K
KChetzel
We're working on implementing equipment in our QMS.
We have an instance where the User Requirements Specifications (URS) is sometimes outside of the QMS and I'm wondering if we made a QS Doc Controlled template does the output of that template always become a controlled document?
We're working to manufacture combination products in the US, Canada, and EU and follow 21 CFR 11, 210, 211, 820 and ISO 13485:2016 closely among others.
We have an instance where the User Requirements Specifications (URS) is sometimes outside of the QMS and I'm wondering if we made a QS Doc Controlled template does the output of that template always become a controlled document?
We're working to manufacture combination products in the US, Canada, and EU and follow 21 CFR 11, 210, 211, 820 and ISO 13485:2016 closely among others.