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Thread: Risk Management- ISO 15189 NC- some help please

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  1. #1
    Forum Member
    Join Date
    Nov 2016

    Risk Management- ISO 15189 NC- some help please

    During a recent UKAS inspection the following NC was raised :
    The QMS has not documented its approach to Risk Management with regards evaluation of the impact of work processes and potential failures on test results.
    Proposed improvement action: Document approach and process and evidence that assessments have been carried out.

    The Blood bank processes already include consideration of risks/ impact on the patient eg: CAPA SOP , IQA/EQA failure SOP, Change control documents.


    1. Is Risk Management/ Quality Risk Management the same thing?

    2. Does this mean the lab needs a separate SOP for QRM based on EU Annex 20, or can a statement be added in the Quality Manual?

    3. Should we be process mapping/ writing an RAs for every process to identify potential failure points/ mitigation?

    4. Is there a simple way to do this?!!

    All comments would be very, very much appreciated.- many thanks.
    Last edited by Orr; 11th Feb 2018 at 10:42 PM. Reason: format

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