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

[Chuck in QA]

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?

 

[Colin]

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.

 

[Marcelo]

Lead auditor trainings are usually certified, that's why there's a difference in price (besides the usual longer time).

 

[randomname]

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.

 

[BoardGuy]

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.

 

[Haresh]

Lead auditor trainings are usually certified, that's why there's a difference in price (besides the usual longer time).

Dear Marcelo,
Suppose we prepared the QMS as per ISO 13485 :2016 by own, without any training from certification body. But most of time I observed that the certification body asking the ISO 13485 training certificate from the certification agency when they come for ISO 13485 certification. So my question is that is it mandatory to have iso 13485 training certificate to the internal auditor though he is competent enough?

 

[Thee Bouyyy]

So my question is that is it mandatory to have iso 13485 training certificate to the internal auditor though he is competent enough?

Play smart. It's time to use "Show me the Shall..."

"Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process."

Nothing on formal qualifications in that context. A person should have specific education/training/experience in a particular discipline really could enhance audit effectiveness.

 

[Haresh]

Play smart. It's time to use "Show me the Shall..."

"Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process."

Nothing on formal qualifications in that context. A person should have specific education/training/experience in a particular discipline really could enhance audit effectiveness.

Thanks a Lot.

 

[Tagin]

Dear Marcelo,
Suppose we prepared the QMS as per ISO 13485 :2016 by own, without any training from certification body. But most of time I observed that the certification body asking the ISO 13485 training certificate from the certification agency when they come for ISO 13485 certification. So my question is that is it mandatory to have iso 13485 training certificate to the internal auditor though he is competent enough?

13485 8.2.4 has this note:

NOTE Further information can be found in ISO 19011

I recommend looking at 19011 (Guidelines for auditing management systems) , as it discusses 'competence' in several sections and even devotes an entire clause to "Competence and evaluation of auditors".

To your specific question, 19011 does not specifically require formal training for an auditor. The general concept is in this quote:

Competence should be evaluated regularly through a process that considers personal behaviour and the ability to apply the knowledge and skills gained through education, work experience, auditor training and audit experience. This process should take into consideration the needs of the audit programme and its objectives. Some of the knowledge and skills described in 7.2.3 are common to auditors of any management system discipline; others are specific to individual management system disciplines. It is not necessary for each auditor in the audit team to have the same competence. However, the overall competence of the audit team needs to be sufficient to achieve the audit objectives.

 

[Haresh]

13485 8.2.4 has this note:


I recommend looking at 19011 (Guidelines for auditing management systems) , as it discusses 'competence' in several sections and even devotes an entire clause to "Competence and evaluation of auditors".

To your specific question, 19011 does not specifically require formal training for an auditor. The general concept is in this quote:

Thanks a Lot for valuable information