Revision histories


Do I have to put my revision history on my documents of can I trace them in my eQMS system? We are a medical device company certified to ISO 13485.


There is no ISO 13485 requirement that requires the version history to be maintained within the document. You do have to have a system in place to trace a document to the change record that revised the version in question.


Completely agree. Revision history is very nice to have--if done appropriately--but tends to be unfeasible for every document to include the changes. Initially it might seem to be easy to maintain, but a mature system may have several revisions to get to a smooth system. Likewise, if the requirement is to have revision history for quality system documents, it would be a good idea to exclude forms--because the revision history may end up being longer than the actual form.

Just some additional thoughts!
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