MDR - Is a formal GSPR Procedure required?

[MakingADifference]

Hi.

I was wondering if people have created a GSPR procedure for the MDR? This was a point during an MDR Upgrade Assessment and I was wondering if people had written a formal procedure against this?

I appreciate that we have to provide a checklist as evidence but is a procedure required?

Thanks.

 

[Ronen E]

No.

 

[MakingADifference]

Exactly my interpretation. The auditor thinks differently!

 

[Ronen E]

"Show me the shall."

 

[shimonv]

Perhaps what you can do is add a small section to your existing regulatory compliance procedure that talks about GSPR and add the Form to the reference list.

Shimon

 

[MakingADifference]

"Show me the shall."

I have had this discussion at great length today. There is no 'shall' there is nothing. I am happy to clarify something in our quality manual etc but not a procedure.

 

[Marc]

Perhaps what you can do is add a small section to your existing regulatory compliance procedure that talks about GSPR and add the Form to the reference list.

Shimon

I agree with this approach. It doesn't take much time and can keep any future issues from occurring.

 

[MakingADifference]

I agree with this approach. It doesn't take much time and can keep any future issues from occurring.

Would you say this would be a Major NC though?

 

[Marc]

No 'shall' so not a non-conformance at all. But it doesn't hurt to take a few minutes to 'future proof' against wayward auditors and wasting time going through verbal battle(s) again.

 

[pziemlewicz]

It doesn't need its own procedure, but it does need to be done. I've referenced GSPR in my Design Control procedure alongside requirements definition.