Abstract

Quality assurance in medical laboratories is vital for ensuring patient safety and enhancing healthcare outcomes. Over the years, laboratory professionals have implemented various quality assurance tools to evaluate and monitor performance, including internal quality control procedures, external quality assessment/proficiency testing programs, use of quality indicators, and implementation of accreditation and certification processes.

Accreditation according to the International Standard ISO 15189 marked a significant milestone by focusing on quality and competence criteria specific to medical laboratories. The peculiarity of ISO 15189 lies in its comprehensive framework, which integrates management principles, technical specifications, and clinical approaches. It emphasizes professional competence, ethical conduct, and collaboration with healthcare stakeholders; its structure aligns with other international standards, enhancing clarity and manageability.

ISO 15189 accreditation empowers laboratory specialists to play a crucial role in diagnostic and therapeutic pathways. The introduction of point-of-care testing requirements in the 2022 edition underscores the importance of governance by qualified laboratory professionals to ensure the training and competency development of non-laboratory personnel. Although ISO 15189 accreditation is internationally recognized and is mandatory for medical laboratories in many countries, efforts should be made to ensure wider adoption of this process to harmonize laboratory practices at the highest level of quality and gain confidence in laboratory performance.