8.3产品和服务的设计和开发

8.3.6、设计和开发更改

组织应对产品和服务设计和开发期间以及后续所做的更改进行适当的识别、评审和控制，以确保这些更改对满足要求不会产生不利影响。

组织应实施一个过程，其含有对于影响客户要求的更改，在执行之前，通知其客户的准则。

组织应保留下列形成文件的信息：

a. 设计和开发更改；

b. 评审的结果；

c. 更改的授权；

d. 为防止不利影响而采取的措施。

设计和开发的更改应按技术状态管理过程的要求进行控制。

8.3.6、Design and development changes

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 implement a process with criteria for notifying its customer, prior to implementation, about changes that affect customer requirements.

The organization shall retain documented information on:

a. design and development changes;

b. the results of reviews;

c. the authorization of the changes;

d. the actions taken to prevent adverse impacts.

Design and development changes shall be controlled in accordance with the configuration management process requirements.