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Impartiality of Internal Auditor ISO 9001/13485

D

Deli88

Involved In Discussions
#1
#1
I'm 99.999% certain this isn't allowed but I want to sound this off against some more experienced people than myself.

As part of out QMS we have 4 process, Purchasing, Customer Order, Production, and Management

As it stands I conduct 3 of the 4 audits, the 4th audit is against the management which I cannot conduct due the fact that I am responsible for this area as the QM.

Is it acceptable for another member of the quality team to conduct this audit or does the person need to be further removed?
 
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blackholequasar

blackholequasar

Involved In Discussions
#2
#2
Newer employees may be able to get away with it, as they are brand new to the process in general, but as a rule of thumb... it's probably not far enough removed to allow internal auditing to be performed. I would bring someone else in to do this part of the audit.

Do you audit the same areas every year? Do you have any other team members for internal audits? (Some smaller companies struggle with this, I completely empathize - in the same boat myself!)
 
B

Big Jim

Super Moderator
#3
#3
There is good guidance for this in ISO 9002:2016. ISO 9001:2015 DOES NOT prohibit you from auditing your own work. That clause from the 2008 version was removed. The guidance in 9002 helps you to keep it impartial and objective.

Some knucklehead auditors just won't let this obsolete requirement die.
 
B

Big Jim

Super Moderator
#4
#4
I answered based on 9001. 13485 does indeed still require that you not audit your own work. The knuckleheads at 13485 are living in the past. They didn't move up to the High Level Outline and their standard is still based on ISO 9001:2008.
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
#5
Big Jim said:
There is good guidance for this in ISO 9002:2016. ISO 9001:2015 DOES NOT prohibit you from auditing your own work. That clause from the 2008 version was removed. The guidance in 9002 helps you to keep it impartial and objective.

Some knucklehead auditors just won't let this obsolete requirement die.
Click to expand...
Just to remind people of the contentious thread on this subject: Informational - Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work)

Internal audits have to be "independent", impartial and objective. If anyone thinks that you can accomplish that, while auditing your own work, I disagree. The wording in ISO 9001:2015 was revised due to the High Level Structure text, but, in my opinion, the intent remains unchanged.

As for the guidance of ISO/TS 9002, see below. It is VERY SPECIFIC

Annotation 2019-12-13 113617.jpg​
 
G

Golfman25

Trusted Information Resource
#6
#6
What we do is we have 4 auditors who are department managers. Then we audit each other. So the purchasing manager/auditor audits the manufacturing guy. The Manufacturing guy audits management. Etc.
 
B

Big Jim

Super Moderator
#9
#9
Sidney Vianna said:
Just to remind people of the contentious thread on this subject: Informational - Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work)

Internal audits have to be "independent", impartial and objective. If anyone thinks that you can accomplish that, while auditing your own work, I disagree. The wording in ISO 9001:2015 was revised due to the High Level Structure text, but, in my opinion, the intent remains unchanged.

As for the guidance of ISO/TS 9002, see below. It is VERY SPECIFIC

Click to expand...
The highlight is good but look at the rest of the sentence. ". . . or areas of the organization where specific job knowledge is required . . . "
and ". . . it may be necessary for a person to audit their own work ."

And then in the next sentence it gows on to tell you how to remain objective and impartial. "In this situation, the organization might have the internal auditor work with a peer, or have the results reviewed by a peer or a manager, to ensure results are impartial."

It would really be wonderful if TC-176 would explain exactly why they removed "auditors shall not audit their own work" from the latest version of the standard. In the meantime the only guidance we have from them is ISO 9002:2016, and what is there IS NOT ENOUGH TO JUSTIFY C,LAIMING THAT THERE WAS NO CHANGE.
 
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