ISO/TS169492009
TECHNICAL SPECIFICATION
ISO9001:2008
Quality management systems
Particular requirements for the application of
ISO 9001:2008 for automotive production and
relevant service part organizations
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Contents Foreword7 Remarks for certification9 Introduction10 0.1 General10 0.2Process approach11 0.3 ISO 9004 Relationship with ISO 900413 0.4 Compatibility with other management systems14 0.5 Goal of this Technical Specification15 1 Scope16 1.1 General16 1.2 Application17 2 Normative reference17 3Terms and definitions18 3.1 Terms and definitions for the automotive industry18 4 Quality management system20 4.1 General requirements 20 4.1.1General requirementsSupplemental21 4.2 Documentation requirements21 4.2.1 General21 4.2.2 Quality manual22 4.2.3 Control of documents22 4.2.3.1 Engineering specifications23 4.2.4 Control of records23 4.2.4.1 Records retention 24 5 Management responsibility24 5.1Management commitment24 5.1.1 Process efficiency24 5.2 Customer focus24 5.3 Quality policy 25 5.4 Planning25 5.4.1 Quality objectives25 5.4.1.1 Quality objectivesSupplemental25 5.4.2Quality management system planning26 5.5 Responsibility, authority and communication26 5.5.1 Responsibility and authority26 5.5.1.1 Responsibility for quality26 5.5.2Management representative27 5.5.2.1 Customer representative27 5.5.3 Internal communication27 5.6 Management review27
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5.6.1General27 5.6.1.1 Quality management system performance28 5.6.2 Review input28 5.6.2.1 Review inputSupplemental28 5.6.3 Review output29 6 Resource management29 6.1Provision of resources29 6.2Human resources29 6.2.1General30 6.2.2 Competence, training and awareness30 6.2.2.1 Product design skills30 6.2.2.2Training31 6.2.2.3 31 6.2.2.4 Employee motivation and empowerment31 6.3 Infrastructure31 6.3.1 Plant, facility and equipment planning32 6.3.2 Contingency plans32 6.4Work environment32 6.4.1 Personnel safety to achieve conformity product requirements32 6.4.2 Cleanliness of premises32 7 Product realization33 7.1 Planning of product realization33 7.1.1 Planning of product realizationSupplemental34 7.1.2 Acceptance criteria34 7.1.3 Confidentiality34 7.1.4Change control34 7.2Customer-related processes34 7.2.1Determination of requirements related to the product35 7.2.1.1Customer-designated special characteristics35 7.2.2 Review of requirements related to the product35 7.2.2.1 Review of requirements related to the produc Supplemental36 7.2.2.2 Organization manufacturing feasibility36 7.2.3 Customer communication36 7.2.3.1 Customer communicationSupplemental37 7.3Design and development37 7.3.1 Design and development planning37 7.3.1.1 Multidisciplinary approach37 7.3.2 Design and development inputs38 7.3.2.1 Product design input38 7.3.2.2Manufacturing process design input39
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7.3.2.3 Special characteristics39 7.3.3Design and development outputs39 7.3.3.1 Product design outputsSupplemental40 7.3.3.2Manufacturing process design output40 7.3.4 Design and development review41 7.3.4.1 Monitoring41 7.3.5 Design and development verification42 7.3.6 Design and development validation42 7.3.6.1 Design and development validationSupplemental42 7.3.6.2 Prototype programme42 7.3.6.3 Product approval process43 7.3.7 Control of design and development changes43 7.4 Purchasing43 7.4.1 Purchasing process44 7.4.1.1 Regulatory conformity44 7.4.1.2 Supplier quality management system development44 7.4.1.3 Customer-approved sources44 7.4.2 Purchasing information45 7.4.3 Verification of purchased product45 7.4.3.1 Incoming product conformity to requirements45 7.4.3.2 Supplier monitoring46 7.5 Production and service provision46 7.5.1 Control of production and service provision46 7.5.1.1 Control plan47 7.5.1.2Work instructions47 7.5.1.3 Verification of job setups47 7.5.1.4 Preventive and predictive maintenance48 7.5.1.5Management of production tooling48 7.5.1.6 Production scheduling49 7.5.1.7 Feedback of information from service49 7.5.1.8 Service agreement with customer49 7.5.2 Validation of processes for production and service provision49 7.5.2.1 Validation of processes for production and service provisionSupplemental50 7.5.3 Identification and traceability50 7.5.3.1 Identification and traceabilitySupplemental50 7.5.4 Customer property51 7.5.4.1 Customer-owned production tooling51 7.5.5. Preservation of product51 7.5.5.1 Storage and inventory51 7.6 Control of monitoring and measuring equipment52
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7.6.1Measurement system analysis53 7.6.2/ Calibration/verification records53 7.6.3 Laboratory requirements53 7.6.3.1 Internal laboratory53 7.6.3.2 External laboratory54 8Measurement, analysis and improvement54 8.1 General55 8.1.1 Identification of statistical tools55 8.1.2 Knowledge of basic statistical concepts55 8.2 Monitoring and measurement55 8.2.1 Customer satisfaction55 8.2.1.1 Customer satisfactionSupplemental56 8.2.2 Internal audit56 8.2.2.1 Quality management system audit57 8.2.2.2Manufacturing process audit57 8.2.2.3 Product audit57 8.2.2.4 Internal audit plans57 8.2.2.5 Internal auditor qualification57 8.2.3Monitoring and measurement of processes58 8.2.3.1Monitoring and measurement of manufacturing processes 58 8.2.4Monitoring and measurement of product59 8.2.4.1 Layout inspection and functional testing59 8.2.4.2 Appearance items60 8.3 Control of nonconforming product60 8.3.1 Control of nonconforming productSupplemental61 8.3.2 Control of reworked product61 8.3.3 Customer information61 8.3.4 Customer waiver61 8.4 Analysis of data61 8.4.1 Analysis and use of data62 8.5 Improvement62 8.5.1 Continual improvement62 8.5.1.1 Continual improvement of the organization62 8.5.1.2Manufacturing process improvement62 8.5.2 Corrective action63 8.5.2.1 Problem solving63 8.5.2.2 Error-proofing63 8.5.2.3 Corrective action impact63 8.5.2.4/ Rejected product test/analysis63 8.5.3 Preventive action64 A Annex A (normative) Control plan65 Bibliography67
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Foreword (ISO)ISO ISO ISO()ISOIEC ISO (the International Organization for Standardization) is a worldwide federation of
national standards bodies (ISO member bodies). The work of preparing International
Standards is normally carried out through ISO technical committees. Each member body
interested in a subject for which a technical committee has been established has the right to
be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical
standardization. ISO/IEC 2 International Standards are drafted in accordance with the rules given in the ISO/IEC
Directives, Part 2. 75% The main task of technical committees is to prepare international standards. Draft
International Standards adopted by the technical committees are circulated to the member
bodies for voting. Publication as an international standard requires approval by at least 75%
of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such
documents, a technical committee may decide to publish other types of normative document:
ISOISO/PAS ISO 50% an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by
50 % of the members of the parent committee casting a vote;
ISO ISO/TS 2/3 an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of
the members of the committee casting a vote.
ISO/TS 16949 IATF ISO/TC176 ISO/TS 16949 was prepared by the International Automotive Task Force (IATF) with
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support from ISO/TC 176, Quality management and quality assurance. ISO9001 :2008 ISO/TS16949(ISO/TS 16949:2002) This third edition of ISO/TS 16949 cancels and replaces the second edition (ISO/TS
16949:2002), which has been technically amended according to ISO 9001:2008. ISO 90012008 Boxed text is original ISO 9001:2008 text. The sector-specific supplemental
requirements are outside the boxes. shallshouldNOTE In this Technical Specification, the word shall indicates a requirement. The word
should indicates a recommendation. Paragraphs marked NOTE are for guidance in
understanding or clarifying the associated requirement. . Where the term such as is used, any suggestions given are for guidance only. A Annex A forms a normative part of this Technical Specification. Remarks for certification IATFIATF IATF
(ANFIA) www.anfia.it (IAOB) www.iaob.org IATF-France www.iatf-france.com
(SMMT) www.smmt.co.uk - (VDA-QMC) www.vda-qmc.de
The certification to this Technical Specification, including customer-specific
requirements if any, is recognized by the customer members of IATF when achieved
according to the IATF certification scheme (see the Rules for achieving IATF recognition).
Details can be obtained at the addresses of the local oversight o
