ISO 9001:2000

7.5.3 Identification and Traceability

Change: Minor re-wording
Procedure Required: NO
Record(s) Required: Traceability (where required)

Comments:
This section requires the organization to, where appropriate, identify the product by suitable means throughout product realization and identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization must control and record the unique identification of the product.

Guidance:
I suggest paraphrasing the wording of the standard in your Quality Manual. If "traceability" is not required, state this in your quality manual.

Because no procedure is required by this section, product identification can be whatever you wish to tell the ISO 9000 auditor on the day of the audit. Many forms of product identification may be acceptable. The ISO 9000 auditor will attempt to verify some degree of consistency in the way that product is identified throughout your operation(s).

If traceability is a requirement, this is typically mandated by laws or regulations external of ISO 9001.

What's Missing from ISO 9001:2000?

There is no clear requirement for identifying components / parts incorporated into the product during production process AND identification of items such as chemicals necessary to manufacture the product.