This jumble of names in the adjacent picture is a bit how one feels when first looking for a Notified Body. Who to pick? How to discern one from the other? To a new company who is just starting down the road of the Quality Management System, this is a bit daunting and I think my first assumption, when I started in this field many years ago, was that as regulatory bodies they would all be pretty much the same.
To give a bit of background – I first worked with the old BS5750 standard, which grew and changed into 9001. When the medical devices company I was working for needed 13485, I registered them to that standard as well, and have worked extensively with it ever since. These two standards are very different, as anyone working with the two will know, even though they both ostensibly address the same issues.
Initially, I thought that the differences in companies and their quality systems, and maybe the auditors themselves, was accounting for the differences I was experiencing with the approaches to the standards across the Notified Bodies I was dealing with. However, as time has passed I have realised that it is the Notified Bodies themselves who have different interpretations, one from the other. This coupled with, of course, the expected difference of one auditor’s opinion over another, does make life difficult. Especially when explaining to the client why the standard says one thing but the Notified Body says another, and it’s down to a difference in perception?? Auditor opinion can be dealt with, discussed and if not agreed on, at least explained, but once a dispute over a point of compliance reaches the offices of the NB they are, in my experience, unlikely to change their view.
I have thought long and hard about whether these differences are an asset or not. When regulations are set by distant bodies like the EU Commission and are handed down as directives to be installed by industry and policed by Notified Bodies one would expect the same rules to apply, as we believe it does with the law of the land.
Having outlined the problems I have come across, I will happily say that some Notified Bodies are extremely practical in their approach to the requirements of ISO13485. Working with them is a pleasure, and is a case of using what is in the standard, together with what is in the Medical Devices Directive. MDD 93/42/EEC is a long document but a fairly clear one and these NBs have a sensible approach that follows what is written down and what makes practical sense for the company involved and their QMS, taking into account their plans for the future. It can also be said that for these NBs you will find consistency across the world in their regional offices.
Unfortunately, other Notified Bodies will work putting their own interpretations of what the clauses in the standards and directives mean, and look at some of the requirements with their own slant on them, insisting that companies follow their direction whatever. This becomes confusing at best. I have also found that with these NBs, there can be inconsistency in other countries.
I think we are all looking for a level playing field in the world of regulatory affairs, and the new directives that came out last September are designed to even things up and improve the situation. I hope this will be the case worldwide.
In the end, however, it may well be that these differences between the approaches of the Notified Bodies is actually healthy and commercial. It certainly makes life challenging and consultants like me are kept on their toes and learning all the time. But should it be this way with something as crucial as medical device regulations and quality systems?
What do you think? I would welcome comments from anyone working in the regulatory world. Is this your experience? Do you work for a Notified Body and can give some information? Please do, I would like to learn more!