Enhance your understanding of how the organisational processes of medical laboratories can be improved by meeting the requirements of ISO 15189:2022 and its focus on clinical utility, obligations to the patient and risk management.
-
Overview
This blended course is designed for organisations embarking on their accreditation journey for diagnostic examination and testing in the laboratory and will support delegate understanding of the new ISO 15189:2022 standard, relating to the competence and quality of Medical Laboratories.
This course focuses on the sample pathway, to highlight the non-linear nature of diagnostic testing and how it can be designed to support the demonstration of conformance and competence to the latest ISO 15189 standard.
The course is split into three parts; pre-course preparation and 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.
For an understanding of the changes between the 2012 edition of the standard and the new ISO 15189:2022, transition courses running from April 2023 are available to book here.
Note: this course does not include the Standard requirements of point-of-care testing (PoCT) that have been subsumed into ISO 15189:2022. A further one-day module covering this is available to book from June 2023 here.
-
Learning outcomes of this course
By the end of the course, learners will be able to:
- Complete a gap analysis for ISO 15189:2022, taking into account the organisational conformance requirements as well as the key considerations.
- Evaluate their existing management system against the ISO 15189:2022 requirements to determine if it supports the demonstration of conformance which includes key considerations of:
- Quality assurance
- Evaluation processes
- Proactive risk management and
- Effective non-conformity mechanisms.
- Review their existing examination methods for conformance and fitness for purpose including key aspects of:
- Selection of methods and supporting services
- Validation
- Traceability
- Measurement uncertainty
- 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.
Those who attend the course in full will receive a certificate of attendance once their invoice has been settled.
-
Key topics
- Introduction and role of the Standard
- Relevant terms and definitions
- Key touch points for:
- Persons and personnel
- Method validation
- Ensuring the quality of examination results
- Reporting of results
- Internal Audit
- Service agreements
- Externally provided products and services
- Risk, Opportunities and Actions
- Requirements regarding patients
- Management system documentation
-
Who should attend?
This course is designed for any individuals responsible for, and involved in, the quality and/or technical support activities relating to medical sample examination and result generation activities within their organisation. This could include:
- Service or Technical Managers and Leads
- Quality managers, leads, coordinators and officers
- Biomedical scientists or Clinical Scientists involved in or looking to develop their careers into quality and accreditation
- Those responsible for the selection, evaluation and procurement of external services
- ISO 15189 Technical Assessors and Assessment Managers
-
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 the ISO 15189:2022 Standard, 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.
-
Meet the trainers
All UKAS trainers are dedicated professionals with years of practical experience in their specialist areas. Many UKAS trainers have previously worked as Assessment Managers, giving delegates the benefit of their wealth of knowledge.
