8.4外部提供的过程、产品和服务的控制

8.4.1.1、组织应：

a. 对于批准状态决定、批准状态更改以及根据其批准状态对外部供方的受控使用的条件确定过程、职责和权限。

b. 保持一份外部供方名录，包括批准状态（如：批准，有条件批准，不批准）和批准范围（如：产品类型、过程类别）；

c. 定期评审外部供方的业绩，包括过程、产品和服务符合性，和准时交付业绩；

d. 当外部供方不能满足要求时，规定采取必要的措施；

e. 明确由供方生成和/或保持的形成文件的信息的控制要求。

8.4.1.1、The organization shall:

a. define the process, responsibilities, and authority for the approval status decision, changes of the approval status, and conditions for a controlled use of external providers depending on their approval status;

b. maintain a register of its external providers that includes approval status (e.g., approved, conditional, disapproved) and the scope of the approval (e.g., product type, process family);

c. periodically review external provider performance including process, product and service conformity, and on-time delivery performance;

d. define the necessary actions to take when dealing with external providers that do not meet requirements;

e. define the requirements for controlling documented information created by and/or retained by external providers.