What To Know
Installation Qualification, Operational Qualification and Performance Qualification, or IQ/OQ/PQ, are the ISO 13485 basis by which you prove that the manufacturing equipment and systems for your medical device will perform as intended. IQ/OQ and PQ protocols also ensure that your manufacturing partners adhere to cGMPs.
IQ proves the process (or equipment), demonstrating that the equipment is installed correctly and shows operational consistency.
OQ documents objective evidence that all equipment functions in alignment with manufacturer specifications.
PQ confirms the performance of equipment used in the manufacturing process can maintain outputs within established tolerances.
How We Can HelpI3 Infotek talent ensures that your medical device documentation proves manufacturer compliance for all equipment and systems. Our consultants specialize in testing and documentation for all phases of IQ/OQ/PQ, such as:
- Perform calibrations of equipment
- Assess equipment design and safety features and environmental conditions
- Review supplier documentation for preventive maintenance
- Verify IQ testing is complete
- Establish standard operating procedures
- Conduct safety/alarm control confirmation
- Verify operating parameters
- Define acceptance and testing criteria