Change controls

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:

• 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/