Change management
I am checking your documents now, but I can't find anything about change management which is referred by 4.1.4 of the 13485.
Could you please advise me how will we show the compliance of this article in our QMS system? A 13485 QMS require a change management procedure or not? If not how we will comply with this article?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
In our toolkit, changes that affect the quality system are covered in the 21_Procedure_for_management_review, as a part of Review inputs. Therefore this requirement from ISO 13485:2016 is fulfilled.
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Feb 12, 2020