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.
When she moved from her IATF-related job to this position in the medical device industry, she took a lot of forms that she developed, adapted them for our industry, and implemented them. One of these forms was our final audit report, which compiles the information from all of the internal audits performed for the month to share with management. At the top of the report she labeled herself as "Lead Auditor".
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.
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?
When she moved from her IATF-related job to this position in the medical device industry, she took a lot of forms that she developed, adapted them for our industry, and implemented them. One of these forms was our final audit report, which compiles the information from all of the internal audits performed for the month to share with management. At the top of the report she labeled herself as "Lead Auditor".
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.
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?