The Challenge
A leading NHS healthcare trust was approaching a UKAS (ISO 15189) audit - and confidence in their existing temperature monitoring system was rapidly eroding.
The system, inherited from years of procurement inertia, could technically monitor fridges and ambient zones, but lacked almost every element required for audit readiness. Incident records were fragmented or missing. CAPA was handled manually on paper or email threads. Certificates of calibration were stored inconsistently - some scanned, some missing, some expired without alert. And perhaps most concerningly, staff struggled to demonstrate what to do when something went wrong.
The risk wasn’t just a failed audit. It was a systemic vulnerability to reputational damage, operational delays, and compromised patient safety.
UKAS accreditation requires not only traceable records but also demonstrable evidence of escalation, root cause identification, corrective action, preventative measures, and a working feedback loop - all embedded in daily operation. The trust’s system failed on nearly every front.
With just months to prepare, the trust needed more than a monitoring upgrade. They needed a compliance framework that aligned with ISO 15189, MHRA guidelines, and internal clinical governance standards - and they needed it fast.
The Sematics® Solution
Sematics® was brought in to provide an integrated, end-to-end compliance infrastructure – tailored to the specific operational and audit needs of NHS pathology and pharmacy environments.
The deployment focused not just on environmental sensors, but on rebuilding the entire data journey: from incident detection, to resolution, to audit presentation.
Intelligent Compliance Architecture
Sematics® delivered a platform that transformed monitoring into an auditable, accountable, and actively managed system:
- Every temperature breach triggered a structured workflow, logging detection time, asset affected, breach severity, and system-logged root cause fields.
- CAPA actions were recorded directly in the platform, assigned to roles, and tracked to closure - no more paper trails or lost email chains.
- Automated alerts followed a strict logic, differentiating between in-hours and out-of-hours response paths, aligned with SOPs and escalation protocols.
- Daily, weekly, and monthly sign-offs were role-based, logged by user, and timestamped - providing full accountability at every review stage.
- Calibration records and certificates were uploaded, categorised, and version-tracked, with automated reminders issued ahead of expiry and approval requests routed to designated approvers.
- Live dashboards gave QA and department leads a single view of current status, active incidents, overdue tasks, and expiring certificates.
Importantly, Sematics® didn’t require staff to change how they worked - it mapped cleanly to existing SOPs, offering guardrails and structure without friction.
The Audit Experience
When the UKAS assessor arrived, they asked for 12 months of incident history for all monitored assets - including root cause actions, calibration status, and escalation evidence.
The trust’s QA lead opened the Sematics® dashboard and walked through it live.
Every incident was immediately accessible - showing what happened, who was notified, what was done, who approved it, and which calibration certificate was in place at the time. The assessor queried calibration traceability; Sematics® provided a certificate chain showing ISO 17025 origins, approval logs, and upcoming expiry dates - all in two clicks.
For the first time, compliance wasn’t a scramble to gather records. It was a clear, auditable story, with a timestamped chain of accountability and outcomes.
The result:
- A clean UKAS audit pass
- Zero non-conformities related to environmental monitoring
- Praise from the assessor on the system’s clarity, integration, and oversight
A New Standard of Operation
Post-audit, the trust reported not only compliance gains - but cultural ones.
Staff knew where to look, what to do, and how their actions were being recorded and reviewed. QA had confidence that if something failed, there was a system in place that didn’t just alert, but managed the incident through to closure.
“Sematics® didn’t just help us pass the audit – it raised our entire standard of operation. It’s become our single source of compliance truth.”
QA Lead, NHS Pathology
Why It Worked
Sematics® succeeded where others failed because it treats compliance as a workflow, not a by-product.
Most systems passively record temperatures and leave the rest to humans. Sematics® builds the structure, tools, and visibility needed to action and evidence every step - from breach detection to audit readiness.
It’s built for clinical-grade environments, where failure isn’t theoretical - it’s operational.
Learn more about how Sematics® supports UKAS ISO 15189 and MHRA GxP data integrity, or schedule a consultation at sematics.com.