FDA 21 CFR Part 820 Medical Device Audit Criteria

Bill Evans

Involved In Discussions
#1
Does anyone have a pre-defined audit criteria that is FDA compliant. I have one for TS-16949 and Visteon. I need to find audit criteria for FDA, can anyone help?
 
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sagai

Quite Involved in Discussions
#3
Audit criteria for FDA mock audit is the 21CFR820 itself.
Yes ... if anyone would like to do that, has to have experience and knowledge to prepare such audit, there is no golden checklist I guess.
Cheers!
 

Bill Evans

Involved In Discussions
#4
There actually is a "pre-defined golden checklist". It is in the gmp publications21 CFR 820 audit checklist.

As a part of the internal audit plan our auditors need to have a criteria that they can use. I am l;ooking for something like I started to develop in the attachment.

Thanks

Bill
 

Attachments

M

MIREGMGR

#5
You don't need to buy or create such a checklist. An official one already exists, available online free from FDA. See the link to the QSIT manual ("Guide to Inspections of Quality Systems") in my prior post above. The exact questions are right in the manual.
 

Bill Evans

Involved In Discussions
#6
Thank you,

I am aware of the QSIT document. I am looking for something in an excel type format that we may use and customize for our internal audits.

Thanks

Bill
 
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