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  • 1.  ISO 13485

    This message was posted by a user wishing to remain anonymous
    Posted 14-Jan-2021 17:03
    This message was posted by a user wishing to remain anonymous

    Hello RAPS Community, 

    I am reaching out in regards to a discussion we are currently having among our company. 

    Our USA subsidiary has always been ISO 13485 Certified. The discussion was brought up that it isn't necessary for our USA subsidiary to hold an ISO 13485 certification as it only kits a few products. All of our manufacturing sites, globally, hold ISO 13485 certificates - and USA would fall under this. 

    Thoughts?


  • 2.  RE: ISO 13485

    Posted 14-Jan-2021 19:22
    Howdy Anon,

    I am not sure if this was your post yesterday as well, but there was some good discussion.  Please follow this this link to see the discussion and feedback.

    Cheers,

    ------------------------------
    Scott Bishop
    Houston TX
    United States
    ------------------------------

    Original Message


  • 3.  RE: ISO 13485

    Posted 19-Jan-2021 16:40
    Edited by Lance Tovar 19-Jan-2021 16:40
    Hi,

    First off, ISO certifications are NOT required...  21 CFR is law/required, and an QMS needs to show compliance. Second, My understanding is that ISO certifications are site specific.  I've never seen an corporate quality system, that covers all other subsidiary sites, be audited for compliance... doesn't mean it doesn't happen... I've just never seen it happen. 

    Hope this helps

    ------------------------------
    Lance Tovar
    RA/QA Specialist
    Roy UT
    United States
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    Original Message


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