Is the quality system from the medical laboratory sufficient for assuring the medical output?
According to ISO 8402 (33), quality is defined as the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. Medical laboratories must provide a high quality service by producing accurate, precise, relevant and comprehensive data that can be applied to the medical management of patients. The tests requested must be appropriate to the medical problem, must be analytically correctly performed and their results interpreted correctly. Appropriateness of tests can only be obtained by a dialogue between the clinician and the medical pathologist. Correct analytical results are based on (i) quality management within the laboratory (ii) the quality of industrially prepared reagents (kits) and systems and on (iii) quality management of the pre-analytical phase outside the laboratory. A bad system, a wrong sampling or a kit with poor performance can never produce a reliable result, even in a laboratory with the best quality ma
