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Internal Auditor Qualifications ? ISO13485 vs. ISO9001

K

kfric

#1
Internal Auditor Qualifications – ISO13485 vs. ISO9001

Hi

We are an ISO9001:2008 registered contract electronics manufacturer who is in the process of adding ISO13485:2003 certification.

My question is with respect to the internal audit training requirements. We have an audit team who are all formally trained ISO9001 internal auditors. What additional training is needed for these auditors to be considered competent to internally audit a QMS that now includes ISO 13845? Is full ISO 13485 Internal Audit training required or is awareness/overview training of the differences between 13485 and 9001 sufficient given that my team are already trained in internal audit techniques?

Thanks in advance for your responses.
 
Elsmar Forum Sponsor
#2
Re: Internal auditor qualifications – ISO13485 vs. ISO9001

Whatever you decide will be the competencies that are applicable, is all that's required. An understanding of the specifics of ISO 13485 is helpful, but after that, you decide on competencies.
 
R

rdesmond

#3
I need help on this. We had our auditor in for a 13485 Pre-Assessment audit. He said it was not acceptable to use a formal 9001 audit training to qualify internal auditors even though we documented that any formal audit training was ok as long as the certified Lead Assessor made an assessment of their qualification as an auditor which I did have the training record for. He said I had to do a training for the 2 people who only had 9001, although one was a CQA and has been in the quality field for 30+ years & has been our Quality Manager for Medical Devices for 5+ years. I see nothing that requires this but feel stuck since our assessor told us this flat out.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I need help on this. We had our auditor in for a 13485 Pre-Assessment audit. He said it was not acceptable to use a formal 9001 audit training to qualify internal auditors even though we documented that any formal audit training was ok as long as the certified Lead Assessor made an assessment of their qualification as an auditor which I did have the training record for. He said I had to do a training for the 2 people who only had 9001, although one was a CQA and has been in the quality field for 30+ years & has been our Quality Manager for Medical Devices for 5+ years. I see nothing that requires this but feel stuck since our assessor told us this flat out.
Time to use the almighty "Show me the Shall..."

The only requirements I see in ISO 13485:2003 explicit to internal auditors are:

Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
Nothing on formal qualifications in that context, let alone anything on 9001 vs. 13485. The requirement to train a +5 years medical devices QM who also has formal ISO 9001 auditor qualifications sounds absurd.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
I am with Ronen and Andy. :agree:

That said, I can also vouch that having specific education/training/experience in a particular discipline really could enhance audit effectiveness. So it seems to me that trainings or seminars might help your internal auditors gain insights that raise the awareness needed to provide better value in audits. But specific requirements for training are generally made by industry groups or customers.
:2cents:
 
R

rdesmond

#6
Sorry - I should have also mentioned that we completely subcontract our annual QMS audit. We use our 6 Internal Auditors to perform interim process,& product audits & to perform CAR verifications. So, I am certainly not looking to be at odds with our assessor but I see no requirement to have auditors trained to a particular standard.
 
#7
...but I see no requirement to have auditors trained to a particular standard.
There are none. Your auditors have to be competent, as per 6.2 of course, but there are no specific requirements for ISO 13485.

Now, with that said... three things to check.
1) What does your own documentation say? If it specifies certain requirements, then you have to either change your documentation, or live up to it.
2) Make sure you don't have any customer specific requirements which require more
3) Check with any regulatory agency that you might be under.

If none of the three above mention additional internal auditor qualifications, then as was said above: "Show me the shall"
 

Ronen E

Problem Solver
Staff member
Moderator
#8
There are none. Your auditors have to be competent, as per 6.2 of course, but there are no specific requirements for ISO 13485.

Now, with that said... three things to check.
1) What does your own documentation say? If it specifies certain requirements, then you have to either change your documentation, or live up to it.
2) Make sure you don't have any customer specific requirements which require more
3) Check with any regulatory agency that you might be under.

If none of the three above mention additional internal auditor qualifications, then as was said above: "Show me the shall"
I'd say "Show me the Shall" holds even if any of the 3 above apply, because if this is the basis of the auditor's statement, he/she should be able to point out such specific basis. I meant "Shall" in the broader sense - a documented, applicable and valid requirement.

Cheers,
Ronen.
 
#9
I'd say "Show me the Shall" holds even if any of the 3 above apply, because if this is the basis of the auditor's statement, he/she should be able to point out such specific basis. I meant "Shall" in the broader sense - a documented, applicable and valid requirement.

Cheers,
Ronen.
Agreed :agree:
 
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