ISO 15189 Certification: A Complete Guide for Medical Laboratories
In today’s healthcare ecosystem, accuracy, reliability, and efficiency in laboratory services are non-negotiable. ISO 15189 certification stands as a globally recognized benchmark for quality and competence in medical laboratories. Whether you run a diagnostic center, a hospital lab, or an independent pathology lab, aligning with ISO 15189 helps demonstrate your commitment to quality healthcare outcomes. This comprehensive guide explores what ISO 15189 is, why it matters, the certification process, its benefits, and how to prepare for successful accreditation. I. What is ISO 15189 Certification? ISO 15189:2012 is an international standard developed by the International Organization for Standardization (ISO) specifically for medical laboratories . It outlines requirements for quality management systems and technical competence , ensuring that laboratories can consistently deliver valid and reliable test results. Unlike general quality standards like ISO 9001, ISO 15189 is ...