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NB's auditing practice called into question...

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Jonathan Wilkie, Jan 19, 2016.

  1. Jonathan Wilkie

    Jonathan Wilkie New Member

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    I am an engineer for a small (<50 employees) medical device manufacturing plant. I am currently working on an R&D project that will be ultimately affected by this updated revision of ISO13485:2015. (according to BSI white pages) Normally a Gap Analysis would be the general course of action for me/us to take to ensure compliance, however; here is the situation - Our NB has indicated that we will be audited on both the ISO13485:2012 (amendments) and ISO13485:2015 this fall and the ISO13485:2015 revision is to be released in the fall. My question is; where is the time needed to complete any gap analysis especially if we are audited prior to the release of 2015 revision? I feel this is just another way for NB's to buckle-up small medical device manufacturers. Does anybody have any direction for me on my situation? Thanks.
     
  2. MarkMeer

    MarkMeer Well-Known Member

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  3. Sidney Vianna

    Sidney Vianna Well-Known Member

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    I am sure you meant EN ISO 13485:2012, as there is no ISO 13485:2012.

    As for the NB unilaterally mandating compliance by the Fall to the ISO 13485:2016, they CAN'T do that. There will be a TRANSITION period for organizations to migrate their systems to the ISO 13485:2016 standard and, I suspect that the IAF will allow for a 3-year transition. During that transition period, YOU (the REGISTRANT) decides when you are going to make the move; not the NB, not the CB.

    Once again, the NB can not unilaterally mandate you to transition if you are not ready.
     
    Last edited: Jan 19, 2016
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  4. Jonathan Wilkie

    Jonathan Wilkie New Member

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    No I did not Mark but I will see if QM(r) has a copy I can review. Thanks for the response. Jon
     
  5. Jonathan Wilkie

    Jonathan Wilkie New Member

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    I am not sure who, how, or why this upcoming audit is in place that would be an alley I can look into. What I do know is that it will ultimately affect how to proceed with the R&D project's compliance activities. Thank you for your response Sidney, I have made the QM aware of your response and I have set up a meeting to specifically discuss this matter. Jon
     

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