J
JeanG
Hi, All
I am very new to ISO14971, i am currently creating a risk management manual, i wonder do we need all detailed procedures like QMS, such as risk plan SOP, risk analysis procedures, risk control procedures, and risk management report procedures? are these all necessary? How do audit check the ISO14971?
Many thanks for your help here.
I am very new to ISO14971, i am currently creating a risk management manual, i wonder do we need all detailed procedures like QMS, such as risk plan SOP, risk analysis procedures, risk control procedures, and risk management report procedures? are these all necessary? How do audit check the ISO14971?
Many thanks for your help here.