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Hello,
This is my first post. We recently completed an initial registration audit for 13485:2003 and 9001:2000. One minor non conformance we received is that we did not COMPLETELY identify all outsourced processes in our quality manual. We clearly indicate in the manual that we do outsource some processes and identify how we control them. I vigorously objected since we identify them in our approved supplier list - each supplier is identified by their service/product. We also showed that we exercise sufficient control over them. The whole observation seemed to hinge on making a complete list of outsourced processes in the quality manual. Am I missing something or is this a complete misread of the standard? We plan to appease them because they said that if we do not they would issue a Major NC. It seems that in the end we have little recourse to object to such observations.

This is my first post. We recently completed an initial registration audit for 13485:2003 and 9001:2000. One minor non conformance we received is that we did not COMPLETELY identify all outsourced processes in our quality manual. We clearly indicate in the manual that we do outsource some processes and identify how we control them. I vigorously objected since we identify them in our approved supplier list - each supplier is identified by their service/product. We also showed that we exercise sufficient control over them. The whole observation seemed to hinge on making a complete list of outsourced processes in the quality manual. Am I missing something or is this a complete misread of the standard? We plan to appease them because they said that if we do not they would issue a Major NC. It seems that in the end we have little recourse to object to such observations.
