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  • 1.  Conflict of Interest

    This message was posted by a user wishing to remain anonymous
    Posted 04-Mar-2019 08:57
    This message was posted by a user wishing to remain anonymous

    Can an employee of a manufacturer also be a Lead Auditor for the same NB as the manufacturer has selected?


  • 2.  RE: Conflict of Interest

    Posted 04-Mar-2019 11:50
    While I don't know explicitly off-hand what the EU rules would be on such an issue, I would expect that the choice of the Lead Auditor in this situation could easily be called into question ​with the specific requirement here.  No employee should have any connection to the NB and vice versa in my opinion because even if there is not a collusion issue, there is the appearance of a collusion issue and that is often worse than any actual collusion.

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: Conflict of Interest

    Posted 05-Mar-2019 11:24
    I highly doubt it as there would be a conflict of interest and a highly suspect impartiality not being in effect.  The NB should have rules against that, but best not tread in those waters because the National Authority could get involved at a later date and cancel the certificate.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Conflict of Interest

    Posted 05-Mar-2019 11:45
    I agree with the other other comments that this is not really feasible.

    While it makes sense for a Notified Body to want to hire an auditor with industry experience (and vice versa), it is very difficult to work for two organizations that are adverse to one another, and it would likely violate the conflict of interest rules for both the company and the NB to participate on both sides of the same matter.   One cannot have professional duties that conflict.   

    I've seen instances where people work for industry and also participate in auditing and governmental work, but never involving their own company, and they would have to "recuse" themselves from any situation where they have influence over their own employer.

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    Roger Cepeda, JD, MBA, RAC
    MedTech Law LLC
    roger@medtech.law
    Mobile: 847-421-8361
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    Original Message


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