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We just had our first stage I and our auditor seemed to find a large issue with the fact we are using a separate document to specifically reference our documented procedures. In the QM we reference this document and say all the documented procedures are referenced in this table. This document is a table which has the clause number and title of each section of ISO 13485:2003 and the procedures we have established for each section. Does this not meet what would be accepted as referenced? I considered putting the table as an appendix but we are a newer company and every time I add a procedure I would need to update my QM.
Overall, our auditor made it seem we had to literally copy and paste the standard into a document we call "Quality Manual" and put our name on it and label next to each section the procedures we have documented for that section. In fact, he told me to plagiarize and copy and paste the standard as much as I could. I have seen examples of this but I don't see this as a way to create a document that will actually be read in my organization, let alone, something that will be followed.
I'm fairly new to ISO, but I have some pretty good FDA background, and FDA always seemed to be much more of the mindset of "if you have it in some reasonable form then you're good." Is this not the way it is with ISO? or is it just this auditor?
Thank you for any and all help!
Overall, our auditor made it seem we had to literally copy and paste the standard into a document we call "Quality Manual" and put our name on it and label next to each section the procedures we have documented for that section. In fact, he told me to plagiarize and copy and paste the standard as much as I could. I have seen examples of this but I don't see this as a way to create a document that will actually be read in my organization, let alone, something that will be followed.
I'm fairly new to ISO, but I have some pretty good FDA background, and FDA always seemed to be much more of the mindset of "if you have it in some reasonable form then you're good." Is this not the way it is with ISO? or is it just this auditor?
Thank you for any and all help!