IQ/OQ/PQ

Haier Biomedical can provide validation services to a range of temperature-controlled equipment to satisfy regulatory requirements. IQ/OQ/PQ stands for install, operation and performance qualification respectively and are quality assurance protocols used to ensure equipment operates accurately and is fit for purpose.

IQ – Installation Qualification

The IQ protocol verifies that the unit has been properly delivered, installed and configured according to the manufacturer.

Example of checks includes:

· Installation conditions – ambient, space, ventilation

· Power supply conditions

· Accessories

OQ – Operation Qualification

The OQ documentation process involves testing the equipment to make sure it performs as specified by the manufacturer. This process should be carried out after installation or when significant maintenance or modifications are carried out.

Example of checks include:

· Switches and light for example power

· Controller functions and configuration

· Alarm tests

PQ – Performance Qualification

The process performance qualification follows a protocol to verify and document that the equipment works within specified range under real conditions.