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Change controls

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Guest user Created:   Oct 08, 2020 Last commented:   Oct 12, 2020

Change controls

I was wondering if you can help me with this question. This is regarding change controls specifically for changes to the quality system procedures such as SOPs and Work Instructions. How would these changes be initiated, reviewed and approved? I noticed there was not a change control form for this and I thought there would have been one in the Procedure for Document and Record Control.

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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 Oct 12, 2020

Yes, you are right, we do not have a change control form. We considered that changes in the documentation would be initiated by the person listed as the document owner. All updates and reviews must be performed in line with the frequency defined in the List of Internal Documents.

All changes to the document must be made by using "Track changes," making visible only the revisions to the previous version, and must be briefly described in the "Change History" table; if the Track changes option is unavailable, or if the changes are too numerous, then the Track changes option is not used.

Furthermore, each document should preferably have a "Change History" table used to record every change made to the document.

For more information about common mistakes with ISO 13485:2016 documentation control and how to avoid them, please see the following article:

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Oct 08, 2020

Oct 12, 2020