Guest
Risk managment plan
HI we are implementing 13485/9001 at the same time.
We have a risk management plan and all within risk management for the medical device. However we also have a non medical deivece intended for industry workerse. Does this device require risk assessment record for that product under 9001?
Assign topic to the user
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Sep 01, 2021
No, these non-medical devices do not require risk assessment. Of course, you have under the ISO 9001:2015 risk analysis and you can cover any specific risks for these there.
More about risk management within ISO 9001 you can find on the following links:
- Methodology for ISO 9001 Risk Analysis https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/
- How to identify risk controls in ISO 9001:2015 https://advisera.com/9001academy/blog/2019/01/21/how-to-identify-risk-controls-in-iso-90012015/
- How to identify risk significance in ISO 9001:2015 https://advisera.com/9001academy/blog/2019/01/14/how-to-identify-risk-significance-in-iso-90012015/
Comment as guest or Sign in
Aug 31, 2021
Sep 01, 2021
Sep 01, 2021