Guest
SOPs ISO 13485 General
Hi
I bought the toolkit for ISO 13485 from you and I noticed the SOPs do not have a definition section at the beginning. Why is that?
Assign topic to the user
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Nov 05, 2020
There are no strict requirements in the standard ISO 13485:2016 that asks for the definition section at the beginning of the documented procedures. Of course, you can do it if you feel it is useful, these are templates and procedures can be customized.
Comment as guest or Sign in
Nov 04, 2020
Nov 05, 2020
Nov 05, 2020