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Risk managment plan

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Guest user Created:   Aug 31, 2021 Last commented:   Sep 01, 2021

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?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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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:

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Aug 31, 2021

Sep 01, 2021