Internal Auditing - ISO 9001 auditing vs. FDA CFR auditing - Which to choose?

T

TJG954 - 2009

You folks have been great with providing answers and advice. Thank you. Here's my next question;

If you do an internal audit, referencing ISO, will that have a negative impact on FDA's recognition of the audit?

I noted that an ISO audit check list was 44 pages long, with an average of 5-6 points per page. That's well over 200 checks. The FDA checklist was 5 pages long with 4-5 points per page, representing less than 25 checks.

I guess my point is that I find far more references to ISO than I do FDA. Can I interchange checklists and still be in compliance with FDA?

Take care, Ted :beerdive: (it's Friday)
 
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ScottK

Not out of the crisis
Leader
Super Moderator
Re: ISO vs FDA

You folks have been great with providing answers and advice. Thank you. Here's my next question;

If you do an internal audit, referencing ISO, will that have a negative impact on FDA's recognition of the audit?

I noted that an ISO audit check list was 44 pages long, with an average of 5-6 points per page. That's well over 200 checks. The FDA checklist was 5 pages long with 4-5 points per page, representing less than 25 checks.

I guess my point is that I find far more references to ISO than I do FDA. Can I interchange checklists and still be in compliance with FDA?

Take care, Ted :beerdive: (it's Friday)

without seeing your checklist I'll say "no" to your question.

FDA wants you to audit to the CFR because their CFR is written specifically for drugs or devices or cosmetics or food.
They don't care if you're ISO or not.

Remember...

ISO is voluntary
FDA CFRs are LAW

So audit to the FDA requirements if you can only do one.

My approach in the past was ISO + FDA GMPs in one system/manual/audit plan.

ps - I edited the title of your post to clarify a bit better.
 
R

Roland Cooke

Re: ISO auditing vs FDA auditing. Which to choose?

Actually you would be falling down on ISO13485 8.2.2.B as well, since your Internal Audit programme would clearly not br taking proper account of the regulatory environment you are in, confirming effective implementation. :cool:


The answer is to audit your QMS, using a combined approach, that covers all elements of the CFR and ISO. There is plenty of overlap so it isn't a huge issue.

(The style of FDA vs ISO audits is very different usually, however, and this would need to be managed appropriately).
 

Doug Tropf

Quite Involved in Discussions
Re: ISO auditing vs FDA auditing. Which to choose?

If you are ISO 13485 certified then I would recommend that the scope of
your internal audit address both ISO and FDA requirements. While the two standards are somewhat harmonized, there are some differences.
 
T

TJG954 - 2009

This company has patented and constructs a new way to process xray images and that now makes us manufacturers. We have received our 510k and the whole regulation process (21 CFR 820) is brand new. My background was in neutraceuticals and I came out of retirement to address this medical device situation. As with small organizations that operated for years without regulation, the implementation is hectic. I have absolutely no guidance. That's why I'm so glad to have found this site of actual practitioners who deal in reality vs philosophy. I have to conduct our first self-audit in about 30 days, and I'm scrambling for the best format.

Thanks again, Ted :thanx:
 

Al Rosen

Leader
Super Moderator
You folks have been great with providing answers and advice. Thank you. Here's my next question;

If you do an internal audit, referencing ISO, will that have a negative impact on FDA's recognition of the audit?

I noted that an ISO audit check list was 44 pages long, with an average of 5-6 points per page. That's well over 200 checks. The FDA checklist was 5 pages long with 4-5 points per page, representing less than 25 checks.

I guess my point is that I find far more references to ISO than I do FDA. Can I interchange checklists and still be in compliance with FDA?

Take care, Ted :beerdive: (it's Friday)
If your procedures are written to meet all the requirements and you audit to them, you will meet the requirements of both.

BTW, FDA is not entitled to view your audit results according to 21cfr820.180(c). They can write up a finding for an ineffective audit system if they writeup too many findings.
 
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