8.3产品和服务的设计和开发

8.3.4、设计和开发控制

组织应对设计和开发过程进行控制，以确保：

a. 规定拟获得的结果；

b. 实施评审活动，以评价设计和开发的结果满足要求的能力；

c. 实施验证活动，以确保设计和开发输出满足输入的要求；

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使用要求或预期用途要求；

e. 针对评审、验证和确认过程中确定的问题采取必要措施；

f. 保留这些活动的形成文件的信息；

g. 批准转入下一阶段。

设计和开发评审的参加者应包括与所评审的设计和开发阶段有关的职能的代表。

注：设计和开发的评审、验证和确认具有不同目的。根据组织的产品和服务的具体情况，可以单独或以任意组合进行。

8.3.4、Design and development controls

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；

g. progression to the next stage is authorized.

Participants in design and development reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed.

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.