Understanding EN ISO 15189: A New Guide for Medical Labs

The EN ISO 15189:2022 standard, released on December 6, 2022, is a major update for medical labs across Europe. It replaces the older standards EN ISO 15189:2012 and EN ISO 22870:2016. The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has created a new guide to help labs understand and implement these changes. The key goals of the update include aligning with ISO/IEC 17025:2017, removing unnecessary rules, focusing on patient safety, minimizing new requirements, and making the text clearer. The EFLM guide aims to educate labs and accreditation bodies about these changes and to assess how previous guidance has been affected. The guide is designed to help everyone involved in lab medicine, from the labs themselves to the accreditation bodies and assessors. It focuses on two main objectives: explaining the changes in the standard and evaluating how these changes impact previous guidance. This should make it easier for labs to understand and adapt to the new rules, ensuring they continue to provide high-quality, safe services for patients.