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Should we keep ISO 9001:2015 when we go for 13485 certification?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Nikki, Jan 18, 2016.

  1. Nikki

    Nikki Well-Known Member

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    I am being asked the question in the title of this post.

    What is the benefits of keeping ISO 9001:2015 when going for our 13485 certification?
    Is it worth keeping at all?

    Should we just go with 13485?

    Thanks in advance for your thoughts.

    -Nikki
     
  2. Golfman25

    Golfman25 Well-Known Member

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    I think that depends on what percentage of your customers/sales is 13485 vs. 9001. Also, determine what your other customers want. In our case when we decided to go TS, we did not include 9001 as I didn't want "two" systems confusing and complicating things. Plus, there is a cost savings. Over the years, that worked well as our TS business increased. Our other customers didn't have an issue with only the TS certification. However, since that time one of our major end users (think big engines and construction equipment) has dropped out of the TS scheme. Thus we have "lost" a lot of applicable TS product (which may be a good thing :) ). My own take would be if you can "get away" with only one standard, that is what I would prefer.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'd stick with ISO 13485 for now. There isn't (apparently) going to be alignment with the "annex SL" which makes for difficulty in many ways with an ISO 9001:2015 QMS - and I don't mean the numbering of the quality manual!
     
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  4. Nikki

    Nikki Well-Known Member

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    Thanks Andy :)
     
  5. Sidney Vianna

    Sidney Vianna Well-Known Member

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    Be aware that, by June 2016 (your customer deadline), very few CB's (if any) would be accredited for ISO 13485:2016. CB auditors might have not been qualified by then, depending on what requirements are imposed onto AB's, CB's and their respective auditors.
     
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  6. QA Bee

    QA Bee Member

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    I have similar question - We will be recertified with ISO 9001:2008 this month. ISO 13485 will be by first half of the year and I am debating weather to keep both standards then or just let go ISO 9001?
     
  7. Nikki

    Nikki Well-Known Member

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    We had a brief meeting today and have decided to forgo the ISO 9001:2015 and we are going straight to the ISO 13485:2003. No one wants to wait around for the 2016 revision...

    While I have read the standard 100 times.. I have some questions...

    For Example:
    "customer complaints (8.5.1) including authorisation when corrective and/or preventive action are not taken."

    This requires me to document WHY CARs or PARs were not issued?
    Or do I need to assign someone to authorize that CARs or PARs are not needed?

    Both?

    Thanks,
    Nikki
     
  8. matkins151

    matkins151 New Member

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    Nikki,
    In your complaint system, when you are ready to close out a complaint and, through investigation, have determined no corrective/preventive action is required (or needed at that time), you need to document justification for this decision and have it signed off by a designated authority.

    Good luck with your certification. I just started a new job where we are working on certifying to both 13485 and AS9100. Big job, not much time.
     
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  9. Scott K

    Scott K Member

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    We carry both right now and will most likely be ditching 9001 at our next re-reg as 95% of our customers only care about 13485. The other 5% don't care if are registered to either.
     

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