Quality management systems ‑ Automotive suppliers ‑ Particular requirements for the application of ISO 9001:2000
质量管理体系－汽车产品供应商－ISO9001:2000对汽车行业的特殊要求
1 Scope
1 范围
1.1 General
1.1 总则
ISO 9001:2000, Quality management systems ‑ Requirements
ISO 9001:2000质量管理体系-要求
1 Scope
1 范围
1.1 总则
This International Standard specifies requirements for a quality management system where an organization
本标准为有下列需求的组织规定了质量管理体系的要求：
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
a)证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品；
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
b)通过体系的有效应用，包括持续改进和预防不合格的过程而达到顾客满意。
NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.
注：在本标准中，术语 产品 仅适用于预期提供给顾客或顾客所要求的产品。
This Technical Specification, in conjunction with ISO 9001:2000, defines the quality management system requirements for the design/development, production and, when relevant, installation and servicing of automotive‑related products.
本技术规范与ISO9001：2000相结合，规定了用于汽车相关产品的设计与开发、生产，安装和服务（若有关时）的质量管理体系要求。
This Technical Specification is applicable to production and service part organization sites where customer specified products are manufactured.
本技术规范适用于组织的顾客指定生产件或服务件的制造现场。
Remote locations such as design centres, corporate headquarters and distribution centres as they support the site form part of the site audit, but cannot obtain stand‑alone certification to this Technical Specification.
现场或外部的支持功能，（例如设计中心、公司总部和配送中心），构成现场审核的一部分，但不能独立获得关于本技术规范的认证。
This Technical Specification can also be applied throughout the automotive supply chain.
本技术规范也适用于整个汽车供应链。
1.2 Application
1.2 应用
ISO 9001:2000, Quality management systems ‑ Requirements
ISO 9001:2000质量管理体系-要求
1.2 Application
1.2 应用
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本标准所有规定的要求是通用的，旨在适用于不同其类型、规模和提供的产品所有组织。
Where any requirements) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
当本标准中任何的要求因组织和其产品的特点而不适用时，可以考虑对其进行删减。
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
除非删减仅限第7章中那些不会影响组织提供符合顾客和适用的法规要求产品的能力或职责任的要求，否则不能声称符合本标准
The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.
本技术规范中，当组织没有产品设计和开发职责，只有7.3中有关的部分是允许的删减。
Permitted exclusions do not include manufacturing process design. For vehicles assembly plants, the authorized exclusions will be prescribed by IATF.
允许的删减不包括制造过程的设计。
2 Normative reference
2 引用标准
The following normative document contains provisions, which, through reference in this text, constitute provisions of this Technical Specification. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Technical Specification are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
通过在本标准中的引用，下列标准包含了构成本标准规定的内容。对标时间版本明确的引用标准，该标准的增补或修订不适用。但是，鼓励使用本标准的各方探讨适用下列标准最新版本的可能性。对于未标时间的引用标准，有关最新版是适用的。ISO及IEC 成员保持现有有效的国际标准的注册地位。
ISO 9000 :2000, Quality management systems ‑ Fundamentals and vocabulary.
ISO 9000：2000质量管理体系—基本原理和术语
3 Terms and definitions
3 术语和定义
ISO 9001:2000, Quality management systems ‑ Requirements
ISO 9001：2000 ，质量管理体系-要求
3 术语和定义
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
为了本国际标准的目的，ISO9000中给出的术语和定义适用。
The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:
本版ISO 9001标准描述供应链使用的术语，已经被更改以反映当前的使用的术语：
Supplier organization customer
供方 组织 顾客
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”
本国际标准所使用的术语 组织 取代ISO 9001 1994中使用的术语 供方，现在使用的供方取代以前适用的术语 “分承包方”。
Throughout the text of this International Standard, wherever the term «product» occurs, it can also mean “service”.
在本国际标准中，当出现术语“产品”时，也能表示“服务”。
3.1 Terms and definitions for the automotive industry
3.1 汽车行业的术语和定义
For the purposes of this Technical Specification, the terms and definitions given in ISO 9000 : 2000 and the following apply.
针对本技术规范的目的，适用ISO9000：2000和以下给出的术语和定义。
However where there are terms for which the wording of the definition differs in ISO 9000: 2000, the definitions given in this Technical Specification apply.
但当某些定义与ISO9000 2000 不同时采用本标准给出的定义。
3.1.1 continual improvement
3.1.1 持续改进
optimization of characteristics and parameters of a product or process at a target value
达到某一目标值,使产品或过程的特性和参数最优。蔡学刚
NOTE Continual improvement is only applicable where conformance has been established.
注：持续改进只有在符合规定的要求之后才适用。
3.1.2 control plan
3.1.2 控制计划
documented descriptions of the systems for controlling parts and processes to provide control of all characteristics important for quality and engineering requirements
对控制产品所要求的系统和过程的文件化的描述。
3.1.3 design responsible organization
3.1.3 具有设计职责的组织
organization with authority to establish a new, or change an existing product specification for product delivered to a customer
组织有权限建立新的、或更改现有的产品规范。
NOTE This responsibility includes testing and verification of design performance within the customer's specified application.
注：本职责包括按顾客制定方法进行设计性能的试验和验证。
3.1.4 error proofing
3.1.4 防错
use of product and manufacturing process design and development features to prevent manufacture of non‑conforming products
产品和制造过程设计和开发以防止制造不合格产品。
3.1.5 laboratory
3.1.5 实验室
test facility that may include chemical, metallurgical, dimensional, physical, electrical, reliability testing or test validation
进行包括但不限于化学、冶金、尺寸、物理、电性能或可靠性试验或试验在内的检验、试验和校准的设施。
3.1.6 laboratory scope
3.1.6 实验室范围
quality record containing the following:
受控文件包括(包括如下内容的质量记录):
· specific tests, evaluations and calibrations that a laboratory is qualified to perform,
-实验室有资格进行的规定试验、评价和校准，
· list of the equipment which it uses to perform the above,
-用以进行上述活动的设备清单，
· list of methods and standards to which it performs the above
-进行上述活动的方法和标准清单；
3.1.7 manufacturing
3.1.7 制造
refers to the processes making or fabricating production materials, or production or service parts, or assemblies, or heat treating, painting, plating or other finishing services.
进行如后生产或装配的过程：生产原材料、生产件或服务件、装配、热处理、焊接、喷漆、电镀或其它最终服务。
3.1.8 outsourcing
3.1.8 外部资源
process of acquiring product from outside the organization
从组织外部获得产品的过程。
3.1.9 predictive maintenance
3.1.9 预测性维护
activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes to prevent disruption of production
基于过程数据通过预测可能的失效模式达到避免维护性问题目的的活动。
3.1.10 premium freight
3.1.10 外部资源
charges incurred additional to contracted delivery
从组织外部获得产品的过程。
3.1.11 remote location
3.1.11 外部场所
location that supports sites and at which non‑production processes occur
支持现场且没有生产过程发生的场所。
3.1.12 site
3.1.12 现场
location at which value‑added production processes occur
增值制造过程发生场所。
NOTE 1 Includes distributors of parts manufactured by other companies.
注1 包括其它公司制造的零件分销商。
NOTE 2 Does not include suppliers of indirect materials, products.
注2 不包括间接材料,产品的供方。
3.1.13 special characteristics
3.1.13 特殊特性
product characteristics or manufacturing process parameters subject to variation which may affect safety or compliance with regulations, fit, function, performance or subsequent processing of product
可能影响安全性或法规的符合性、配合、功能、性能或后续生产过程的产品特性或制造过程参数。
4 Quality management system
4 质量管理体系
4.1 General requirements
4.1 总要求
ISO 9001:2000, Quality management systems ‑‑ Requirements
ISO 9001:2000质量管理体系-要求
4 Quality management system
4 质量管理体系
4.1 General requirements
4.1 总要求
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
组织必须按本标准的要求建立质量管理体系，形成文件，加以实施和保持，并持续改进其有效性。
The organization shall
组织必须：
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
a）识别质量管理体系所需的过程，及其在组织中的应用（见1.2）
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
c）确定为确保这些过程有效运作和控制所需的准则和方法；
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
d）确保可获得必要的资源和信息，以支持这些过程的运作和监视；
e) monitor, measure and analyse these processes, and
e）监视、测量和分析这些过程；
f) implement actions necessary to achieve planned results and continual improvement of these processes.
f) 实施必要的措施，以实现对这些过程策划的结果和对这些过程的持续改进。
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
组织必须按本标准的要求管理这些过程。
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
针对组织所选择的任何影响产品符合要求的外包过程，组织必须确保对其实施控制。对此类外包过程的控制必须在质量管理体系中加以识别。
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
上述质量管理体系所需的过程应当包括与管理活动、资源提供、产品实现和测量有关的过程。
NOTE When the organization outsources, it is not permitted to delegate the technical responsibility.
注：组织从外部获得产品时不允许对技术责任授权
4.2 Documentation requirements
4.2 文件要求
4.2.1 General
4.2.1 总则
ISO 9001:2000, Quality management systems ‑‑ Requirements
ISO 9001:2000, 质量管理体系-要求
4.2 Documentation requirements
4.2 文件要求
4.2.1 General
4.2.1 总则
The quality management system documentation shall include
质量管理体系文件必须包括：
a) documented statements of a quality policy and quality objectives,
a） 形成文件的质量方针和质量目标；
b) a quality manual,
b） 质量手册；
c) c) documented procedures required by this International Standard,
c） 标准所要求的形成文件的程序；
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and
d） 组织为确保其过程有效策划、运作和控制所需的组文件；
e) records required by this International Standard (see 4.2.4).
e) 本标准所要求的记录（见4.2.4）
NOTE 1 Where the term "documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.
注1:本标准出现 “形成文件的程序”之处，即要求建立该程序，形成文件，并加以实施和保持。
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
注2 :不同组织质量管理体系文件的多少与详略程度取决于：
a) the size of organization and type of activities,
a） 组织的规模和活动的类型；
b) the complexity of processes and their interactions, and
b） 过程及其相互作用的复杂程度；
c) the competence of personnel.
c） 人员的能力。
NOTE 3 The documentation can be in any form or type of medium.
注3: 文件可采用任何形式或类型的媒体。
4.2.2 Quality manual
4.2.2 质量手册
ISO 9001:2000, Quality management system ‑‑ Requirements
ISO 9001:2000质量管理体系-要求
4.2.2 Quality manual
4.2.2 质量手册
The organization shall establish and maintain a quality manual that includes
组织应编制和保持质量手册，质量手册包括：
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
a）质量管理体系的范围，包括任何删减的细节与合理性（见1.2）
b) the documented procedures established for the quality management system, or reference to them, and
b）为质量管理体系编制的形成文件的程序或对其引用；
c) a description of the interaction between the processes of the quality management system.
c） 对质量管理体系过程之间的相互作用的表述。
NOTE The above applies to all the requirements of this Technical Specification.
注：以上适用于本标准的所有要求。
4.2.3 Control of documents
4.2.3 文件控制
ISO 9001:2000, Quality management system ‑‑ Requirements
ISO 9001:2000质量管理体系-要求
4.2.3 Control of documents
4.2.3 文件控制
Documents required by the quality management system shall be controlled. Quality records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
质量管理体系所要求的文件必须予以控制。记录是一种特殊类型的文件，必须依据4.2.4 要求进行控制。
A documented procedure shall be established to define the controls needed
必须编制形成文件的程序，以规定以下方面所需的控制:
a) to approve documents for adequacy prior to issue,
a)文件发布前得到批准,,以确保文件是充分与适宜的
b) to review and update as necessary and re‑approve documents,
b )必要时对文件进行评审与更新,,并再次批准
c) to ensure that changes and the current revision status of documents are identified,
c )确保文件的更改和现行修订状态得到识别
d) to ensure that relevant versions of applicable documents are available at points of use,
d )确保在使用处可获得的适用文件的有关版本
e) to ensure that documents remain legible and readily identifiable,
e )确保文件保持清晰、易于识别
f) to ensure that documents of external origin are identified and their distribution controlled, and]
f )确保外来文件得到识别，并控制其分发
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
g )防止作废文件的非预期使用，若因任何原因而保留作废文件时，对这些文件进行适当的标识。
f
4.2.3.1 Engineering specifications
4.2.3.1工程规范
The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer required schedule.
组织必须建立过程文件以保证及时评审、发放和实施所有顾客工程标准规范以及按顾客要求进度的更改。
The organization shall maintain a record of the date on which each change is implemented in production.
组织必须保存每项更改在生产中实施日期的记录。
Implementation shall include updates documents.
实施必须包括对所有适当文件的更新。
NOTE 1 Timely review should be as soon as possible, and not exceed two working weeks.
评审应尽快进行，时间必须不能超过两个工作周。
NOTE 2 A change in these standards/specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc.
注：当这些规范在设计记录中引用或如果影响到生产件批准程序文件时，如控制计划、失效模式及后果分析FMEAs 等等，对这些标准/规范的更改，要求更新顾客生产件批准的记录。
4.2.4 Control of records
4.2.4 记录的控制
IS0 9001:2000, Quality management system ‑‑ Requirements
ISO 9001:2000质量管理体系-要求
4.2.4 Control of records
4.2.4 记录控制
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
必须建立并保持记录，以提供符合要求和质量管理体系有效运行的证据。记录必须保持清晰、易于识别和检索。必须编制形成文件的程序，以规定质量记录的标识、贮存、保护、检索、保存期限和处置所需的控制。
NOTE 1 "Disposition" above includes disposal.
注1 上面“处置”包括废弃；
NOTE 2 "Quality records" also include customer‑specified records.
注2 “质量记录”也包括顾客指定的记录
4.2.4.1 Records retention
4.2.4.1记录保存
The organization shall define retention periods for quality management system related documents and records to satisfy regulatory and customer requirements as a minimum.
记录控制必须满足法规和顾客的要求。
5 Management responsibility
5 管理职责
5.1 Management commitment
5.1 管理承诺
ISO 9001:2000, Quality management systems ‑ Requirements
ISO 9001:2000质量管理体系-要求
5 Management responsibility
5 管理职责
5.1 Management commitment
5.1 管理承诺
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
最高管理者必须通过以下活动，对其建立、实施质量管理体系并持续改进其有效性的承诺提供证据：
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
a)向组织传达满足顾客和法律法规要求的重要性；
b) establishing the quality policy,
b)制定质量方针；
c) ensuring that quality objectives are established,
c)确保质量目标的制定；
d) conducting management reviews, and
d)进行管理评审；
e) ensuring the availability of resources.
e)确保资源的获得。
5.1.1 Process efficiency
5.1.1 过程效率
Top management shall monitor the product realization processes and the support processes to assure their effectiveness and efficiency.
最高管理者必须评审产品实现过程和支持过程以确保它们有效性和效率
5.2 Customer focus
5.2 以顾客为关注焦点
ISO 9001:2000, Quality management systems – Requirements
ISO 9001:2000质量管理体系-要求
5.2 Customer focus
5.2 以顾客为关注焦点
Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
最高管理者必须以增进顾客满意为目的，确保顾客的要求得到确定并予以满足（见7.2.1和8.2.1）。
5.3 Quality policy
5.3 质量方针
ISO 9001:2000, Quality management systems – Requirements
ISO 9001:2000质量管理体系-要求
5.3 Quality policy
5.3 质量方针
Top management shall ensure that the quality policy
最高管理者必须确保质量方针：
a) is appropriate to the purpose of the organization,
a)与组织的宗旨相适应；
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
b)包括对满足要求和持续改进质量管理体系有效性的承诺；
c) provides a framework for establishing and reviewing quality objectives,
c)提供制定和评审质量目标的框架；
d) is communicated and understood within the organization, and
d)在组织内得到沟通和理解；
e) is reviewed for continuing suitability.
e)在持续适宜性方面得到评审
5.4 Planning
5.4 策划
5.4.1 Quality objectives
5.4.1 质量目标
ISO 9001:2000, Quality management systems ‑‑ Requirements
ISO 9001:2000，质量管理体系-要求
5.4 Planning
5.4 策划
5.4.1 Quality objectives
5.4.1 质量目标
Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1) are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
最高管理者必须确保在组织的相应职能和层次上建立质量目标，质量目标包括满足产品要求所需的内容（见7.1）。质量目标必须是可测量的，并与质量方针保持一致。
5.4.1.1 Quality objectives – Supplemental
5.4.1.1质量目标-补充
Top management shall define quality objectives and measurements that shall be included in the business
plan and used to deploy the quality policy.
最高管理者必须确定质量目标和测量方法，并将它们必须包括在业务计划中，以展开质量方针。
NOTE Quality objectives should address customer expectations and be achievable within a defined time period.
质量目标应该考虑顾客期望并在规定的时间内实现。
5.4.2 Quality management system planning
5.4.2 质量管理体系策划
ISO 9001:2000, Quality management systems ‑‑ Requirements
ISO 9001:2000质量管理体系-要求