International organization for standardization 15189 in medical laboratory practice: A review of standards and implementation

To promote accuracy, reliability, and patient safety in laboratory diagnostics, the International Organization for Standardization (ISO) 15189 has been established as an important standard for medical laboratories worldwide, ensuring that they meet stringent laboratory quality requirements. Despite this, its implementation is not an easy task and presents challenges such as the resource-intensive nature of ISO15189 adoption, training gaps, and resistance to change in many regions, particularly in low-resource settings, when incorporating a unified approach to laboratory quality management system (QMS). The risk-based thinking, patient-centered care, and standard flexibility have allowed laboratories to adopt new technologies such as automation and digital platforms to enhance accuracy, efficiency, and patient care. Furthermore, integration with regulatory frameworks has facilitated harmonization across different countries, resulting in a more consistent approach to laboratory quality systems. The future of ISO 15189 is characterized by an increasing focus on collaborative efforts, the digital revolution of laboratories, sustainability, and proactive risk management. This is an attempt to analyze the current scenario of QMS in the context of ISO 15189, focusing on its implementation, challenges, and future directions to make ISO 15189 more accessible to laboratories globally.