ISO 9001:2000

ISO 9001:2000, section 7.1 Planning of Product Realization

Change: Relaxed Requirements
Procedure Required: NO
Record(s) Required: NONE

Comments:
This section requires the organization to plan and develop the processes needed for product realization. The planning must be consistent with other requirements of the quality management system and determine, as appropriate, the:

a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements.

Guidance:
I suggest paraphrasing the wording of the standard in your Quality Manual.

CAUTION - Phantom Requirement:
As a minimum, ISO 9000 auditors expect to see a flow chart depicting the product realization process. The ISO 9000 auditors will focus on reviewing training records as justification for the lack of in-depth procedures and work instructions. I suggest that companies who have existing product realization procedures (e.g., from the requirements of ISO 9001:1994) to continue to maintain those procedures and work instructions where-ever beneficial. In many manufacturing processes a drawing or schematic is all that is necessary to meet this requirement.