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Document control version question

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Guest user Created:   Jun 30, 2022 Last commented:   Jul 04, 2022

Document control version question

I am hoping that someone can help me with a question about document control for ISO 13485. With version control you give examples in the documentation as per below: https://i.imgur.com/zn36OTF.png With regards to the versions above, there is a document on version 1.2 and another on 0.6. When changes are made how are you suggesting document version is changed? Does it go from 0.0 to 0.9 and then go to 1.0? Or are minor changes illustrated by the .X number and major changes be a whole numerical shift from 0 to 1? The procedure doesn’t explain this hence me checking. And if it is the latter, how should I distinguish between a minor change and a major change?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 04, 2022

This is really up to you. There are no requirements for how it is supposed to be done. I can share with you only my experience and it is as follows: 

Do it as simpler as possible. The simpler the system for changing document revisions, the easier it will be for you to keep track of all changes. Typos of course do not need specially marked revision states, a different arrangement of words in a sentence, or headings either. 


Everything else needs to be recorded as a change. Use the change log table for a description of all changes. 

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Jun 30, 2022

Jul 04, 2022