8.3.4 Design and development controls 设计和开发控制
The organization shall apply controls to the design and development process to ensure that:
a) the results to be achieved are defined;
b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;
c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;
d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;
e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities;
f) documented information of these activities is retained.
NOTE Design and development reviews, verification and validation have distinct purposes. They can be
conducted separately or in any combination, as is suitable for the products and services of the organization.
组织对对设计和开发过程进行控制以确保：
a) 要实现的结果得到确定；
b) 实施评审，以评价设计和开发结果满足要求的能力；
c) 实施验证活动，以确保设计和开发的输出满足设计和开发输入的要求；
d) 实施确认活动，以确保形成的产品和服务能够满足规定的应用或预期用途；
e) 对评审或验证和确认活动中确定的问题采取必要的措施；
f) 保留这些活动的形成文件的信息。
注：设计和开发的评审、验证和确认具有不同的目的，他们可以按适合组织的方式单独或任意组合进行。
8.3.5 Design and development outputs 设计和开发输出
The organization shall ensure that design and development outputs:
a) meet the input requirements;
b) are adequate for the subsequent processes for the provision of products and services;
c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.
The organization shall retain documented information on design and development outputs.
组织应确保设计和开发的输出：
a) 满足输入的要求；
b) 对于产品和服务提供的后续过程是充分的；
c) 适当时，包含或引用监视和测量要求以及接收准则；
d) 规定了产品和服务的预期目的以及安全和正常提供所必须的产品和服务的特性。
组织应保留设计和开发输出的形成文件的信息。
8.3.6 Design and development changes 设计和开发的更改
The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.
The organization shall retain documented information on:
a) design and development changes;
b) the res
8.2.3 Review of the requirements for products and services产品和服务要求的评审
8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply
products and services to a customer, to include:
a) requirements specified by the customer, including the requirements for delivery and postdelivery activities;
b) requirements not stated by the customer, but necessary for the specified or intended use, when known;
c) requirements specified by the organization;
d) statutory and regulatory requirements applicable to the products and services;
e) contract or order requirements differing from those previously expressed.
The organization shall ensure that contract or order requirements differing from those previously defined are resolved.
The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information, such as catalogues.
8.2.3.1 组织应确保其有能力满足提供给顾客的产品和服务的要求，组织应在向顾客承诺提供产品和服务之前实施评审，包括：
a) 顾客规定的要求，包括交付和交付后活动的要求；
b) 顾客虽然没有明示，但规定用途或已知的预期用途所必需的要求；
c) 组织规定的要求；
d) 适用于产品和服务的法律法规要求；
e) 与以前表述不一致的合同或订单的要求。
组织应确保与以前规定不一致的合同或订单要求已得到解决。
顾客没有提供其要求的文件化说明时，组织应在接受前对顾客要求进行确认。
注：在某些情况下，如网络销售，对每一个订单进行正式的评审可能是不实际的。作为替代方法，可对提供给顾客的有关的产品信息进行评审，如产品目录。
8.2.3.2 The organization shall retain documented information, as applicable:
a) on the results of the review;
b) on any new requirements for the products and services.
8.2.3.2 适用时，组织应保留以下方面的形成文件的信息：
a) 评审结果；
b) 产品和服务的任何新要求。
8.2.4 Change to requirements for products and service 产品和服务要求的变更
The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.
若产品和服务要求发生变更，组织应确保相关的形成文件的信息得到修改，并确保相关人员知道已变更的要求。
8.3 Design and development of products and services 产品和服务的设计和开发
8.3.1 General 总则
The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.
组织应建立、实施和维护设计和开发过程，以适用于确保后续的产品和服务的提供。
8.3.2 Design and development planning 设计和开发策划
In determining the stages and controls for design and development, the organization shall consider:
a) the nature, duration and complexity of the design and development activities;
b) the required process stages, including applicable design and development reviews;
c) the required design and development verification and validation activities;
d) the responsibilities and authorities involved in the design and development process;
e) the internal and external resource needs for the design and development of products and services;
f) the need to control interfaces between persons involved in the design and development process;
g) the need for involvement of customers and users in the design and development process;
h) the requirements for subsequent provision of products and services;
i) the level of control expected for the design and development process by customers and other
relevant interested parties;
j) the documented information needed to demonstrate that design and development requirements have been met.
在确定设计和开发的阶段和控制时，组织应考虑：
a) 设计和开发活动的性质、持续时间和复杂性；
b) 所需的过程阶段，包括适用的设计和开发评审；
c) 所需的设计和开发的验证和确认；
d) 设计和开发过程涉及的职责和权限；
e) 产品和服务的设计和开发所需的内部和外部资源；
f) 控制设计和开发过程涉及的个人之间的接口的需求；
g) 顾客和用户参与设计和开发过程的需求；
h) 后续的产品和服务提供的要求；
i) 顾客和其他有关相关方对设计和开发过程所期望的控制程度；
j) 证实设计和开发要求已得到满足所需的形成文件的信息。
8.3.3 Design and development Inputs 设计和开发输入
The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider:
a) functional and performance requirements;
b) information derived from previous similar design and development activities;
c) statutory and regulatory requirements;
d) standards or codes of practice that the organization has committed to implement;
e) potential consequences of failure due to the nature of the products and services.
Inputs shall be adequate for design and development purposes, complete and unambiguous.
Conflicting design and development inputs shall be resolved.
The organization shall retain documented information on design and development inputs.
组织应确定有关设计和开发的产品和服务的具体类型的基本要求，组织应考虑：
a) 功能和性能要求；
b) 来自以前类似设计和开发活动的信息；
c) 法律法规要求；
d) 组织承诺执行的标准或行业规则；
e) 产品和服务的性质引起的潜在失效后果。
输入应满足设计和开发目的，完整并且清楚。
设计和开发输入的矛盾应予以解决。
组织应保留设计和开发输入的形成文件的信息。
组织应在受控条件下实施产品和服务的提供。
适用时，受控条件应包括：
a) 获得规定的形成文件的信息：
1) 生产的产品、提供的服务或执行的活动的特性
2) 要达到的结果；
b) 获得和使用适宜的监视和测量资源；
c) 在适当阶段进行监视和测量，以验证过程或输出的控制准则及产品和服务的接收准则已得到满足；
d) 使用适宜的设备和过程环境；
e) 指派胜任的人员，包括所要求的资格；
f) 当生产和服务提供过程形成的输出不能由后续的监视或测量加以验证，组织应对这些过程实现所策划的结果的能力进行确认和定期再确认；
g) 实施防止人为错误的措施；
h) 实施产品和服务的放行、交付和交付后活动。
8.5.2 Identification and traceability 标识和可追溯性
The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.
The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.
必要时，组织应使用适宜的方法识别输出，以确保产品和服务的符合性。
组织应在产品和服务提供的全过程中，针对监视和测量要求识别输出的状态。
有可追溯性要求的场合，组织应控制输出的一性标识，并应保留可追溯性所需的形成文件的信息。
8.5.3 Property belonging to customers or external providers 顾客或者外部供方财产
The organization shall exercise care with property belonging to customers or external providers while it is under the organization’s control or being used by the organization.
The organization shall identify, verify, protect and safeguard customers’ or external providers’ property provided for use or incorporation into the products and services.
When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.
NOTE A customer’s or external provider’s property can include material, components, tools and equipment,
premises, intellectual property and personal data.
组织应爱护在组织控制下或组织使用的顾客或外部供方财产。
组织应识别、验证、保护和维护供其使用或构成产品和服务的顾客或外部供方财产。
若顾客或外部供方财产丢失、损坏或发现其他不适合使用的情况时，组织应报告顾客或外部供方，并保留有关已发生状况的形成文件的信息。
注：顾客或外部供方财产可以包括材料、组件、工具和设备、顾客现场、知识产权和个人数据。
8.5.4 Preservation 防护
The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection
组织应在产品和服务提供期间对输出进行必要的防护，以确保符合要求。
注：防护可以包括标识、搬运、污染控制、包装、储存、传送或运输以及保护。
8.5.5 Post-delivery activities 交付后活动
The organization shall meet requirements for post-delivery activities associated with the products and services.
In determining the extent of post-delivery activities that are required, the organization shall consider:
a) statutory and regulatory requirements;
b) the potential undesired consequences associated with its products and services;
c) the nature, use and intended lifetime of its products and services;
d) customer requirements;
e) customer feedback.
NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as recycling or final disposal..
组织应满足与产品和服务有关的交付后活动的要求。
在确定所需的交付后活动的程度时，组织应考虑：
a) 法律法规要求；
b) 与产品和服务有关的潜在不期望的后果；
c) 产品和服务的性质、用途和预期寿命；
d) 顾客要求；
e) 顾客反馈。
注：交付后活动可包括诸如担保条件下的措施、合同规定的维护服务、附加服务如回收或较终处置。
8.5.6 Control of changes 变更的控制
The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.
The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review..
组织应对生产或服务提供的变更进行评审和控制，以确保必要的与持续符合要求。
组织应保留描述变更的评审结果、有权变更的人员以及评审引起的任何必要措施的形成文件的信息。
组织应在适当阶段实施策划的安排，以验证产品和服务要求已得到满足。
除非得到有关授权人员的批准，适用时得到顾客的批准，否则在策划的安排已圆满完成之前，不应向顾客放行产品和服务。
组织应保留产品和服务放行的形成文件的信息，形成文件的信息应包括：
a) 符合接受准则的证据；
b) 有权放行人员的可追溯性。
审核目的
过程质量审核是对影响过程质量的各因素是否按质量控制计划所规定的要求进行控制、控制是否有效、能否适应等进行审查与评价。
过程质量审核的目的，就是通过审核，检查在生产现场是否按质量控制计划规定的措施执行、是否符合标准，评价其有效性，同时发现问题进行改进，以保证过程质量的稳定。
过程质量审核的内容：
① 操作者是否具备规定的能力或资格；
② 是否按图样、工艺规程和作业指导书进行加工；
③ 设备、工装、刀具等是否符合要求，并且使用正确；
④ 原材料、毛坯、协作件是否符合要求；
⑤ 图样、工艺文件、检验文件等是否完整、统一、正确、有效；
⑥ 是否按规定正确的开展质量检验工作；
⑦ 制造、装配现场环境是否良好；
⑧ 过程质量控制点的设置是否合理，控制的文件等是否齐全，能否真正起到控制的作用。
过程质量审核应根据管理部门的安排有计划的定期进行，审核的重点应是建立质量控制点的过程，以评定其质量控制活动。
开展过程质量审核，可有效改进过程质量控制方法，完善质量控制点的预防控制的作用，为改善过程质量控制、保证产品质量起到积极的作用。
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