A
arbela
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
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