Guest
Using ISO 9001 documents for ISO 13485
I am currently working through the ISO 13485 documentation, and have noticed that some of the documentation is similar to the ISO 9001 documentation. If applicable, could I use some of the templates / documents that we have for ISO 9001 for 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 18, 2022
Yes, you can. This applies mostly to, for example, forms and procedures for internal audit, corrective measures, and non-compliant products.
On the following link you can find the article that compares ISO 9001 and ISO 13485:
- Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
Comment as guest or Sign in
Jul 15, 2022
Jul 18, 2022
Jul 18, 2022