S snoopy2017 Nov 26, 2017 #1 Nov 26, 2017 #1 I know I am late to the game. I am going to be involved in transitioning a company to ISO 13485:2016. Can somebody provide me with some guidance on how I can integrate a risk management approach in our SOPs? Thank you.
I know I am late to the game. I am going to be involved in transitioning a company to ISO 13485:2016. Can somebody provide me with some guidance on how I can integrate a risk management approach in our SOPs? Thank you.
Ronen E Problem Solver Staff member Moderator Nov 26, 2017 #2 Nov 26, 2017 #2 https://elsmar.com/Forums/iso-13485...dure.html?highlight=Risk+based+approach+13485 You’d have found it by searching Elsmar for “risk based approach 13485” or similar terms. There are more threads on this topic.
https://elsmar.com/Forums/iso-13485...dure.html?highlight=Risk+based+approach+13485 You’d have found it by searching Elsmar for “risk based approach 13485” or similar terms. There are more threads on this topic.