Any equipment purchased is normally done on the basis of the manufacturers published specifications. The original guarantee shows that the equipment is performing to the manufacturer’s specifications and is confirmed with the manufacturers test certificate. The affirmation as to whether the instrument is performing to the manufacturers specification is often not questioned until its first service and calibration. Many companies recognise the inadequacy of this state of affairs. It is now deemed necessary that the equipment be validated prior to any reading being reported; indeed the instruments initial performance data gives a point zero position for any further service and calibration offering appropriate trend analysis of the instruments performance metrics. These procedures ensure equipment is properly installed, operating to expected performance as it is delivered to the users laboratory – not just the manufacturers facility.

The Qualification procedure consists of:
Installation qualification (pre-installation)
Operational Qualification
Performance Qualification

See:
Analytical Integrity: Confidence
Microlab Technologies risk assessment