ISO 13485 - Internal Auditor Independence and Process Owners

A

arbela

#1
Hi all.
I'm the QA manager at a small MD startup. We're just setting up our QMS in preparation for our first ISO 13485 audit. As often is the case with small companies, QA is involved directly in the implementation of many processes, and to avoid bias and impartiality and maintain independence, I've contracted an external consultant to audit those processes. However, since the consultant is also obliged by our IA process, I fear a conflict of interests might be declared when that consultant is required to audit the Internal Audits process. I should point out that I have applied this solution before with no questions asked by the NB. Am I over reacting, or is there a reasoning that can and should be used to resolve this conflict? For example, I have referred to ISO 19011:2011 sec. 4(e) to explain why the fact that I am the author of all the QS policies does not make me their owner, and therefore does not create bias when I audit any process for which I am not explicitly mentioned as responsible. Your thoughts are welcome:)
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
When you outsource your internal audit process, the key thing is to ensure the competence of the consultant. I would not be too concerned with his/her objectivity and impartiality.
 
A

arbela

#3
thanks for the reassurance. And yes, i have the consultant competency issue covered in the policy - apart from using it myself to assure i get my money's worth for the activity, i know the NB will look for it as well.
 

RCW

Quite Involved in Discussions
#4
Interesting but true story....

I had an auditor one time who insisted that my internal audit system needed to be audited by the bookkeeper here as they were dealing with the company's financials and were outside the umbrella of the QMS. Totally lost in his logic, I quizzed him.
Q: "Does the bookkeeper have to follow the internal audit procedure?"
A: "Oh yes indeed!"
Q: "Then they should be trained in that procedure?"
A: "But of course!"
Q: "Then aren't they involved in the QMS then at that point?"

He shut up and backed down immediately. Gee, wonder why I never used that registrar again.....
 
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