ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training

Philip B

Quite Involved in Discussions
I do a lot of our audits and I am not 'ISO 13485 lead-auditor' trained. As others have said there is no requirement for this. You just need to demonstrate competence (experience, training, qualifications etc) and independence.
 

James

Involved In Discussions
Our company's Quality Manager acts as the Head Team Auditor for our Internal Audit program. We are certified to ISO 13485:2016 and all of our internal auditors, Quality Manager, included, have received training as ISO 13485:2016 internal auditors. At a former job, our Quality Manager received training as a LEAD Auditor for a different industry, specifically IATF.

<snip>

So my question is this: what additional training is given to an ISO13485 lead auditor versus a "regular" ISO13485 internal auditor, and is that additional training different than what they would receive as an IATF lead auditor? My understanding is that certification as a lead auditor gives you the tools to plan, schedule, and review the internal audits of the team... basically, to act as a leader and planner for the rest of the internal audit team. Is there really so much different being taught between the two types of lead auditor that she will have to take 4 more days of training AGAIN to become a "legitimate" ISO13485 lead auditor?

My only relevant formal qualification is as an ISO 9001 Lead Auditor; I'm essentially doing the same function as your lead auditor but from a QA perspective; I audit the internal auditors audits. We only make class 1 devices. I'd argue strongly that our documented procedure is sufficient, and would agree with others that you need to push back.

James
 

Schkund

Involved In Discussions
@Jim Wynne, he cited section 8.2.4 a) of ISO 13485:2016...

"The organization shall conduct internal audits at planned intervals to determine whether the quality management system conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements established by the organization, and applicable regulatory requirements."

We feel we showed evidence of meeting this section and our organizational QMS requirements and we told our auditor this. Unfortunately, he was determined that this was a finding. Throughout the rest of the audit there were several additional instances in which we felt our responses to his findings and comments fell on deaf ears.

Some days the bear gets you...
 

James

Involved In Discussions
@Jim Wynne, he cited section 8.2.4 a) of ISO 13485:2016...

"The organization shall conduct internal audits at planned intervals to determine whether the quality management system conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements established by the organization, and applicable regulatory requirements."

We feel we showed evidence of meeting this section and our organizational QMS requirements and we told our auditor this. Unfortunately, he was determined that this was a finding. Throughout the rest of the audit there were several additional instances in which we felt our responses to his findings and comments fell on deaf ears.

Some days the bear gets you...

He needs to demonstrate very specifically with evidence where you have not achieved conformance to that clause. It can't be his 'gut feeling' or 'thoughts', it needs to be absolute.

Appeal.
 

Jim Wynne

Leader
Admin
@Jim Wynne, he cited section 8.2.4 a) of ISO 13485:2016...

"The organization shall conduct internal audits at planned intervals to determine whether the quality management system conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements established by the organization, and applicable regulatory requirements."

We feel we showed evidence of meeting this section and our organizational QMS requirements and we told our auditor this. Unfortunately, he was determined that this was a finding. Throughout the rest of the audit there were several additional instances in which we felt our responses to his findings and comments fell on deaf ears.

Some days the bear gets you...
It appears that you might have an incompetent auditor. There's nothing in evidence here to indicate that anything there was violated. The clause makes no reference to anyone's status as "lead" auditor being a requirement. You can't allow auditors to make up their own requirements. I would appeal.
 

Tidge

Trusted Information Resource
A poor attempt at humor follows:

The clause makes no reference to anyone's status as "lead" auditor being a requirement. You can't allow auditors to make up their own requirements. .

Perhaps the auditor has some past experience with RoHS and is only familiar with "lead-free" requirements?
 

Carol2015

Involved In Discussions
I do a lot of our audits and I am not 'ISO 13485 lead-auditor' trained. As others have said there is no requirement for this. You just need to demonstrate competence (experience, training, qualifications etc) and independence.
Thank you!
 

Schkund

Involved In Discussions
Thank you for all of your feedback, all! We ended up appealing two of the three findings that this auditor gave us and both of the appealed findings were retracted, so while it was a very frustrating experience at the time, we were at least able to feel vindicated in our argument to drop it as a nonconformance.
 

tking87

Registered
I do a lot of our audits and I am not 'ISO 13485 lead-auditor' trained. As others have said there is no requirement for this. You just need to demonstrate competence (experience, training, qualifications etc) and independence.

I would still push back as already mentioned there is no actual requirement not being meet. but here is my 2 cents.

This is where they may be coming from.

For formal training I've completed going through TPECS (Training Provider & Examiner Certification Scheme), a Lead Auditor & 13485 Auditor are two separate trainings. The Lead Auditor would receive training on ISO 19011:2018 and given a (AU) and (TL) certificate. A 13485:2016 Auditor would receive training on the 13485 standard and given a (MD) certificate. You can compete these at the same time and your certificate will show all completed.

Hope this helps,
 

Schkund

Involved In Discussions
I would still push back as already mentioned there is no actual requirement not being meet. but here is my 2 cents.

This is where they may be coming from.

For formal training I've completed going through TPECS (Training Provider & Examiner Certification Scheme), a Lead Auditor & 13485 Auditor are two separate trainings. The Lead Auditor would receive training on ISO 19011:2018 and given a (AU) and (TL) certificate. A 13485:2016 Auditor would receive training on the 13485 standard and given a (MD) certificate. You can compete these at the same time and your certificate will show all completed.

Hope this helps,

That's the funny thing, tking.... our Quality Manager was able to provide her certification as a Lead Auditor AND her separate certification as an ISO 13485:2016 Auditor, but he insisted that she specifically needed to have a combined ISO 13485:2016 LEAD Auditor certificate. He was determined that having the two separate certifications was not sufficient.
 
Top Bottom