Contents
Page
Foreword.............................................................................................................................................................vii
Remarks for certification....................................................................................................................................viii
Introduction ......................................................................................................................................................... ix
0.1 General................................................................................................................................................... ix
0.2 Process approach.................................................................................................................................... x
0.3 Relationship with ISO 9004 .................................................................................................................... xii
0.4 Compatibility with other management systems ...................................................................................... xii
0.5 Goal of this Technical Specification....................................................................................................... xii
1 Scope...............................................................................................................................................................1
1.1 General....................................................................................................................................................1
1.2 Application ...............................................................................................................................................1
2 Normative references ......................................................................................................................................2
3 Terms and definitions ......................................................................................................................................2
3.1 Terms and definitions for the automotive industry....................................................................................2
4 Quality management system ............................................................................................................................4
4.1 General requirements..............................................................................................................................4
4.1.1 General requirements — Supplemental ...........................................................................................4
4.2 Documentation requirements ...................................................................................................................5
4.2.1 General............................................................................................................................................5
4.2.2 Quality manual.................................................................................................................................5
4.2.3 Control of documents .......................................................................................................................6
4.2.3.1 Engineering specifications.............................................................................................................6
4.2.4 Control of records............................................................................................................................6
4.2.4.1 Records retention ..........................................................................................................................7
5 Management responsibility ...............................................................................................................................7
5.1 Management commitment.......................................................................................................................7
5.1.1 Process efficiency ............................................................................................................................7
5.2 Customer focus .......................................................................................................................................7
5.3 Quality policy............................................................................................................................................7
5.4 Planning...................................................................................................................................................8
5.4.1 Quality objectives .............................................................................................................................8
5.4.1.1 Quality objectives — Supplemental...............................................................................................8
5.4.2 Quality management system planning .............................................................................................8
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.............................................................................................................9
5.5.2.1 Customer representative ...............................................................................................................9
5.5.3 Internal communication ....................................................................................................................9
5.6 Management review ................................................................................................................................9
5.6.1 General............................................................................................................................................9
5.6.1.1 Quality management system performance..................................................................................10
5.6.2 Review input ..................................................................................................................................10
5.6.2.1 Review input — Supplemental ....................................................................................................10
5.6.3 Review output................................................................................................................................10
6 Resource management..................................................................................................................................11
6.1 Provision of resources ............................................................................................................................11
6.2 Human resources ..................................................................................................................................11
6.2.1 General ..........................................................................................................................................11
6.2.2 Competence, training and awareness ............................................................................................11
6.2.2.1 Product design skills ....................................................................................................................11
6.2.2.2 Training.......................................................................................................................................12
6.2.2.3 Training on the job .......................................................................................................................12
6.2.2.4 Employee motivation and empowerment.....................................................................................12
6.3 Infrastructure..........................................................................................................................................12
6.3.1 Plant, facility and equipment planning ............................................................................................12
6.3.2 Contingency plans ..........................................................................................................................12
6.4 Work environment .................................................................................................................................13
6.4.1 Personnel safety to achieve conformity to product requirements...................................................13
6.4.2 Cleanliness of premises..................................................................................................................13
7 Product realization .........................................................................................................................................13
7.1 Planning of product realization................................................................................................................13
7.1.1 Planning of product realization — Supplemental ............................................................................14
7.1.2 Acceptance criteria .........................................................................................................................14
7.1.3 Confidentiality ................................................................................................................................14
7.1.4 Change control ...............................................................................................................................14
7.2 Customer-related processes...................................................................................................................14
7.2.1 Determination of requirements related to the product ....................................................................14
7.2.1.1 Customer-designated special characteristics ..............................................................................15
7.2.2 Review of requirements related to the product ...............................................................................15
7.2.2.1 Review of requirements related to the product — Supplemental ................................................15
7.2.2.2 Organization manufacturing feasibility .........................................................................................15
7.2.3 Customer communication...............................................................................................................15
7.2.3.1 Customer communication — Supplemental ................................................................................16
7.3 Design and development ........................................................................................................................16
7.3.1 Design and development planning .................................................................................................16
7.3.1.1 Multidisciplinary approach............................................................................................................16
7.3.2 Design and development inputs .....................................................................................................17
7.3.2.1 Product design input ....................................................................................................................17
7.3.2.2 Manufacturing process design input ............................................................................................17
7.3.2.3 Special characteristics .................................................................................................................17
7.3.3 Design and development outputs ...................................................................................................18
7.3.3.1 Product design outputs — Supplemental ....................................................................................18
7.3.3.2 Manufacturing process design output..........................................................................................18
7.3.4 Design and development review.....................................................................................................19
7.3.4.1 Monitoring ...................................................................................................................................19
7.3.5 Design and development verification..............................................................................................19
7.3.6 Design and development validation................................................................................................19
7.3.6.1 Design and development validation — Supplemental .................................................................19
7.3.6.2 Prototype programme ..................................................................................................................20
7.3.6.3 Product approval process ............................................................................................................20
7.3.7 Control of design and development changes .................................................................................20
7.4 Purchasing.............................................................................................................................................20
7.4.1 Purchasing process........................................................................................................................20
7.4.1.1 Statutory and regulatory conformity ............................................................................................21
7.4.1.2 Supplier quality management system development....................................................................21
7.4.1.3 Customer-approved sources .......................................................................................................21
7.4.2 Purchasing information...................................................................................................................21
7.4.3 Verification of purchased product...................................................................................................21
7.4.3.1 Incoming product conformity to requirements .............................................................................22
7.4.3.2 Supplier monitoring.....................................................................................................................22
7.5 Production and service provision............................................................................................................22
7.5.1 Control of production and service provision ...................................................................................22
7.5.1.1 Control plan .................................................................................................................................22
7.5.1.2 Work instructions........................................................................................................................23
7.5.1.3 Verification of job set-ups ............................................................................................................23
7.5.1.4 Preventive and predictive maintenance ......................................................................................23
7.5.1.5 Management of production tooling ..............................................................................................24
7.5.1.6 Production scheduling .................................................................................................................24
7.5.1.7 Feedback of information from service .........................................................................................24
7.5.1.8 Service agreement with customer ...............................................................................................24
7.5.2 Validation of processes for production and service provision ........................................................24
7.5.2.1 Validation of processes for production and service provision — Supplemental..........................25
7.5.3 Identification and traceability ..........................................................................................................25
7.5.3.1 Identification and traceability — Supplemental............................................................................25
7.5.4 Customer property.........................................................................................................................25
7.5.4.1 Customer-owned production tooling............................................................................................25
7.5.5 Preservation of product ..................................................................................................................26
7.5.5.1 Storage and inventory .................................................................................................................26
7.6 Control of monitoring and measuring equipment ...................................................................................26
7.6.1 Measurement system analysis .......................................................................................................27
7.6.2 Calibration/verification records .......................................................................................................27
7.6.3 Laboratory requirements ................................................................................................................27
7.6.3.1 Internal laboratory.......................................................................................................................27
7.6.3.2 External laboratory ......................................................................................................................27
8 Measurement, analysis and improvement......................................................................................................28
8.1 General..................................................................................................................................................28
8.1.1 Identification of statistical tools .......................................................................................................28
8.1.2 Knowledge of basic statistical concepts .........................................................................................28
8.2 Monitoring and measurement.................................................................................................................28
8.2.1 Customer satisfaction....................................................................................................................28
8.2.1.1 Customer satisfaction — Supplemental ......................................................................................29
8.2.2 Internal audit..................................................................................................................................29
8.2.2.1 Quality management system audit ..............................................................................................29
8.2.2.2 Manufacturing process audit .......................................................................................................29
8.2.2.3 Product audit ...............................................................................................................................30
8.2.2.4 Internal audit plans ......................................................................................................................30
8.2.2.5 Internal auditor qualification.........................................................................................................30
8.2.3 Monitoring and measurement of processes ...................................................................................30
8.2.3.1 Monitoring and measurement of manufacturing processes ........................................................30
8.2.4 Monitoring and measurement of product........................................................................................31
8.2.4.1 Layout inspection and functional testing......................................................................................31
8.2.4.2 Appearance items........................................................................................................................31
8.3 Control of nonconforming product ..........................................................................................................32
8.3.1 Control of nonconforming product — Supplemental.......................................................................32
8.3.2 Control of reworked product ...........................................................................................................32
8.3.3 Customer information .....................................................................................................................32
8.3.4 Customer waiver............................................................................................................................32
8.4 Analysis of data......................................................................................................................................33
8.4.1 Analysis and use of data.................................................................................................................33
8.5 Improvement..........................................................................................................................................33
8.5.1 Continual improvement...................................................................................................................33
8.5.1.1 Continual improvement of the organization .................................................................................33
8.5.1.2 Manufacturing process improvement...........................................................................................34
8.5.2 Corrective action............................................................................................................................34
8.5.2.1 Problem solving ...........................................................................................................................34
8.5.2.2 Error-proofing..............................................................................................................................34
8.5.2.3 Corrective action impact ..............................................................................................................34
8.5.2.4 Rejected product test/analysis.....................................................................................................34
8.5.3 Preventive action ............................................................................................................................35
Annex A (normative) Control plan......................................................................................................................36
A.1 Phases of the control plan ......................................................................................................................36
A.2 Elements of the control plan ...................................................................................................................36
Bibliography........................................................................................................................................................38