O
olidix
HI, our NB SGS, at the end of our audit, will go under the "93/42/EEC Checklist" and they will ask if we have process for all the different point. Does anyone here have this list ?
HI, our NB SGS, at the end of our audit, will go under the "93/42/EEC Checklist" and they will ask if we have process for all the different point. Does anyone here have this list ?
These changes include anything from a change in the head count
Notified Bodies can effect processes as they see fit to ensure continued conformance of their clients with the applicable directives
jmlacroix
This is not a new requirement, take a look at 93/42EEC annex 2 section 3.4 "The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered." We were asked by our NB to put this into a procedure a couple of years ago, with the scandal i think the NB are just tightening up. I would be asking them for some sort of definition of what a substantial change in head count would be. Changes to design (especially if class 11a/b or 111) are a given for notification.