Course: Transitioning to ISO 15189:2022 

including risk assessment & requirements for Point of Care Testing

In December 2022 the International Organization for Standardization (ISO) finally published the long-awaited new version of ISO 15189, ISO15189:2022. All accredited laboratories are expected to transition to this new standard in the coming months and all laboratories on their way to accreditation have to amend their quality management system to comply with it. 

Major new elements are:

• The role of the management has become much more prominent.
• The quality management system has to be driven by the outcomes of risk assessments using a process approach.
• Requirements related to Point of Care Testing outside the laboratory are now included in the standard.

In addition:

• Accredited laboratories have to prepare a transition plan to comply with the new standard.

Course objective

This course will provide you with all the necessary knowledge and skills needed to transition to ISO 15189:2022 compliance using a risk-based approach.

Learning outcomes 

After this course participants will be able to: 

• Describe the structure of ISO 15189:2022 and explain the major differences with ISO 15189:2012. 
• Identify key elements to be included in the transition plan.
• Explain the crucial role of the laboratory’s management in implementing, transitioning to, and coordinating a quality management system based on ISO 15189:2022.
• Explain how to ensure compliance of Point of Care Testing outside the laboratory with ISO 15189:2022.
• Conduct risk assessments using a process approach.
• Develop a risk control plan to manage risks and optimize laboratory quality management.
• Embed risk management in the continuous improvement cycle of the laboratory quality management system.

Course format 

The course is provided online with live facilitation through MS Teams. It is an interactive course which combines plenary lectures with group- andindividual exercises. There will be plenty of time to ask questions andexchange experiences. The duration of the course is one week consisting ofdaily sessions of approximately 4-5 hours. The total duration of the course is20-24 hours.

For groups, this course can also be provided onsite as a 3-4-day face-to-face intensive course. Contact us for more information.

Target audience

This course is aimed at laboratory quality officers, managers and staff who are responsible for, or involved in, the laboratory’s quality management system that is currently based on ISO15189:2012, but needs to transition to ISO 15189:2022. Participants from accredited as well as not yet accredited laboratories are welcome to participate. Basic knowledge of quality management and the ISO15189:2012 standard is expected. The course language is English.

Why DATOS?

DATOS designs, develops and provides courses that are provided by DATOS itself as well as for other organizations. Our unique training methodology is based on adult learning principles. This means that each course helps participants to acquire new knowledge and skills through many interactive individual and group exercises making use of their own professional experience. We provide our courses worldwide and they are very well received with average scores of more than 9 out of 10 (and often over 9.5 out of 10). 

Your lead trainer

Dr. Tjeerd Datema is one of the founders of DATOS and has more than 13 years’ experience in strengthening laboratory quality management worldwide. He has assessed, mentored, and trained laboratories and their staff all over Asia and Africa in developing and implementing laboratory quality management systems. He is also the lead developer of WHO’s Laboratory Quality Stepwise Implementation (LQSI) tool. In 2020 he defended his PhD thesis “Strengthening health laboratories in low- and middle-income countries through implementation of a quality management system”. 

Eligibility criteria

• As this interactive course contains many exercises, a good command of English is essential.
• Basic knowledge of quality management and the ISO 15189:2012 standard is expected.
• Participants need to have access to their own copy of the ISO 15189:2022 standard. This can be ordered through: https://www.iso.org/standard/76677.html (not included in the course fee). NOTE: ISO does not allow the provision of copies of the standard to course participants.
• For the online course, a stable internet connection is required.

Contact us for more information on provision of this course.