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Risk Based Approach Document 03 13485

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Chris P Created:   Nov 25, 2022 Last commented:   Nov 26, 2022

Risk Based Approach Document 03 13485

Hello 

I had my stage 1 audit, which went well.  I had a minor non conformity on the quality manual.  Document 03_Quality_Manual.  

The non conformity was as follows:  the quality management requirements are not fully inplemented because it was not made clear in the quality manual which process apply risk based approach.  

This was in reference to 4.1.2.

But the quality manual template does not reference a risk based approach.  The only time in document 03 that risk is mentioned is under section 7 for product realization.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 26, 2022

Basically, for all processes, you need to have a risk-based approach so that you can control them. You are right that we did not mention anything about the risk-based approach and, since we are currently finishing the second edition of the toolkit, we will add it. 

If you are using the Key performance indicators, those are usually elements of how processes are based on the risks.  

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