I
IZAKK
Hi, First off, this is a great forum; I can?t believe all of the information that is available here. Second, this is my first post so please take it easy on me.
I have recently been given the task of reviewing our QMS documents and performing gap analysis to ISO 13485. In the Document Control procedure that I am reviewing there is a section for periodic document review with a requirement to have review performed on controlled documents every two years at a minimum.
My question is where exactly is the requirement / clause for this in the 13485 standard? And since documents of external origins are controlled do they need to have this review as well? Thanks in advance for any help.
I have recently been given the task of reviewing our QMS documents and performing gap analysis to ISO 13485. In the Document Control procedure that I am reviewing there is a section for periodic document review with a requirement to have review performed on controlled documents every two years at a minimum.
My question is where exactly is the requirement / clause for this in the 13485 standard? And since documents of external origins are controlled do they need to have this review as well? Thanks in advance for any help.