This course is designed for organisations planning to undertake the transition to the new version of ISO 15189 (2022) for medical laboratory examination and testing. It is a video-based delivery of the face-to-face ISO 15189:2022 Transition course without direct interaction with the trainers.
It is split into 3 parts:
- Foundation information introducing the structural shift, changes in terms and definitions,
- Major changes to each section of the standard including video based trainer-led delivery.
- End-of-course test of understanding, key take-home, messages, and minor changes to consider.
To enhance your learning experience, we have curated links to relevant further reading, and a downloadable notebook for you to capture your reflections.
Who is this course for?
This course is aimed at anyone with pre-existing knowledge and working experience of the implementation and/or application of ISO 15189:2012 requirements.
ISO 15189:2022 Transition - Video Based Learning
£550 exc VAT Online
By the end of the course, learners will be able to:
- Complete their gap analysis for ISO 15189:2022, taking into account the major changes identified and discussed as well as the key considerations.
- Evaluate their existing risk management system against the ISO 15189:2022 requirements to determine if it is fit for purpose.
- Consider their relationships with patients and users and determine if these are effective in supporting the development of their service, as well as demonstrating conformity with the requirements of ISO 15189:2022.
- Introduction and change in emphasis
- Update of terms and definitions
- Impactful changes to:
- General requirements
- Structure and governance requirements
- Resource requirements
- Process requirements
- Management system requirements
Anyone with pre-existing knowledge and working experience of the implementation and/or application of ISO 15189:2012 requirements.
This course is expected to take approximately four to six hours to complete.
This training is presented as self-paced, modular online eLearning. After your payment for this training is processed, you will receive an email including a link to access the course material. This is available 24/7 and will be accessible to you for 12 months from the date of purchase.
When completed, you will be issued with a certificate of completion and a digital badge.