Guest
Is special training necessary to get company certified to ISO 13485?
We are ISO 9001 certified company. I'm lead auditor certified. Do I need to take special training to get the company certified to ISO 13485?
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
Jul 09, 2020
No, I do not think that you need special training. You have to study the ISO 13485:2016 requirements that differ from the ISO 9001:2015.
For start, I recommend you read the following article:
- Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
You can find a lot of articles in our ISO 13485:2016 Knowledge database and on ISO 13485:2016 Academy Blog.
- ISO 13485 Knowledgebase https://advisera.com/13485academy/knowledgebase/
- ISO 13485 Blog https://advisera.com/13485academy/blog/
Comment as guest or Sign in
Jul 07, 2020
Jul 09, 2020
Jul 09, 2020