8.3产品和服务的设计和开发
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,确定基本的要求。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决定的、失效的潜在后果。
f. 适用时,淘汰的潜在后果(例如:材料、过程、部件、设备、产品)。
设计和开发输入应满足设计和开发的目的,且应完整、清楚。
应解决相互冲突的设计和开发输入。
组织应保留有关设计和开发输入的形成文件的信息。
注:组织也可以将其他的信息考虑作为设计和开发的输入,诸如标杆、外部供方反馈、内部生成的数据、和服务数据。
8.3.3、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.
f. when applicable, the potential consequences of obsolescence (e.g., materials, processes, components, equipment, products).
Inputs shall be adequate for design and deveConflicting design and development inputs shall be resolved.
The organization shall retain documented informatlopment purposes, complete and unambiguous.
ion on design and development inputs.
NOTE: The organization can also consider as design and development inputs other information such as benchmarking, external provider feedback, internally generated data, and in-service data.