Hi,
Just had a third party audit for FDA, 13485, and the Canadian Medical Device Regulations. One of the audit findings addressed the lack of "a technical and geographic scope" in our Quality Manual. I have searched 21 CFR, 13485, and CMDR, but cannot find a reference to that particular item. Any ideas?

:thanx:

Hi,
Just had a third party audit for FDA, 13485, and the Canadian Medical Device Regulations. One of the audit findings addressed the lack of "a technical and geographic scope" in our Quality Manual. I have searched 21 CFR, 13485, and CMDR, but cannot find a reference to that particular item. Any ideas?

:thanx:I don't believe there is a requirement, either stated or implied, in the standard, the QSR, MDD or CMDR. Check which section of the standard the auditor referenced. During my last surveillance audit, only three weeks ago, our auditor mentioned that he couldn't write up a finding against the regulations (MDD or CMDR), only the standard. The standard states in part,4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusion and/or nonapplication
(see 1.2),This may be another situation of an ISO or FDA auditor making it up as he goes along. Remember the third party auditors had to undergo training by FDA before they were "let loose". Look at, ISO 9001:2000 - Exclusion of 7.5.2 - External Audit finding (http://elsmar.com/Forums/showthread.php?t=16189&highlight=validate)

Now having said all of this, I will tell you that the scope of my manual includes the products and location as well as the standards and regulations covered by the manual.