MDD 93/42/EEC Checklist during Audit

[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 ?

 

[Ronen E]

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 ?

Hello and welcome to the Cove

It sounds like a proprietary list. I'm not aware of any such generic MDD process checklist.

Cheers,
Ronen.

 

[clupin]

Perhaps this is the essential requirements checklist?

 

[wrodnigg]

I also think, he asked for the essential requirements checklist.

You have to demonstrate the evaluation of the fulfillment of all applicable essential requirements in Annex I of the MDD.

 

[jmlacroix]

This is a checklist that SGS has. I just come out from an audit with SGS, and there are questions in there that were a surprise to me. One example is the need to have a documented procedure to notify SGS about changes and the form to be used to notify SGS. These changes include anything from a change in the head count, changes to core procedure, design changes (obviously), new or withdrawn products, etc.

I complained that I did not mind having such a procedure, but that I mind learning about in an audit an receiving a non-conformance about it mad, and that SGS should tell their customer about these requirements of the MDD as if it is indeed in the MDD, you have to read between the lines to see it! The SGS auditor told me that indeed SGS should be better in telling its customer about it!

Now, I am in the process of writing such a procedure: if any of you have something that they are willing to share, I would not mind looking at it!

 

[Ronen E]

These changes include anything from a change in the head count

I would be very curious to learn where this is required in the MDD (even between the lines).

 

[Sidney Vianna]

Such controls are an outcome of the expected heightened oversight to be performed by NB’s. The Competent Authorities are tightening the policing of NB’s, leading to this type of requirements. Obviously Notified Bodies can effect processes as they see fit to ensure continued conformance of their clients with the applicable directives, but they should certainly be proactive and communicate with their clients when changes are implemented.

 

[Ronen E]

Notified Bodies can effect processes as they see fit to ensure continued conformance of their clients with the applicable directives

As a general principle that sounds OK, but the content of the original post indicated that it’s aparently been taken one step beyond “conformance with the applicable directives”.

 

[rob73]

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.

 

[Ronen E]

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.

I respectfully disagree over a few points:

1. Having a requirement for <X> is not the same as a requirement for a written procedure to do <X>. An org can sometimes perfectly do something without having a written procedure for it. Anyone dealing with QMS (for instance, but not only, ISO 9001) is very aware of this difference. It’s considered fine not to have a written procedure for something where the standard (the MDD in this case) doesn’t spell out a requirement for a written procedure.

2. A change in head count is not a change in the QMS nor in the product range, therefore it should not be required to be reported to the NB.

3. Design changes must be reported to the NB only where a Design Examination (see Annex II s. 4) was required in the initial conformity assessment, ie where the NB actually reviewed and approved the design in the first place. Hence lower class devices (that don’t require a Design Examination) are exempt from reporting design changes to the NB between audits.

By the way, there is already some published guidance dealing with what is or isn’t a substantial change that requires reporting.