Having purchased the ISO13485 toolkit, I have a couple of questions related to Document Control Numbers (Doc Code).
We have a mature system, but it is due for overhaul and simplification. But because of our mature system, for most of the documents in your system we have existing Document Control numbers, many with considerable revision history. My preference is to renumber the documents to the Doc Codes in your List of Documents. is it considered best practice to include the Doc Control Number in a Document Change but keep the revision number in sequence? For example: Doc 00 (Procedure for Document and Record Control) Rev 1 (if we were implementing your document as a new document) is fine. But we are replacing our document 423-01 Rev 4 with this document. So would we do a Document Change that includes the renumbering of this document to 00, but use Rev 5 to clarify that this is not a new document (even though a new Doc Control Number)? Or is there a better approach to this?