Revision histories

regi_601

Registered
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.
 

Hezabelle

Registered
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.
 

emilymadsen

Registered
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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