8.5生产和服务提供

8.5.2、标识和可追溯性

需要时，组织应采用适当的方法识别输出，以确保产品和服务合格。

组织应维持产品和服务的技术状态的标识，以便识别产品实际的技术状态和约定的技术状态之间的任何区别。

组织应在生产和服务提供的整个过程中按照监视和测量要求识别输出状态。

当使用接收授权媒体时（例如，印章、电子签名、口令），组织应对媒体建立的控制。

当有可追溯要求时，组织应控制输出的唯一性标识，且应保留所需的形成文件的信息以实现可追溯。

注：可追溯性要求可以包括：

—— 整个产品寿命期内维持标识；

—— 能追溯由同批原材料生产的所有产品，或同一生产批产品的最终去向（如交付、报废）；

—— 对于组件，能追溯其装配的部件及上一级的组件；

—— 对给定的产品，能追溯其生产（加工、装配、检验/验证）的连续的记录。

8.5.2、Identification and traceability

The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of products and services.

The organization shall maintain the identification of the configuration of the products and services in order to identify any differences between the actual configuration and the required configuration.

The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.

When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), the organization shall establish controls for the media.

The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.

NOTE: Traceability requirements can include:

—— the identification to be maintained throughout the product life;

—— the ability to trace all products manufactured from the same batch of raw material, or from the same manufacturing batch, to the destination (e.g., delivery, scrap);

—— for an assembly, the ability to trace its components to the assembly and then to the next higher assembly;

—— for a product, a sequential record of its production (manufacture, assembly, inspection/verification) to be retrievable.