The organization has defined suitable means to identify outputs when it is necessary to ensure the conformity of products and services. This may involve assigning unique identifiers, such as serial numbers, batch codes, or physical labels, to products or batches.
The organization needs to also identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision.
When traceability is a requirement, the organization also needs to define controls for the unique identification of outputs, and shall retain the documented information necessary to enable traceability.
