Advancing quality in clinical laboratories: ISO 15189:2022 updates

This white paper provides a comprehensive overview of the key updates introduced in ISO 15189:2022, the international standard for quality and competence in medical laboratories. It highlights the enhanced focus on risk management, integration of point-of-care testing, alignment with ISO 17025:2017, and a greater emphasis on patient-centric care. The document explains the necessity of robust internal and external quality controls for compliance, details methodologies for implementing these controls, and illustrates their impact on diagnostic accuracy and patient outcomes through real-world case studies. It also offers practical strategies for achieving and maintaining regulatory compliance, emphasizing the critical role of continuous quality management in advancing laboratory standards and improving healthcare delivery.