Despite numerous published reports of the need for TQM activities in health care organizations and their widespread diffusion within the health care industry, whether they make a difference remains an unresolved issue. In this article, we discuss the major reasons why the impacts of TQM should be assessed, what needs to be measured during assessment activities, and significant methodological issues that can confound the evaluation of TQM effects. An audit framework is described that can be used to depict the types of effects that TQM may have on the performance of health care organizations. Assessment guidelines are offered that will hopefully benefit the future efforts of institutional managers and health services researchers in their attempts to determine whether TQM activities do in fact make a significant difference.