ISO 15189 accreditation: enhancing laboratory performance, safety, and personnel competence

Abstract

ISO 15189 accreditation provides a structured framework to ensure quality and reliability in clinical laboratories. Evidence from multiple international settings demonstrates that implementing ISO 15189–based quality management systems (QMS) can significantly improve analytical accuracy, operational efficiency, and laboratory reliability. Accredited laboratories show lower error rates, reduced sample rejection, and faster turnaround times compared with non-accredited counterparts. Furthermore, ISO 15189 implementation contributes to enhanced patient safety by decreasing the frequency and severity of laboratory incidents and promoting accountability and traceability in laboratory workflows. Structured training and competency assessment programs aligned with the standard have strengthened staff skills, professional ethics, and overall testing capabilities. The 2022 revision of ISO 15189 introduces structural updates, integration of point-of-care testing, and increased emphasis on risk-based approaches, supporting continuous improvement in laboratory practice. Collectively, these findings highlight ISO 15189 as an effective and practical framework for improving laboratory performance, promoting patient-centered care, and fostering a culture of safety and continuous professional development. This mini review summarizes current evidence and real-world experiences, providing guidance for laboratory managers and clinicians aiming to optimize quality and safety in laboratory medicine.