LIS Software for UK Medical Laboratories — ISO 15189:2022
A laboratory information system for UK labs working to ISO 15189:2022 — including the point-of-care testing the 2022 edition brought inside the same accreditation.
What a UK lab is assessed against
UK medical laboratories are accredited by UKAS against ISO 15189. The standard moved to its 2022 edition, and the transition arrangements were firm about the date.
ISO 15189:2022 was published on 6 December 2022 and replaced the 2012 edition. From 6 December 2025 only accreditation to the 2022 edition is valid; services that had not transitioned faced suspension.
In SamLab: Report formats, reference ranges, methods and interpretations configurable per test, so a format change is a setting rather than a redevelopment.
The 2022 edition absorbed the point-of-care testing requirements previously held in ISO 22870:2016 — one accreditation now covers the central laboratory and its POCT services together.
In SamLab: Results captured from analyzers and from manual entry live in the same record, with the same audit trail and the same report.
Every annual UKAS assessment of an accredited laboratory had to include a transition assessment.
In SamLab: Audit logs and result revision history that can be exported for an assessor without a database query.
Source: UKAS — ISO 15189:2022 transition arrangements · checked 2026-08-04. Accreditation is granted to the laboratory, not to its software — what SamLab provides is the records an assessor asks to see.
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Questions from United Kingdom laboratories
Does SamLab support ISO 15189:2022?
SamLab produces the records an ISO 15189 assessment looks for: configurable report formats carrying reference ranges, methods and interpretations, barcoded specimen traceability, IQC with Levey-Jennings, and audit logs with full result revision history. Accreditation itself is awarded to the laboratory by UKAS, not to the software.
We run point-of-care testing. Is that covered by the same accreditation?
Yes. ISO 15189:2022 absorbed the point-of-care requirements previously held in ISO 22870:2016, so one accreditation now covers the central laboratory and its POCT services together. In SamLab, results captured from an analyzer and results entered by hand live in the same record, with the same audit trail and the same report — which is what a single accreditation now expects.
Is accreditation to the 2012 edition still acceptable?
No. UKAS transition arrangements required laboratories to move from ISO 15189:2012 to the 2022 edition by 6 December 2025. From that date only accreditation to the 2022 edition is valid, and services that had not transitioned faced suspension of their existing accreditation.
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