When hospitals implement new medical technologies, validation is more than a formality, it’s a promise of safety, traceability, and performance.
At UV Smart, that process begins with Installation Qualification (IQ), the first step in ensuring every UV-C disinfection device is installed and ready to deliver validated, repeatable results.
What Is Installation Qualification (IQ)?
Installation Qualification verifies that each device has been installed correctly, in the right environment, and according to manufacturer specifications. The concept is well-documented across regulated industries. IQ confirms that installation meets the approved design and supplier requirements.
See more in Greenlight Guru’s overview of the IQ/OQ/PQ process.
Why IQ Matters
Before a single instrument is disinfected, IQ ensures that:
- The installation site meets environmental and electrical requirements.
- The device is properly configured and connected to the hospital’s infrastructure.
- Serial numbers, software versions, and calibration data are accurately documented.
- All safety features and interlocks are verified to function as designed.
These are not just good practice, they’re critical for regulatory compliance and internal traceability.
According to the IMDRF guidance on process validation, “Installation qualification (IQ) establishes by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification.”
In short: IQ gives infection-prevention teams and biomedical engineers confidence that the device is ready for operational validation and future audits.
How UV Smart Supports IQ
The UV Smart service team or a certified distributor performs Installation Qualification with precision and documentation that align with ISO 13485 and the EU Medical Device Regulation (MDR).
Each IQ includes
- Environmental and electrical checks (space, voltage, ventilation)
- Device setup and registration (serial numbers, model, firmware)
- Software and firmware verification
- Safety interlock testing
- Completion of the IQ documentation package
These records become part of the hospital’s Quality Management System (QMS),ensuring full traceability for regulators and internal audits.
For a helpful breakdown of these expectations, see Sifo Medical’s guide to Installation Qualification.
A Seamless Start to Validation
Once IQ is complete, hospitals can proceed confidently to Operational Qualification(OQ), which is the next phase that verifies the device functions exactly as intended under controlled conditions.
Together, these stages form the backbone of a validated UV-C disinfection workflow, ensuring patient safety, staff confidence, and process efficiency.
Key Takeaway
Installation Qualification isn’t just a technical step, it’s the foundation of trust between UV Smart and the healthcare institutions that rely on our technology.
By validating every detail from the start, we help hospitals focus on what matters most: safe, effective infection prevention without chemical consumables.
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.
.jpg)
