ISO 15189:2022, titled Medical Laboratories — Requirements for Quality and Competence, is a standard developed by the  Technical Committee ISO/TC 212. It outlines requirements for quality and competence in medical laboratories to promote reliable and accurate laboratory results, crucial for patient diagnosis and treatment.

This standard is applicable to medical laboratories in developing and assessing their management systems and competence and supports recognition of a laboratory's competence by laboratory users, regulatory authorities, and accreditation bodies. Additionally, ISO 15189 includes specific requirements for point-of-care testing (POCT), enabling laboratories to provide testing at or near the site of patient care.

ISO 15189:2022 replaces ISO 15189:2012 and ISO 22870:2016 (for POCT), both of which have been withdrawn with this latest publication.

The standard emphasizes a framework for quality management systems and technical competence. It aligns with ISO 22367 for risk management, ISO 15190 for laboratory safety, and ISO 20658 for sample collection and transport. Laboratories are encouraged to address risks and opportunities to increase management system effectiveness, reduce the probability of invalid results, and minimize harm to patients, personnel, and the environment.

Supporting continuous improvement and global comparability of patient examination results, ISO 15189 can be applied across fields like diagnostic imaging and blood banks. It facilitates cooperation between medical laboratories and healthcare services, harmonizing methods and procedures.

When seeking accreditation, laboratories are advised to select an accreditation body that operates according to ISO/IEC 17011, tailored for medical laboratories. The format of ISO 15189:2022 is based on ISO/IEC 17025:2017, enhancing applicability for both quality and technical competence.

For more detailed information about ISO 15189, visit the official International Organization for Standardization (ISO) website  for ISO 15189 - Medical Laboratories - Quality and Competence page.