TS169492002英文原版標準(pdf 48)

Contents
Page
Foreword vii
Remarks for certification viii
Introduction ix
0.1 General ix
0.2 Process approach ix
0.3 Relationship with ISO 9004 xi
0.3.1 IATF Guidance to ISO/TS 16949:2002 xi
0.4 Compatibility with other management systems xi
0.5 Goal of this Technical Specification xii
1 Scope 1
1.1 General 1
1.2 Application 1
2 Normative reference 2
3 Terms and definitions 2
3.1 Terms and definitions for the automotive industry 2
4 Quality management system 3
4.1 General requirements 3
4.1.1 General requirements — Supplemental 4
4.2 Documentation requirements 4
4.2.1 General 4
4.2.2 Quality manual 5
4.2.3 Control of documents 5
4.2.3.1 Engineering specifications 5
4.2.4 Control of records 6
4.2.4.1 Records retention 6
5 Management responsibility 6
5.1 Management commitment 6
5.1.1 Process efficiency 6
5.2 Customer focus 7
5.3 Quality policy 7
5.4 Planning 7
5.4.1 Quality objectives 7
5.4.1.1 Quality objectives — Supplemental 7
5.4.2 Quality management system planning 7
5.5 Responsibility, authority and communication 8
5.5.1 Responsibility and authority 8
5.5.1.1 Responsibility for quality 8
5.5.2 Management representative 8
5.5.2.1 Customer representative 8
5.5.3 Internal communication 8
5.6 Management review 9
5.6.1 General 9
5.6.1.1 Quality management system performance 9
ISO/TS 16949:2002(E)
iv
? ISO 2002 – All rights reserved
? ANFIA, ? CCFA/FIEV, ? SMMT, ? VDA, ? DaimlerChrysler, Ford Motor Company, General Motors Corp. –
All rights reserved
5.6.2 Review input 9
5.6.2.1 Review input — Supplemental 9
5.6.3 Review output 10
6 Resource management 10
6.1 Provision of resources 10
6.2 Human resources 10
6.2.1 General 10
6.2.2 Competence, awareness and training 10
6.2.2.1 Product design skills 11
6.2.2.2 Training 11
6.2.2.3 Training on the job 11
6.2.2.4 Employee motivation and empowerment 11
6.3 Infrastructure 11
6.3.1 Plant, facility and equipment planning 11
6.3.2 Contingency plans 12
6.4 Work environment 12
6.4.1 Personnel safety to achieve product quality 12
6.4.2 Cleanliness of premises 12
7 Product realization 12
7.1 Planning of product realization 12
7.1.1 Planning of product realization — Supplemental 13
7.1.2 Acceptance criteria 13
7.1.3 Confidentiality 13
7.1.4 Change control 13
7.2 Customer-related processes 13
7.2.1 Determination of requirements related to the product 13
7.2.1.1 Customer-designated special characteristics 14
7.2.2 Review of requirements related to the product 14
7.2.2.1 Review of requirements related to the product — Supplemental 14
7.2.2.2 Organization manufacturing feasibility 14
7.2.3 Customer communication 14
7.2.3.1 Customer communication — Supplemental 15
7.3 Design and development 15
7.3.1 Design and development planning 15
7.3.1.1 Multidisciplinary approach 15
7.3.2 Design and development inputs 15
7.3.2.1 Product design input 16
7.3.2.2 Manufacturing process design input 16
7.3.2.3 Special characteristics 16
7.3.3 Design and development outputs 16
7.3.3.1 Product design outputs — Supplemental 17
7.3.3.2 Manufacturing process design output 17
7.3.4 Design and development review 17
7.3.4.1 Monitoring 17
7.3.5 Design and development verification 18
7.3.6 Design and development validation 18
7.3.6.1 Design and development validation — Supplemental 18
ISO/TS 16949:2002(E)
? ISO 2002 – All rights reserved
? ANFIA, ? CCFA/FIEV, ? SMMT, ? VDA, ? DaimlerChrysler, Ford Motor Company, General Motors Corp. –
All rights reserved v
7.3.6.2 Prototype programme 18
7.3.6.3 Product approval process 18
7.3.7 Control of design and development changes 19
7.4 Purchasing 19
7.4.1 Purchasing process 19
7.4.1.1 Regulatory conformity 19
7.4.1.2 Supplier quality management system development 19
7.4.1.3 Customer-approved sources 19
7.4.2 Purchasing information 20
7.4.3 Verification of purchased product 20
7.4.3.1 Incoming product quality 20
7.4.3.2 Supplier monitoring 20
7.5 Production and service provision 21
7.5.1 Control of production and service provision 21
7.5.1.1 Control plan 21
7.5.1.2 Work instructions 21
7.5.1.3 Verification of job set-ups 21
7.5.1.4 Preventive and predictive maintenance 22
7.5.1.5 Management of production tooling 22
7.5.1.6 Production scheduling 22
7.5.1.7 Feedback of information from service 22
7.5.1.8 Service agreement with customer 22
7.5.2 Validation of processes for production and service provision 23
7.5.2.1 Validation of processes for production and service provision — Supplemental 23
7.5.3 Identification and traceability 23
7.5.3.1 Identification and traceability — Supplemental 23
7.5.4 Customer property 24
7.5.4.1 Customer-owned production tooling 24
7.5.5 Preservation of product 24
7.5.5.1 Storage and inventory 24
7.6 Control of monitoring and measuring devices 24
7.6.1 Measurement system analysis 25
7.6.2 Calibration/verification records 25
7.6.3 Laboratory requirements 25
7.6.3.1 Internal laboratory 25
7.6.3.2 External laboratory 25
8 Measurement, analysis and improvement 26
8.1 General 26
8.1.1 Identification of statistical tools 26
8.1.2 Knowledge of basic statistical concepts 26
8.2 Monitoring and measurement 26
8.2.1 Customer satisfaction 26
8.2.1.1 Customer satisfaction — Supplemental 26
8.2.2 Internal audit 27
8.2.2.1 Quality management system audit 27
8.2.2.2 Manufacturing process audit 27
8.2.2.3 Product audit 27
ISO/TS 16949:2002(E)
vi
? ISO 2002 – All rights reserved
? ANFIA, ? CCFA/FIEV, ? SMMT, ? VDA, ? DaimlerChrysler, Ford Motor Company, General Motors Corp. –
All rights reserved
8.2.2.4 Internal audit plans 27
8.2.2.5 Internal auditor qualification 28
8.2.3 Monitoring and measurement of processes 28
8.2.3.1 Monitoring and measurement of manufacturing processes 28
8.2.4 Monitoring and measurement of product 29
8.2.4.1 Layout inspection and functional testing 29
8.2.4.2 Appearance items 29
8.3 Control of nonconforming product 29
8.3.1 Control of nonconforming product — Supplemental 30
8.3.2 Control of reworked product 30
8.3.3 Customer information 30
8.3.4 Customer waiver 30
8.4 Analysis of data 30
8.4.1 Analysis and use of data 31
8.5 Improvement 31
8.5.1 Continual improvement 31
8.5.1.1 Continual improvement of the organization 31
8.5.1.2 Manufacturing process improvement 31
8.5.2 Corrective action 31
8.5.2.1 Problem solving 32
8.5.2.2 Error-proofing 32
8.5.2.3 Corrective action impact 32
8.5.2.4 Rejected product test/analysis 32
8.5.3 Preventive action 32
Annex A (normative) Control plan 33
A.1 Phases of the control plan 33
A.2 Elements of the control plan 33
Bibliography 34
..............................