Journal:Identifying risk management challenges in laboratories

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Full article title Identifying risk management challenges in laboratories
Journal Accreditation and Quality Assurance
Author(s) Tziakou, Evdoxia; Fragkaki, Argyro G.; Platis, Agapios N.
Author affiliation(s) Hellenic Open University, National Centre for Scientific Research “Demokritos”, University of the Aegean
Primary contact fragkaki at bio dot demokritos dot gr
Year published 2023
Volume and issue 28(3)
DOI 10.1007/s00769-023-01540-3
ISSN 1432-0517
Distribution license Creative Commons Attribution 4.0 International
Website https://link.springer.com/article/10.1007/s00769-023-01540-3
Download https://link.springer.com/content/pdf/10.1007/s00769-023-01540-3.pdf (PDF)

Abstract

Over the years, risk management has gained significant importance in laboratories of every kind. The safety of workers, the accuracy and reliability of laboratory results, issues of financial sustainability, and protection of the environment play an important role in decision-making in both industry and service-based labs. In order for a laboratory to be considered reliable and safe, and therefore competitive, it is recommended to comply with the requirements of international standards and other regulatory documents, as well as use tools and risk management procedures.

In this paper, information is summarized concerning the terms “risk” and “risk management,” which are then approached through the latest ISO 9001, ISO/IEC 17025, and ISO 14001 standards. The process of risk management based on the ISO 31000 standard is described, and the options for treatment and the techniques that can be applied in the risk management process based on the latest ISO 31010 standard are grouped and indicated. Additionally, a literature review examines the reasons that have led laboratories to integrate risk management techniques into their quality management systems, the most common mistakes that occur in the various phases of laboratory tests, their causes, and their consequences, as well as the proposed treatments. The aim of this work is to highlight significant challenges concerning the need to implement management procedures in the daily routine, while warning, raising awareness of, and informing about existing risk management methods that can be implemented, methodologically and technically, to laboratories, under internationally recognized and updated standards.

Keywords: risk-based thinking, risk management, risk assessment techniques, laboratories, control measures

Introduction

References

Notes

This presentation is faithful to the original, with only a few minor changes to presentation, spelling, and grammar. We also added PMCID and DOI when they were missing from the original reference.