The integrity of a patient result depends entirely on the integrity of the sample behind it. Under ISO 15189 compliance, laboratories must ensure that samples are collected, stored, transported, and received under strictly controlled and traceable conditions. Yet for many laboratories, maintaining continuous visibility over samples outside the lab remains one of the most difficult parts of compliance.
Across Australia, the United Kingdom, and Europe, accreditation authorities including NATA, UKAS, DAkkS, Cofrac, and INAB are raising expectations for how laboratories monitor the pre-analytical process. Manual temperature checks, basic data loggers, or scattered spreadsheet-based workflows no longer satisfy auditor expectations.
To support laboratories through this transition and the upcoming global enforcement of ISO 15189:2022 on 5 December 2025, BinaryMed provides an integrated suite of ISO 15189 compliance solutions designed to eliminate blind spots and deliver real-time, audit-ready data across the entire sample journey.
The Global Shift Toward ISO 15189:2022 Compliance
ISO 15189 defines the internationally recognised requirements for quality, competence, and risk management in medical laboratories. The 2022 revision expands the standard’s focus on:
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Traceability and data integrity
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Objective evidence of environmental control
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Risk-based thinking across all phases
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Preanalytics and sample handling requirements
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Documented corrective actions and continual improvement
For laboratories accredited by NATA, UKAS, and European bodies, the expectations are clear:
Labs must demonstrate consistent sample tracking compliance and maintain a complete, verifiable audit trail for every specimen.
The challenge is that most non-conformances occur before samples reach the analyser, during the pre-analytical phase.
The Pre-Analytical Gap: Where Most Risks Occur
Studies show that up to 70 percent of laboratory errors originate during the pre-analytical phase.* These errors don’t happen because of poor science, they happen because of process blind spots.
Common pre-analytical risks include:
Samples incorrectly labeled
Cooler boxes with unknown temperature history
Storage fridges at collection centres going out of range
Couriers leaving specimens in vehicles without environmental control
Misplaced shipments between collection centres and laboratories
Insufficient documentation of transport timelines
Each gap directly undermines a lab’s ability to maintain ISO 15189 sample tracking and provide objective evidence during an audit.
Traditional tools like manual temperature logs or USB data loggers are inherently limited. They capture retrospective data, cannot generate real-time alerts, and often produce fragmented documentation, leaving laboratories vulnerable to non-conformances.
What ISO 15189:2022 Expects from Laboratories
To comply with ISO 15189:2022, laboratories must demonstrate:
Traceability: Unique, continuous tracking of samples from collection through to receipt.
Environmental Control: Temperature and handling conditions must be monitored within defined limits.
Documentation: Records must be secure, complete, and retrievable during audits.
Corrective Action: Deviations must be detected, recorded, and addressed promptly.
Risk Management: Data must be used to identify vulnerabilities and drive continual improvement.
Auditors from NATA, UKAS, or EU bodies expect objective evidence, not assumptions.
This is why real-time laboratory sample monitoring has become essential for modern accreditation.
BinaryMed’s Integrated Approach to ISO 15189 Compliance
BinaryMed provides a fully integrated suite of sample monitoring solutions designed to strengthen ISO 15189 compliance across the entire pre-analytical process. The Cicada Voyager delivers continuous, real-time visibility of samples in transit, monitoring temperature, location, and handling conditions to ensure every specimen remains within validated ranges. At collection centres and within the laboratory, Sentinel maintains controlled storage environments by monitoring fridges, freezers, and rooms around the clock.
All monitoring data flows seamlessly into the Binary Cloud, which consolidates manifests, timestamps, storage records, deviation alerts, and corrective-action documentation into a single audit-ready platform. This integrated approach provides laboratories with the objective evidence required for ISO 15189:2022 compliance, supports NATA and UKAS accreditations, and eliminates blind spots across the pre-analytical phase.
How BinaryMed Supports Key ISO 15189:2022 Clauses
| ISO 15189:2022 Clause | Summary Requirement | BinaryMed's Compliance Support |
|---|---|---|
| 6.3 & 6.6 | Facilities, storage & environmental control | Sentinel monitors fridges, freezers and rooms with full digital traceability. |
| 7.2 | Traceability, storage, handling, transport | Cicada Voyager provides end-to-end real time tracking and temperature monitoring. |
| 7.5 | Nonconfirming work | Automated alerts and deviation logs allow immediate investigation. |
| 7.6 | Information management | Binary Cloud stores time-stamped, tamper-proof records for audits. |
| 8.5 | Risk & opportunity management | Trend data identifies recurring issues for improvement. |
| 8.7 | Corrective actions | Actions are logged, timestamped and traceable. |
| 8.8 | Evaluation & continual improvement | Long-term data supports internal audits and accreditation renewals. |
To explore the full clause-by-clause breakdown, download our free PDF guide below.
Supporting Accreditation Bodies Worldwide
BinaryMed’s solutions are designed to meet the expectations of all major accreditation authorities:
NATA (Australia)
Cicada Voyager and Sentinel provide complete environmental and transport histories, enabling laboratories to present objective evidence during NATA assessments.
UKAS (United Kingdom)
Continuous monitoring, alerts, and full traceability support UKAS requirements for risk management, process control, and documented corrective action.
European Accreditation Bodies
Systems such as DAkkS, Cofrac, and INAB reference ISO 15189 directly. BinaryMed’s cloud platform ensures data integrity across multilingual, multi-site laboratory networks.
Real-World Example: Turning Visibility Into Confidence
Consider a national diagnostic network transporting hundreds of cooler boxes between collection centres and central labs each day. Historically, temperature monitoring relied on USB data loggers that were reviewed only if a problem was suspected.
After deploying Cicada Voyager, the lab gained live visibility of every shipment. When a courier vehicle experienced a refrigeration fault, the platform immediately sent an alert. The logistics team diverted the shipment, preserved sample integrity, and avoided an expensive recollection cycle.
During their next NATA compliance audit, the laboratory demonstrated complete traceability including temperature stability, location history, and corrective-action documentation directly within the Binary Cloud dashboard.
Conclusion
Achieving ISO 15189 sample tracking compliance is about more than passing an audit. It’s about embedding a system that continuously validates itself through objective data.
BinaryMed enables that by making every sample movement transparent, every temperature excursion visible, and every decision defensible.
Whether your accreditation is governed by NATA, UKAS, or another international authority, BinaryMed’s laboratory sample monitoring technology provides the assurance that every pre-analytical step is controlled, recorded, and ready for review.
If you would like to learn more about BinaryMed’s real-time monitoring solutions and how they can help your lab achieve ISO 15189 compliance, contact us or book a demo.
