giveswritten assurance that a product, processor service conforms to specific requirements.

CERTIFYING BODY OR REGISTRAR

A third party company, (i.e., a companyindependent of the supplier and its customer)whose business is to evaluate the organization’squality system for conformity to ISO 9001:2008

Certification Bodies in Ethiopia(accredited by

An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body.

REMEMBER!!!

pe 6421 chapter 3 iso 9000 quality system oct 13 2014

Engineering

benefits of iso

requirements of iso

history of iso

significance of iso

primary standards of

quality management systemsiso

quality management principles

quality managementiso