Establishing and maintaining laboratory quality standards are essential to generate reliable results to support clinical and public health actions. The Laboratory Quality Standards present a minimum set of standards that can be readily adapted by countries and applied to laboratories at every level of the health-care system. This document also outlines mechanism to implement them. This document will be of help to national policy-makers as well as regulators in developing national laboratory quality standards. It provides a simple approach to meet the minimum requirements set with the ultimate objective to comply with ISO 15189 in a logical and step-by-step manner.