TS16949中英文对照 2

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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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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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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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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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有09版的吗？？？？？？？？？？？？？

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有09版的吗？？？？？？？？？？？？？