EU MDR - Liability Clause per article 31

Ronen E

Problem Solver
Staff member
Moderator
#21
I think there is a lack of distinction between compliance auditing (external certification and some internal audits), adherence & operational auditing (should be in internal audits) and improvement audits.
John Broomfield's comments feel more like the latter two, and do add value beyond the limited intent of focused regulations.
I often dislike an antagonistic attitude but it is necessary when auditors overstep the scope of their audits or the nature of the finding transforms from a requirement not being met to it not being met in the way they (or the auditing organisations' internal policies) see fit. However, there are audits which are not for certification but for improvement with best practice. There it is not about what any law (directly or indirectly) says you must do, but what is wise to do as indicated through an auditor who has seen many types of organisations through many phases of growth. There the auditor selected by management is chosen based on trust in value they might bring, which is a rather different relation to the auditor forced on you because of (mandatory) certification.
Yes, sorry, I was arguing from a compliance perspective only. I thought that that was the context, since the discussion is in the EU MD regulations forum and started from a question related to MDR compliance.
From a wider perspective I agree.
 
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John Broomfield

Staff member
Super Moderator
#23
John, the PIP case is not a very good example because it stemmed from fraud.
Ronen,

True, the victims though are now suffering even more from the lack of liability insurance.

PIP breast implant scandal: Victims visited by bailiffs https://www.bbc.co.uk/news/uk-england-48132572

That was why I chose this example.

I am not sure if this case has heightened the awareness of MD auditors or changed the policy of CBs with regard to auditing the sufficient of liability insurance as part of the auditee’s risk management.

Liability insurance may also have become a condition of the contracts between CBs and their MD clients as part of the CB’s risk management.

I hope you agree that our conversation has been useful.

John
 
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