Application of the FMEA Tool in an Accredited Testing Laboratory in the Context of the ISO/IEC 17025:2017 Standard

Abstract

Organizations and laboratories tend to integrate systems based on risk management. Risk management helps to optimize laboratory processes and information flow, increase valid and reliable results, and make better decisions. This paper describes the development and present trends in risk management related to standard ISO/IEC 17025. This paper focuses on risk assessment in the accredited testing laboratories using the FMEA tool. In the basic eight defined laboratory areas, risks were identified and evaluated, and methods were proposed to minimize them.

Keywords

• failure mode and effect analysis (FMEA)
• risk assessment
• accredited laboratory
• ISO/IEC 17025
• management system