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Medical Laboratories Awareness - ISO 15189:2022

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 in this highly interactive blended course.

Issued:

October 30, 2026

Issued by:

United Kingdom Accreditation Service (UKAS)

Expiration date:

None

Issued by

United Kingdom Accreditation Service (UKAS)

Awarded to

Liv Macey

Medical Laboratories Awareness - ISO 15189:2022

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 in this highly interactive blended course (2 days classroom and approx 1 day coursework). This 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.

Earning criteria

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Complete a gap analysis for ISO 15189:2022, taking into account the organisational conformance requirements as well as the key considerations.

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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:

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- Quality assurance

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- Evaluation processes

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-Proactive risk management and

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- Effective non-conformity mechanisms.

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Review their existing examination methods for conformance and fitness for purpose including key aspects of:

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- Selection of methods and supporting services

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- Validation

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- Traceability

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- Measurement uncertainty

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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.

About the issuer

United Kingdom Accreditation Service (UKAS)

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