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§5.1 Qualification stages
Equipment and systems are qualified in three stages: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Each stage is approved before the next begins.
§5.2 Installation qualification
IQ confirms the equipment is installed to specification. All critical instruments used during IQ must hold in-date calibration certificates; an out-of-date certificate is recorded as a deviation and assessed for impact on the qualification.
§5.4 Performance qualification
PQ demonstrates consistent performance under routine conditions, typically across three consecutive phases, with all results within acceptance limits.