Factors affecting instrument performance, including maintenance, calibration, and service frequency, are additional parameters that must be included in any PCR verification/validation process. Laboratories and manufacturers must establish and maintain appropriate procedures for performing:
- Installation qualification (IQ)
- Operation qualification (OQ)
- Performance qualification (PQ)
IQ, OQ, and PQ must be performed for all instruments that are components of an integrated testing system. Please note that these topics are not being discussed in this course. For further information, reference the Clinical and Laboratory Standards Institute (CLSI) document QMS13-A, Quality Management System: Equipment.
