ISO/TS16949：2009
标准
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ISO/TS16949：2009
技术规范
TECHNICAL SPECIFICATION
质量管理体系—
汽车生产件及相关服务件组织应用 ISO9001:2008的特殊要求
Quality management systems —
Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations
目录Contents
前言Foreword………………………………………………………………………………7
有关认证的说明Remarks for certification…………………………………………………9
引言Introduction……………………………………………………………………………10
0.1总则General……………………………………………………………………………10
0.2过程方法Process approach………………………………………………………………11
0.3与ISO 9004的关系Relationship with ISO 9004………………………………………13
0.4与其他管理体系的相容性Compatibility with other management systems……………14
0.5本技术规范的目的Goal of this Technical Specification………………………………15
1范围Scope…………………………………………………………………………………16
1.1总则General……………………………………………………………………………16
1.2应用Application…………………………………………………………………………17
2引用标准Normative reference……………………………………………………………17
3术语和定义Terms and definitions…………………………………………………………18
3.1汽车行业术语和定义Terms and definitions for the automotive industry………………18
4质量管理体系Quality management system………………………………………………20
4.1总要求General requirements …………………………………………………………20
4.1.1总要求—补充General requirements—Supplemental…………………………………21
4.2文件要求Documentation requirements…………………………………………………21
4.2.1 总则General…………………………………………………………………………21
4.2.2 质量手册Quality manual……………………………………………………………22
4.2.3文件控制Control of documents………………………………………………………22
4.2.3.1工程规范Engineering specifications………………………………………………23
4.2.4
记录
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控制Control of records…………………………………………………………23
4.2.4.1记录保存Records retention……………………………………………………… 24
5管理职责Management responsibility……………………………………………………24
5.1管理承诺Management commitment……………………………………………………24
5.1.1过程效率Process efficiency…………………………………………………………24
5.2以顾客为关注焦点Customer focus……………………………………………………24
5.3质量方针Quality policy ………………………………………………………………25
5.4策划Planning……………………………………………………………………………25
5.4.1质量目标Quality objectives…………………………………………………………25
5.4.1.1质量目标—补充Quality objectives—Supplemental………………………………25
5.4.2质量管理体系的策划Quality management system planning…………………………26
5.5职责、权限与沟通Responsibility, authority and communication………………………26
5.5.1职责和权限Responsibility and authority……………………………………………26
5.5.1.1质量职责Responsibility for quality…………………………………………………26
5.5.2管理者代表Management representative………………………………………………27
5.5.2.1顾客代表Customer representative…………………………………………………27
5.5.3内部沟通Internal communication……………………………………………………27
5.6管理评审Management review…………………………………………………………27
5.6.1总则General……………………………………………………………………………27
5.6.1.1质量管理体系绩效Quality management system performance……………………28
5.6.2评审输入Review input………………………………………………………………28
5.6.2.1评审输入—补充Review input—Supplemental……………………………………28
5.6.3评审输出Review output………………………………………………………………29
6资源管理Resource management…………………………………………………………29
6.1资源提供Provision of resources…………………………………………………………29
6.2人力资源Human resources………………………………………………………………29
6.2.1总则General……………………………………………………………………………30
6.2.2能力、培训和意识Competence, training and awareness……………………………30
6.2.2.1产品设计技能Product design skills…………………………………………………30
6.2.2.2培训Training…………………………………………………………………………31
6.2.2.3岗位培训……………………………………………………………………………31
6.2.2.4员工的激励Employee motivation and empowerment………………………………31
6.3基础设施Infrastructure…………………………………………………………………31
6.3.1工厂、设施和设备策划Plant, facility and equipment planning………………………32
6.3.2应急
计划
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Contingency plans…………………………………………………………32
6.4工作环境Work environment……………………………………………………………32
6.4.1为达成产品要求符合性的人员安全Personnel safety to achieve conformity product requirements…………………………………………………………………………………32
6.4.2生产现场的清洁Cleanliness of premises……………………………………………32
7产品实现Product realization………………………………………………………………33
7.1产品实现的策划Planning of product realization………………………………………33
7.1.1产品实现的策划—补充Planning of product realization—Supplemental……………34
7.1.2接收准则Acceptance criteria…………………………………………………………34
7.1.3保密性Confidentiality…………………………………………………………………34
7.1.4更改控制Change control………………………………………………………………34
7.2与顾客有关的过程Customer-related processes…………………………………………34
7.2.1与产品有关的要求的确Determination of requirements related to the product………35
7.2.1.1顾客指定的特殊特性Customer-designated special characteristics…………………35
7.2.2与产品有关的要求的评审Review of requirements related to the product…………35
7.2.2.1与产品有关的要求的评审—补充Review of requirements related to the produc— Supplemental…………………………………………………………………………………36
7.2.2.2组织制造可行性Organization manufacturing feasibility…………………………36
7.2.3顾客沟通Customer communication…………………………………………………36
7.2.3.1顾客沟通—补充Customer communication—Supplemental………………………37
7.3设计和开发Design and development……………………………………………………37
7.3.1设计和开发策划Design and development planning…………………………………37
7.3.1.1多方论证方法Multidisciplinary approach…………………………………………37
7.3.2设计和开发输入Design and development inputs……………………………………38
7.3.2.1产品设计输入Product design input…………………………………………………38
7.3.2.2制造过程设计输入Manufacturing process design input……………………………39
7.3.2.3特殊特性Special characteristics……………………………………………………39
7.3.3设计和开发输出Design and development outputs……………………………………39
7.3.3.1产品设计输出—补充Product design outputs—Supplemental……………………40
7.3.3.2制造过程设计输出Manufacturing process design output…………………………40
7.3.4设计和开发评审Design and development review……………………………………41
7.3.4.1监视Monitoring……………………………………………………………………41
7.3.5设计和开发验证Design and development verification………………………………42
7.3.6设计和开发确认Design and development validation………………………………42
7.3.6.1设计和开发确认—补充Design and development validation—Supplemental……42
7.3.6.2样件计划Prototype programme……………………………………………………42
7.3.6.3产品批准过程Product approval process…………………………………………43
7.3.7 设计和开发更改的控制Control of design and development changes………………43
7.4 采购Purchasing………………………………………………………………………43
7.4.1采购过程Purchasing process…………………………………………………………44
7.4.1.1法规符合性Regulatory conformity…………………………………………………44
7.4.1.2供方质量管理体系开发Supplier quality management system development………44
7.4.1.3顾客批准的供方Customer-approved sources………………………………………44
7.4.2采购信息Purchasing information……………………………………………………45
7.4.3采购产品的验证Verification of purchased product…………………………………45
7.4.3.1进货产品对要求的符合性Incoming product conformity to requirements…………45
7.4.3.2对供方监视Supplier monitoring……………………………………………………46
7.5 生产和服务提供Production and service provision……………………………………46
7.5.1生产和服务提供的控制Control of production and service provision………………46
7.5.1.1控制计划Control plan………………………………………………………………47
7.5.1.2作业指导书Work instructions………………………………………………………47
7.5.1.3作业准备验证Verification of job setups……………………………………………47
7.5.1.4预防性和预见性维护Preventive and predictive maintenance……………………48
7.5.1.5生产工装的管理Management of production tooling………………………………48
7.5.1.6生产计划Production scheduling……………………………………………………49
7.5.1.7服务信息反馈Feedback of information from service………………………………49
7.5.1.8与顾客的服务
协议
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Service agreement with customer………………………………49
7.5.2生产和服务提供过程的确认Validation of processes for production and service provision……………………………………………………………………………………49
7.5.2.1生产和服务提供过程的确认—补充Validation of processes for production and service provision—Supplemental……………………………………………………………50
7.5.3标识和可追溯性Identification and traceability………………………………………50
7.5.3.1标识和可追溯性—补充Identification and traceability–Supplemental……………50
7.5.4顾客财产Customer property…………………………………………………………51
7.5.4.1顾客所有的工装Customer-owned production tooling……………………………51
7.5.5.产品防护Preservation of product……………………………………………………51
7.5.5.1贮存和库存Storage and inventory…………………………………………………51
7.6监视和测量设备的控制Control of monitoring and measuring equipment……………52
7.6.1测量系统分析Measurement system analysis…………………………………………53
7.6.2校准/验证记录Calibration/verification records………………………………………53
7.6.3实验室要求Laboratory requirements…………………………………………………53
7.6.3.1内部实验室Internal laboratory………………………………………………………53
7.6.3.2外部实验室External laboratory……………………………………………………54
8测量、分析和改进Measurement, analysis and improvement……………………………54
8.1总则General……………………………………………………………………………55
8.1.1统计工具的确定Identification of statistical tools……………………………………55
8.1.2基础统计概念知识 Knowledge of basic statistical concepts………………………55
8.2 监视和测量Monitoring and measurement……………………………………………55
8.2.1顾客满意Customer satisfaction………………………………………………………55
8.2.1.1顾客满意—补充Customer satisfaction—Supplemental……………………………56
8.2.2内部审核Internal audit………………………………………………………………56
8.2.2.1质量管理体系审核Quality management system audit……………………………57
8.2.2.2制造过程审核Manufacturing process audit…………………………………………57
8.2.2.3产品审核Product audit………………………………………………………………57
8.2.2.4内部审核计划Internal audit plans…………………………………………………57
8.2.2.5内审员资格Internal auditor qualification……………………………………………57
8.2.3过程的监视和测量Monitoring and measurement of processes………………………58
8.2.3.1制造过程的监视和测量Monitoring and measurement of manufacturing processes 58
8.2.4产品的监视和测量Monitoring and measurement of product…………………………59
8.2.4.1全尺寸检验和功能试验Layout inspection and functional testing…………………59
8.2.4.2外观项目Appearance items…………………………………………………………60
8.3不合格品控制Control of nonconforming product………………………………………60
8.3.1不合格品控制—补充Control of nonconforming product—Supplemental…………61
8.3.2返工产品的控制Control of reworked product………………………………………61
8.3.3顾客通知Customer information………………………………………………………61
8.3.4顾客特许Customer waiver……………………………………………………………61
8.4数据分析Analysis of data………………………………………………………………61
8.4.1数据分析和使用Analysis and use of data……………………………………………62
8.5改进Improvement………………………………………………………………………62
8.5.1持续改进Continual improvement……………………………………………………62
8.5.1.1组织的持续改进Continual improvement of the organization………………………62
8.5.1.2制造过程的改进Manufacturing process improvement……………………………62
8.5.2纠正措施Corrective action……………………………………………………………63
8.5.2.1解决问
题
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的方法Problem solving…………………………………………………63
8.5.2.2防错Error-proofing…………………………………………………………………63
8.5.2.3纠正措施影响Corrective action impact……………………………………………63
8.5.2.4拒收产品的试验/分析Rejected product test/analysis………………………………63
8.5.3预防措施Preventive action……………………………………………………………64
附录A控制计划Annex A (normative) Control plan………………………………………65
参考文献Bibliography………………………………………………………………………67
前言 Foreword
国际标准化组织(ISO)是由各国标准化机构（ISO成员机构）组成的世界性联合会。国际标准的拟定由ISO技术委员会负责。各成员机构若对某技术委员会所选定的主题感兴趣，均有权参加该委员会的工作。与ISO保持联系的各国组织(官方的或非官方的)也可参加该项工作。ISO与国际电器委员会（IEC）在电工技术标准化方面保持密切合作的关系。
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.
本国际标准是依照ISO/IEC导则第2部分中的规则制定的。
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
技术委员会的主要任务是制定国际标准。本国际技术标准草案已由技术委员会通过，并传阅各成员机构一共投票表决。国际标准的公布需要至少75%的参加投票的成员团体批准。
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.
在其它情况下，特别是在市场急需某个文件时，技术委员会可以决定出版其他形式的规范文件：
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:
—ISO公布的可获得规范（ISO/PAS）代表一项在一个ISO工作小组内的技术专家达成的协议，在相应委员会的成员的投票中有50%投票赞成后就可以出版发行；
—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;
—ISO技术规范（ISO/TS），是技术委员会成员之间达成的协议，在委员会成员所投票中有2/3投票赞成后就可以出版发行。
—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.
ISO/TS 16949是由国际汽车工业特别行动小组（IATF），在ISO/TC176 质量管理和质量保证技术委员会支持下制定的。
ISO/TS 16949 was prepared by the International Automotive Task Force (IATF) with support from ISO/TC 176, Quality management and quality assurance.
通过根据ISO9001 :2008所作的技术修订，第三版的ISO/TS16949取消并替代了第二版(ISO/TS 16949:2002)
This third edition of ISO/TS 16949 cancels and replaces the second edition (ISO/TS 16949:2002), which has been technically amended according to ISO 9001:2008.
方框内的文本是ISO 9001：2008的原文内容，方框外是行业特殊补充的要求。
Boxed text is original ISO 9001:2008 text. The sector-specific supplemental requirements are outside the boxes.
在本技术规范中，“应”（shall）表示要求，“应当”（should）表示建议。标示有“注”（NOTE）的段落是对理解或澄清相关要求的指南。
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.
所有用“例如”引出的建议都只具有指导性作用.
Where the term “such as” is used, any suggestions given are for guidance only.
附录A是本技术规范的引用文件，构成技术规范的一部分。
Annex A forms a normative part of this Technical Specification.
有关认证的说明Remarks for certification
按照IATF的认证方案（见《IATF认可规则》）所获取的本技术规范的认证，包括任何的顾客特殊要求（如果有），将获得IATF的顾客成员的认可。
详细情况可以从以下的国际汽车推动小组的当地监督办公室处获得：
意大利汽车工业协会 (ANFIA) www.anfia.it
美国国际汽车监督署(IAOB) www.iaob.org
IATF-France www.iatf-france.com
英国汽车制造与贸易商谢(SMMT) www.smmt.co.uk
德国汽车工业协会-质量管理中心 (VDA-QMC) www.vda-qmc.de
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”).
Details can be obtained at the addresses of the local oversight offices of IATF cited below:
Associazione Nazionale Fra Industrie Automobilistiche (ANFIA)
Web site: www.anfia.it
International Automotive Oversight Bureau (IAOB)
Web site: www.iaob.org
IATF-France
Web site: www.iatf-france.com
Society of Motor Manufacturers and Traders Ltd. (SMMT Ltd.)
Web site: www.smmt.co.uk
Verband der Automobilindustrie Qualit?tsmanagement Center (VDA-QMC)
Web site: www.vda-qmc.de
引言 Introduction
0.1 总则 General
ISO9001:2008 质量管理体系要求
ISO 9001:2008 Quality management systems — Requirements
引言 Introduction
0.1 总则 General
采纳质量管理体系是组织的一项战略性决策。一个组织的质量管理体系的设计和实施受下列因素的影响：
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:
a) 组织的环境、该环境的变化或与该环境有关的风险；
b) 组织不断变化的需求；
c) 组织的具体目标；
d) 组织所提供的产品；
e) 组织所采用的过程；
f) 组织的规模和组织结构。
a) Its organizational environment, changes in that environment, and the risks associated with that environment;
b) Its varying needs;
c) Its particular objectives;
d) The products it provides;
e) The processes it employs;
f) Its size and organizational structure.
统一质量管理体系的结构或文件不是本标准的目的。
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
本标准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。
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.
本标准能用于内部和外部（包括认证机构）评价组织满足顾客、适用于产品的法律法规要求和组织自身要求的能力。
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。
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
0.2 过程方法 Process approach
ISO9001:2008 质量管理体制体系—要求
ISO 9001:2008 Quality management systems — Requirements
本标准鼓励在建立、实施质量管理体系以及在改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意度。
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.
为了使组织有效运行，应确定和管理许多相互联系的活动。通过使用资源和管理，将输入转换为输出的一项或一组活动，可视为一个过程，通常，一个过程的输出直接形成下一个过程的输入。
For an organization to function effectively, it has to determine 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.
为了产生期望的结果，由过程组成的系统在组织内的应用，连同这些过程的识别和相互作用，以及对这些过程的管理，可称之为“过程方法”。
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.
过程方法的一个优点是对过程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。
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.
在质量管理体系应用过程方法时，强调以下方面的重要性：
a) 理解和满足要求；
b) 需要从增值的角度考虑过程；
c) 获得过程绩效和有效性的结果；
d) 在客观测量的基础上，持续改进过程。
When used within a quality management system, such an approach emphasizes the importance of:
a) Understanding and fulfilling requirements;
b) The need to consider processes in terms of added value;
c) Obtaining results of process performance and effectiveness; and
d) Continual improvement of processes based on objective measurement.
图1所反映的以过程为基础的质量管理体系模式展示了第4章至第8章中所提出的过程联系。该图反映了在规定输入要求时，顾客起着重要的作用。对顾客满意的监视，要求组织对顾客关于组织是否已满足其要求的感受信息进行评价。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。
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.
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：
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；
D－实施：实施过程；
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；
A－处置：采取措施，以持续改进过程业绩。
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:
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies;
Do: implement the processes;
Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results;
Act: take actions to continually improve process performance.
0.3 与ISO9004的关系 Relationship with ISO 9004
ISO9001:2008 质量管理体制体系—要求
ISO 9001:2008 Quality management systems — Requirements
0.3 与ISO9004的关系 Relationship with ISO 9004
ISO9001和ISO9004都是质量管理体系标准，这两项标准相互补充，但也可单独使用。
ISO9001 and ISO9004 are quality management system standards which have been designed to complement each other, but can also be used independently.
ISO9001规定了质量管理体系要求，可供组织内部使用，也可用于认证或合同目的。ISO9001所关注的是质量管理体系在满足顾客要求方面的有效性。
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting cu
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