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Advice needed: Shall I report my not complying company to NB / competent Authority (Europe)

#1
Hi guys,
can you give me some advice on legally based requirements to report your own company to NB or competent authority?

Situation:
- Company was taken over by new owner in may 2020. Since then I (authorized representative) had zero communication with the the new CEO. He denies any invitations and communication. Ergo: We do not fulfill the requirements of Management Involvement as required in ISO 13485 and our corresponding procedures.

- Our processes require the review and approval of a) department managers or b) subject matter experts. As almost 50% of the staff has already left, we are not following those processes anymore. Everybody in R&D is forced to make and sign documents they are only half-wise competent for.

- I have handed in my retirement note, which will get into force end of February 2021. No reaction on this.

So my questions are:

1) Must I, by law, report anything of this? I signed contracts with or NB, where I agreed to assure that the certified QMS is in place.
2) Is there any way i can legally get out off this and state that I can not fullfill my responsibilities s authorized representative anymore, due to sickness or the work conditions?

Any advice appreciated.
 
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Ninja

Looking for Reality
Staff member
Super Moderator
#2
Have you retained a competent attorney in the field?
Have you researched "Whistle Blower" laws and regulations?

If no: do those things, in order.
If yes, or once the answer is yes: pose those questions to your attorney.

Free advice is worth exactly what you paid for it...and it seems you're in deeper than that...HTH
 
#3
Hi Ninja,
Well, I did not yet contact the competent authority/NB yet. Searched for some "whistle blower" possibilities, but it does not seem as those exist at TÜV SÜD.
I would take an attorney, but I think that this question is so special, that I needed to give him at lest a regulation he could point to.
 
#4
When signing the yearly agreements with the NB, I agree that I will make sure that the certified QMS is followed. Does that mean, that I have to inform the NB, if I believe it is not followed anymore. Or may company say, that at the point of signature it was the true believe, that we would follow.
Oh boy!
 

planB

Super Moderator
#7
Rev0lverbraut,

only my personal 2 cents: your user name indicates a German-speaking European country. To my knowledge, no Austrian or German law requires you to "whistle-blow", and essentially only persons with authorized signatory (typically CEO and "Prokurist" etc) can be really held personally accountable. If you are not in this role and and just an "ordinary" employee with a quality/regulatory function, then you signed the contract on behalf of your legal entity, not binding you personally.

For legal advice in Austria, you could contact the "Arbeiterkammer" for free.

HTH,
 
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