What is ISO 15189?

Lab technician examining test tube for adherence to ISO 15189 to prepare medical laboratory for accreditation.

Medical laboratory test results account for 70% of medical decisions, showing how important these facilities are for health and safety in patient care. Medical laboratories take part in services that include patient preparation and identification and collecting, processing, and examining of samples. Standards such as ISO 15189:2012 bring a higher level of quality and efficiency for these laboratories.

What exactly is ISO 15189, and how does it ensure competence and patient safety?

ISO 15189 General Scope

ISO 15189 relates to the disciplines of medical laboratory services and can also be applied to those working in other services such as medical imaging, physics, etc. Based on ISO/IEC 17025 and ISO 9001, ISO 15189 outlines requirements for competence and quality. The laboratory director will have the responsibility for the overall operation and administration of the laboratory. Specific responsibilities are defined, such as providing effective leadership of the medical laboratory service and implementing a safe laboratory environment in compliance with good practice and applicable requirements.

Through ISO 15189 requirements, laboratory management can commit to a quality management system  to improve their effectiveness. A quality policy will be explicitly created for that organization. Laboratory management will review the QMS to make sure continuing adequacy and effectiveness are attained.

Continuous Improvement

While following ISO 15189, continuous improvement is made by resolution of complaints, identification and control of nonconformities, corrective action, preventive action, and evaluation and audit. By looking at the many aspects that interact with the QMS, is the standard allows for a well-rounded viewpoint that allows for better management and efficiency for the organization.

Core Activities

ISO 15189 outlines requirements for service agreements, as well as all parts of the examination processes. Results of examinations need to be reported accurately and clearly, and the release of these results and those procedures are also specified in this standard. If a laboratory needs to outsource to another laboratory, that organization will also have to comply with ISO 15189.

Personnel, environment, supplies, information management, and record-keeping are also all monitored and evaluated as a part of this standard to ensure quality.

The current edition of ISO 15189 was published in 2012, but a revision of the standard is currently under development. It is expected for publication in 2023.

Learn More About ISO 15189

If a medical laboratory follows ISO 15189, they meet both the technical competence and the management system requirements that make it possible to deliver consistent, technically valid results. The organization adhering to ISO 15189 is able to reduce risks and costs as well as engage in continual improvement with a globally recognized standard.

To learn more about ISO 15189, visit the ANAB page on ISO 15189 medical laboratory accreditation or ANAB’s self-paced course Overview of ISO 15189:2012.

ISO 15189:2012 – Medical Laboratories – Requirements For Quality And Competence is available on the ANSI Webstore. It is also available at a discount as part of the ISO 22367 / ISO 15189 / ISO 15190 / ISO/TS 20658 – Medical Laboratories Package.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.