ISO 15189 Awareness

It is for staff, scientists, technicians and managers in medical laboratories, including those involved in point-of-care testing. It helps every laboratory team member understand quality and competence requirements and their own part in delivering reliable results for patient care. No prior knowledge of ISO 15189 is needed.

It covers why quality and competence in medical laboratories matter to patients and clinicians; impartiality, confidentiality and requirements regarding patients; structural and governance requirements; personnel, facilities, equipment and externally provided services; the pre-examination, examination and post-examination processes; point-of-care testing within the 2022 edition; and management system requirements, including risks, nonconformities, audits and review.

ISO 15189 Awareness is a set of short video modules followed by practice questions and a final exam. The course page shows the current number of modules and the approximate video runtime; allow additional time for the practice questions and the exam. With 12 months of access, you can complete it in one sitting or spread it over several sessions.

Yes. Learners who reach the 70% pass mark in the final exam receive a Sterling Academy Certificate of Completion for ISO 15189 Awareness. Each certificate carries a unique number and a QR code, and anyone can check it online using the certificate number and the holder's surname. It is a training certificate for the individual learner.

Yes. ISO 15189 Awareness is a self-paced online course made of short video modules, in English with captions. You study at your own pace during 12 months of access, and practice questions after modules help you check your understanding before the final exam. If a point is unclear, questions are answered by a Sterling consultant.

ISO 15189 Awareness is US$19 per learner. Teams save 20% for 11 to 50 learners and 30% for 51 to 200 learners; 201 or more learners are priced on request. Client administrators can track their team's progress. Prices are in US dollars, excluding taxes, and Sterling confirms final pricing and enrolment.

No. The Certificate of Completion is a training certificate: it shows that one person completed ISO 15189 Awareness and reached the pass mark in its final exam. It is not certification of an organisation to ISO 15189, and Sterling does not certify organisations. Accreditation of a medical laboratory is granted by an accreditation body after its own assessment; this course helps staff understand what that assessment looks for.

Yes. Point-of-care testing sits within the scope of the 2022 edition of ISO 15189, and the course covers it. The course also follows the laboratory's work through the pre-examination, examination and post-examination processes, helping learners recognise risks to patients at each stage and understand why impartiality and confidentiality matter.