8.3.3、设计和开发输入

组织应针对所设计和开发的具体类型的产品和服务，确定必需的要求。组织

应考虑：

a）功能和性能要求；

b）来源于以前类似设计和开发活动的信息；

c）法律法规要求；

d）组织承诺实施的标准或行业规范；

e）由产品和服务性质所导致的潜在的失效后果；

f）适用时，性能衰退的潜在后果（如材料，过程，部件，设备和产品）。

针对设计和开发的目的，输入应是充分和适宜的，且应完整、清楚。

相互矛盾的设计和开发输入应得到解决。

组织应保留有关设计和开发输入的成文信息。

注：组织也可考虑将其它信息——如标杆产品、外部供方反馈、内部产生数据和服务中数据——作为设计和开发的输入。

8.3.1、Design and Development Inputs

The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider:

a. functional and performance requirements;

b. information derived from previous similar design and development activities;

c. statutory and regulatory requirements;

d. standards or codes of practice that the organization has committed to implement;

e. potential consequences of failure due to the nature of the products and services.

Inputs shall be adequate for design and development purposes, complete, and unambiguous. Conflicting design and development inputs shall be resolved.

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