Introduction to ISO 15189 for Medical Laboratories

ISO 15189:2022 is the latest edition of the standard that sets out requirements for quality and competence specifically within medical laboratories. ISO 15189 can be used by medical laboratories in developing their quality management systems and assessing their own competence. The aim is to have confidence in the validity and reliability of testing services on patient samples.

The standard can be applied to wide-ranging activities in the laboratory, including patient preparation, the end-to-end management and reporting of samples, and the issues of safety and ethics in medical laboratory work.

This course is an introduction to ISO 15189:2022 requirements for quality systems in medical laboratories, and does not require you to have any prior knowledge. It is primarily aimed at people who work in and around medical laboratories, including technicians, purchasers of lab services, and users of clinical test services.

Your next step in quality systems in medical laboratories could be to train as an internal auditor. This would give you the skills to test your quality system against the requirements of ISO 15189, helping your organisation to improve on an ongoing basis. Our 2-day ISO 15189 Internal Auditor training course will teach you how to prepare, perform and follow up an internal audit.

If you are interested in the wider concept of quality systems within laboratories, you may like to take a look at our programme of training for ISO 17025, which range from introduction through to auditing and implementation.

Yes, we will send you a certificate on completion of the course to confirm your new skills. You can use this certificate to share with colleagues and managers, add to your CV, and upload to LinkedIn.

This 1-day course is equivalent to 7 hours CPD.

The International Organization for Standardization suggests that while ISO 15189 is aimed at medical laboratories, it can equally provide benefits in other healthcare disciplines, such as diagnostic imaging, respiratory therapy, physiological sciences, blood banks and transfusion services.

The goal is similar for all these services – to promote the welfare of patients and confidence in the quality and competence of the service being provided.