Management system guidance
8.5 Product and service provision
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8.5.2 Identification and traceability
This requirement is comparable to the requirements from ISO 9001:2008 Clause 7.5.3 - Identification and traceability. You should seek and record evidence that product is identified (as appropriate) and its status with regards to monitoring and measuring (conforming or not) is identified throughout the manufacturing processes.
Where traceability is a requirement, you should expect to see that your organization is controlling and recording the unique identity of the product throughout the production process to ensure that only products that have passed the required inspections and tests are utilised.
Your organization must have a process in place for the identification and traceability of outputs, in terms of the monitoring and measurement requirements at all stages of production, to enable the demonstration of conformity to requirements, e.g. physical part marking, labeling, tags, bar codes, signage, visual indicators, part segregation, lay down areas, storage racks.
There are several ways of identifying products to prevent them becoming mixed with other parts, components, or orders. The most obvious is using tags or stickers with a unique traceability identifier, such as a lot or batch number included on the product labels. The identification may be engraved in the product itself, or the product may simply be marked by a colour.
Establish and implement a procedure to identify the product through the design, development, manufacture and delivery stages. The established a traceability system should track components from raw material through inspection, test, and final release operations, including rework:
- Establish the identity and status of products;
- Maintain the identity and status of products;
- Maintain records of serial or batch numbers.
The auditor will expect to see that product is identified (as appropriate) and its status with regards to monitoring and measuring (conforming or not) is identified throughout the product realization processes.
Where traceability is a requirement, the auditor will expect to see that the organization is controlling and recording the unique identification of the product. If you need a procedure and forms to help control your business's product and service provision process, click here.
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Monitoring, measurement, analysis and evaluation
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