TS16949中英文对照 2

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0.3 Relationship with ISO 9004
与GB/T 19004的关系
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。
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 customer requirements.
GB/T 19001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。在满足顾客要求方面，GB/T 19001所关注的是质量管理体系的有效性。
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization's overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
与GB/T 19001相比，GB/T 19004为质量管理体系更宽范围的目标提供了指南。除了有效性，该标准还特别关注持续改进组织的总体业绩与效率。对于最高管理者希望通过追求业绩持续改进而超越GB/T 19001要求的那些组织，GB/T 19004推荐了指南。然而，用于认证或合同不是GB/T 19004的目的。


NOTE
The knowledge and use of the eight quality management principles referred to in the ISO 9000:2000 and ISO 9004:2000 can be demonstrated and cascaded through the organization by top management.
注：应当由最高管理者在组织内宣传和贯彻ISO 9000:2000和ISO 9004:2000中提及的八项质量管理原则的知识及其应用。

0.3.1 IATF Guidance to ISO/TS 16949:2002
"IATF Guidance to ISO/TS 16949:2002" is a document containing recommended automotive industry practices, examples, illustrations and explanations, and provides assistance in the application to conform to the requirements of this Technical Specification.
《IATF关于ISO/TS 16949:2002的指南》是一份包含了推荐性的汽车行业实践、范例、图解和解释的文件，并对符合本标准要求的应用提供帮助。

This IATF Guidance document is not intended for certification or for contractual purposes
此IATF指南文件不拟用于认证或合同的目的。

0.4 Compatibility with other management systems与其他管理体系的相容性

ISO 9001:2000, Quality management systems － Requirements

0.4 Compatibility with other management systems与其他管理体系的相容性
This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community.
为了使用者的利益，本标准与GB/T 24001—1996相互趋近，以增强两类标准的相容性。
This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management systems) in order to establish a quality management system that complies with the requirements of this International Standard.
本标准不包括针对其他管理体系的要求，如环境管理、职业卫生与安全管理、财务管理或风险管理的特定要求。然而本标准使组织能够将自身的质量管理体系与相关的管理体系要求结合或整合。组织为了建立符合本标准要求的质量管理体系，可能会改变现行的管理体系。

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7.2 Customer related processes与顾客有关的过程

7.2.1 Determination of requirements related to the product与产品有关的要求的确定

ISO 9001:2000, Quality management systems － Requirements

7.2 Customer related processes与顾客有关的过程

7.2.1 Determination of requirements related to the product与产品有关的要求的确定
The organization shall determine
组织应确定：
a)        requirements specified by the customer, including the requirements for delivery and post delivery activities,
a）顾客规定的要求，包括对交付及交付后活动的要求；
b)        requirements not stated by the customer but necessary for specified or intended use, where known,
b）顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求；
c)        statutory and regulatory requirements related to the product, and
c）与产品有关的法律法规要求；
d)        any additional requirements determined by the organization.
d）组织确定的任何附加要求。

NOTE 1    Post delivery activities include any after sales product servicing provided as part of the customer contract or purchase order.
注1：交付后活动包括作为顾客合同或采购订单一部分所提供的任何售后产品服务。

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7 Product realization产品实现

7.1 Planning of product realization产品实现的策划
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
组织应策划和开发产品实现所需的过程。产品实现的策划应与质量管理体系其他过程的要求相一致（见4．1）。
In planning product realization, the organization shall determine the following, as appropriate:
在对产品实现进行策划时，组织应确定以下方面的适当内容：
a)
quality objectives and requirements for the product;
a）产品的质量目标和要求；
b)
the need to establish processes, documents, and provide resources specific to the product;
b）针对产品确定过程、文件和资源的需求；
c)
required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
c）产品所要求的验证、确认、监视、检验和试验活动，以及产品接收准则；
d)
records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
d）为实现过程及其产品满足要求提供证据所需的记录（见4．2．4）。
The output of this planning shall be in a form suitable for the organization's method of operations.
策划的输出形式应适合于组织的运作方式。
NOTE 1
A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.
注1：对应用于特定产品、项目或合同的质量管理体系的过程（包括产品实现过程）和资源作出规定的文件可称之为质量计划。
NOTE 2
The organization may also apply the requirements given in 7.3 to the development of product realization processes.
注2：组织也可将7．3的要求应用于产品实现过程的开发。


NOTE
Some customers refer to project management or advanced product quality planning as a means to achieve product realization. Advanced product quality planning embodies the concepts of error prevention and continual improvement as contrasted with error detection and is based on a multidisciplinary approach.
注：有些顾客将项目管理或产品质量先期策划作为一种产品实现的方法。产品质量先明策划包含着防错和持续改进的概念，与找出错误不同，而且是基于多方论证的方法。

7.1.1 Planning of product realization － Supplemental产品实现的策划－补充
Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan.
作为质量计划的一部分，产品实现的策划应包括顾客要求和对其技术规范引用。

7.1.2 Acceptance criteria接收准则
Acceptance criteria shall be defined by the organization and, where required, approved by the customer.
组织应规定接收准则，要求时，由顾客批准。
For attribute data sampling, acceptance criteria shall be zero defects (see 8.2.3.1).
对于计数型数据抽样，接收水平应是零缺陷（见8.2.3.1）。

7.1.3 Confidentiality保密
The organization shall ensure the confidentiality of customer‑contracted products and projects under development, and related product information.
组织应确保顾客委托的正在开发的产品、项目和有关产品信息的保密。

7.1.4 Change control更改控制
The organization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation.
组织应有一个对影响产品实现的更改进行控制并作出反应的过程。任何更改的影响，包括由任何供方引起的更改，都应进行评估，且应规定验证和确认的活动，以确保与顾客要求相一致。更改在实施前应予以确认。
For proprietary designs, impact on form, fit and function (including performance, and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated.
对有专有权的设计，对外形、配合、功能（包括性能和/或耐久性）的影响应与顾客共同进行评审，以便所有的影响都能得到适当的评价。
When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met.
当顾客要求时，还应满足附加的验证/标识要求，如对新产品引入的那些要求。
NOTE 1
Any product realization change affecting customer requirements requires notification to, and agreement from, the customer.
注1：任何影响顾客要求的产品实现的更改都要通知顾客，并征得顾客同意。
NOTE 2
The above requirement applies to product and manufacturing process changes.
注2：以上要求适用于产品和制造过程更改。

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6.2.2.4 Employee motivation and empowerment员工激励与授权

The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization.

组织应有一个激励员工实现质量目标、开展持续改进和建立促进创新环境的过程。该过程应包括在整个组织内提高质量和技术的意识。

The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives [see 6.2.2 d)].

组织应有一个过程，以测量员工对于所从事活动的相关性和重要性，以及如何为实现质量目标作出贡献[（见6.2.2d）]的认知程度。
6.3 Infrastructure基础设施

ISO 9001:2000, Quality management systems － Requirements

6.3 Infrastructure基础设施
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
组织应确定、提供并维护为达到产品符合要求所需的基础设施。适用时，基础设施包括：
a)        buildings, workspace and associated utilities,
a）建筑物、工作场所和相关的设施；
b)        process equipment (both hardware and software), and
b）过程设备（硬件和软件）；
c)        supporting services (such as transport or communication).
c）支持性服务（如运输或通讯）。

6.3.1 Plant, facility and equipment planning工厂、设施和设备策划
The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and value added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations.
组织应采用多方论证的方法（7.3.1.1）来制定工厂、设施和设备的计划。工厂的布局应优化材料的转移、搬运，以及对场地空间的增值使用，并应便于材料的同步流动。应制定并实施对现有操作的有效性进行评价和监视的方法。
NOTE    These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system.
注：这些要求应当关注精益制造原则以及与质量管理体系有效性的关联。

6.3.2 Contingency plans应急计划
The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns.
组织应制定应急计划，以便在紧急情况下（如公用事业的供应中断、劳动力短缺，关键设备故障和售后退货等）满足顾客的要求。

6.4 Work environment工作环境

ISO 9001:2000, Quality management systems – Requirements

6.4 Work environment工作环境
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
组织应确定并管理为达到产品符合要求所需的工作环境。

6.4.1 Personnel safety to achieve product quality与实现产品质量相关的人员安全
Product safety and means to minimize potential risks to employees shall be addressed by the organization, especially in the design and development process and in manufacturing process activities.
组织应强调产品安全性和方法，以最大程度地降低对员工造成的潜在风险，特别是在设计和开发过程、制造过程活动中。

6.4.2 Cleanliness of premises生产现场的清洁
The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs.
组织应保持生产现场处于与产品和制造过程的需求相协调的有序、清洁和维护的状态。

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6 Resource management资源管理

6.1 Provision of resources资源提供

ISO 9001:2000, Quality management systems － Requirements

6 Resource management资源管理

6.1 Provision of resources资源提供
The organization shall determine and provide the resources needed
组织应确定并提供以下方面所需的资源：
a)
to implement and maintain the quality management system and continually improve its effectiveness, and
a）实施、保持质量管理体系并持续改进其有效性；
b)
to enhance customer satisfaction by meeting customer requirements.
b）通过满足顾客要求，增强顾客满意。


6.2 Human resources人力资源

6.2.1 General总则

ISO 9001:2000, Quality management systems － Requirements

6.2 Human resources人力资源

6.2.1 General总则
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
基于适当的教育、培训、技能和经验，从事影响产品质量工作的人员应是能够胜任的。


6.2.2 Competence, awareness and training能力、意识和培训

ISO 9001:2000, Quality management systems – Requirements

6.2.2 Competence, awareness and training能力、意识和培训
The organization shall
组织应：
a)
determine the necessary competence for personnel performing work affecting product quality,
a）确定从事影响产品质量工作的人员所必要的能力；
b)
provide training or take other actions to satisfy these needs,
b）提供培训或采取其他措施以满足这些需求；
c)
evaluate the effectiveness of the actions taken,
c）评价所采取措施的有效性；
d)
ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
d）确保员工认识到所从事活动的相关性和重要性，以及如何为实现质量目标作出贡献；
e)
maintain appropriate records of education, training, skills and experience.
e）保持教育、培训、技能和经验的适当记录（见4．2．4）。


6.2.2.1 Product design skills产品设计技能
The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques.
组织应确保具有产品设计责任的人员有达到设计要求的能力，且熟练掌握适用的工具和技术。
Applicable tools and techniques shall be identified by the organization.
组织应识别适用的工具和技术。

6.2.2.2 Training培训
The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements.
组织应建立并保持形成文件的程序，识别培训需求并使所有从事影响产品质量活动的人员具备能力。承担特定任务的人员应具备要求的资格，在满足顾客要求方面给予特别的关注。
NOTE 1
This applies to all employees having an effect on quality at all levels of the organization.
注1：本要求适用于组织内各层次中影响质量的所有员工。
NOTE 2
An example of the customer specific requirements is the application of digitized mathematically based data.
注2：顾客特殊要求的一个例子：数字型数字数据的应用。

6.2.2.3 Training on the job岗位培训
The organization shall provide on-the-job training for personnel in any new or modified job affecting product quality, including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements.
对影响产品质量的岗位，组织应对新上岗或或工作的人员提供岗位培训，包括合同工和代理工作人同。应将不符合质量要求给顾客带来的后果告知对质量有影响的工作人员。

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NOTE    The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
注：管理者代表的职责可包括与质量管理体系有关事宜的外部联络。

5.5.2 1 Customer representative顾客代表
Top management shall designate personnel with responsibility and authority to ensure that customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development.
最高管理者应指定人员，赋于其职责和权限，以确保顾客的要求得到体现，包括特殊特性的选择、制定质量目标和相关的培训、纠正和预防措施、产品设计和开发。

5.5.3 Internal communication内部沟通

ISO 9001:2000, Quality management systems － Requirements

5.5.3 Internal communication内部沟通
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
最高管理者应确保在组织内建立适当的沟通过程，并确保对质量管理体系的有效性进行沟通。

5.6 Management review管理评审

5.6.1 General总则

ISO 9001:2000, Quality management systems － Requirements

5.6 Management review管理评审

5.6.1 General总则
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
最高管理者应按策划的时间间隔评审质量管理体系，以确保其持续的适宜性、充分性和有效性。评审应包括评价质量管理体系改进的机会和变更的需要，包括质量方针和质量目标。
Records from management reviews shall be maintained (see 4.2.4).
应保持管理评审的记录（见4．2．4）。

5.6.1.1 Quality management system performance质量管理体系绩效
These reviews shall include all elements of the quality management system and its performance trends as an essential part of the continual improvement process.
作为持续改进过程的一个必不可少的部分，这些评审应包括对质量管理体系的所有要求及其业绩趋势的评审。
Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1).
对质量目标进行监视及对不良质量成本定期报告和评价应是管理评审的一部分内容。（见8.4.1和8.5.1）。
These results shall be recorded to provide, as a minimum, evidence of the achievement of
这些结果应给予以记录，至少能为以下方面的成绩提供证据：
        the quality objectives specified in the business plan, and
        经营计划中规定的质量目标；
        customer satisfaction with product supplied.
        对所供应产品的顾客满意情况。

5.6.2 Review input评审输入

ISO 9001:2000, Quality management systems － Requirements

5.6.2 Review input评审输入
The input to management review shall include information on
管理评审的输入应包括以下方面的信息：
a)        results of audits,
a）审核结果；
b)        customer feedback,
b）顾客反馈；
c)        process performance and product conformity,
c）过程的业绩和产品的符合性；
d)        status of preventive and corrective actions,
d）预防和纠正措施的状况；
e)        follow up actions from previous management reviews,
e）以往管理评审的跟踪措施；
f)        changes that could affect the quality management system, and
f）可能影响质量管理体系的变更；
g)        recommendations for improvement.
g）改进的建议。

5.6.2.1 Review input － Supplemental评审输入－补充
Input to management review shall include an analysis of actual and potential field failures and their impact on quality, safety, or the environment.
管理评审输入应包括实际的和潜在的售后失效及其对质量、安全或环境的影响分析。

5.6.3 Review output评审输出

ISO 9001:2000, Quality management systems – Requirements

5.6.3 Review output评审输出
The output from the management review shall include any decisions and actions related to
管理评审的输出应包括与以下方面有关的任何决定和措施：
a)        improvement of the effectiveness of the quality management system and its processes,
a）质量管理体系及其过程有效性的改进；
b)        improvement of product related to customer requirements, and
b）与顾客要求有关的产品的改进；
c)        resource needs.
c）资源需求。

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5.4 Planning策划



5.4.1 Quality objectives质量目标



ISO 9001:2000, Quality management systems － Requirements



5.4 Planning策划



5.4.1 Quality objectives质量目标

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1a)] are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

最高管理者应确保在组织的相关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 a)]。质量目标应是可测量的，并与质量方针保持一致。



5.4.1.1 Quality objectives － Supplemental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.

最高管理者应确定质量目标及测量要求，并应包含在经济计划中，用于质量方针的展开。

NOTE    Quality objectives should address customer expectations and be achievable within a defined time period.

注：质量目标应当体现顾客期望并在规定的时间内是可实现的。



5.4.2 Quality management system planning质量管理体系策划



ISO 9001:2000, Quality management systems － Requirements



5.4.2 Quality management system planning质量管理体系策划

Top management shall ensure that

最高管理者应确保：

a)    the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and

a）对质量管理体系进行策划，以满足质量目标以及4．1的要求；

b)    the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

b）在对质量管理体系的变更进行策划和实施时，保持质量管理体系的完整性。



5.5 Responsibility, authority and communication职责、权限与沟通



5.5.1 Responsibility and authority职责和权限



ISO 9001:2000, Quality management systems － Requirements



5.5 Responsibility, authority and communication职责、权限与沟通



5.5.1 Responsibility and authority职责和权限

Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization.

最高管理者应确保组织内的职责、权限得到规定和沟通。



5.5.1.1 Responsibility for quality质量职责

Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements.

应立即把不符合要求的产品或过程通报给负有纠正措施职责和权限的管理者。

Personnel responsible for quality shall have the authority to stop production to correct quality problems.

负责产品质量的人员，应有权停止生产，以纠正质量问题。

Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring product quality.

所有班次的生产作业都应安排负责保证产品质量的人员，或指定其代理人员。



5.5.2 Management representative管理者代表



ISO 9001:2000, Quality management systems － Requirements



5.5.2 Management representative管理者代表

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes

最高管理者应指定一名管理者，无论该成员在其他方面的职责如何，应具有以下方面的职责和权限：

a)         ensuring that processes needed for the quality management system are established, implemented and maintained,

a）确保质量管理体系所需的过程得到建立、实施和保持；

b)         reporting to top management on the performance of the quality management system and any need for improvement, and

b）向最高管理者报告质量管理体系的业绩和任何改进的需求；

c)         ensuring the promotion of awareness of customer requirements throughout the organization.

c）确保在整个组织内提高满足顾客要求的意识。

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5 Management responsibility管理职责

5.1 Management commitment管理承诺

ISO 9001:2000, Quality management systems － Requirements

5 Management responsibility管理职责

5.1 Management commitment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
最高管理者应通过以下活动，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过程效率

Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency.
最高管理者应评审产品实现过程和支持过程，以确保它们的有效性和效率。

5.2 Customer focus以顾客为关注焦点

ISO 9001:2000, Quality management systems – Requirements

5.2 Customer focus以顾客为关注焦点
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
最高管理者应以增强顾客满意为目的，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质量方针

ISO 9001:2000, Quality management systems – Requirements

5.3 Quality policy质量方针
Top management shall ensure that the quality policy
最高管理者应确保质量方针：
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。