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1、ISO/TS 16949 Table of contents based on ISO9001:2000 changes 1.1.ScopeScope 1.1 General 1.2 Applicability 2.2.Normative ReferencesNormative References 3.3.Terms and DefinitionsTerms and Definitions3.3.Terms and DefinitionsTerms and Definitions 4.4.Quality Management SystemQuality Management System 4
2、.1 General Requirements4.1 General Requirements 4.2 Documentation Requirements4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality manual 4.2.3 Control of Documents 4.2.3.1 Engineering Specifications 4.2.4 Control of Records 4.2.4.1 Records Retention ISO/TS 16949 Table of contents based on ISO
3、9001:2000 changes 5.Management Responsibility 5.1 Management commitment5.1 Management commitment 5.1.1 Process Oriented Organization 5.2 Customer focus5.2 Customer focus 5.3 Quality Policy5.3 Quality Policy5.3 Quality Policy5.3 Quality Policy 5.3.1 Quality Policy Supplemental 5.4 Planning5.4 Plannin
4、g 5.4.1 Quality Objectives 5.4.1.1 Quality Objectives Supplemental 5.4.2 Quality Management Systems Planning 5.5 Responsibility, authority and communication5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 5.5.1.1 Quality Responsibility ISO/TS 16949 Table of contents
5、 based on ISO9001:2000 changes 5.5.2 Management Representative 5.5.2.1 Customer representative 5.5.3 Internal Communication 5.6 Management Review5.6 Management Review5.6 Management Review5.6 Management Review 5.6.1 General 5.6.1.1 Quality Management system Performance 5.6.2 Review Input 5.6.2.1 Revi
6、ew Input Supplemental 5.6.3 Review Output 6. Resource Management 6.1 Provision of Resources6.1 Provision of Resources 6.2 Human Resources6.2 Human Resources 6.2.1 General ISO/TS 16949 Table of contents based on ISO9001:2000 changes 6.2.2 Competence, awareness and training 6.2.2.1 Product design skil
7、ls 6.2.2.2 Training 6.2.2.3 Training on the Job 6.2.2.4 Employee motivation, empowerment and satisfaction 6.3 Infrastructure6.3 Infrastructure 6.3.1 Plant facility and equipment planning 6.3.2 Contingency Plan 6.4 Work environment6.4 Work environment 6.4.1 Safety 6.4.2 Cleanliness of premises 6.5 So
8、urcing6.5 Sourcing ISO/TS 16949 Table of contents based on ISO9001:2000 changes 7 7Product RealizationProduct Realization 7.1 Planning of Product realization7.1 Planning of Product realization 7.1.1 Quality Plan requirements 7.1.2 Change Control 7.2 Customer Related Processes7.2 Customer Related Pro
9、cesses7.2 Customer Related Processes7.2 Customer Related Processes 7.2.1 Determination of requirements related to the product 7.2.1.2 Customer designated Special characteristics 7.2.2 Review of requirements related to the product 7.2.2.1 Review Supplemental 7.2.2.2 Manufacturing Feasibility 7.2.3 Cu
10、stomer communication 7.2.3.1 Customer communication Supplement 7.3 Design and Development7.3 Design and Development 7.3.1 Design and Development Planning 7.3.1.1 Multidisciplinary approach ISO/TS 16949 Table of contents based on ISO9001:2000 changes 7.3.2 Design and Development inputs 7.3.2.1 Produc
11、t Design inputs 7.3.2.2 Manufacturing Process design inputs 7.3.2.3 Innovation 7.3.2.4 Special Characteristics7.3.2.4 Special Characteristics 7.3.3 Design and Development Outputs 7.3.3.1 Product Design outputs Supplemental 7.3.3.2 Manufacturing Process design outputs 7.3.4 Design and development rev
12、iew 7.3.4.1 Monitoring 7.3.5 Design and Development verification 7.3.5.1 Process Verification 7.3.6 Design and Development validation 7.3.6.1 Design and Development validation Supplement 7.3.6.2 Prototype Program 7.3.6.3 Product Approval Process ISO/TS 16949 Table of contents based on ISO9001:2000 c
13、hanges 7.3.7 Control of Design and Development changes 7.3.7.1 Control of Design and Development Changes Supplemental 7.4 Purchasing7.4 Purchasing 7.4.1 Purchasing process 7.4.1.1 Regulatory compliance7.4.1.1 Regulatory compliance 7.4.1.2 Supplier Quality Management systems development 7.4.1.3 Custo
14、mer approved sources 7.4.2 Purchasing information 7.4.3 Verification of purchased product 7.5 Production and Service provision7.5 Production and Service provision 7.5.1 Control of Production and service provision 7.5.1.1 Control Plan 7.5.1.2 Work instruction 7.5.1.3 Verification of Job setups 7.5.1.
15、4 Preventive and predictive maintenance 7.5.1.5 Tooling Management ISO/TS 16949 Table of contents based on ISO9001:2000 changes 7.5.1.6 Production Scheduling 7.5.1.7 Feedback information from Service 7.5.1.8 Service agreement with Customer 7.5.2 Validation of processes and service provision 7.5.3 Id
16、entification and traceability 7.5.4 Customer property 7.5.4.1 Customer Owned tooling 7.5.6 Preservation of Product 7.5.6.1 Storage and Inventory 7.6 Control of monitoring and measuring devices7.6 Control of monitoring and measuring devices 7.6.1 Measurement System Analysis 7.6.2 Calibration records
17、7.6.3 Laboratory requirements 7.6.3.1 Internal Laboratory 7.6.3.2 External Laboratory ISO/TS 16949 Table of contents based on ISO9001:2000 changes 8 8Measurement, Analysis and ImprovementMeasurement, Analysis and Improvement 8.1 General8.1 General 8.1.1 Identification of Statistical tools 8.1.2 Know
18、ledge of Basic statistical concepts 8.2 Monitoring and measurement8.2 Monitoring and measurement8.2 Monitoring and measurement8.2 Monitoring and measurement 8.2.1 Customer Satisfaction 8.2.1.1 Customer satisfaction Supplemental 8.2.2 Internal audit 8.2.2.1 Internal audit plans 8.2.2.2 Quality manage
19、ment systems audit 8.2.2.3 Manufacturing Process audit 8.2.2.4 Product audit 8.2.2.5 Internal auditor qualification 8.2.3 Monitoring and measurement of Processes 8.2.3.1 Monitoring and measurement of processes - Supplemental ISO/TS 16949 Table of contents based on ISO9001:2000 changes 8.2.4 Monitori
20、ng and measurement of Product 8.2.4.1 Acceptance criteria 8.2.4.2 Incoming product quality 8.2.4.3 Supplier monitoring 8.2.4.4 Layout inspection and Functional testing 8.2.4.5 Appearance items 8.3 Control of nonconforming product8.3 Control of nonconforming product 8.3.1 Customer information 8.3.2 C
21、ontrol of reworked product 8.3.3 Customer authorization 8.4 Analysis of Data8.4 Analysis of Data 8.4.1 Analysis and use of Company level data ISO/TS 16949 Table of contents based on ISO9001:2000 changes 8.5 Improvement8.5 Improvement 8.5.1 Continual improvement 8.5.1.1 Organizational continual impro
22、vement 8.5.1.2 Manufacturing Process improvement8.5.1.2 Manufacturing Process improvement 8.5.2 Corrective action 8.5.2.1 Problem solving 8.5.2.2 Mistake proofing 8.5.2.3 Corrective Action impact 8.5.2.4 Returned product test/analysis 8.5.3 Preventive action 8.5.3.1 Mistake proofing for preventive a
23、ction ISO/TS16949 standard is compared against the ISO9001:2000 standard The addition in the TS16949 standard are listed in the second column The clauses in the current edition of TS16949 that addresses these elements are listed in the last columnthese elements are listed in the last column If there
24、 is “-” in the last column, it indicates that it is a new addition in the ISO/TS16949 standard A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) 1.1 GeneralNote added regarding Remote location and applications 1.2 ApplicabilityNote added about Design Responsible Org
25、anizations 2 Normative ReferenceNo additions 3 Terms and Definitions3.1 Highlighted automotive terms and definitions A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 4.1 General requirements Note relating to subcontracting added4.2.1 4.2 Documentati
26、on Note relating to additional documentation 4.2.2.1 4. Quality Management System 4.2 Documentation requirements 4.2.1 General Note relating to additional documentation requirements added 4.2.2.1 4.2.2.2 4.2.2 Quality Manual No additions4.2.1 4.2.3 Control of Documents 4.2.3.1 Engineering Specificat
27、ions4.5.1,4.5.2.1,4.5.2.2 4.5.3 4.2.4 Control of Records 2 Notes added 4.2.4.1 Records Retention 4.16.1 4.16.2 A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 5.1 Management commitment5.1.1 Process Oriented Organization 4.1.1.1 5.2 Customer FocusNo
28、 additions- 5. Management Responsibility 5.3 Quality Policy5.3.1 Quality Policy Supplemental 4.1.1.1 5.4 Planning 5.4.1 Quality Objectives 5.4.1.1 Quality Objectives Supplemental 4.1.1.2 5.4.2 Quality Management Systems Planning No additions4.2.3.1 5.5 Responsibility, authority and communication 5.5
29、.1 Responsibility and Authority 5.5.1.1 Quality Responsibility4.1.2.1 4.1.2.1.3 4.1.2.2.2 A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 5.5.2 Management Representative5.5.2.1 Customer Representative4.1.2.3 4.1.2.1.2 5.5.3 Internal CommunicationNo
30、 addition- 5. Management Responsibility 5.5.3 Internal CommunicationNo addition 5.6 Management Review 5.6.1 General 5.6.1.1 Quality Management System Performance Note added to the above element 4.1.3.1 4.1.3.2 4.2.8 5.6.2 Review Input5.6.2.1 Review input Supplemental - 5.6.3 Review OutputNote relati
31、ng to the output added- A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 6.1 Provision of resourcesNo addition4.1.2.2.1 6.2 Human ResourcesNo addition- 6. Resource Management 6.2 Human Resources 6.2.1 General No addition 6.2.2 Competence, awareness
32、and training 6.2.2.1 Product design skills 6.2.2.2 Training 6.2.2.3 Training on the Job 6.2.2.4 Employee motivation, empowerment and satisfaction 4.4.2.2 4.18.1,4.18.2 4.18.3 4.1.6 6.3 Infrastructure6.3.1 Plant, facility and equipment planning 6.3.2 Contingency plan 4.2.5 4.9.1 4.9.1.3 A snapshot of
33、 the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 6.4 Work environment6.4.1 Safety 6.4.2 Cleanliness of premises 4.1.7.1 4.9.1.2 6.5 Sourcing- 5. Resource Management 6.5 Sourcing A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000)
34、Current TS16949 7.1 Planning for Product Realization Note added relating to APQP Process 7.1.1 Quality Plan requirements 7.1.2 Change Control 4.2.4.1 4.2.3.2 - 7. Product Realization 7.1.2 Change Control - 7.2 Customer Related Processes 7.2.1 Determination of requirements related to the product 2 no
35、tes added 7.2.1.1 Customer designated special characteristics 4.4.4.1 4.9.1.4 7.2.2 Review of requirements related to the product Note relating to waiver added 7.2.2.1 Review Supplemental 7.2.2.2 Manufacturing feasibility 4.3.1,4.3.2.1, 4.3.2.2,4.3.3, 4.3.4,4.2.4.8 7.2.3 Customer communication7.2.3.
36、1 Customer communication - Suppliment 4.1.2.4 A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 7.3 Design and DevelopmentNote added saying that this is applicable to both product and process design and development 4.4 7.3.1 Design and Development No
37、te added relating to error 4.4.2.1 7. Product Realization 7.3.1 Design and Development Planning Note added relating to error prevention 7.3.1.1 Multidisciplinary approach 4.4.3 4.1.2.4 4.2.4.9.1 4.2.4.4 7.3.2 Design and Development inputs Note added 7.3.2.1 Product design inputs 7.3.2.2 Manufacturin
38、g Process design inputs 7.3.2.3 Innovation 7.3.2.4 Special Characteristics 4.4.4.1 4.4.4.2, 4.4.4.3 4.2.4.9.2 - 4.2.4.7 A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 7.3.3 Design and Development outputs 7.3.3.1 Product Design outputs Supplemental
39、 7.3.3.2 Manufacturing Process design output 4.4.5.1 4.4.5.2 4.2.4.9.3 7. Product Realization design output 7.3.4 Design and Development Review Note added 7.3.4.1 Monitoring 4.4.6,4.1.2.4 4.2.4.3 4.2.4.2 7.3.5 Design and Development Verification 7.3.5.1 Process Verification 4.4.7 4.2.4.9.4 7.3.6 Des
40、ign and Development Validation Note added 7.3.6.1 Design and Development Validation Supplemental 7.3.6.2 Prototype program 7.3.6.3 Product Approval Process 4.4.8.1 4.4.8.2 4.4.8.3 4.2.4.11 A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 7.3.7 Contr
41、ol of Design and Development Changes Note added 7.3.7.1 Control of Design and Development Changes - Supplemental 4.4.9.1 4.4.9.2 4.2.4.11 7.4 Purchasing2 Notes added4.6.1.1 7. Product Realization 7.4 Purchasing 7.4.1 Purchasing Process 2 Notes added 7.4.1.2 Regulatory compliance 7.4.1.3 Supplier Qua
42、lity management systems development 7.4.1.4 Customer approved sources 4.6.1.1 4.6.2.1 4.6.1.3 4.6.2.2 4.6.1.2 7.4.2 Purchasing informationNo addition4.6.3 A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 7.4.3 Verification of Purchased product No ad
43、dition4.6.4.1 4.6.4.2 7.5 Production and Service Provision 7.5.1 Control of production and Note added 7.5.1.2 Control Plan 7.5.1.3 Work Instructions 4.9.1.1 4.2.4.10 4.9.2 7. Product Realization 7.5.1 Control of production and service provision 7.5.1.3 Work Instructions 7.5.1.4 Verification of Job s
44、etups 7.5.1.5 Preventive and predictive maintenance 7.5.1.6 Tooling Management 7.5.1.7 Production Scheduling 7.5.1.8 Feedback of information from Service 7.5.1.9 Servicing agreement with customer 4.9.2 4.9.4 4.9.1.5 4.2.6 4.15.6.2 4.15.6.3 4.19.1 4.19.2 4.19.3 A snapshot of the additions ISO9001:200
45、0TS16949 (All are additions to ISO9001:2000) Current TS16949 7.5.2 Validation of Processes for production and service provision Note added4.9.1.1 7.5.3 Identification and traceability Note added4.8,4.12 7.5.4 Customer propertyNote added4.7.1 7. Product Realization 7.5.4 Customer propertyNote added 7
46、.5.4.1 Customer Owned tooling 4.7.1 4.7.2 7.5.5 Preservation of product7.5.5.1 Storage and inventory4.15.1,4.15.2 4.15.3.1 4.15.3.2 4.15.4.1 4.15.4.2 4.15.4.3 4.15.5, 4.15.6.1 A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 7.6 Control of monitorin
47、g and measuring devices Note added relating to identification 7.6.1 Measurement System Analysis 7.6.2 Calibration Records 4.11.1.1 4.11.2 4.11.1.2 4.11.3 7. Product Realization 7.6.3 Laboratory requirements 7.6.3.1 Internal Laboratory 7.6.4.1 External Laboratory 4.11.3 4.10.6 - - A snapshot of the a
48、dditions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 8.1 General8.1.1 Identification of Statistical Tools 8.1.2 Knowledge of basic statistical concepts 4.20.1 4.20.2 4.20.3 4.20.4 8.2 Monitoring and Note added 8. Measurement, analysis and Improvement 8.2 Monitoring and me
49、asurement 8.2.1 Customer satisfaction Note added 8.2.1.1 Customer satisfaction Supplemental 4.1.1.3 4.15.6.2 8.2.2 Internal Audit8.2.2.1 Internal audit plans 8.2.2.2 Quality management system audit 8.2.2.3 Manufacturing process audit 8.2.2.4 Product audit 8.2.2.5 Internal auditor qualification 4.17.1.1 4.17.2.1 4.17.2.2 4.17.2.3 4.17.2.4 4.17.3 A snapshot of the additions ISO9001:2000TS16949 (All are additions to ISO9001:2000) Current TS16949 8.2.3 Monitoring and measurement of processes 8.2.3.1 Monitoring and measurement of processes supplemental 4.