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。

组织应保持产品和服务的型态的识别，以识别产品实际型态和所需型态之间的任何不同。

组织应在生产和服务提供的整个过程中按照监视和测量的要求识别输出的状态。

当使用可接受授权媒介时（如印章、电子签名、密码），组织应对媒介建立适当的控制。

当有可追溯要求时，组织应对输出所拥有的唯一性的标识进行控制，并应保留所需的成文信息以实现可追溯。

不可投入服务使用的产品应得到控制并与可投入服务使用的产品进行物理隔离。

注：追溯要求包括：

—— 在产品寿命期内能保持标识；

—— 所有产品能追溯到由同一批原材料制造，或来自相同制造批次，以及最终去向（如交付、报废）；

—— 对于组件，能追溯其组件以及后面更高一级的组件；

—— 产品台账上对产品状态的标识（例如：全新的、大修过的、维修过的、变更过的、重建的等）

—— 对于产品，能追溯其生产的一系列记录（制造、装配、检验/验证）。

组织应在拆分批次、仓储、包装和防护的过程中通过适当的方式（如标签、条式码等）来维持产品在供应商的发货清单上列出的标识与可追溯性。上述要求也适用于分包给外部供应商的拿取和包装行为。

在拆分批次交付产品时，下列信息应被保存：

—— 从外部供应商处得到的数量与交付出去的数量；

—— 采购订单（PO）编号；

—— 顾客名称。

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.

Unserviceable product shall be controlled and physically segregated from serviceable product.

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;

—— the identification of the product’s condition in inventory (e.g., new, overhauled, repaired, altered, rebuilt).

The organization shall maintain product identification and traceability by suitable means (e.g., labels, bar codes) from receipt; during splitting, storage, packaging, and preservation operations and until delivery. This includes handling or packing operations outsourced to external providers.

When delivering split product, the following information shall be retained:

—— amount delivered relative to amount received from external provider,

—— purchase order number(s),

—— customer's name(s).