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Design company not ISO13485 using a Manufacturing company that is ISO13485.

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by TKOMaine, Nov 9, 2021.

  1. TKOMaine

    TKOMaine New Member

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    Looking for knowledge.
    In process of working with a Design company that has no ISO certifications or QMS. We are ISO13485, ISO9001:2015 & AS9100D certified. We exclude Design.
    We are concerned that the Design company has no method of CAPA, RMA internal systems etc.
    Does the Design company need to be at least ISO certified if making medical product that ends up in the end customers hands. I.e the public.?

    Thanks in advance,
    TKOMaine
     
    TKOMaine, Nov 9, 2021
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  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @TKOMaine ;
    First things first. Are you indicating that your organization is sourcing the design through a design company? If so, then your organization can not EXCLUDE design, as your organization is responsible via the sourcing and control of your supplier.

    Remember, your organization is either ...
    1- "build to print" ,wherein, the customer designs the product and only the customer can alter the design. In this scenario your organization can/should EXCLUDE design.
    Or...
    2- design responsible whether your organization itself is doing the design or your organization is sourcing the design.

    Hope this helps.
    Be well.
     
    John C. Abnet, Nov 9, 2021
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    @John C. Abnet - great description!

    TKOMaine: An organization which designs a medical device but doesn't employ a defined, documented process including some of the things you'd find in ISO 13485 - (RMA if you only design isn't likely to be present) is risky...
     
    Andy Nichols, Nov 9, 2021
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  4. yodon

    yodon Well-Known Member

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    Aside from the good points made already, how would you qualify and approve this supplier if those are your requirements and they don't meet them?
     
    yodon, Nov 9, 2021
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  5. TKOMaine

    TKOMaine New Member

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    Thank you, I agree. I will be feeding back some details to this company. We may not build product with out them having some kind of Quality system. We may end up being responsible for the product some how.
     
    TKOMaine, Nov 10, 2021
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  6. TKOMaine

    TKOMaine New Member

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    Hi Thank you for replying and question. In this case they would be our customer, we are the Manufacture with the certs, they have nothing?
     
    TKOMaine, Nov 10, 2021
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  7. TKOMaine

    TKOMaine New Member

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    Thank you! We are in a weird spot, we don't want to turn down the work yet concerned we might be implicated or something.
     
    TKOMaine, Nov 10, 2021
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not so weird, as it happens. It's a matter or risk and risk treatment(s). Your management should seriously look at the cost/benefit of entering into an agreement to make a (potentially flawed) product and what that could cost, compared to what the PROFIT margin is. Most organizations mark their work up by 25% but unless you can really tie down all the cost of scrap, rework, reprocessing and so on, you may be in all reality, making far less money. When management sit down and take a long cold, hard look at it, "discretion is the better part of valor"...

    Are far as risk treatment goes, is the customer willing to have their design checked by anyone? Maybe an FMEA performed on the design and then they work on anything overlooked/needs verification etc.?
     
    Andy Nichols, Nov 10, 2021
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