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:
This course will provide all the necessary knowledge and skills needed to transition to ISO 15189:2022 compliance using a risk-based approach.
After this course participants will be able to:
The course is provided online with live facilitation through MS Teams. It is an interactive course which combines plenary lectures with group- and individual exercises. There will be plenty of time to ask questions and exchange experiences. The duration of the course is four days consisting of daily sessions of approximately 4 hours. The total duration of the course is 16 hours.
For groups, this course can also be provided onsite face-to-face as a four-day intensive course. Contact us for more information on onsite provision of this course.
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, as well as a stable internet connection.
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 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”.