[Recommendations for the preparation of the quality manual]

Abstract

A quality manual includes the quality policy as established by the management of the medical laboratory, the objectives and indicators to control the quality management system. This manual describes the quality management system and the structure of the documentation used, with reference to supporting documents and technical procedures. It is also the responsibility of the management to establish, implement and monitor the proper functioning of all equipment, reagents and analytical systems. The management needs to ensure that preventive maintenance is done on a regular basis and all the manufacturers 'recommendations should be adopted and made available to laboratory staff. The development of a manual quality is one of the first steps of the management of quality in a medical laboratory. A model of quality manual for a fictive laboratory is given as well in annex to helping to prepare as a concrete basis.

Keywords: ISO 15189; accreditation; document control; quality manual; quality objectives; quality policy.