Document Changes (Revisions) and associated Risk Analysis

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sagai

Quite Involved in Discussions
#12
In ISO 13485, "Product Realization" is discussed under s. 7. Document change control (including review and approval of changes) is discussed under s. 4.2.3, hence I fail to see any direct applicability of the clause your auditor cited to document change control.
It is in this particular case incidentally it is a case, however I would not encourage anyone to believe when two sub-chapter is not under the same Chapter than ultimately there is no direct connection between them. Cheers!
 

Ronen E

Problem Solver
Staff member
Moderator
#16
It is in this particular case incidentally it is a case, however I would not encourage anyone to believe when two sub-chapter is not under the same Chapter than ultimately there is no direct connection between them. Cheers!
When it comes to "show me the SHALL", every word counts. Other than that I tend to agree.
 
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