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13485 Base Templates #78

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13485 Base Templates #78

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yujanshrestha
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This is a starting point for a lean QMS. These templates are meant to be highly modified by the adopting organization but it sets up a foundation.

This is a template for creating record templates.
… systems.

The idea is the organization QMS will live in its own git repository and the product QMS will live in the same git repository as the codebase.
I don't think it matters what branch the bug was found on. It's release status is the important bit.
I had originally added this to distinguish it from the quality manual taken from sequentially reading 13485. I found the IMDRF a better source for the quality manual.
@bastiao
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bastiao commented Nov 5, 2022

Nice work here.
Any plans to merge this still in draft, PR?

@yujanshrestha
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Hi @bastiao. Thank you!

We have been focusing on regulatory recently so this QMS PR has been deprioritized for the time being. Do you have something you plan to use it for?

Yujan

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bastiao commented Nov 5, 2022

To be honest l, I'm still learning if I could use rdm and how it can produce reports based on a Github repo. It seems good to have also QMS, like for instance, could be used to use management review, and other reports.

Do you have anything in mind required to move this forward?

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