posted 22 June 2001 10:09 AM               

Regards
Jim

posted 22 June 2001 03:52 PM               

Exerpt from Interpretation by DNV Cert (our registrar):
The most likely exclusions are limited to clause 7 and may include design and development, traceability when this is not a specified requirement from regulations or the customer and customer property when it is not used during the realization process or incorporated into the final product. One final clause that may be excluded in very special circumstances, is control of monitoring and measuring devisces. The exclusion of this clause would only be allowable when an organization did not use monitoring or measuring devices during the realization of its product. This situation may be encountered during the auditing of a firm that provides services.

Whenever any part of the standard is excluded from the scope of the management system it must be clearly stated and justified within the quality manual as required by clause 4.2.2. Furthermore, it is not acceptable to claim compliance with ISO 9001 when an organization chooses to exclude a portion of their system that clearly contributes to the realization of their product or service. It will be the responsibility of the Registrar to ensure that the scope of the management system is properly reflected in the quality manual and used in all advertising.

In the determination of whether a particular portion of clause 7 is applicable the general question that must be answered is whether the organization retains the overall responsibility for product realization. For guidance and assistance in determining applicability see the ISO publication ISO/TC 176/SC 2/N 524.

Hope this information helps

Edited to fix some typos