Identifying risk management challenges in laboratories

Abstract

Over the years, risk management gains significant importance in laboratories of every kind. The safety of workers, the accuracy and reliability of laboratory results, issues of financial sustainability as well as the protection of the environment play an important role in decision-making in both industry and services. In order a laboratory to be considered as reliable, safe, and therefore competitive, it is recommended to comply with the requirements of international standards and other regulatory documents as well as to 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, 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, information from the literature is referred to the reasons that led the laboratories to integrate in their quality system risk management techniques, the most common mistakes that occur in the various phases of laboratory tests, their causes, 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, to warn, raise awareness and inform about existing ways of risk management that can be implemented, methodologically and technically, to laboratories, under internationally recognized and updated standards.