Quality planning in the 'in vitro diagnostic' industry

In vitro diagnostic (IVD) manufacturers play an important role in helping to provide laboratory results that meet the needs of patient care. Industry, the primary source of new technologies, uses established processes to assure a continuous supply of products that satisfies health care needs. The processes include validation of user needs, with well-controlled procedures that are used to manufacture quality products. Management uses routine audits and customer complaint monitoring to identify improvement opportunities. The processes used in the IVD industry are recognized quality practices that should be, and often are, used in the clinical laboratory.