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

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Per ISO 19011:2011

5.3.2 Competence of the person managing the audit programme The person managing the audit programme should have the necessary competence to manage the programme and its associated risks effectively and efficiently, as well as knowledge and skills in the following areas: — audit principles, procedures and methods; — management system standards and reference documents; — activities, products and processes of the auditee; — applicable legal and other requirements relevant to the activities and products of the auditee; — customers, suppliers and other interested parties of the auditee, where applicable. The person managing the audit programme should engage in appropriate continual professional development activities to maintain the necessary knowledge and skills to manage the audit programme
 

tking87

Registered
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.

Schkund, Yeah... that is ridiculous. The AU and TL is a separate standard (ISO 19011), regardless of the industry it is applied to. 13485, 14001, 9001, it doesn't matter. The auditor can't see the forest for the trees at this point.


Ed, we're up to 19011:2018 now. Also, are you trying to highlight something in this clause?
 

Schkund

Involved In Discussions
Per ISO 19011:2011

5.3.2 Competence of the person managing the audit programme The person managing the audit programme should have the necessary competence to manage the programme and its associated risks effectively and efficiently, as well as knowledge and skills in the following areas: — audit principles, procedures and methods; — management system standards and reference documents; — activities, products and processes of the auditee; — applicable legal and other requirements relevant to the activities and products of the auditee; — customers, suppliers and other interested parties of the auditee, where applicable. The person managing the audit programme should engage in appropriate continual professional development activities to maintain the necessary knowledge and skills to manage the audit programme
Would you not consider Lead Auditor training and ISO 13485:2016 training sufficient and appropriate for these activities? Is there even such a thing as one ISO 13485:2016 Lead Auditor training that would provide any knowledge or skills that would not be obtained in the two separate training courses?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Would you not consider Lead Auditor training and ISO 13485:2016 training sufficient and appropriate for these activities? Is there even such a thing as one ISO 13485:2016 Lead Auditor training that would provide any knowledge or skills that would not be obtained in the two separate training courses?
I think the requirements are clear that for an internal audit there is a lot of latitude in the choice.
 

bme007

Starting to get Involved
She doesn't audit Quality Systems where she is listed as the process owner. Rather, she audits areas such as Purchasing, production processes on the floor, etc. She is the Quality Manager, but it doesn't mean that she is the one executing all aspects of the quality management system; those responsibilities are distributed among our managers.

I tend to agree that if someone put down on an important document their position title, a lead auditor in this case, regardless how much he/she knows or how much experience they have, they must provide proof in the form of a certification, like a lead auditor training certification, not based on the know or the experience…
 

Jim Wynne

Leader
Admin
I tend to agree that if someone put down on an important document their position title, a lead auditor in this case, regardless how much he/she knows or how much experience they have, they must provide proof in the form of a certification, like a lead auditor training certification, not based on the know or the experience…
Can you cite a requirement of any kind to support the idea that "...proof in the form of a certification..." must be provided?
 

bme007

Starting to get Involved
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.
 

bme007

Starting to get Involved
Schkund. Oh I see now after reading your latest post. In this case, I agreed with other opinion. However, the question is should she fights (pushes back) at the company auditor or makes a peaceful cooperation with the auditor to get him revised his report?
 

Jim Wynne

Leader
Admin
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.
Some companies have their own forklift certification/licensing process and won't accept third-party certification. This really has nothing to do with auditors, though. Although I retired about six years ago, I was the lead internal auditor for the company where I was working, and then came a customer requirement for there to be a RABQSA-certified lead auditor on staff. I had to go to Detroit for five days to take (what was then) the RABQSA TS16949/ISO 9001 lead auditor training. When I finished it I was still the lead auditor in the company. If I own the company, I can designate a "lead" auditor, or call that position Grand Poobah of Auditing, or whatever else I want to call it, but I shouldn't refer to a non-certified person as a certified lead auditor.
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.
And the "legitimate proof" can be in the form of the company CEO verifying that she is indeed the lead auditor. There can be no nonconformity, even in internal audits, if no requirement was unfulfilled. The internal auditor doesn't get to decide unilaterally that "Lead Auditor" is always synonymous with "third-party certified Lead auditor."
 

bme007

Starting to get Involved
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.
 
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