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  • 1.  GAP Analysis - ISO 13485 and ISO 15189

    Posted 27-Apr-2023 14:02

    Wondering if anyone has had to complete, and would be willing to share, a GAP analysis between ISO 13485 and ISO 15189?  If there is a publicly available resource as well that you can reference that would be helpful as well.   My initial search did not generate any relevant outputs.  Thank you!



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    Sandra Veenstra
    Director - Quality Assurance and Regulatory Affairs
    Moncton NB
    Canada
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  • 2.  RE: GAP Analysis - ISO 13485 and ISO 15189

    Posted 01-May-2023 14:35

    Hello Sandra,

    Probably this article would lead you in that direction, ISO 15189: QMS for Medical Laboratories (qualitymeddev.com) 



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    Ajit Basrur
    Worcester MA
    United States
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    Original Message


  • 3.  RE: GAP Analysis - ISO 13485 and ISO 15189

    Posted 10-May-2023 16:22

    Hi Sandra, There is nothing online readily available. ISO 13485 is a standard for quality management systems for medical devices, while ISO 15189 is a standard for quality management systems for medical laboratories. Therefore, there are significant differences between the two standards. It's ideal to start with ISO 13485checklist and  ISO 15189 checklist and comparing and finding the gaps.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
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    Original Message


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