8.3产品和服务的设计和开发

8.3.5、设计和开发输出

组织应确保设计和开发输出：

a. 满足输入的要求；

b. 对于后续的产品和服务的提供过程是充分的；

c. 包括或引用监视和测量的要求，适当时，包括接收准则；

d. 规定对于预期目的、安全和正确提供的产品和服务的基本特性；

e. 适用时，规定所有关键项目，包括所有关键特性，以及对这些项目要采取的特殊措施；

f. 发行前得到授权人员的批准。

组织应确定对产品进行标识、制造、验证、使用和维护所要求的数据。

注：数据可以包括：

——定义产品技术状态和设计特性所必要的图纸，零件清单和规范；

——保证产品符合性所需的材料、过程、制造和装配数据；

——运行和维护产品的技术数据和维修方案。

组织应保留设计和开发输出的形成文件的信息。

8.3.5、Design and development outputs

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；

e. specify, as applicable, any critical items, including any key characteristics, and specific actions to be taken for these items;

f. are approved by authorized person(s) prior to release.

The organization shall define the data required to allow the product to be identified, manufactured, verified, used, and maintained.

NOTE: Data can include:

—— the drawings, part lists, and specifications necessary to define the configuration and the design features of the product;

—— the material, process, manufacturing, assembly, handling, packaging, and preservation data needed to provide and maintain a conforming product or service;

—— the technical data and repair schemes for operating and maintaining the product.

The organization shall retain documented information on design and development outputs.