Stages of validation

Stages of validation

Validation is broken into three key stages:

• Installation Qualification (IQ): Confirms that equipment, such as steriliser or washer-disinfector, has been installed according to the manufacturer’s specifications. This includes checking physical installation, utilities, and environment.
• Operational Qualification (OQ): Confirms the equipment functions correctly. This involves testing cycles and controls – usually with the machine empty or using test materials.
• Performance Qualification (PQ): Confirms that the equipment, when used with typical reusable medical devices and loading patterns, consistently produces clean and sterile items. This involves running actual process cycles using biological and chemical indicators.

Before conducting any validation, the calibration status of all monitoring and testing instruments needs to be confirmed.