GENERIC MODEL OF ISO 9000

GENERIC MODEL OF ISO 9000Be The Best ThroughProcess Improvement

US QUALITYMilitary Standards

MIL-Q-9058 A

NATOQuality Standards

AQAPI (1970)

BritishStandards 5750

(1979)

ISO 9000(A Series of Standards)

ISO 9000 QMSBe The Best ThroughProcess Improvement

Say what you do

Do What you say

Prove it

Describe your quality system

Make your system work

Have your system certified byan independent third part?

STAIR - CASE FUNCTION FOR STANDARD FORMATION

Be The Best ThroughProcess Improvement

ABLE

LEADERSHIPNew Proposals (NP)

Working Draft (WD)

Committee Draft (CD)

ISO Technical Committee (TS)

Draft International Standard (DIS)

75% Voting Required of Member Bodies

Establishment of ISO Standard

Refinemen

t & Im

provement

DEVELOPMENT OF QUALITY MANAGEMENT STANDARDS

Year Standard Country

1963 MIL Q 9857A US Military

1969 NATO AQAP NATO

1970 US 10 CFR 50 US Fed. Regulations

1971 ASME Boiler Code (Mech. Eng.) USA

1972 BS 4891 UK

1973 Defence Standards 05-21 et seq UK Modif

1975 CSA Z.299 Canadian

AS 1821/22/23 Australia

AS 1821/22/23 Revision “

BS 5179 UK

1979 US ANSI/ASQC Z1.15 USA

BS 5750 Parts 1-3 United Kingdom

1981 BS 5750 Parts 4-6 United Kingdom

1985 CSA Z.299 Revision Canadian

1987 ISO 9000, AS 3900, BS 5750 Revision, NZS 5600 (later renumbered as NZS

9000), US/ANSI/ASQC Q90-94 )later renumbered as Q9000)

1994 ISO 9000 revised Geneva, Switzerland


BENEFITS OF ISO 9000

EXTERNAL BENEFITS

Competitive edge

World Wide Recognition

Better Company Image

Higher Perceived Quality

Improved Customer Satisfaction

Able to stay in business

Quality Benefits

Consistency in Product / Services

Stepping Stone for TQM

Documentation. Communication, Standardization


INTERNAL BENEFITS

Role Clarity, Responsibility, accountability

Better Management Control

Better Work Efficiency

Increase On-time Delivery

Constant Skill Level

Building Block for Quality Culture

KAIZEN Improvement

COMMON MISUNDERSTANDINGS

ISO 9000 applies only to certain products

ISO 9000 is only one standard

ISO 9000 can be achieved by only preparing certain types of documents

ISO 9000 is Total Quality Control (TQC)

ISO 9000 is only a burden and an additional cost

It’s a matter of days or weeks to achieve the certification

Implementing ISO 9000 involves only a few managers

Quality audit is done only once

ISO requires extra staff

ISO is to steel our technology

ISO restricts our exports

Document rubbish and get certification


THE 20 ELEMENTS OF THE ISO 9000 MODELS


NO ELEMENTS ISO 9001 ISO 9002 ISO 90031. Management Responsibility

2. Quality System

3. Contract Review

4. Design Control

5. Document and Date Control

6. Purchasing

7. Control of customer-supplied product

8. Product identification and traceability9. Process Control

10. Inspection and testing

11. Control of inspection, measuring and test equipment

12. Inspection and test status

13. Control of nonconforming product

14. Corrective and preventive action

15. Handling, storage, packaging, preservation and delivery

16. Control of quality records

17. Internal Quality Audits

18. Training

19. Servicing

20. Statistical Techniques

Element present Element present but less stringent Element NOT Present

A SIMPLE EXAMPLE OFPROCESS ANALYSIS


QualityManual

Procedures

Work Instructions(functional, departmental)

Other documentation(forms & records, process sheets, visual aids, posted

instructions, test & inspection sheets)

Level 1DefinesApproach andResponsibility

Level 2Defines who,What, When

Level 3Answers How

Level 4Results: Showsthat the systemis operating

THE STEPS TOWARDS ISO 9000


Decide to go forISO 9000

Decide to go forISO 9000

ACTIONACTION

AppointQuality Manager

AppointQuality Manager

Write PolicyWrite Policy

DefineResponsibilities

DefineResponsibilities

Describe ProcessesDescribe Processes

Writeprocedures

Writeprocedures

Implementquality system

Implementquality system

Audit the systemAudit the system

Get registeredGet registered

Publicizesyour success

Publicizesyour success

Select ISO 9001or ISO 9002

Select ISO 9001or ISO 9002

Set up anISO 9000 group

Set up anISO 9000 group

Get staffcommitment

Get staffcommitment

Involvestaff

Involvestaff

Get staff to adoptnew procedures

Get staff to adoptnew procedures

Train auditorsTrain auditors

Maintainthe systemMaintain

the system

Quality PolicyQuality Policy

Job descriptionJob description

ProceduresProcedures

Organization chartOrganization chart

ManualManual

Audit reportsAudit reports

ISO 9000Certification

ISO 9000Certification

OUTPUTSOUTPUTS

AUDIT PROCESS FLOW SHEET


Plan AuditPlan Audit

ProductionService

ProductionService

ProblemFound

ProblemFound

DO AuditDO Audit

DetermineCause

DetermineCause

Issue NonconformanceReport

Issue NonconformanceReport

Take CorrectiveAction

Take CorrectiveAction

IssueReport

IssueReport


TYPES OF CERTIFICATION

Accredited Certification (Registration)

Independent Certification (Third)

Customer Certification (Second)

Self Certification (First)

Cost

Leve

l of Q

ualit

y

The Process of Certification and Surveillance

Be The Best ThroughProcess Improvement Contact several

certification bodies

Contact severalcertification bodies

Apply for certificationApply for certification

Complete questionnaire;get quotations

Complete questionnaire;get quotations

Selectcertification bodies

Selectcertification bodies

Certification bodychecks your manual

Agree date for assessmentAgree date for assessment

Certification bodychecks your system

Get ISO 9000certification

Regular surveillancevisits for 3 years

Make ChangesMake Changes

Make ChangesMake Changes

PASS

FAIL

PASS

FAIL

Make ChangesMake ChangesFAIL

Flow Chart of Customer Complaint Form


MRMR

YES

NO

ISSUANCE OF CCF

Receipt of Customer Complaint from the PlanningReceipt of Customer Complaint from the Planning

Q.CQ.C

Mark to Concerned Deptt.Mark to Concerned Deptt.

Prepare the Investigation ReportsPrepare the Investigation Reports

InvestigationInvestigation

Discussed with PM (CL)Discussed with PM (CL)

Is the Investigation satisfactoryIs the Investigation satisfactory

Sent to MRSent to MR

Discussed in Cust. Complaint meetingDiscussed in Cust. Complaint meeting

Minutes of Meeting Circulated + CarsMinutes of Meeting Circulated + Cars Feed back to

Customer by Sales

Feed back toCustomer by Sales

PROCESS APPROACHBe The Best ThroughProcess Improvement

The systematic identification and management of the processes employed by an organization, and the interactions between such processes.

(QMS-GUIDELINES FOR PERFORMANCE IMPROVEMENT ISO/DIS 9004)

ISO 9004-1: 1994 ISO 9004-2: 1991 ISO 9004-3: 1993 ISO 9004-4: 1993 ISO 9004-4/Cor.1: 1994


INTEGRATION OF ISO 9000 SERIES INTO FOURPRIMARY STANDARDS

ISO 9000: Quality Management System-Concepts and vocabulary

ISO 9001: Quality Management System: Requirements

ISO 10011: Guidelines for Auditing Quality System

ISO 9000 : REV 2000

ISO 9004: Quality Management System: Guidelines

System Requirements / Structure of the Standard

Provision of resources

Human resources

Infrastructures

Work environment

6 Resource Management

General requirements

Documentation Requirements

Planning

Customer related processes

Design & development

Purchasing

Production & service provision

Management Commitment

Customer focus

Quality policy

Planning

Responsibility, authority & communication

Management Reviews

5 Management Responsibility

8 Measurement Analysis & improvement

4 Quality Management System

7 Product Realization

General

Monitoring & measurement

Control of NCP

Analysis of data

Improvements

Application of the Elements in Departments

COMPANY – WIDE

Department

Department

4.1; 4.2

5.1; 5.3

5.4; 5.6

6.1; 6.2

6.3; 6.4;

7.5

8.4; 8.5

5.2; 7.1; 7.2Sales

7.4Design

7.4Purchase

7.1; 7.5 Production

7.6; 8.1; 8.28.3; 8.4Testing

7.5Stores

5.5Administration

7.2Service


EIGHT POINT AGENDA OF REV 2000

QM Principles

Customer Focus

Involvementof People

Mutually beneficialsupplier Relationship

System Approachto Management

Leadership

Factual Approachto decision Making

Process Approach

Continual Improvement


SEVEN STEPS ACTION PLAN FORTRANSFORMATION TO ISO 9001:2000

Conduct Mgt Review + Internal AuditConduct Mgt Review + Internal Audit

Revise DocumentationRevise Documentation

Review Quality Policy + ObjectivesReview Quality Policy + Objectives

Increase Human SkillsIncrease Human Skills

Do Process MappingDo Process Mapping

Conduct Gap Analysis Conduct Gap Analysis

Create AwarenessCreate Awareness


ACTION STEPS FOR CONTINUAL IMPROVEMENT

Reason for Improvement Current Situation Analysis Search Alternative Solutions Evaluation of Effects Standardization of New Solution Evaluation for efficiency of process & effectiveness of Improvement action.


Customer Needs TreeNeeds

AvailabilityMaintainability

Reliability

AgreedDelivery

EmergencyDelivery

Quick Correct

Supply chainAnalysis

Supply

ZeroInspection BEST

Defect FreeHigh

RunabilityAvailability

Delivery Response Matchbetweensupplier &customer

ConsistentSupplier

VMI CPI

Visible Hidden Visible Hidden

CurrentFuture


KANO MODEL

Must be (one dimensional)

Attractive Quality

Customer’s Satisfaction

Basic Quality (Must be)

Customer’s Dissatisfaction

Quality

Expected Quality(one dimensional)


Competence Needs

Existing NeedsCompetence

of People

Present Needsof Organization Govt. Policies Emerging Markets

Strategic & operationalfuture needs of organization Changing Standards Regulation &

Statutory Req.


Legal Requirements

(Boiler Heating Area)(Water Consumption)

(Chemical flow)(Gases Emission)

(Dumping ofexplosive materials)

(Air/ / Noise Pollution)

(Safety Equip. /for Clean Area)

Products Processes Activities

Labour lawsPension Fund

OAEB (Old Age Employee)Social Security

Compensatory leave

Gazette Holiday

Ethical Issues

Work Hours

Promotion of ethical

• Benefits to interested parties• Role of organization in the protection of community interest• Promotion of ethical interpretation.


Work Environment

Motivation, Employee Satisfaction,High performance of People

Physical Factors Human Factors

NoiseLight

HumidityHygiene

Air Flow

Vibration

Pollution (Air / Paper)

Cleanliness

Heat

Creative work methodology

Protective Equipment

Opportunities for greaterinvolvement

Greater earning opportunities

Special facilities (Night allowance,Conveyance allowance, TAPA,Heat allowance Compensatoryleave, overtime

Safety rules

Ergonomics


COMMUNICATION TOOLS

• Team briefings and other meetings• Notice Boards• In-house Journals / magazines (HELLO, etc)• Audio-visual and electronic Media.• SAP Mail• Internal mail / CC mail• On-site briefings


INFORMATION

Needs for security

Innovation

Information

Knowledge Base

Factual Decisions

Need forConfidentiality

Innovation

++

++

+ve

+ve


Training

Awareness

Competence

Core

Core

Core

Training

Skill

Education

Experience

HumanResource


TRAINING CYCLE

1. Define Training Needs

MONITOR

3. Provide for Training

2. Design and plan training

4. Evaluate training outcomes


Information

Needs

External sourceof information

Strategic DevelopmentHelps in Factual DecisionsEffective CommunicationExplore potential improvement

Internal sourceof Information

Appropriate SecurityConfidentiality


LEADERSHIP HEXAGON

Unity of Purpose (vision)

Dire

ctio

n (P

ath)

Car

eer P

ath

Internal

Environment

(co-here

nce)

Hanging Objectives Linked

Role Model

Policies

Culture

Motivate

Turnover

System

Behaviour


FUNDAMENTAL APPROACHES FOR IMPROVEMENT

Innovative Approach.(System Approach)

•Defining objectives and outline for improvement

•Analysis of existing as-is process and realizing opportunities for innovative change (Process Mapping)

•Planning of process improvement

•Implementation of improvement

Kaizen (SSCI)(Stair case function Approach)

•QCC

•Natural Work Groups

•QIT


CORRESPONDENCE BETWEENISO 9001:1994 AND ISO 9001:2000

DESCRIPTION DESCRIPTION0 Introduction 0 Introduction

0.1 General

0.2 Process approach

Fig 1 Quality Management Process Model

0.3 Relationship with ISO 9004

0.4 Compatibility with other management systems

1 Scope 1 Scope1

a) and b) parts 1.1 General

1.2 Application

2 Normative Reference 2 Normative references2

3 Definitions 3 Terms and definitions3

3.1 Product

3.2 Tender

3.2 Contract

4 Quality system requirements 4 Quality management system requirements4.1 General requirements

4.2 Documentation requirements

4.2.1 General

4.2.2 Quality manual (Part of 4.2.1)

4.2.3 Control of documents



DESCRIPTION DESCRIPTION4.2.4 Control of records

5 Management responsibility

5.1 Management commitment

5.2 Customer focus

5.3 Quality Policy

5.4 Planning (Part of 4.1.1)

4.1.2.3 Management representative 5.4.1 Objectives (Part of 4.1.1)5.5.2

Management review 5.4.2 Quality management system planning (Part of 4.1.1)

5.5 Responsibility, authority and communication

4.1.2 General 5.5.1 Responsibility and authority4.1+4.2.22

4.2.2 Quality system procedures 5.5.2 Management representative4.2.1

4.2.3 Quality Planning

4.3 Contract review

4.3.1 General

4.3.2 Review 5.6.3 Review input5.6.3 Review output

6 Resources management (Part of 4.1.2.2)

6.1 Provision of resources (Part of 4.1.2.2)

4.1 Management responsibility4.1.1 Quality policy 5.1+5.3+5.4.1

4.1.2 Organization Only

4.1.2 Responsibility and authority 5.5.1

4.1.2.2 Resources 6.1+6.2.1

4.1.3 5.6.1+8.5.1

Quality system4.2 Only

5.5.3 Internal communication (Part of 4.1.2)5.4.2+7.1

5.6 Management ReviewOnly5.6.1 General

5.2+7.2.1+7.2.2+7.2.3

4.3.3 Amendment to a contract 7.2.2

4.3.4 Records 7.2.2

4.4 Design control Only

4.4.1 General

4.4.2 Design and development planning 7.3.1



DESCRIPTION DESCRIPTION6.2 Human resources (Part of 4.1.2.2)

6.2.1 General (Part of 4.1.2.1)

6.2.2 Competence, awareness and training (Part of 5.18)

6.3 Infrastructure

6.4 Work environment

4.4.9 Design changes 7 Product realization7.3.7

Document Control and data control 7.1 Planning of Product realization (Part of 4.9)

7.2 Customer-related processes

4.5.2 Document and data approval and issue 7.2.1 Determination of requirements related to the product4.2.3

4.5.3 Document and data changes 7.2.2 Review of requirements related to the product (Part of 4.3.2)4.2.3

4.6 Purchasing

4.6.1 General

4.6.2 Evaluation of subcontractors

4.6.3 Purchasing data 7.3.2 Design and development inputs7.3.3 Design and development outputs

7.3.6 Design and development validation

7.3.7 Control of design and development changes

4.4.4 Design input4.4.5 Design output 7.3.3

4.4.6 Design review 7.3.4

4.4.7 Design verification 7.3.5

4.4.8 Design validation 7.3.6

4.5 Only

General4.5.1 4.2.3

7.2.3 Customer communication (Note 9 Part of 4.3.4)Only

7.3 Design and development7.3.1 Design and development planning

7.4.2

4.6.4 Verification of purchased product 7.4.3

4.6.4.1 Supplier verification subcontractors premises 7.3.4

4.6.4.2 Customer verification of subcontracted product 7.3.5

4.7 Control of customer supplied product

4.8 Product identification and control 7.5.3

4.4.3 Organization and technical interfaces 7.3.1

7.2.1+7.3.2

7.4.1

Design and development reviewDesign and development verification

7.5.4



DESCRIPTION DESCRIPTION7.4 Purchasing

7.4.1 Purchasing Process (General)

7.4.2 Purchasing information

7.4.3 Verification of purchased product

7.5 Production and service operations

4.10.2.3 7.5.2 Validation of processes for production and service provision

7.5.3 Identification and traceability

7.5.4 Customer property

4.10.4 Final inspection and testing 7.5.5 Preservation of product8.2.4

4.10.5 Inspection and test records 7.6 Control of measuring and monitoring devices7.5.3+8.2.4

4.11 Control of inspection, measuring and

test equipment

4.11.1 General

4.11.2 Control procedures 8.1 General8.2 Monitoring and measurement

8.2.3 Monitoring and measurement Customer satisfaction

4.10 Inspection and testing4.10.1 General 7.1+8.1

4.10.2 Receiving inspection and testing 7.4.3+8.2.4

4.10.2.1

4.10.2.2

In-process inspection and testing4.10.3 8.2.4

Only

8 Measurement, analysis and improvement

7.6

4.12 Inspection and test status 7.5.3

4.13 Control of nonconforming product 8.2.1

4.13.1 General 8.2.2

4.13.2 Review and disposition of

Nonconforming product

4.9 Process control 6.3+6.4+7.5.1+7.5.2

Only

7.6

Customer satisfactionInternal audits

8.3

7.5.1 Control of production and service provision

Only

8.3



DESCRIPTION DESCRIPTION8.2.4 Monitoring and measurement of Product

8.3 Control of nonconforming product

4.15.1 8.4 Analysis of data

8.5 Improvement

8.5.1 Continual improvement

4.15.4 Packaging 8.5.2 Corrective action7.5.5

4.15.5 Preservation 8.5.37.5.5

4.15.6 Delivery

Control of quality records

4.17 Internal quality audits

4.18 Training

4.14.1 General4.14.2 Corrective action 8.5.2

4.14.3 Preventive action 8.5.3

4.15

Storage4.15.3 7.5.5

7.5.1

6.2.2

4.19 Servicing 7.5.1

4.20 Statistical techniques

4.20.1 Identification of need

4.20.2 Procedures

4.14 Corrective and preventive action Only

8.5.2+8.5.3

8.2.2+8.2.3

8.1+8.2.3+8.2.3+8.4

Only

8.1+8.2.3+8.2.4+8.4

Handling, storage, packaging, Only

preservation and delivery

General

Handling4.15.2 7.5.5

4.2.44.16

GENERIC MODEL OF ISO 9000

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Transcript of GENERIC MODEL OF ISO 9000