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。

组织应实施一个建立了准则的过程使会影响到顾客要求的更改在实施前能通知顾客。

组织应保留下列方面的成文信息：

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型态管理的过程控制。

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.