I'm giving training next week, on ISO13485/MDD to prospective third-party assessors for SGS. We run the training as need arises, typically that's two to three times a year.

The candidates have a range of backgrounds, we recruit people with a medical devices background and minimum that they have done the 5-day ISO9001 lead auditor course. The technical background of the candidates varies a lot, but they are most often quality assurance people, perhaps who also provide (non-conflicting) consultancy services.


(Experienced auditors, e.g. those that have joined us from another certification body, typically just need to sit our exams and get trained on our procedures, they don't have to sit through the whole course).


Assuming the candidates pass the separate exams for ISO13485 and MDD, they then need to qualify in the field, first as Surveillance Assessors, and subsequently as Lead Assessors. That takes from a few weeks to a few months, depending on various factors.
(Qualification for CMDCAS is independent of this process, as Health Canada runs its own training.)


We are continuously sprucing up the training course content. The technical core of the course is essentially unchanged, but various things get lesser or greater prominence over time, and there are various new elements all the time. Risk management and GHTF guidance are hot topics for example, and the course now includes the imminent requirements of 2007/47/EC.

But aside from all the technical content, it is important not to overlook the customer perspective as well. So here's your chance, comments welcome..... :)

I assume this is free with the understanding that some people from the class will be offered 'positions' as third-party assessors for SGS (a screening process). Is that correct?

Sorry if I wasn't clear enough.

This is not open-to-all training. The recruitment screening process has already been completed via review of general and technical CVs and a telephone or FTF interview.

What is happening now is they are undergoing the first stage of internal training (i.e. education on auditing against 13485/MDD), there are some additional field-based phases as described above.

It is our hope and intent that all the candidates pass all stages of the training, and we work hard to ensure that happens. If someone proves to be unsuitable (rare, but it happens), then we have to recruit someone else and start the process all over again.



The reason for my post is that it would be neat to include some "real-life" feedback, not just from my personal audit clients, not just from other SGS audit clients.

What do you want from your auditors, and is this different for ISO13485/MDD than for (e.g.) ISO9001?

One example I thought of, direct from discussion here on Elsmar Cove, is a need to discuss how Risk Management gets applied to subcontractors.

I'll include a brief chat about that.