Clinical laboratories have an important role in improving patient care. The past decades have seen enormous changes with unpredictable improvements in analytical performance, range of tests and capacity to manage large volumes of work. At the same time, there has been a dramatic fall in the rate of laboratory errors. However, there is now a growing awareness that the testing process includes the time before samples reach the laboratory and after reports have been printed and that these areas need to be included in the quality assessment of the total testing process. Laboratory quality should include a focus on patient safety and clinical effectiveness. Services should be patient-centred, timely, efficient and equitable, and finally, should be moulded to ensure optimal outcomes. There is a need to define quality indicators that will ensure there is appropriate choice and selection of tests, use of the appropriate assay standardization and the correct interpretation of the assay results at the appropriate time. These are the areas in which a quality laboratory can, and should, now involve itself.