For lab quality managers before a UKAS visit
ISO 15189 temperature checklist
One A4 page on what UKAS assessors look for on fridges, freezers, incubators and rooms under ISO 15189:2022, from records and alarms to calibration and measurement uncertainty. Free to download.
- The clauses that touch temperature, in plain English
- The evidence to have ready, item by item
- From the team that monitors for 25 NHS organisations
The usual gaps
Where inspections go wrong
- 01
Alarm limits that ignore uncertainty.
An alarm at exactly 8.0 °C can pass a reading that is really out of range. UKAS LAB 48 sets out the decision rules.
- 02
Readings nobody signed off.
The data exists, but nothing shows it was reviewed, by whom and when.
- 03
The room nobody monitors.
The fridges are covered. The room the analysers and reagents sit in isn't.
How JTF does it
One team, three steps
- 01
Records and review
Every temperature-dependent unit listed with its range, recorded, reviewed and signed off.
- 02
Alarms and response
Limits that allow for uncertainty, cover out of hours, and a recorded response to every alarm.
- 03
Calibration and uncertainty
Traceable calibration, certificates matched to each sensor, and a documented decision rule.
Questions
Before you book
Is this official UKAS guidance?
No. It's our reading of ISO 15189:2022 and UKAS guidance, with the sources listed. Your assessor's view is the one that counts.
Does it cover the 2022 version?
Yes. The clause numbers are from ISO 15189:2022.
Does it cover blood fridges?
It covers the temperature evidence for any lab unit. Blood storage also falls under the Blood Safety and Quality Regulations 2005, which the checklist notes.
Sources
- ISO 15189:2022 Medical laboratories: requirements for quality and competence
- UKAS: Medical laboratory accreditation (ISO 15189)
- UKAS LAB 48: Decision rules and statements of conformity
- JTF guide: Measurement uncertainty in medical laboratory temperature monitoring
- The Blood Safety and Quality Regulations 2005