what r the ISO 13485 quality system principles and practices.
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.