What constitutes an “expert” with respect to a NB auditor?

[SteveK]

We recently had some Technical Files (class IIa and IIb) audited (on site) by NB auditors. Now in the TF review report the auditors positions are described as “Technical Expert”. However, they clearly had no practical expertise with the actual products; though they had a regulatory background, and only appeared to appraise them clause by clause against the relevant standards. So what defines a “Technical Expert”? We have quite a range of products covering about ten different specific standards (including both electrical and non-electrical products) – I am not counting QMS, risk, usability, electrical safety, labelling etc. related ones here. So for example how could you be an expert in say wound care products one minute, and then also respiratory systems the next?

Steve

 

[Marcelo]

This is a tricky question (or better yet, the the question and answer are tricky).

One of the requirements of the MDD (which are very simple right now) regarding NBs is that they have the necessary expertise to work with the products and Conformity Assessment routes in the Scope they are notified for. The products are divided into groups. However, there's no hard requirements for competence, as each NB defines their own requirements.

The NBOG Designating Authorities handbook do have some guidance, and the NB-MED Code of Conduct for Notified Bodies have some more detailed suggestions as well. However, they are still guidance (from what I understand, the Code has to be followed by members of NB-MED, but this created a situation in which several NBs could not comply with it and ended up leaving NB-MED).

Finally, the MDD evaluation is basically a QMS audit (and in the case of Class III, there's a prior Design Dossier review), so in principle the auditors (which audit most parts) might not need to have technical expertise in everything, however, there's where the product assessor (see Code of Conduct) comes in where there's need of a more technical expertise.

This expertise problem is one of the main problems related to NBs (in fact, to certification bodies as well), because they usually do not have enough expertise to evaluate what they must evaluate (this is very easily noticed in specific fields such as human factors/usability engineering and software).