Key updates and critical changes for medical laboratory services, outlining the transition considerations of ISO 15189:2022 from ISO 15189:2012, including, but not limited to; the focus on clinical utility, obligations to the patient and risk management.
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Overall
This blended course is designed for organisations planning to undertake the transition to the new version of ISO 15189 (2022) for medical laboratory examination and testing. This event will support delegates in their understanding of the new standard relating to the competence and quality of Medical Laboratories.
The course is split into three parts; pre-course exercise, instructor-led training and post-course activity, with a mandatory requirement for completion of a 4-hour online pre-course module by no later than 1 week before the classroom/virtual instructor-led training. The post-course module is not mandatory but is recommended, as it further expands on other requirements not covered in detail during the trainer-led session.
Please ensure you read the minimum requirements for this course before booking to attend.
NOTE: This transition training event focuses on critical changes from the 2012 version of ISO 15189 to the new 2022 edition. It is not suitable for organisations and customers without experience and knowledge of the previous requirements within ISO 15189:2012.
For learners without existing knowledge and experience in accredited medical laboratory services, ISO 15189:2022 awareness courses running from April 2023 are available to book here.
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Learning outcomes of this course
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.
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Key topics
- 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
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Who should attend?
Anyone with pre-existing knowledge and working experience of the implementation and/or application of ISO 15189:2012 requirements.
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Minimum requirements
Learners will be required to complete a pre-course exercise for this course and are responsible for ensuring that approximately four hours are dedicated to this activity prior to attending the instructor-led session.
NOTE: If the pre-course submission is not completed at least 1 week in advance of the course start date, the learner will not be permitted to access the instructor-led session and the standard terms and conditions of transfer/cancellation will apply.
Learners will need access to both the ISO 15189:2012 and 15189:2022 standards, either electronic or hard-copy. Standards can be purchased from BSI or ISO.
UKAS Academy virtual courses are usually delivered via the Adobe Connect application. Download links for this free programme can be found within our minimum requirements.
Any additional requirements will be detailed in the joining instructions sent after a booking has been confirmed.
