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  • 1.  ISO 13485 Scope

    Posted 30-Oct-2018 12:12
    ​If we make components for a medical device (not finished or useable as shipped, but become finished devices by our customer), can those be included in our ISO 13485 QMS Scope or can they not be included because they are not medical devices, as-shipped, and thus, have to be under an ISO 9001 Scope?

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    Tim White
    Leadership, QA
    Lewis Center OH
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  • 2.  RE: ISO 13485 Scope

    Posted 31-Oct-2018 09:15
    In short, ISO 13485:2016 allows you to define the scope of your organisation.  Companies that are suppliers to medical device companies often obtain ISO 13485 certification and with the 2016 version this is much better that you can define role in relations to supplying components to medical device companies.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: ISO 13485 Scope

    Posted 01-Nov-2018 19:02
    ​Tim

    There is no restriction to preclude component manufacturers from adopting the Quality Management Systems requirements of ISO 13485, the title "Medical devices - Quality management systems - Requirements for regulatory purposes" notwithstanding.

    The Introduction to ISO 13485 : 2016 states: "The requirements in this International Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations."

    In fact, OEM manufacturers sourcing components specifically designed and supplied for use in medical devices prefer critical suppliers to be ISO 13485 certified – referred to as "quality system parity".  See: MDDI Regulatory Outlook - The Empirical Value of Risk Management

    ISO 13485 also allows organization to document in their Quality Manual those activities that are excluded from the scope of the quality management system, with justification for non-application.

    See also: https://elsmar.com/elsmarqualityforum/threads/iso13485-application-may-subcomponents-or-non-medical-products-be-excluded.26591/



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    Homi Dalal RAC
    Regulatory Affairs Leader
    Christchurch
    New Zealand
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    Original Message


  • 4.  RE: ISO 13485 Scope

    Posted 02-Nov-2018 07:02
    Hi Tim

    I must agree with Richard and Homi and I can add: Obtaining a 13485-certificate will definitely make you more attractive to your customers and the medical market as such because it is your customers responsibility to justify using your product. It will be easier for your customers to get the justification they need as to why the rely on your services/products if you have the test reports etc. necessary for your own certification. In fact you would make life so much easier for noth yourself AND your customer if you were able to demonstrate compliance to the standards before they ask you.
    So don't hold back. Go for it

    Best regards

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    Dorthe Wallin
    Regulatory Compliance Officer
    Cortex Technology
    Hadsund
    Denmark
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    Original Message


  • 5.  RE: ISO 13485 Scope

    Posted 02-Nov-2018 13:54
    Edited by Tim White 02-Nov-2018 15:24
    ​When I review the ISO 13485:2016 Introduction, I do not conclude that a component manufacturer can be certified to the standard.  The Introduction states that the Standard "can be used" and that the supplier can choose to "conform to the requirements...".  I think "used" and "conform" are different than "certified".  Certainly, any company can use the standard and conform to it.

    However, if component manufacturers are actually being certified to the standard, then it must be allowed and I must be interpreting the standard too literally.

    Thanks for the inputs!

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    Tim White
    Leadership, QA
    Lewis Center, OH
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    Original Message


  • 6.  RE: ISO 13485 Scope

    Posted 04-Nov-2018 14:50
    ​

    Tim, my organization is a component manufacturer serving as a critical component vendor to OEMs and is certified to ISO 13485: 2016 so yes, you are interpreting the standard too literally.



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    Homi Dalal RAC
    Regulatory Affairs Leader
    Christchurch
    New Zealand
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    Original Message


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