ISO 9001 Implementation Guide

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7.5.3 Identification and traceability

* 7.5.3 Identification and traceability *

Where appropriate, the organization shall identify the product by suitable means throughout product realization.

The organization shall identify the product status with respect to monitoring and measurement requirements.

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.

(from BS EN ISO 9001:2000)

This clause combines two related elements - product identification and traceability and inspection and test status.

Not all products or services necessarily need to have specific identification or traceability. But if this clause applies to your organization (this might be a contractual requirement or a statutory requirement in some industries), you must examine these three issues carefully to ensure conformance. This should include all stages of product realization—from customer-related processes to receipt of all material to be used in your product's), all the way through production to final delivery to your customer. Additionally, this identification must be recorded and maintained. Often, traceability is included in your scope of registration wording, so customers can see the levels of control in place.

Traceability is more important in some sectors than others. For instance, a company that manufactures drinking straws might not require specific traceability processes, but the canned beverage industry (which might use straws), lot numbers, the time, date and shift of manufacture are critical so in the event of a problem, the product can be easily or readily recalled. If this is a requirement in your industry, be sure you can trace the history, application or location of that which is under consideration.

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