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How you document changes in your QMS?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Bill M, Jan 12, 2021.

  1. Bill M

    Bill M New Member

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    I had a discussion with my colleague regarding how to document changes in our company. We are a small company that produces software for medical devices and we are certified. I was curious about how you document changes? you have templates, set procedures, or it's unique for each element or event?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Changes to what? It makes a difference.
     
  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Bill M . As @Andy Nichols mentioned, it would help if we had some additional information. Pending receipt of that information, I would council that your process should define what is meant by "change". Years ago I came up with the term ..."if it's wrong, or gone, can it lead to a nonconformance"? If the answer is "yes", then change point control is likely necessary.

    In addition to that council, also consider what your ORGANIZATION needs. The knowledge and history of when some changes took place can help protect your organization and potentially limit exposure to what product/processes may have been impacted by the change (and just as importantly, what product/processes were NOT impacted by the change). Be selfish. Ensure whatever you do is in the best interest of your organization (and its clients) and NOT simply for satisfying an auditor.

    Hope this helps.

    Be well.
     
    Jennifer Kirley likes this.