ISO 13485 quality system principle


(silakshmi rayapati) #1

what r the ISO 13485 quality system principles and practices.


(Simon Gooden) #2

This mostly applies to biological manufacturers and their quality systems. Compliant software, raw material and retain tracking, batch accountability. Getting your hands on a pDF would be very useful. I know if you are 9001, this is the next step. I remember reading the intention was to replace 9001 with added focus to the entire quality system. Also I know training was a big change as well. Good luck.