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ISO 9001:2000 QUALITY MANAGEMENT SYSTEM (QMS)
- BY AJAY DESAI 1
ISO BODY STRUCTURE (Based at GENEVA, SWITZERLAND)
144 COUNTRIES ARE MEMBERS
REPRESENTATIVE IN BUREAU OF INDIAN STANDARDS (BIS), NEW DELHI
CHAIRMAN OF BIS REPRESENTS TC176 WHICH PUBLISH ISO STANDARDS
TOP INDUSTRIALISTS OF WORLD LIKE BILL GATES, MUKESH AMBANI, LAXMI MITTAL, ETC. - HONORARY MEMBERS
CERTIFIED LEAD AUDITORS ALL OVER THE WORLD APPROVED BY IRCA BOARD, UK - HONORARY MEMBERS
2
THE HIERARCHY OF CERTIFICATION BODY ISO BODY A) ACCREDITION BOARD UKAS
RVA
SAS
JASANZ
DAR
QCI (NABCB)
B) CERTIFICATION BODIES BVQI
DNV
SWISO/ KPMG
ICS/ICL
TUV
BIS 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 1.1 1.2 2 3 4 4.1 4.2
SCOPE GENERAL APPLICATION NORMATIVE REFERENCE TERMS AND DEFINITIONS QUALITY MANAGEMENT SYSTEM (QMS) GENERAL DOCUMENTATION REQUIREMENTS 19
8 PARAGRAPHS (8 SECTIONS) 5 5.1 5.2 5.3 5.4 5.5
MANAGEMENT RESPONSIBILITY MANAGEMENT COMMITMENT CUSTOMER FOCUS QUALITY POLICY PLANNING RESPONSIBILITY, AUTHORITY & COMMUNICATION 5.6 MANGEMENT REVIEW 20
8 PARAGRAPHS (8 SECTIONS) 6 6.1 6.2 6.3 6.4
RESOURCE MANAGEMENT PROVISION OF RESOURCES HUMAN RESOURCES INFRASTRUCTURE 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 8.1 8.2 8.3 8.4 8.5
MEASUREMENT, ANALYSIS & IMPROVEMENT GENERAL MONITORING & MEASUREMENT CONTROL OF NON CONFORMING PRODUCT ANALYSIS OF DATA 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
- BY AJAY DESAI 1
ISO BODY STRUCTURE (Based at GENEVA, SWITZERLAND)
144 COUNTRIES ARE MEMBERS
REPRESENTATIVE IN BUREAU OF INDIAN STANDARDS (BIS), NEW DELHI
CHAIRMAN OF BIS REPRESENTS TC176 WHICH PUBLISH ISO STANDARDS
TOP INDUSTRIALISTS OF WORLD LIKE BILL GATES, MUKESH AMBANI, LAXMI MITTAL, ETC. - HONORARY MEMBERS
CERTIFIED LEAD AUDITORS ALL OVER THE WORLD APPROVED BY IRCA BOARD, UK - HONORARY MEMBERS
2
THE HIERARCHY OF CERTIFICATION BODY ISO BODY A) ACCREDITION BOARD UKAS
RVA
SAS
JASANZ
DAR
QCI (NABCB)
B) CERTIFICATION BODIES BVQI
DNV
SWISO/ KPMG
ICS/ICL
TUV
BIS 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 1.1 1.2 2 3 4 4.1 4.2
SCOPE GENERAL APPLICATION NORMATIVE REFERENCE TERMS AND DEFINITIONS QUALITY MANAGEMENT SYSTEM (QMS) GENERAL DOCUMENTATION REQUIREMENTS 19
8 PARAGRAPHS (8 SECTIONS) 5 5.1 5.2 5.3 5.4 5.5
MANAGEMENT RESPONSIBILITY MANAGEMENT COMMITMENT CUSTOMER FOCUS QUALITY POLICY PLANNING RESPONSIBILITY, AUTHORITY & COMMUNICATION 5.6 MANGEMENT REVIEW 20
8 PARAGRAPHS (8 SECTIONS) 6 6.1 6.2 6.3 6.4
RESOURCE MANAGEMENT PROVISION OF RESOURCES HUMAN RESOURCES INFRASTRUCTURE 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 8.1 8.2 8.3 8.4 8.5
MEASUREMENT, ANALYSIS & IMPROVEMENT GENERAL MONITORING & MEASUREMENT CONTROL OF NON CONFORMING PRODUCT ANALYSIS OF DATA 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
