ISO 15189:2022 in Clinical Biochemistry Laboratories: A Practical Review for Quality Improvement

Abstract

Background: ISO 15189:2022 is the latest international standard that defines the requirements for quality and competence in medical laboratories. Compared with previous editions, it places greater emphasis on patient safety, risk-based thinking, impartiality, digitalization, personnel competence, and continual quality improvement. Clinical biochemistry laboratories play a vital role in patient diagnosis and treatment; therefore, effective implementation of ISO 15189:2022 is essential to ensure reliable, accurate, and timely laboratory services. Objective: This review aims to provide a comprehensive overview of the requirements of ISO 15189:2022 and their practical implementation in clinical biochemistry laboratories. It highlights the major changes introduced in the 2022 edition and discusses their significance in improving laboratory quality management systems. Methods: This review is based on an analysis of ISO 15189:2022 requirements, relevant CLSI guidelines, NABL accreditation criteria, and published scientific literature related to laboratory quality management and clinical biochemistry practice. Results: The review summarizes key aspects of laboratory organization, personnel competence, equipment management, reagent control, sample management, method verification and validation, measurement uncertainty, internal quality control, external quality assessment, risk management, document control, internal audits, management review, and continual improvement. Practical examples relevant to routine clinical biochemistry laboratories are included to facilitate effective implementation.