Qualification

Documented evidence that equipment, utilities or facilities are correctly designed, installed, operate as intended and perform in actual use. Japanese documents follow the staged model of PIC/S Annex 15: design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), completed before process validation starts. Qualification applies to new equipment and is repeated, in part, after changes (requalification). A literal translation such as 'suitability evaluation' hides the link to DQ, IQ, OQ and PQ, so use 'qualification' in English and keep the stage abbreviations.