The ISO 9002 Quality Assurance Management System

8/18/2019 The ISO 9002 Quality Assurance Management System

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The ISO 9002 QualityThe ISO 9002 QualityAssurance ManagementAssurance Management

SystemSystem

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QUALITY EDUCATION:QUALITY EDUCATION:

Customer Satisfaction

Whole

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Quality

Service

Involvement


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ORGANIZATION

WITH

Input Output

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LOUSY MANAGEMENT


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Upgrading :Upgrading :

Service Quality

Product Quality

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Personnel Quality

By...


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A Proven Successful A Proven Successful

Quality Assurance SystemQuality Assurance System

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ISO 9000


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6

ISO 9002 Certification


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A BRIEF INTRODUCTIONA BRIEF INTRODUCTION

TOTO

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ISO 9000ISO 9000


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QUALITY MANAGEMENT PRINCIPLESQUALITY MANAGEMENT PRINCIPLES

1. Customer focus

2. Leadership

3.Involvement of people

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4. rocess approac

5. System approach to management

6. Continual improvement

7. Factual approach to decision making

8. Mutually beneficial supplier relationships


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ISO 9000 is about QUALITYISO 9000 is about QUALITY

Quality is:

defined by customer needs

defined in terms of fitness for purpose

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ac eve roug con nuousimprovement

managed through prevention not

detection

‘getting it right at the first time’

measurable


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ISO stands for ISO stands for

I nternational

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O rganization for

S tandardization


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Self Self--manageablemanageable

PP--DD--CC--AA

Plan what you do

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r ecord what you did

Check the results

Act on the difference


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ISO 9000 REQUIRES :ISO 9000 REQUIRES :

PLAN, DO, CHECK & ACT

with CONSISTENCY :

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MANAGEMENT SUPPORTS

RESOURCES MANAGEMENT

PROCESS MANAGEMENT RESULTS ANALYSIS

CONTINUOUS IMPROVEMENT


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THE CONTINUOUS IMPROVEMENTTHE CONTINUOUS IMPROVEMENT

MECHANISMMECHANISM

UNSATISFACTORY OUTCOME

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MECHANISMMECHANISM


WORK IMPROVEMENT TEAM

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MECHANISMMECHANISM



CAUSE INVESTIGATION

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MECHANISMMECHANISM



CAUSE INVESTIGATION

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CORRECTIVE ACTION


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MECHANISMMECHANISM



CAUSE INVESTIGATION

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CORRECTIVE ACTION

PREVENTIVE ACTION


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MECHANISMMECHANISM



CAUSE INVESTIGATION

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CORRECTIVE ACTION

PREVENTIVE ACTION

REVIEW


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MECHANISMMECHANISM



CAUSE INVESTIGATION

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CORRECTIVE ACTION

PREVENTIVE ACTION

REVIEW



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MECHANISMMECHANISM



CAUSE INVESTIGATION

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CORRECTIVE ACTION

PREVENTIVE ACTION

REVIEW


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MECHANISMMECHANISM



CAUSE INVESTIGATION

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CORRECTIVE ACTION

PREVENTIVE ACTION

REVIEW

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Quality Plan

Quality Manual

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roce ures

Working InstructionReference Document

O 9000O 9000 20 l20 l


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ISO 9000ISO 9000 -- 20 Elements20 Elements

4.1 Management Responsibility

4.2 Quality System

4.3 Contract Review

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4.4 Design Control

4.5 Document & Data Control

4.6 Purchasing

ISO 9000ISO 9000 20 El20 El


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4.7 Control of Customer SuppliedProduct

4.8 Product Identification andTraceability

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.

4.10 Inspection and Test Status

4.11 Control of Inspection, Measuring and

Test Equipment.

ISO 9000ISO 9000 20 El t20 El t


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4.12 Inspection and Test Status4.13 Control of NonconformingProduct

4.14 Corrective & Preventive Action

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4.15 Handling , Storage, Packaging,

Preservation and Delivery

4.16 Control of Quality Records4.17 Quality Audits


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4.18 Training

4.19 Servicing

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4.20 Statistical Techniques

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StagesStages

Setting up Steering CommitteeDesign of Management System

Training all Staff

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system

Implementation

Monitoring & Evaluation

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StagesStages

Internal Audit & Pre-assessment audit Certification Audit

Registration

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Internal Q Audit

Surveillance Visit

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Self Self--manageablemanageable

Plan what you do

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Record what you did

Check the results

Act on the difference


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StandardizedStandardized

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ear y s e requ remen s

guidelines

World-wide acceptance


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SystematicSystematic

Inter-relationship of elements

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Team work


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Customer Customer--orientedoriented

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ee s e ne y customer

Stress on customer satisfaction

Enhancement of quality culture


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Objectively assessedObjectively assessed

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nterna au t e -assessment

Audit by 3rd party

The management system governs


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Clearly DocumentedClearly Documented

Data and record control

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Document process


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Human resourcesHuman resourcesplanning and controlplanning and control

inin

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ISO 9001 QMSISO 9001 QMS

5 1 M t it t5 1 M t it t


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5.1 Management commitment5.1 Management commitment

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Top management shall provide evidence of its

commitment to the development and improvement of

the quality management system by:

d) Ensuring the availability of necessary resources

5 5 2 R ibilit d5 5 2 R ibilit d


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5.5.2 Responsibility and5.5.2 Responsibility and

authorityauthority

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Functions and their interrelations within the

organization, including responsibilities and

authorities, shall be defined and communicatedin order to facilitate effective quality

management.

5 5 4 I t l i ti5 5 4 I t l i ti


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5.5.4 Internal communication5.5.4 Internal communication

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The organization shall ensure communication

between its various levels and functions

regarding the processes of the quality

management system and their effectiveness.

6 1 P i i f6 1 P i i f


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6.1 Provision of resources6.1 Provision of resources

The organization shall determine and provide,

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n a me y manner, e resources nee e

a) To implement and improve the processes of

the quality management system, and

b) To address customer satisfaction.

6 2 1 A i t f l6 2 1 A i t f l


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6.2.1 Assignment of personnel6.2.1 Assignment of personnel

Personnel who are assi ned res onsibilities

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defined in the quality management system shall

be competent on the basis of applicable

education, training, skills and experience.

6 2 2 Training awareness and6 2 2 Training awareness and


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6.2.2 Training, awareness and6.2.2 Training, awareness and

competencycompetency

The organization shall:

a)Identify competency needs for personnel

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performing activities affecting quality;

b) Provide training to satisfy these needs;

c) Evaluate the effectiveness of the training provided;

6 2 2 Training awareness and6 2 2 Training awareness and


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6.2.2 Training, awareness and6.2.2 Training, awareness and

competencycompetency

d) Ensure that its employees are aware of he

relevance and importance of their activities

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of the quality objective;

e) Maintain appropriate records of education,

experience, training and qualifications.

7 4 1 Purchasing control7 4 1 Purchasing control


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7.4.1 Purchasing control7.4.1 Purchasing control

The organization shall control its purchasing

rocesses to ensure urchased roduct conforms

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to requirements.

The type and extent of control shall be dependent

upon the effect of subsequent realization processesand their output.

7 4 1 Purchasing control7 4 1 Purchasing control


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7.4.1 Purchasing control7.4.1 Purchasing control

The organization shall evaluate and select

suppliers based on their ability to supply product

in accordance with the or anization’s

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requirements.

Criteria for selection on periodic evaluation shall

be defined.The result of evaluations and follow-up actions

shall be recorded

7 4 2 Purchasing information7 4 2 Purchasing information


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7.4.2 Purchasing information7.4.2 Purchasing information

Purchasing documents shall contain information

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describing the product to be purchased,

including where appropriate:

- personnel


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THANKS!THANKS!

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Any Questions ?Any Questions ?

??

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Thank youvery much for

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your pa ence:

)

Documents

The ISO 9002 Quality Assurance Management System