Risk Management- ISO 15189 NC- some help please

[Bob Walters]

1. I think risk management is the broader term, quality risk management is part of "risk management"
4. Our approach to risk assessment for ISO 15189 is to use FMEA. The steps of the analytical process including the pre-analytical, analytical, and post analytical phases can be analysed in turn. The risk mitigated at each step. The output of an FMEA can be a Quality Control Plan if desired. The CLSI have produced guidance and there is also guidance in ISO/TS 22367

[EClarke]

I like the FMEA approach and am considering a standalone document on QRM for BT. I see a lot of value in process mapping for BT. Perhaps start with your critical BT processes within your validation master plans?? You will already have assessed them as critical so you are almost there?