8.1.2、型态管理

当适用于组织以及它的产品和服务时，组织应建立、实施和控制一个型态管理的过程，以确保在产品生命周期内物理和功能属性的识别和控制。这个过程应：

a）按要求控制产品的身份标识和可追溯性，包括已确认的变更的执行情况；

b）保证成文信息(如要求、设计、验证、确认以及与接收有关的文件)与实际产品和服务的属性是一致的；

8.1.1、Configuration Management

The organization shall plan, implement, and control a process for configuration management as appropriate to the organization and its products and services in order to ensure the identification and control of physical and functional attributes throughout the product lifecycle. This process shall:

a. control product identity and traceability to requirements, including the implementation of identified changes;

b. ensure that the documented information (e.g., requirements, design, verification, validation and acceptance documentation) is consistent with the actual attributes of the products and services.