8.5生产和服务提供

8.5.5、交付后的活动

组织应满足与产品和服务相关的交付后活动的要求。

在确定所要求的交付后活动的覆盖范围和程度时，组织应考虑：

a. 法律法规要求；

b. 与产品和服务相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。

f. 服役中数据的收集和分析(例如：性能、可靠性、经验教训)；

g. 控制、升级和提供关于产品使用、维护、维修和大修的技术文件；

h. 对于组织之外进行工作所要求的控制（例如：外场作业）;

i. 生产/客户支持（例如：询问、培训、质保、维护、备件、资源和淘汰）。

当交付后发现问题时，组织应采取适当的措施，包括调查和汇报；

注：交付后活动可能包括保证条款所规定的相关活动，诸如合同规定的维护服务，以及回收或最终报废处置等附加服务等。

8.5.6、更改控制

组织应对生产和服务提供的更改进行必要的评审和控制，以确保持续地符合要求。

应识别授权批准生产或服务提供的更改的人员。

注：生产或服务提供的更改可以包含影响过程、生产设备、工具或软件程序的更改。

组织应保留形成文件的信息，包括有关更改评审结果、授权进行更改的人员以及根据评审所采取的必要措施。

8.5.5、Post-delivery activities

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.

f. collection and analysis of in-service data (e.g., performance, reliability, lessons learned);

g. control, updating and provision of technical documentation relating to product use, maintenance, repair, and overhaul;

h. controls required for work undertaken external to the organization (e.g., off-site work);

i. product/customer support (e.g., queries, training, warranties, maintenance, replacement parts, resources, obsolescence).

When problems are detected after delivery, the organization shall take appropriate action including investigation and reporting.

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.

8.5.6、Control of changes

The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

Persons authorized to approve production or service provision changes shall be identified.

NOTE: Production or service provision changes can include the changes affecting processes, production equipment, tools, or software programs.

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.