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Supply for Medical Device - ISO 13485

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Susan7, Mar 21, 2019.

  1. Susan7

    Susan7 New Member

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    Hi Everyone,

    I have a question about suppliers for medical devices and ISO 13485. I work with a medical device developer and we are working with a medical device manufacture. The medical device manufacturer (which puts all the parts together) is ISO 13485 and appears to have good quality systems in place. My question is, do the suppliers to the medical device (ex. one supplier makes a rubber component), need to be ISO 13485 or FDA registered, or have some other quality system in place? Also, will the sub suppliers be FDA inspected as well the medical device manufacturer?

    The rubber component manufacturer, is compliant with ISO standard testing and we will be testing the materials. I'm just curious what other quality certification or registration (if any) would be needed from FDA.

    Final question, does the supply section of ISO 13485, require the device manufacturer (who packages it), to check on the quality systems in place of their suppliers that make some of their materials/parts?

    Thanks in advance for any assistance.
    Sue
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I can answer this one: The answer is NO, unless you have a very high confidence (like 110%) the supplier isn't going to screw something up... Now, not to say that being certified is 100%, but, it's a good place to begin. Not having a QMS in place is going to put more burden on your organization to assure (provide confidence) in product. That means a $$$ burden.
     
  3. Susan7

    Susan7 New Member

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    Thank you for your answer Andy. I didn't think they were required, but wanted to make sure.

    It sounds like we should make sure they have a QMS in place to ensure quality.

    Another question. Although it's not required to have ISO 13485 or be FDA registered, do you know if it's general standard practice for suppliers to opt in and get ISO 13485, or any another nationally known QMS system? Or do they just develop an in house QMS to ensure quality. I'm wondering what is general standard practice for quality measures in this case.

    Thanks again
     
    Andy Nichols likes this.
  4. tony s

    tony s Well-Known Member

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    I would assume that you have a copy of the ISO 13485 standard. Is there a specific statement in the standard that requires your organization to require suppliers to be certified also?
     

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