ISO 9001:2000 QUALITY

MANAGEMENT SYSTEM
(QMS)

- BY AJAY DESAI

1
 ISO BODY STRUCTURE
(Based at GENEVA, SWITZERLAND)

144 COUNTRIES
ARE MEMBERS
TOP INDUSTRIALISTS CERTIFIED
OF WORLD LIKE LEAD
REPRESENTATIVE BILL GATES, AUDITORS
MUKESH AMBANI, ALL OVER
IN BUREAU OF THE WORLD
INDIAN LAXMI MITTAL,
STANDARDS ETC. APPROVED
(BIS), NEW - HONORARY BY IRCA
DELHI MEMBERS BOARD, UK
- HONORARY
CHAIRMAN OF BIS MEMBERS
REPRESENTS TC-
176 WHICH
PUBLISH ISO
STANDARDS 2
 THE HIERARCHY OF
CERTIFICATION BODY

ISO BODY

A) ACCREDITION BOARD

QCI
UKAS RVA SAS JASANZ DAR
(NABCB)

B) CERTIFICATION BODIES

SWISO/
BVQI DNV ICS/ICL TUV BIS
KPMG
3
 WHAT IS ISO?
“ISO” WORD IS DERIVED FROM “ISOS” GREEK
WORD
ISO MEANS INTERNATIONAL ORGANIZATION FOR
STANDARDS
ISO HAS PUBLISHED 23700 NOS. OF STANDARDS
ISO HAS 144 (ONE HUNDRED FORTY FOUR)
COUNTRIES AS ITS MEMBER
ISO 9000 – FIRST PUBLISHED IN 1987
ISO 9000 – FIRST REVISION IN 1994
ISO 9000 – SECOND REVISION ON 15TH DECEMBER
2000 (LATEST REVISION)

4
 ISO 9000 IS SERIES OF
STANDARDS
IN 1987 & 1994 – THE CERTIFICATION SERIES
WERE:
ISO – 9001 – DESIGN & DEVELOPMENT, R&D,
MARKETING TO MANUFACTURING. ALL CLAUSES
WERE APPLICABLE
ISO – 9002 – MARKETING TO MANUFACTURING
CLAUSES WERE ONLY APPLICABLE
ISO – 9003 – SERVICE INDUSTRIES WERE ELIGIBLE
ISO – 9004 – GUIDELINES FOR PERFORMANCE
IMPROVEMENT
DURING 2ND REVISION OF ISO – 9001:2000
ONLY ISO 9001:2000 WAS FINALIZED AND OTHERS
9002 & 9003 WERE OBSOLETE TO AVOID
CONFUSION IN CERTIFICATION SERIES.
5
 NOW ONLY FOLLOWING
STANDARDS ARE APPLICABLE
ISO – 9000 : 2000 QMS – GENERIC IN
NATURE – SERIES OF STANDARD –
DEFINES FUNDAMENTALS VOCABULARY
ISO – 9001 : 2000 QMS – FULFILLS
REQUIREMENTS OF STANDARD
ISO – 9004 : 2000 QMS – GUIDELINES FOR
PERFORMANCE IMPROVEMENT
ISO – 19011:2002 – GUIDELINES FOR
AUDITING QUALITY SYSTEM &
ENVIRONMENTAL MANAGEMENT SYSTEM
(CRITERIA FOR AUDITORS)

6
 General Benefits from ISO
9001:2000
 IT HELPS THE UNIT IN PUTTING ITS HOUSE IN ORDER, IN
TERMS OF CLARITY OF ALL OPERATION.

 IT HELD THAT CUSTOMERS TO FEEL CONFIDENT ABOUT

THEIR INTERNAL QUALITY ASSURANCE MANAGEMENT
SYSTEM.

 IT BRINGS A POSITIVE CHANGE IN WORK CULTURE.

 IT IS PROVED THAT ONLY ONE QUALITY SYSTEM CAN

SATISFY THE REQUIREMENT OF VARIOUS CUSTOMERS.

 INTRODUCES QUALITY COST AND HENCE INCREASES

PROFIT.

7
 General Benefits from ISO
9001:2000
1. IT ENSURE QUALITY & PRODUCTION CAN BE INCREASED.

3. BEING GLOBALLY ACCEPTED THIRD-PARTY

CERTIFICATION SCHEME, IT ELIMINATES FREQUENT
SECOND PARTY ASSESSMENTS, REQUIRED EARLIER BY
THE CUSTOMERS.

5. INCREASE BOTTOM LINE RESULT AND PROFITABILITY

WITH OPTIMUM USE OF RESOURCES.

7. ENHANCE CUSTOMERS, STAKE HOLDER & INTERESTED

PARTIES SATISFACTION.

8
 ISO & OTHER STANDARDS
ISO – 14001 : 2004 – ENVIRONMENTAL
MGMT. SYSTEM (EMS)

CE MARKING – CONFORMITY OF EUROPEAN

STANDARDS

QS – 9000 / TS – 16949 – QUALITY STD. FOR

AUTOMOTIVE INDUSTRIES

HACCP – HAZARD ANALYSIS & CRITICAL

CONTROL POINTS, FOOD SAFETY 9
 ISO & OTHER STANDARDS
OHSAS – 18001 – OCCUPATIONAL HEALTH &
SAFETY MGT. SYSTEM

API QI APIQR – QUALITY STANDARDS FOR

OIL AND GAS INDUSTRY EQUIPMENT

ISO – 13485 – QUALITY STD. FOR MEDICAL

DEVICES

S.A. – 8000 – SOCIAL ACCOUNTABILITY

ISO 9001/14001/18001 INTEGRATED MGT.

SYSTEM 10
 QUALITY MANUAL -
LEVEL 1

 QUALITY POLICY
 QUALITY OBJECTIVES
 REQUIREMENT STANDARDS
 OTHER STATUTORY &
REGULATORY REQUIRMENTS

11
 QUALITY PROCEDURES
LEVEL - 2
 4.2.3 CONTROL OF DOCUMENTS
 4.2.4 CONTROL OF RECORDS
 8.2.2 INTERNAL QUALITY AUDITS
 8.3 CONTROL OF NON CONFORMING
PRODUCTS
 8.5.2 CORRECTIVE ACTION
 8.5.3 PREVENTIVE ACTION

12
 QUALITY PLAN
LEVEL - 3
 INCOMING INSPECTION PLAN
 IN PROCESS INSPECTION PLAN
 FINAL TEST REPORT / INSPECTION
PLAN
 WORK INSTRUCTIONS

FORMS / FORMATS/RECORDS
LEVEL - 4
13
 23 MANDATORY RECORDS
 5.6.1 – MANAGEMENT REVIEW
(GENERAL)
 6.2.2 – COMPETENCE, AWARENESS &
TRAINING
 7.1 – PLANNING & PRODUCTION
 7.2.2 – REVIEW OF REQUIREMENT
RELATED TO PRODUCT
 7.3.2 – DESIGN & DEVELOPMENT
INPUTS
14
23 MANDATORY RECORDS
7.3.3 – DESIGN & DEVELOPMENT
OUTPUTS
7.3.4 – DESIGN & DEVELOPMENT REVIEW
7.3.5 – DESIGN & DEVELOPMENT
VERIFICATION
7.3.6 – DESIGN & DEVELOPMENT
VALIDATION
7.3.7 – CONTROL OF DESIGN &
DEVELOPMENT CHANGES

15
 23 MANDATORY RECORDS
1. 7.4.1 – PURCHASING PROCESS
2. 7.5.2(d) – AVAILABILITY & USE OF M/M
DEVICES
3. 7.5.3 – PRESERVATION O PRODUCT
4. 7.5.4 – CUSTOMER PROPERTY
5. 7.6 – CONTROL OF MONITORING &
MEASURING DEVICES
6. 7.6(a) – STANDARDS USED FOR
CALIBRATION OR VERIFICATION OF
MEASURING EQUIPMENT
16
 23 MANDATORY RECORDS
1. 7.6(c) – IDENTIFIED & ENABLE THE
STATUS OF CALIBRATION
2. 7.6 (d) – RESULT OF CALIBRATION &
VERIFICATION
3. 8.2.2 – INTERNAL AUDIT (QSP - 3)
4. 8.2.4 – MONITORING & MEASUREMENT OF
PRODUCTS
5. 8.3 – CONTROL OF NON CONFORMING
PRODUCTS (QSP - 4)
6. 8.5.2 – CORRECTIVE ACTION (QSP - 5)
7. 8.5.3 – PREVENTIVE ACTION (QSP - 6)
17
 8 MANAGEMENT PRINCIPLES
 CUSTOMER FOCUS
 LEADERSHIP
 INVOLVEMENT OF PEOPLE
 PROCESS APPROACH
 SYSTEM APPROACH
 CONTINUAL IMPROVEMENT
 FACTUAL APPROACH TO DECISION
MAKING
 MUTUAL BENEFICIAL SUPPLIER
RELATIONSHIPS

18
 8 PARAGRAPHS (8
SECTIONS)
1 SCOPE
1.1 GENERAL
1.2 APPLICATION
2 NORMATIVE REFERENCE
3 TERMS AND DEFINITIONS
4 QUALITY MANAGEMENT SYSTEM (QMS)
4.1 GENERAL
4.2 DOCUMENTATION REQUIREMENTS

19
 8 PARAGRAPHS (8
SECTIONS)
5 MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT
5.2 CUSTOMER FOCUS
5.3 QUALITY POLICY
5.4 PLANNING
5.5 RESPONSIBILITY, AUTHORITY &
COMMUNICATION
5.6 MANGEMENT REVIEW
20
 8 PARAGRAPHS (8
SECTIONS)
6 RESOURCE MANAGEMENT
6.1 PROVISION OF RESOURCES
6.2 HUMAN RESOURCES
6.3 INFRASTRUCTURE
6.4 WORK ENVIRONMENT

21
 8 PARAGRAPHS (8
SECTIONS)
7 PRODUCT REALIZATION
7.1 PLANNING OF PRODUCT REALIZATION
7.2 CUSTOMER RELATED PROCESSES
7.3 DESIGN & DEVELOPMENT
7.4 PURCHASING
7.5 PRODUCTION & SERVICE PROVISION
7.6 CONTROL OF MONITORING & MEASURING
DEVICES

22
 8 PARAGRAPHS (8
SECTIONS)
8 MEASUREMENT, ANALYSIS &
IMPROVEMENT
8.1 GENERAL
8.2 MONITORING & MEASUREMENT
8.3 CONTROL OF NON CONFORMING
PRODUCT
8.4 ANALYSIS OF DATA
8.5 IMPROVEMENT
23
 5 MAIN CLAUSES
(1, 2 & 3 ARE GENERAL CLAUSES)

 4 QUALITY MANAGEMENT SYSTEM

 5 MANAGEMENT RESPONSIBILITY
 6 RESOURCE MANAGEMENT
 7 PRODUCT REALIZATION
 8 MEASUREMENT ANALYSIS &
IMPROVEMENT
24
THANK YOU…!!

25