Determination and application of desirable analytical performance goals: the ISO/TC 212 approach

Abstract

Desirable analytical performance goals are needed to place clinical laboratories' quality management plan on a rational basis. While the most important basis of desirable analytical performance goals is medical needs, a well-established quality management plan must take into account economic and regulatory needs. There are many approaches that have been proposed for determining desirable analytical performance goals. The ISO/TC 212 approach for rationalizing the various approaches for determining desirable analytical performance goals, which is based on the ability to meet medical needs, is presented.