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.
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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.
Delegates who complete this training will be able to attend our free post-course drop-in sessions to support their learning. The hour-long virtual sessions run monthly and can be attended as many times as required to ask our training team any post-course questions.
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 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 here.
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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.
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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
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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
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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 one 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.
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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.
- Daniel Boyland
- Darren Edwards
- John Ringrow
- Rachel Boyer-Blanchard
- Elizabeth Wilkinson-Smith
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Readiness Assessment Tool
If you are considering applying for accreditation, start your self-assessment against the expectations of ISO 15189:2022 and find out how ready you are to apply.
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FAQs
Will I receive a MedLabs Awareness – ISO 15189 course certificate?
Once you have successfully completed the MedLabs Awareness – ISO 15189 course, you will receive a certificate of attendance as well as a digital badge which can be shared on social media to showcase your new skills to your network.
Will I need to take an exam?
Successful completion of the MedLabs Awareness – ISO 15189 course will require your completion of the pre-course work, full attendance and active participation during the trainer-led session and taking the post-course online learning and knowledge check. Activities to check learners’ understanding will often be scheduled after key topics during the trainer-led session, but there is no final exam.
What are the minimum and maximum delegate numbers for the in-company MedLabs Awareness – ISO 15189 course?
We recommend a minimum of four delegates for the in-company MedLabs Awareness – ISO 15189 course. Some courses can have up to twenty participants. Please contact our Sales Team at [email protected] or call us on +44 (0) 1784 429018 to discuss your in-house virtual or on-site course requirements.
What are the benefits of the UKAS Training Academy?
- Courses are developed by UKAS, the UK’s sole national accreditation body with over 25 years’ experience in assessing to the standards.
- Dedicated training advisors to help find the best course or training programme for you.
- Trainers who are practicing Assessment Managers or Technical Assessors for UKAS, specialising in the standard they teach.
- Complimentary post-course clinic support for 12 months after course completion, with monthly access to UKAS trainers to address any challenges faced after the course.
- Leading virtual platform facilitating interaction throughout, including group exercises, quizzes and role play.
- In-company courses for multiple delegates, with options for either virtual or on-site delivery.
- eLearning modules for those looking for bitesize learning.
- UKAS Academy certificate and digital badge to share on your socials and add to individual training records for increased confidence in your competency.
What availability do you have on the MedLabs Awareness – ISO 15189 course?
Please contact our training advisors at [email protected] or call +44 (0) 1784 429018 to discuss the current availability of each course.
What is blended learning and why is it beneficial?
Blended learning combines self-directed eLearning with trainer-led sessions, in a seamless learning flow. This allows the learner flexibility in completing ‘part one’ of the course and ensures all learners enter the trainer-led session with the same knowledge of the foundational principles to be further explored and expanded upon during the course.
This blended course also includes additional content, reflection exercises and quizzes after the trainer-led session, designed to consolidate the delegate’s learning and enhance knowledge retention. Blended courses also include post-trainer-session eLearning, to consolidate the delegate’s learning and improve knowledge retention.What are the costs for the MedLabs Awareness – ISO 15189 course and how do I pay?
- The blended MedLabs Awareness – ISO 15189 course can be booked at £1350.00 + VAT per delegate with a purchase order number, and will be invoiced as soon as the booking is processed. The invoice can be cleared by BACS or card payment over the phone. The invoice value must be paid by the course start date.
- eLearning modules can be purchased online with a credit or debit card. If you are spending over £250 in a single transaction please contact our training team for additional payment options.
Do you provide post training support?
The MedLabs Awareness – ISO 15189 course price includes access to our post course clinics, which are run virtually every month and are open to all delegates for a 12-month period after attending qualifying UKAS Academy training.
This blended course also includes post-trainer-session eLearning, to consolidate the delegate’s learning and improve knowledge retention.What are the minimum requirements of the MedLabs Awareness – ISO 15189 course?
The minimum requirements of the MedLabs Awareness – ISO 15189 course are:
- Completion of a self directed Part 1 eLearning module (approximately four hours in duration).
- Access to a copy of the ISO 15189:2022 Standard.
- Access to two computer screens for group exercises (if virtual).
- Virtual courses will require the Adobe Connect application. Download links for this free programme can be found within our minimum requirements.
How is the virtual MedLabs Awareness – ISO 15189 course delivered?
The virtual MedLabs Awareness – ISO 15189 course is delivered using Adobe Connect. Links to download this free application, alongside the minimum requirements for virtual courses, can be found here. Our virtual courses are highly interactive and include group exercises, discussions and regular delegate participation throughout.
We strongly suggest you check you are able to download and test the Adobe Connect application prior to booking your virtual course. If you have any issues with the download or test, please don’t hesitate to contact [email protected].
