Hi,

Basic question. I can't find anything in ISO 13485 or FDA QSR that requires a signature or initials on a vaulted hard copy of a mgt review minutes (which contains all of the slides, CAPAs etc ... from the meeting). I can see an auditor asking 'how do you approve your quality records'. Even with these records not viewable to FDA inspectors, I'm surprised that this isn't specifically stated (even in a guidance document).

I've looked at ISO 14969 (the guidance for ISO 13485). Not the FDA QSR Preamble.

Does anyone have any thoughts on this?

Thanks:frust:

21 CFR 820.20(c) says that the mgmt review has to be documented with the results and date of the review. 820.186 says that documents mentioned in 820.20 have to be QSRs that comply with 820.40. Looking at 820.40 it says that you have to have the date and signature of your reviewers/approvers for your documents. Assuming your mgmt review team reviews/approves the results/minutes of the meetings then they have to sign/date them.

:2cents:

gholland, I followed your logic up to the point of 820.40. 820.40 says that designated individual(s) review...and approve. So, to me, it doesn't imply that the entire review team reviews / approves - just the designated individual(s).

I've seen companies get dinged because they do require every meeting attendee to review and approve minutes. This often results in someone not being available for approval and the record somehow gets filed without all signatures. Even if they do get all signatures, approvals often take weeks (it sits on someone's desk for a few days, etc.).

So I agree that approval is required, just not the entire team.

Yes you have the right of it, the designated person/people will have to sign. I just made the assumption that would be the team.

Hi,

Basic question. I can't find anything in ISO 13485 or FDA QSR that requires a signature or initials on a vaulted hard copy of a mgt review minutes (which contains all of the slides, CAPAs etc ... from the meeting). I can see an auditor asking 'how do you approve your quality records'. Even with these records not viewable to FDA inspectors, I'm surprised that this isn't specifically stated (even in a guidance document).

I've looked at ISO 14969 (the guidance for ISO 13485). Not the FDA QSR Preamble.

Does anyone have any thoughts on this?

Thanks:frust:

Although it's not about management review, there's some related discussion in this thread: Calibration Certificates - Do Calibration Certificates Need to be Reviewed? (http://elsmar.com/Forums/showthread.php?t=24727).

We have "Prepared By", "Reviewed By" and "Approved By" for these minutes.