Integrating Risk Management into Medical Laboratory Quality Systems: ISO 15189:2022 Perspectives
TL;DR
The standard, ISO 15189: Medical Laboratories – Requirements for Quality and Competence, emphasizes a risk-based approach to ensure the reliability of laboratory results, patient safety, and continuous improvement of laboratory processes.
Abstract
Risk management has become a fundamental component of quality management systems in medical laboratories seeking accreditation according to ISO 15189:2022. The standard, ISO 15189: Medical Laboratories – Requirements for Quality and Competence, emphasizes a risk-based approach to ensure the reliability of laboratory results, patient safety, and continuous improvement of laboratory processes. The standard complements ISO 15189:2022 by focusing specifically on the prevention of patient harm through systematic risk management practices. Risk management is not limited to technical procedures but extends to personnel competence, equipment performance, information systems, environmental conditions, and organizational processes. Effective risk management enables laboratories to identify potential hazards, assess their impact, implement preventive measures, and monitor the effectiveness of controls.