[Equipment qualification].

Abstract

The qualification of the equipment is a particularly important stage in the transfusional process. On the one hand, of many standards such as those of certification or that of accreditation require it, just as the good transfusional practices; in addition, the practices of steps of quality assurance develop this aspect. Indeed, the absence of the realization of this qualification of material having an influence on the finished product, can lead to an error in the product. This qualification passes by various stages of which some are major such as the drafting of the schedule of conditions, the drafting of the operational protocol of qualification, the decision made for the setting in routine. Finally so that this qualification takes all its dimensions it is necessary to carry out methods linked to the international system of measurement. Moreover certain questions after reflexions must find response such as which unit to check, and only this one, the equipment is - it a complex one, is there a maintenance contract? Once all these elements taken into account, the questions having found their answer, the operational protocol will then well be built, the decisions of settings in routine could be done and the sets of the finalized stages.