ISO 13485 Clause 8.2.2 - Internal auditor from within the company to be audited

A

Asherlee

#1
Hi to the members of the forum,

ISO 13485 says in clause 8.2.2 that “auditors shall not audit their own work”.
The NOTE in 8.2.2 refers to ISO 19011, which I do not have. ISO 19011:2002 provides guidance on the principles of auditing, and is applicable to all organizations needing to conduct internal or external audits of quality.

Question: can a member of a company audit an area in the company in which he/she is employed, when he/she has overall or indirect responsibility for the area concerned, but does not directly work in the area to be audited?

Thanks for the input.

Asherlee
 
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Al Rosen

Staff member
Super Moderator
#2
Asherlee said:
Hi to the members of the forum,

ISO 13485 says in clause 8.2.2 that “auditors shall not audit their own work”.
The NOTE in 8.2.2 refers to ISO 19011, which I do not have. ISO 19011:2002 provides guidance on the principles of auditing, and is applicable to all organizations needing to conduct internal or external audits of quality.

Question: can a member of a company audit an area in the company in which he/she is employed, when he/she has overall or indirect responsibility for the area concerned, but does not directly work in the area to be audited?

Thanks for the input.

Asherlee
Regardless of how you interpret the standard, I don't think it's appropriate. There is always a possibility of a conflict of interest or a question of objectivity developing during the audit.
 
#3
To expand on Al' thoughts (I'm thinking along those same lines), the key is that audits must be objective and impartial. The smaller the organization, the more difficult it is to find someone who is not engaged in multiple processes. For example, perhaps everyone buys stuff, or checks product in. I have general responsibility for either of the above. I can still audit it, but would not be able to audit the stuff I buy, or check in.
 
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