汽车行业生产件和相关服务件的组织实施ISO90012000的特殊要求(46)中英文(1).docx

TECHNICAL ISO/TS
SPECIFICATION 16949

Second Edition
20020301
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 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 nonboxed 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 Français 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 (VDAOMC/Germany)

Contents

Page
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
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
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 Customerrelated processes
7.2.1 Determination of requirements related to the product
7.2.1.1 Customerdesignated 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 Customerapproved 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 setups
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
7.5.3.1 Identification and traceability  Supplemental
7.5.4 Customer property
7.5.4.1 Customerowned 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 Errorproofing
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。

Foreword前言
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 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 standardization.
国际标准化组织（ISO）是由各国标准化团体（ISO成员团体）组成的世界性的联合会。制定国际标准工作通常由ISO的技术委员会完成。各成员团体若对某技术委员会确定的项目感兴趣，均有权参加该委员会的工作。与ISO保持联系的各国际组织（官方的或非官方的）也可参加有关工作。ISO与国际电工委员会（IEC）在电工技术标准化方面保持密切合作的关系。

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
国际标准遵照ISO/IEC导则第3部分的规则起草。

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.
由技术委员会通过的国际标准草案提交各成员团体投票表决，需取得了至少75%参加表决的成员团体的同意，才能作为国际标准正式发布。

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:
- 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;
- 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.

An ISO/PAS or ISO/TS is reviewed after three years with a view to deciding whether it should be confirmed for a further three years, revised to become an International Standard, or withdrawn. In the case of a confirmed ISO/PAS or ISO/TS, it is reviewed again after six years at which time it has to be either transposed into an International Standard or withdrawn.

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.
ISO/TS 16949:2002是由国际汽车推动小组(IATF)和日本汽车制造商协会(JAMA)，在ISO/TC 176，质量管理和质量保证技术委员会的支持下共同制定的。

This second edition of ISO/TS 16949 cancels and replace the first edition (ISO/TS 16949:1999), which has been technically revised.
本第二版ISO/TS 16949取代经技术性修订的第一版ISO/TS 16949 (ISO/TS 16949:1999)。

Boxed text is original ISO 9001:2000 text. The sectorspecific supplemental requirements are outside the boxes.
方框内的文字是ISO 9001:2000原文。方框外的文字是行业特殊补充要求。

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.
在本技术规范中，“必须”(shall)表示要求。“应该”(should)表示推荐。标有“注”(NOTE)的段落是理解或澄清相关要求的指导性解释。

Where the term "such as" is used, any suggestions given are for guidance only.
所有用“如”(such as)引出的建议仅具有指导性作用。

Annex A forms a normative part of this Technical Specification.
附录A构成本技术规范的一部分。
Remarks for certification/有关认证的说明

The certification to this Technical Specification, including customerspecific 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").
按照IATF的认证安排获得本技术规范的认证，包括顾客特殊要求（如果有），将获得IATF顾客成员的承认。参见“获得IATF认可的规则”。

Details can be obtained at the addresses of the local oversight bodies of IATF cited below:

Associazione Nazionale Fra Industrie Automobilistiche (ANFIA)
Web site: www.anfia.it email: [e-mail]

International Automotive Oversight Bureau (IAOB)
Web site: www.iaob.org email: [e-mail]

Federation des Industries des Equipements pour Vehicules (FIEV)
Comite des Constructeurs Francais d'Automobiles (CCFA)
Web site: www.iatf email: iatf@iatfF

Society of Motor Manufacturers and Traders Ltd. (SMMT Ltd.)
Web site: www.smmt.co.uk email: [e-mail]

Verband der Automobilindustrie (VDA) Qualitatsmanagement Center (QMC)
Web site: www.vdaqmc.de email: info@vdaqmc.de

Introduction引言

0.1 General总则

ISO 9001:2000, Quality management systems － Requirements

Introduction引言

0.1 General总则
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality 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 uniformity of documentation.
采用质量管理体系应当是组织的一项战略性决策。一个组织质量管理体系的设计和实施受各种需求、具体目标、所提供的产品、所采用的过程以及该组织的规模和结构的影响。统一质量管理体系的结构或文件不是本标准的目的。
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.
本标准所规定的质量管理体系要求是对产品要求的补充。“注”是理解和说明有关要求的指南。
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements.
本标准能用于内部和外部（包括认证机构）评定组织满足顾客、法律法规和组织自身要求的能力。
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
本标准的制定已经考虑了GB/T 19000和GB/T 19004中所阐明的质量管理原则。

0.2 Process approach过程方法

ISO 9001:2000, Quality management systems － Requirements

0.2 Process approach过程方法
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
本标准鼓励在建立、实施质量管理体系以及改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意。
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 output from one process directly forms the input to the next.
为使组织有效运作，必须识别和管理众多相互关联的活动。通过使用资源和管理，将输入转化为输出的活动可视为过程。通常，一个过程的输出直接形成下一个过程的输入。
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”.
组织内诸过程的系统的应用，连同这些过程的识别和相互作用及其管理，可称之为“过程方法”。
An advantage of the process approach is the ongoing control that it provides over the linkage between the