Guest user Created: May 16, 2022 Last commented: May 17, 2022

Risk-based approach

We are doing our first ISO 13485 certification now. Our auditor want to have "Risk-based approach" for some of our processes. Can you provide me some example here? Our auditor say they can be as an unique standard table which we integrate it use in different processes. Do you have any idea here?

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Kristina Zvonar Brkić May 17, 2022

Yes, a risk-based approach is a requirement stated in 4.1.2 of the ISO 13485:2016 - apply a risk-based approach to the control of the appropriate processes needed for the quality management system. This means that for each process you need to be aware of possible risks that can occur, and you must have a mechanism for how to control them.

Definitively it can be in a table where you will have your processes, risks than can occur, and then control measures.

Some approaches regarding the risk you can find in the following article:

Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits - https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/

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May 16, 2022

May 17, 2022

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