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JoshuaSaltsgave's avatar
JoshuaSaltsgave
Qrew Member
7 years ago

Quick Base and ISO 13485:2016

Hi Everyone - Has anyone had experience with Quick Base program validation per requirements of ISO 13485:2016? Our organization is currently working on meeting the requirements of ISO 13485:2016 (from 9001:2015) and are interested in hearing from anyone else who is ISO 13485 certified and uses Quick Base. Any help is greatly appreciated!
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  • MCFNeil's avatar
    MCFNeil
    Qrew Captain
    7 years ago
    I know of a few ISO Auditors that use QuickBase, and a few medical companies that use it.  

    Using QB for the compliance aspect of the ISO 13485:2016 will greatly depend on how you set up your system.  Its all driven off of process, so if you have a well defined process and translate to a well defined app, you should be good to go.
  • JoshuaSaltsgave's avatar
    JoshuaSaltsgave
    Qrew Member
    7 years ago

    Thank you Matt.

    The concern I am trying to address is how to conduct a "validation" of the apps we use. For example, one app is used for completing engineering change requests. Since the app is created and owned by us, we need to provide that it is validated and operates as intended.

  • MCFNeil's avatar
    MCFNeil
    Qrew Captain
    7 years ago
    If you wanted to validate it, you would need to have an expert dive into the inner workings of the app and provide an "app review" compared to your documented process.

    I've performed a few of these, but I don't have any ISO authority.   On the flip side, I doubt that there are any ISO auditors out there that know QB well enough to do it properly.

    Option C is to have a new person in your company try to get into the app and see if (without any training) they can go through the workflow properly.  That is always a good sign of how focused the workflow is.