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

Jim Wynne

Leader
Admin
To Jim. "I had to go to Detroit for five days to take (what was then) the RABQSA TS16949/ISO 9001 lead auditor training". There you go, you should have some sort of training certification after you completed it. Thanks.
Indeed I did. But I was the company's lead auditor before that. Once again, where is the nonconformity?
 

bme007

Starting to get Involved
Jim. If the auditor finds no issue thru his/her audit, then the company should be in conforming. On the other note “…selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.” (ref. 8.2.2, ISO9000).
 

Jim Wynne

Leader
Admin
From the original quote, with my emphasis:
The auditor for the company that provides our ISO certification is giving us a minor nonconformance because there is no evidence that she has been trained as an ISO13485 lead auditor, only two separate certificates, one for lead auditing in another industry, and another for 13485, but not as a lead auditor. Our process doesn't state anything about a lead auditor, simply that the Quality Manager is the team leader for our internal auditing group, but because one form refers to her as a lead auditor, we are receiving a nonconformance.
Jim. If the auditor finds no issue thru his/her audit, then the company should be in conforming. On the other note “…selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.” (ref. 8.2.2, ISO9000).
There is nothing here to indicate that the lead auditor in question is auditing her own work. If a CB auditor issued an NC without any requirement being cited on which to base it, the finding should be challenged because again, there can't be a nonconformity in the absence of a documented requirement.
 

Sidney Vianna

Post Responsibly
Leader
Admin
Hi Jim. It is my opinion.
That pretty much sums it up. However, for findings to be categorized as non-conformity, the EVIDENCE must show that requirements (from the audit criteria) are not being complied with. Opinions, likes and dislikes might even trigger findings, such as observations, opportunity for improvement, etc...The litmus test for a valid nc is the existence of:
a) a requirement
b) a failure
c) evidence to support the conclusion of the failure.
 

Mike S.

Happy to be Alive
Trusted Information Resource
In AS9100 world, about 10 years ago, my former employer decided on their own to send their Lead Internal Auditor for formal Lead Auditor Certification. Just felt it was good training.

The next year, their new AS9100 registrar auditor asked if the LA was certified and he said yes, and showed his cert, and the registrar auditor said "good, if you didn't have that I'd write a NC, the LA has to be certified". Well, there was no NC for us, so no nothing to fight, but the guy was wrong.
 

Cthames

Involved In Discussions
Hi Jim. It is my opinion. If you have many years of experience driving a forklift in you past employment does not mean the new company will allow you to operate one if you don’t have the training certification.
When I said “must be provided”, I mean to solve the issue with “nonconformance” they received from the company auditor, she/he needs a legitimate proof for the argument with the auditor.
Nonconformities are written based on lack of adherence to a requirement, not auditor opinions. If an auditor is writing NCs for their opinions, I'd argue that it was not an unbiased audit.
 

Mikey324

Quite Involved in Discussions
When you take a lead auditor training course, you are trained to ISO 13485 requirements. Regardless, this should not be a finding.

But wait, how can the Quality Manager be doing an internal audit? "Auditors shall not audit their own work." I would give you a nonconformity for that. Just sayin'...

You would have to find evidence that this was an issue.
@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...

I can't connect the "finding" with the requirement??? Was your system audited at planned intervals? If so, show them that and say move on. I dislike the statement on nonconformity that doesn't match up to the requirement they point out.
 

Jim Wynne

Leader
Admin
When you take a lead auditor training course, you are trained to ISO 13485 requirements. Regardless, this should not be a finding.

But wait, how can the Quality Manager be doing an internal audit? "Auditors shall not audit their own work." I would give you a nonconformity for that. Just sayin'...
Who said that the auditor was auditing her own work?
 

Randy

Super Moderator
In AS9100 world, about 10 years ago, my former employer decided on their own to send their Lead Internal Auditor for formal Lead Auditor Certification. Just felt it was good training.

The next year, their new AS9100 registrar auditor asked if the LA was certified and he said yes, and showed his cert, and the registrar auditor said "good, if you didn't have that I'd write a NC, the LA has to be certified". Well, there was no NC for us, so no nothing to fight, but the guy was wrong.

The Lead Auditor's gotta be a boob, being in possession of a training certificate does not make one certified, especially for something like AS9100, it just signifies accomplishing the requirements of a training course. He deserves a NC for not knowing the difference.
 
Who said that the auditor was auditing her own work?
The first post made it seem like the quality manager was auditing all systems. However, after my comment, the OP clarified that the lead auditor was not auditing her own work. I would redact, but I can't edit that post.
 
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