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ISO 13485: Suppliers to Medical Device company

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by GregL, Dec 6, 2016.

  1. GregL

    GregL New Member

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    Are suppliers to a Medical Device company required to be ISO 13485 Registered? For example: A supplier is molding a component to a Medical Device, for a Medical Device Manufacturer, using the manufacturers tool. Is the supplier required to be ISO 13485 Registered?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's difficult to give you a definitive answer, GregL. When you say "is it required" we need to know what you mean as it "required by"...what? It's not in ISO 13485 as far as I can recall. It might be required by a customer or even a product certification, (but I rather doubt it). Tell us from which perspective are you asking? Suppliers? Customers? Or some other like a consultant's or even a CB auditor's view point...
     
  3. GregL

    GregL New Member

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    I'm trying to determine if and regulatory (FDA, ISO etc.) requirements demand that Suppliers or Subcontractors to a Medical Device Manufacturer be ISO 13485 registered in order to provide those services or components? I understand that Customers can require this of the supplier or subcontractor however, if the supplier or subcontractor is not the owner of the device and only manufactures components to customers specifications, do medical device regulations require the supplier or sub-contractor to have a ISO13485 registered QMS?

    Thanks!
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm unfamiliar with regulatory requirements - usually they don't specifically mandate "registration" but allude to compliance - and certainly ISO 13485 doesn't make it a requirement to pass it down the food chain.
     
  5. Vintage Goose

    Vintage Goose Active Member

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    Hi Greg, there is no specific requirement for a moulder to be certified to ISO 13485 unless they are placing produict on the market under their own name. However, some customers may request it, especially if you also do assembly or packaging, as it can simplify the customer's registration under the Medical Device Directive. If you are doing this, make sure you have a good contract defining design ownership and change responsibilities, and also complaint handling.

    Under FDA it can be more complicated, especially if you are providing a finished product; ie one packaging and labelled. In this case, you may not be required to register with FDA, but it would be expected that you comply with the relevant parts of 21CFR820 as you may be subject to inspection by FDA. If you are just moulding a component that the customer assembles and packs, then the chance of inspection is very low.

    Chris
     
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  6. yodon

    yodon Active Member

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    A complicating factor here is the Notified Body. If the supplier is considered "critical" then the NB may decide they need to audit them. The audit may be avoided if the supplier is registered to 13485 through an accredited agency. It doesn't make registration a requirement but it certainly may simplify your life and save you some $$.
     
  7. johnnymo77

    johnnymo77 Member

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    Our company has been molding parts for a medical device company in Southwest Michigan for years with only TS16949. We are primarily Automotive but do sell over 100 part numbers to this company.

    Just this week, this customer has started discussions with us about using MedAccred (http://p-r-i.org/medaccred/). So far, they haven't discussed standards but are talk about auditing critical processes.
     
  8. Vintage Goose

    Vintage Goose Active Member

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    I'm not an expert on TS standards, but I suspect that if you comply with TS16949, you are 99% compliant with ISO13485 already. The names might be different, but the requirements are very similar.
     
  9. indicator

    indicator Member

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    I believe that it is not a mandatory requirement, But you need to make sure that they can supply products as per your specifications and you have control measure which can include incoming quality check and audit, etc. Basically monitoring and re-evaluation of suppliers, and action to be taken when purchasing requirements are not met.
     
    Last edited: Sep 7, 2017

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