Document Control Numbers (Doc Code)
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?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
You can solve this situation in at least three ways.
One way is the way that you have described in your question.
Another way is for the company to make a decision that from a certain date you will start with a new document tagging (e.g. 01.10.2020), that all documents will start from revision 0, and there will be a combination of documents from the toolkit and your existing documents. In this case, you will describe this as a change in the quality management system, in the archive, you will have all of this „old“ versions with all relevant changelogs and start with the new numbering process.
The third way is that you use your numbering of existing documents and take our numbering for the new documents.
Try to see which way is the easiest way for you and all employees, which way will be the easiest to implement in everyday work.
For more information about common mistakes with ISO 13485:2016 documentation control and how to avoid them, please see the following link:
- Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/
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Sep 30, 2020