ISO 13485:2016 - Internal Auditor Training vs. Lead Auditor Training

Have any of you trained to Oriel Stat A Matrix Internal auditor training and/or Lead Auditor training? Both are to 13485. I have a QA person I want to send to the training. I took the Lead auditor training a few years back and was wondering if the internal auditor training was pretty much the same. There is a $1000 difference between them. Any advice?
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I can't speak specifically about the courses you mention, or ISO 13485 but generally internal and external audit skills are very similar. In both cases you will need to prepare for the audit, interview people and collect evidence and report your findings.

Where they differ is in the scale of the audit and the depth to which you go into the standard. For the internal audit a person needs to have a broad understanding of what the requirements are but for the external audit s/he needs a thorough understanding.

Usually an internal auditor will take a process/area/department to audit whilst an external auditor will be looking at the whole company.

Which one to go for - internal first every time for me and then if you need to, progress to the LA course in the future.


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My guess is that the internal audit course will focus primarily on planning-conducting-reporting audits, while the lead auditor will focus on this PLUS a significant review/understanding of 13485. However, internal auditors don't necessarily need to focus to 13485, but instead to your internal policies & procedures.

It really comes down to the level (breadth, depth) of competencies you want to develop.


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One major deference between Internal Auditor and Lead Auditor certifications is course content. Both types of auditors must understand basic audit guidance of ISO 19011 but a Lead auditor must also understand the requirements from certification bodies found in the ISO 17021 series of Standards.

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