Trends in the Accreditation of Medical Laboratories by ISO 15189

Abstract

In areas such as transfusion, transplantation, and sports medicine, laboratory results are critical to the diagnosis of pathologies. In order to minimize intra- and interlaboratory variability of results, it is equally important to harmonize quality management and technical practices in the medical laboratory. To ensure the competence of medical laboratories, ISO 15189, 3rd edition, establishes international standards. A set of critical principles for effective management and control of technical specifications has been outlined in this document. December 2022 marked the publication of the fourth edition of this standard. An in-depth analysis of the ISO 15189 standard is presented in this chapter.