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1、 DRAFTISO/TC 176 N660TECHNICALISO/TSSPECIFICATION 16949Second edition20020301Quality management systemsAutomotive suppliersParticular requirements for the application of ISO 9001:2000Systèmes de management de la qualitéFournisseurs de !'automobileExigences particulières pour !'
2、;application de !'ISO 9001:2000Reference number ISO/ITS 16949:2002(E)© ISO 2002All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without perm
3、ission in writing from the publisher.International Organization for StandardizationCase postale 56 CH1211 Genève 20SwitzerlandInternet isoiso.chThe content inside the boxed text of this document is ISO 9001:2000 text and is protected by the above copyright statement.The text outside the boxes h
4、as been originated by the International Automotive Task Force. Copyright for this text is held by ANFIA, CCFA/FIEV, SMMT, VDA (see below) and the car manufacturers DaimIerChrysler A.G., Ford Motor Company, General Motors Corp.Neither this Technical Specification nor any extract from it may be reprod
5、uced 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 nonboxed text should be addressed to one of the addresses below:International A
6、utomotive Oversight Bureau (IAOB/USA)Associazione Nazionale Fra Industrie Automobilistiche (ANFIA/Italy)Comite des Constructeurs Français d'Automobiles (CCFA/France)Fédération des Industries des Equipements pour Véhicules (FIEV/France)Society of Motor Manufacturers and Trader
7、s (SMMT/UK)Verband der Automobilindustrie Qualitatsmanagement Center (VDAOMC/Germany)ContentsContentsiiForewordviRemarks for certificationviiIntroductionviii0.1 Generalviii0.2 Process approachviii0.3 Relationship with ISO 9004x0.3.1 IATF Guidance to ISO/TS 16949 : 2002x0.4 Compatibility with other m
8、anagement systemsx0.5 Goal of this Technical SpecificationxQuality management systems Automotive suppliers Particular requirements forthe application of ISO 9001:200011 Scope11.1 General11.2 Application12 Normative reference23 Terms and definitions23.1Terms and definitions for the automotive industr
9、y24 Quality management system54.1 General requirements54.2 Documentation requirements54.2.1 General54.2.2 Oualitv manual64.2.3 Control of documents64.2.3.1 Engineering specifications74.2.4 Control of records74.2.4.1 Records retention75 Management responsibility75.1 Management commitment75.1.1 Proces
10、s efficiency85.2 Customer focus85.3 Quality policy85.4 Planning85.4.1 Oualitv objectives85.4.1.1 Quality objectives Supplemental85.4.2 Ouality management system planning95.5 Responsibility, authority and communication95.5.1 Responsibility and authority95.5.1.1 Responsibility for quality95.5.2 Manage
11、ment representative95.5.2 1 Customer representative105.5.3 Internal communication105.6 Management review105.6.1 General105.6.1.1 Quality management system performance105.6.2 Review input105.6.2.1 Review input Supplemental115.6.3 Review output116 Resource management116.1 Provision of resources116.2 H
12、uman resources116.2.1 General116.2.2 Competence, awareness and training126.2.2.1 Product design skills126.2.2.2 Training126.2.2.3 Training on the job126.2.2.4 Employee motivation and empowerment126.3 Infrastructure126.3.1 Plant, facility and equipment planning136.3.2 Contingency plans136.4 Work envi
13、ronment136.4.1 Personnel safety136.4.2 Cleanliness of premises137 Product realization137.1 Planning of product realization137.1.1 Planning of product realization Supplemental147.1.2 Acceptance criteria147.1.3 Confidentiality147.1.4 Change control147.2 Customerrelated processes157.2.1 Determination o
14、f requirements related to the product157.2.1.1 Customerdesignated special characteristics157.2.2 Review of requirements related to the product157.2.2.1 Organization manufacturing feasibility167.2.3 Customer communication167.2.3.1 Customer communication Supplemental167.3 Design and development167.3.1
15、 Design and development planning167.3.1.1 Multidisciplinary approach177.3.2 Design and development inputs177.3.2.1 Product design input177.3.2.2 Manufacturing process design input177.3.2.3 Special characteristics177.3 3 Design and development outputs187.3.3.1 Product design outputs Supplemental187.3
16、.3.2 Manufacturing process design output187.3.4 Design and development review197.3.4.1 Monitoring197.3.5Design and development verification197.3.6 Design and development validation197.3.6.1 Design and development validation Supplemental197.3.6.2 Prototype programme207.3.6.3 Product approval process2
17、07.3.7 Control of design and development changes207.4 Purchasing207.4.1 Purchasing process207.4.1.1 Regulatory compliance217.4.1.2 Supplier quality management system development217.4.1.3 Customerapproved sources217.4.2 Purchasing information217.4.3 Verification of purchased product217.4.3.1 Incoming
18、 product quality227.4.3.2 Supplier monitoring227.5 Production and service provision227.5.1 Control of production and service provision227.5.1.1 Control plan227.5.1.2 Work instructions237.5.1.3 Verification of job setups237.5.1.4 Preventive and Predictive maintenance237.5.1.5 Management of production
19、 tooling237.5.1.6 Production scheduling247.5.1.7 Feedback of information from service247.5.1.8 Servicing agreement with customer247.5.2 Validation of processes for production and service provision 247.5.2.1 Validation of processes for production and service provision Supplemental 247.5.3 Identificat
20、ion and traceability247.5.3.1 Identification and traceability Supplemental257.5.4 Customer property257.5.4.1 Customerowned production tooling257.5.5 Preservation of product257.5.5.1 Storage and inventory257.6 Control of monitoring and measuring devices267.6.1 Measurement system analysis267.6.2 Calib
21、ration records267.6.3 Laboratory requirements277.6.3.1 Internal laboratory277.6.3.2 External laboratory278 Measurement, analysis and improvement278.1 General278.1.1 Identification of statistical tools288.1.2 Knowledge of basic statistical concepts288.2 Monitoring and measurement288.2.1 Customer sati
22、sfaction288.2.1.1 Customer satisfaction Supplemental288.2.2 Internal audit288.2.2.1 Quality management system audit298.2.2.2 Manufacturing process audit298.2.2.3 Product audit298.2.2.4 Internal audit plans298.2.2.5 Internal auditor qualification298.2.3 Monitoring and measurement of processes298.2.3.
23、1 Monitoring and measurement of manufacturing processes308.2.4 Monitoring and measurement of product308.2.4.1 Layout inspection and functional testing318.2.4.2 Appearance items318.3 Control of nonconforming product318.3.1 Control of nonconforming product Supplemental318.3.2 Control of reworked produ
24、ct318.3.3 Customer information328.3.4 Customer waiver328.4 Analysis of data328.4.1 Analysis and use of data328.5 Improvement328.5.1 Continual improvement328.5.1.1 Continual improvement of the organization338.5.1.2 Manufacturing process improvement338.5.2 Corrective action338.5.2.1 Problem solving338
25、.5.2.2 Errorproofing338.5.2.3 Corrective action impact338.5.2.4 Rejected product test/analysis348.5.3 Preventive action34Annex A35A.1 Phases of the control plan35A.2 Elements of the control plan35ISO 9001:2000 headings are normal type face, IATF headings are in italicsForewordISO (the International
26、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 esta
27、blished has the right to be represented on that committee. International organizations, governmental and nongovernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of Electrotechnical standardizat
28、ion.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.In other circumstances, particularly when there is an urgent market requiremen
29、t for such documents, a technical committee may decide to publish other types of normative document: 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
30、 the parent committee casting a vote; 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 2I3 of the members of the committee casting a vote.An ISO/PAS or ISO/TS is reviewed every three year
31、s with a view to deciding whether it can be transformed into an International Standard.ISO/TS 16949 : 2002 was prepared by the International Automotive Task Force (IATF) and Japan Automobile Manufacturers Association Inc. (JAMA), with support from ISO/TC 176, Quality management and quality assurance
32、.This second edition of ISO/TS 16949 cancels and replace the first edition (ISO/TS 16949:1999) , which has been technically revised.Boxed text is original ISO 9001:2000 text. The sectorspecific supplemental requirements are outside the boxes.In this Technical Specification, the word "shall"
33、; indicates requirements. Paragraphs marked "NOTE" are for guidance in understanding or clarifying the associated requirement. The word "should" appearing in a NOTE is for guidance only.Where the term "such as" is used, any suggestions given are for guidance only.Remark
34、s for certificationThe certification to this Technical Specification, including customerspecific requirements if any, is recognized by the customers members of IATF when achieved according to the IATF certification scheme (see the "Rules for achieving IATF recognition").Details can be obta
35、ined at the addresses of the local oversight bodies of IATF cited below:Associazione Nazionale Fra Industrie Automobilistiche (ANFIA)Web site: www.anfia.itemail: anfiaanfia.itInternational Automotive Oversight Bureau (IAOB)Web site: www.iaob.orgemail: hhodderiaob.orgFederation des Industries des Equ
36、ipements pour Vehicules (FIEV)Comite des Constructeurs Frangais d'Automobiles (CCFA)Web site: www.iatfemail: iatfiatfFSociety of Motor Manufacturers and Traders Ltd. (SMMT Ltd.)Web site: www.smmt.co.ukemail: qualitysmmt.co.ukVerband der Automobilindustrie (VDA) Qualitatsmanagement Center (QMC)We
37、b site: www.vdactmc.de email: infovdaqmc.deIntroduction0.1 GeneralISO 9001:2000, Quality management systems Requirements Introduction0.1 GeneralThe adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's qualit
38、y management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformit
39、y of documentation.The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.This International Standard can be used by intern
40、al and external parties, including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements.The quality management principles stated in ISO 9001 and ISO 9004 have been taken into consideration during the development of th
41、is International Standard.0.2 Process approachISO 9001:2000, Quality management systems Requirements0.2 Process approachThis International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance cus
42、tomer satisfaction by meeting customer requirements.For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the
43、output from one process directly forms the input to the next.The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.An advantage of the process approach
44、is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.When used within a quality management system, such an approach emphasizes the importance ofa) understanding and fulfilling requi
45、rements,b) the need to consider processes in terms of added value,c) obtaining results of process performance and effectiveness, andd) continual improvement of processes based on objective measurement.The model of a processbased quality management system shown in Figure 1 illustrates the process lin
46、kages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this Internat