Operational Qualification: Proving the Power and Safety of UV Smart Technology

Operational Qualification (OQ) is where UV Smart technology proves its performance. Each cycle, sensor, and safety check is validated for consistency and compliance.

Once Installation Qualification (IQ) is complete, Operational Qualification (OQ) is where proof meets performance.

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At this stage, every UV Smart device, from the D60 and D45, is verified to operate exactly as designed, under controlled conditions. OQ provides the documented evidence hospitals need before routine clinical use, demonstrating that UV Smart technology performs safely, consistently, and incompliance with international standards.

What Is Operational Qualification (OQ)?

Operational Qualification (OQ) confirms that the UV Smart device operates according to its design and performance specifications.

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It proves that each cycle delivers the correct UV-C dosage, every safety interlock functions properly, and all data logs, sensors, and systems behave as expected.

According to the Greenlight Guru guide to process validation, “OQ demonstrates that the equipment will operate according to its operational specifications in the environment in which it will be used.”

This phase establishes objective, traceable proof that UV Smart devices meet their intended use before they’re introduced into real-world hospital workflows.

Why OQ Matters

OQ bridges the gap between setup and clinical use, ensuring that every system performs within validated control limits.

It’s also a key expectation under ISO13485 and the EU Medical Device Regulation (MDR).

For regulatory context, UV Smart explains the standards further in Current Laws and Regulations Regarding UV-C and MDR vs MDD: What’s Changed.

During OQ, UV Smart validates:

UV-C intensity and dose with calibrated reference sensors.
Cycle accuracy and repeatability under controlled conditions.
Door and safety interlocks, emergency stops, and fail-safes.
Environmental tolerances temperature, and amperage through the lamps.
Pre-clean steps and leak tests make sure the user did all the steps.

These steps ensure full compliance with MDR, ISO 13485, and quality-management principles set by the IMDRF/GHTF Process Validation guidance.

How UV Smart Conducts OQ

All OQ procedures are performed by UV Smart service engineers or certified distributors, using validated testing protocols and calibrated instruments.

Each OQ package includes:

Device identification and setup validation, which confirms power supply, firmware, and connectivity.
UV-C dose verification using reference meters to measure lamp output and amperage in the lamps.
Safety interlock testing, including door sensors and emergency stops.
Workflow simulation for intended devices such as ultrasound probes and ENT scopes.
Software verification, which confirms audit trails, data logs, and notifications.

All results are recorded in the official OQ report, signed by both UV Smart and hospital representatives.

As noted by IMDRF and the FDA’s Process Validation guidance, “Operational Qualification establishes by objective evidence that the process control limits and action levels are capable of being achieved.”

For deeper insight into how our products support measurable, repeatable performance, visit the UV Smart product pages.

How OQ Fits Within the Validation Chain

OQ sits at the heart of UV Smart’s validation structure:

Installation Qualification (IQ) – Verifies proper setup and documentation.

Operational Qualification (OQ) – Proves that systems meet operational specs under test conditions.
Performance Qualification (PQ) – Confirms consistent results in real clinical workflows.

Together, they form the framework for UV Smart’s validated UV-C disinfection process, supported by resources in our UV Academy.

Key Takeaway

OQ is where UV Smart’s technology proves its reliability and safety.

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By validating every cycle, dose, and log, we help hospitals adopt UV-C disinfection with confidence, ensuring safety, traceability, and measurable infection prevention.

The Complete UV Smart Validation Series

Together, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) form the foundation of UV Smart’s validated UV-C disinfection process, ensuring every device is installed correctly, performs safely, and delivers consistent results in daily hospital workflows.

Installation Qualification (IQ): The Foundation of Safe and Validated UV-C Disinfection
Establishes that every UV Smart device is properly installed, documented, and ready for validation in compliance with MDR and ISO 13485 standards.
Operational Qualification (OQ): Proving the Power and Safety of UV Smart Technology
Confirms that each system operates exactly as designed, verifying UV-C dosage, cycle performance, and safety interlocks under controlled conditions.
Performance Qualification (PQ): Proven Results in Real Clinical Workflows
Demonstrates consistent, validated UV-C disinfection in real hospital environments, ensuring traceable, reliable results across everyday clinical use.

Together, these three phases ensure UV Smart partners and hospitals can adopt UV-C disinfection with complete confidence, backed by data, documentation, and engineering expertise.