
Issued:
October 30, 2026
Issued by:
United Kingdom Accreditation Service (UKAS)
Expiration date:
None
Issued by
United Kingdom Accreditation Service (UKAS)
Awarded to
Medical Laboratories Awareness - ISO 15189:2022
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.
