RRML - Approaching Risk Management in Medical Laboratories

ISSN online: 2284-5623

ISSN-L: 1841-6624

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Dr. Adrian Man

Nr. 30(2)/2022 DOI:10.2478/rrlm-2022-0017


Approaching Risk Management in Medical Laboratories

Remona Eliza David

Correspondence should be addressed to: Remona Eliza David


Risk is one of the greatest challenges in a medical laboratory. Risk-based thinking is a concept that always preoccupies medical laboratory technicians. The objectives of this work were to bring forward the specialty standards recommendations for the implementation of risk management principles in medical laboratory, the accreditation requirement of ISO 15189:2012; to demonstrate that the understanding of the fundamental notions of the concept of risk, the effectively apply of the means of identifying, assessing and controlling risks, and the risk monitoring and handling through strategies of acceptance, elimination, transfer and mitigation of risks can ensure the continuous improvement processes. A model to approach to risk management in a medical laboratory establishes the inputs, the outputs, the techniques, and the activities carried out in each of the following sub-processes of the risk management process: risk management process planning, risk identification, risk analysis and evaluation, development of the risk response plan and risk monitoring, control and revision. The concepts of risk and risk management are applied accordingly to standards ISO 31000:2018 and ISO 22367:2020 of International Organization for Standardization (ISO). Risk management ensures that the fundamental requirements for healthy, proactive internal control of the medical laboratory are met.

Keywords: quality control and evidence based laboratory medicine

Received: 1.3.2022
Accepted: 28.3.2022
Published: 9.4.2022

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How to cite
David RE. Approaching Risk Management in Medical Laboratories. Rev Romana Med Lab. 2022;30(2):125-39. DOI:10.2478/rrlm-2022-0017