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TECHNICAL SPECIFICATION

ISO/TS 16949

Second Edition 2002-03-01

质量管理体系-

汽车行业生产件和相关服务件的组织实施 ISO 9001:2000的特殊要求

Quality management systems -

Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations

International Automotive Task Force

Reference number ISO/TS 16949:2002 (B)

ISO/TS 16949:2002 (B)

? ISO 2002

All 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 permission in writing from either ISO’s member body in the country of the requester.

The 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 has 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, Ford Motor Company, General Motors Corp.

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) Comite des Constructeurs Fran?ais d'Automobiles (CCFA/France) Fédération des Industries des Equipements pour Véhicules (FIEV/France) Society of Motor Manufacturers and Traders (SMMT/UK)

Verband der Automobilindustrie - Qualitatsmanagement Center (VDA-OMC/Germany)

? 2002-ISO - All rights reserved

? 2002-ANFIA, ?2002- CCFA/FIEV, ? 2002-SMMT, ?2002- VDA,

? 2002-DaimIerChrysler, 2002-Ford Motor Company, 2002-General Motors Corp. - All rights reserved

ISO/TS 16949:2002 (B)

Contents

Foreword前言

Remarks for certification有关认证的说明 Introduction引言 0.1 General总则

0.2 Process approach过程方法

0.3 Relationship with ISO 9004 与ISO 9004的关系

Page

0.3.1 IATF Guidance to ISO/TS 16949:2002 IATF关于ISO/TS 16949:2002的指南 0.4 Compatibility with other management systems与其他管理体系的相容性 0.5 Goal of this Technical Specification本技术规范的目的 1 Scope范围 1.1 General总则 1.2 Application应用

2 Normative reference引用标准 3 Terms and definitions术语和定义

3.1Terms and definitions for the automotive industry汽车行业的术语和定义 4 Quality management system 4.1 General requirements

4.1.1 General requirements - Supplemental 4.2 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

5 Management responsibility 5.1 Management commitment 5.1.1 Process efficiency 5.2 Customer focus 5.3 Quality policy 5.4 Planning

5.4.1 Quality objectives

5.4.1.1 Quality objectives - Supplemental 5.4.2 Quality management system planning 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 5.5.1.1 Responsibility for quality 5.5.2 Management representative 5.5.2 1 Customer representative 5.5.3 Internal communication 5.6 Management review 5.6.1 General

5.6.1.1 Quality management system performance 5.6.2 Review input

5.6.2.1 Review input - Supplemental 5.6.3 Review output

6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 General

6.2.2 Competence, awareness 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 and empowerment 6.3 Infrastructure

? 2002-ISO - All rights reserved

? 2002-ANFIA, ?2002- CCFA/FIEV, ? 2002-SMMT, ?2002- VDA,

? 2002-DaimIerChrysler, 2002-Ford Motor Company, 2002-General Motors Corp. - All rights reserved

Page ii

ISO/TS 16949:2002 (B)

6.3.1 Plant, facility and equipment planning 6.3.2 Contingency plans 6.4 Work environment

6.4.1 Personnel safety to achieve product quality 6.4.2 Cleanliness of premises 7 Product realization

7.1 Planning of product realization

7.1.1 Planning of product realization - Supplemental 7.1.2 Acceptance criteria 7.1.3 Confidentiality 7.1.4 Change control

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product 7.2.1.1 Customer-designated special characteristics 7.2.2 Review of requirements related to the product

7.2.2.1 Review of requirements related to the product - Supplemental 7.2.2.2 Organization manufacturing feasibility 7.2.3 Customer communication

7.2.3.1 Customer communication - Supplemental 7.3 Design and development

7.3.1 Design and development planning 7.3.1.1 Multidisciplinary approach 7.3.2 Design and development inputs 7.3.2.1 Product design input

7.3.2.2 Manufacturing process design input 7.3.2.3 Special characteristics

7.3 3 Design and development outputs

7.3.3.1 Product design outputs - Supplemental 7.3.3.2 Manufacturing process design output 7.3.4 Design and development review 7.3.4.1 Monitoring

7.3.5Design and development verification 7.3.6 Design and development validation

7.3.6.1 Design and development validation -Supplemental 7.3.6.2 Prototype programme 7.3.6.3 Product approval process

7.3.7 Control of design and development changes 7.4 Purchasing

7.4.1 Purchasing process 7.4.1.1 Regulatory conformity

7.4.1.2 Supplier quality management system development 7.4.1.3 Customer-approved sources 7.4.2 Purchasing information

7.4.3 Verification of purchased product 7.4.3.1 Incoming product quality 7.4.3.2 Supplier monitoring

7.5 Production and service provision

7.5.1 Control of production and service provision 7.5.1.1 Control plan

7.5.1.2 Work instructions

7.5.1.3 Verification of job set-ups

7.5.1.4 Preventive and Predictive maintenance 7.5.1.5 Management of production tooling 7.5.1.6 Production scheduling

7.5.1.7 Feedback of information from service 7.5.1.8 Servicing agreement with customer

7.5.2 Validation of processes for production and service provision

7.5.2.1 Validation of processes for production and service provision - Supplemental 7.5.3 Identification and traceability

? 2002-ISO - All rights reserved

? 2002-ANFIA, ?2002- CCFA/FIEV, ? 2002-SMMT, ?2002- VDA,

? 2002-DaimIerChrysler, 2002-Ford Motor Company, 2002-General Motors Corp. - All rights reserved

Page iii

ISO/TS 16949:2002 (B)

7.5.3.1 Identification and traceability - Supplemental 7.5.4 Customer property

7.5.4.1 Customer-owned production tooling 7.5.5 Preservation of product 7.5.5.1 Storage and inventory

7.6 Control of monitoring and measuring devices 7.6.1 Measurement system analysis 7.6.2 Calibration/Verification records 7.6.3 Laboratory requirements 7.6.3.1 Internal laboratory 7.6.3.2 External laboratory

8 Measurement, analysis and improvement 8.1 General

8.1.1 Identification of statistical tools

8.1.2 Knowledge of basic statistical concepts 8.2 Monitoring and measurement 8.2.1 Customer satisfaction

8.2.1.1 Customer satisfaction - Supplemental 8.2.2 Internal audit

8.2.2.1 Quality management system audit 8.2.2.2 Manufacturing process audit 8.2.2.3 Product audit

8.2.2.4 Internal audit plans

8.2.2.5 Internal auditor qualification

8.2.3 Monitoring and measurement of processes

8.2.3.1 Monitoring and measurement of manufacturing processes 8.2.4 Monitoring and measurement of product 8.2.4.1 Layout inspection and functional testing 8.2.4.2 Appearance items

8.3 Control of nonconforming product

8.3.1 Control of nonconforming product- Supplemental 8.3.2 Control of reworked product 8.3.3 Customer information 8.3.4 Customer waiver 8.4 Analysis of data

8.4.1 Analysis and use of data 8.5 Improvement

8.5.1 Continual improvement

8.5.1.1 Continual improvement of the organization 8.5.1.2 Manufacturing process improvement 8.5.2 Corrective action 8.5.2.1 Problem solving 8.5.2.2 Error-proofing

8.5.2.3 Corrective action impact

8.5.2.4 Rejected product test/analysis 8.5.3 Preventive action

Annex A (normative) Control Plan附录A (标准的) 控制计划 A.1 Phases of the control plan/控制计划的阶段 A.2 Elements of the control plan/控制计划的要素 Bibliography/引用文献

NOTE In this table of contents, ISO 9001:2000 headings are normal type face, IATF headings are in italics. 注:在本目录中,ISO 9001:2000的标题是正体字,IATF的标题是斜体字。

? 2002-ISO - All rights reserved

? 2002-ANFIA, ?2002- CCFA/FIEV, ? 2002-SMMT, ?2002- VDA,

? 2002-DaimIerChrysler, 2002-Ford Motor Company, 2002-General Motors Corp. - All rights reserved

Page iv

ISO/TS 16949:2002 (B)

Bibliography引用文献

[1] ISO 9004:2000, Quality management systems - Guidelines for performance improvements

1)

[2] ISO 10011-1:1990, Guidelines for auditing quality systems – Part 1 Auditing [3] ISO 10011-2:1991, Guidelines for auditing quality systems – Part 2: Qualification criteria for quality systems

1)

auditors

1)

[4] ISO 10011-3:1991, Guidelines for auditing quality systems – Part 3: Management of audit programmes [5] ISO 10012-1:1992, Quality assurance requirements for measurement – Part 1: Metrological confirmation system for measuring equipment [6] ISO 10012-2:1997, Quality assurance requirements for measurement – Part 2: Guidelines for control of measurement processes

2)

[7] ISO/IEC 17025:1999, General requirements for the competence of testing and calibration laboratories [8] IATF Guidance to ISO/TS 16949:2002

1) Now revised as ISO 19011, Guidelines on quality and/or environmental management auditing. 2) Formerly designated ISO/IEC Guide 25.

? ISO 2002 - All rights reserved

? ANFIA, ? CCFA/FIEV, ? SMMT, ? VDA, ? DaimIerChrysler AG, Ford Motor Company, General Motors Corp. All rights reserved BV030207

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