08-30195548-DC.pdf
a Date: 19 December 2008 Origin: International Latest date for receipt of comments: 20 February 2009 Project no.: 2008/04245 Responsible committee: QS/1 Quality management and quality assurance procedures Interested committees: Title: Draft DD ISO/TS 16949: 2009 Quality management systems: Particular requirements for the application of ISO 9001: 2008 for automotive production and relevant service part org anizations Supersession information: If this document is published as a standard, the UK implementation of it will supersede NONE and partially supersede. NONE If you are aware of a current national standard which may be affected, please notify the secretary (contact details below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 20 February 2009. This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publication. No acknowledgement will normally be sent. 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Direct tel: 020 8996 7792 Responsible Committee Secretary: Mrs Sara Walton (BSI) E-mail: sara.waltonbsigroup.com Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8996 7001 Form 36 Version 8.0 DPC: 08/30195548 DC Licensed Copy: London South Bank University, South Bank University, 02/02/2009 03:32, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on international discussions in which the UK has taken an active part. Your comments on this draft are invited and will assist in the preparation of the consequent standard. Comments submitted will be reviewed by the relevant BSI committee before sending the consensus UK vote and comments to the international secretariat, which will then decide appropriate action on the draft and the comments received. If the international standard is approved, it is possible the text will be published as an identical British Standard. 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Licensed Copy: London South Bank University, South Bank University, 02/02/2009 03:32, Uncontrolled Copy, (c) BSI Reference number ISO/TS 16949:2009(E) © ISO 2009 TECHNICAL SPECIFICATION ISO/TS 16949 Third edition 2009-xx-xx Quality management systems Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations Systèmes de management de la qualité Exigences particulières pour l'application de l'ISO 9001:2008 pour la production de série et de pièces de rechange dans l'industrie automobile Licensed Copy: London South Bank University, South Bank University, 02/02/2009 03:32, Uncontrolled Copy, (c) BSI ISO TS 16949:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. 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Neither this Technical Specification nor any extract from it may be reproduced in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise without prior written permission being secured. Requests for permission to reproduce and/or translate non-boxed text should be addressed to one of the addresses below: International Automotive Oversight Bureau (IAOB/USA) Associazione Nazionale Fra Industrie Automobilistiche (ANFIA/Italy) Fédération des Industries des Équipements pour Véhicules (FIEV/France) Society of Motor Manufacturers and Traders (SMMT/UK) Verband der Automobilindustrie - Qualitätsmanagement Center (VDA-QMC/Germany) ii © ISO 2009 All rights reserved © ANFIA, © FIEV, © SMMT, © VDA, © Chrysler, © Ford Motor Company, © General Motors Corp. All rights reserved © PSA Peugeot Citroën, © Renault All rights reserved Licensed Copy: London South Bank University, South Bank University, 02/02/2009 03:32, Uncontrolled Copy, (c) BSI ISO TS 16949:2009(E) © ISO 2009 All rights reserved © ANFIA, © FIEV, © SMMT, © VDA, © Chrysler, © Ford Motor Company, © General Motors Corp. All rights reserved © PSA Peugeot Citroën, © Renault All rights reserved iii Contents Page Forewordvii Remarks for certificationviii Introduction.ix 0.1 General.ix 0.2 Process approach.ix 0.3 Relationship with ISO 9004.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 Supplemental4 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 specifications5 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 efficiency6 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 Supplemental7 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 representative8 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 Licensed Copy: London South Bank University, South Bank University, 02/02/2009 03:32, Uncontrolled Copy, (c) BSI ISO TS 16949:2009(E) iv © ISO 2009 All rights reserved © ANFIA, © FIEV, © SMMT, © VDA, © Chrysler, © Ford Motor Company, © General Motors Corp. All rights reserved © PSA Peugeot Citroën, © Renault All rights reserved 5.6.2 Review input9 5.6.2.1 Review input Supplemental .9 5.6.3 Review output10 6 Resource management.10 6.1 Provision of resources.10 6.2 Human resources10 6.2.1 General .10 6.2.2 Competence, training and awareness .10 6.2.2.1 Product design skills.11 6.2.2.2 Training.11 6.2.2.3 Training on the job11 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 quality12 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 criteria13 7.1.3 Confidentiality13 7.1.4 Change control 13 7.2 Customer-related processes .13 7.2.1 Determination of requirements related to the product13 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 communication14 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 approach15 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 characteristics16 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 review17 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 Supplemental18 7.3.6.2 Prototype programme.18 Licensed Copy: London South Bank University, South Bank University, 02/02/2009 03:32, Uncontrolled Copy, (c) BSI ISO TS 16949:2009(E) © ISO 2009 All rights reserved © ANFIA, © FIEV, © SMMT, © VDA, © Chrysler, © Ford Motor Company, © General Motors Corp. All rights reserved © PSA Peugeot Citroën, © Renault All rights reserved v 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 sources19 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 instructions21 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 scheduling22 7.5.1.7 Feedback of information from service22 7.5.1.8 Service agreement with customer22 7.5.2 Validation of processes for production and service provision 23 7.5.2.1 Validation of processes for production and service provision Supplemental23 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 equipment. 24 7.6.1 Measurement system analysis25 7.6.2 Calibration/verification records25 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 tools26 8.1.2 Knowledge of basic statistical concepts26 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 8.2.2.4 Internal audit plans .27 8.2.2.5 Internal auditor qualification28 Licensed Copy: London South Bank University, South Bank University, 02/02/2009 03:32, Uncontrolled Copy, (c) BSI ISO TS 16949:2009(E) vi © ISO 2009 All rights reserved © ANFIA, © FIEV, © SMMT, © VDA, © Chrysler, © Ford Motor Company, © General Motors Corp. All rights reserved © PSA Peugeot Citroën, © Renault All rights reserved 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
