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© 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 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 (VDA OMC/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 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
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。

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 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.
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 sector specific 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 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").
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    e mail: anfia@anfia.it

International Automotive Oversight Bureau (IAOB)
   Web site: www.iaob.org    e mail: quality@iaob.org

Federation des Industries des Equipements pour Vehicules (FIEV)
Comite des Constructeurs Francais d'Automobiles (CCFA)
   Web site: www.iatf france.com    e mail: iatf@iatf France.com

Society of Motor Manufacturers and Traders Ltd. (SMMT Ltd.)
   Web site: www.smmt.co.uk    e mail: quality@smmt.co.uk

Verband der Automobilindustrie (VDA) Qualitatsmanagement Center (QMC)
   Web site: www.vda qmc.de    e mail: info@vda qmc.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 individual processes within the system of processes, as well as over their combination and interaction.
过程方法的优点是对诸过程的系统中单个过程之间的联系以及过程的组合和相互作用进行连续的控制。
When used within a quality management system, such an approach emphasizes the importance of
过程方法在质量管理体系中应用时，强调以下方面的重要性：
a)    understanding and fulfilling requirements,
a）理解并满足要求；
b)    the need to consider processes in terms of added value,
b）需要从增值的角度考虑过程；
c)    obtaining results of process performance and effectiveness, and
c）获得过程业绩和有效性的结果；
d)    continual improvement of processes based on objective measurement.
d）基于客观的测量，持续改进过程。
The model of a process based quality management system shown in Figure 1 illustrates the process linkages 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 International Standard, but does not show processes at a detailed level.
图1所反映的以过程为基础的质量管理体系模式展示了4～8章中所提出的过程联系。这种展示反映了在规定输入要求时，顾客起着重要作用。对顾客满意的监视要求对顾客有关组织是否已满足其要求的感受的信息进行评价。该模式虽覆盖了本标准的所有要求，但却未详细地反映各过程。
NOTE   In addition, the methodology known as "Plan Do Check Act" (PDCA) can be applied to all processes. PDCA can be briefly described as follows.
注：此外，称之为“PDCA”的方法可适用于所有过程。PDCA模式可简述如下：
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.
P——策划：根据顾客的要求和组织的方针，为提供结果建立必要的目标和过程；
Do: implement the processes.
D——实施：实施过程；
Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.
C——检查：根据方针、目标和产品要求，对过程和产品进行监视和测量，并报告结果；
Act: take actions to continually improve process performance.
A——处置：采取措施，以持续改进过程业绩。

           Key图释

                   Value-adding activities增值活动
                   Information flow信息流

Figure 1   Model of a process based quality management system/图1   以过程为基础的质量管理模式

0.3 Relationship with ISO 9004     与GB/T 19004的关系

ISO 9001:2000, Quality management systems － Requirements

0.3 Relationship with ISO 9004   与GB/T 19004的关系
The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently.
GB/T 19001和GB/T 19004已制定为一对协调一致的质量管理体系标准，他们相互补充，但也可单独使用。
Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair.
虽然这两项标准具有不同的范围，但却具有相似的结构，以有助于他们作为协调一致的一对标准的应用。