Get FREE 12-month access to the AI-Powered Knowledge Base worth $450
with your ISO 9001 toolkit purchase
Limited-time offer – ends June 27, 2024

Expert Advice Community

SOPs ISO 13485 General

  Quote
Created:   Nov 04, 2020 Last commented:   Nov 05, 2020

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?

0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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. 

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Nov 04, 2020

Nov 05, 2020

Suggested Topics