title: The EC4 quality manual model.
abstract: One of the priorities of the European Confederation of Clinical Chemistry (EC4) is the harmonisation of the clinical laboratory profession in Europe. One of the first steps is to try to harmonise the quality systems, that is, the clinical laboratory organisational structure, responsibilities, procedures, processes and resources involved in quality management. The "EC4 Essential Criteria" were published by the Working Group on Harmonisation of Quality Systems in order to facilitate the development or the update of a quality system in a clinical laboratory, and to encourage international bodies to produce specific Standards for the clinical laboratory. Furthermore, the EC4 Working Group has produced a Quality Manual Model, which includes a sample of quality policy documents and some operational directions for an imaginary laboratory. This Quality Manual Model was prepared following the "EC4 Essential Criteria." Its purpose is that any quality system developed following the Manual could be accredited or certified against any Standard. The EC4 Quality Manual Model will be available, free of charge, to clinical laboratory professionals.
authors: Servei de Bioquímica, Hospital de la Santa Creu i Sant Pau, Av. Sant Antoni M. Claret, 167, E-08025, Barcelona, Spain. jqueralto@hsp.santpau.es
authors: J M
authors: JM
authors: Queraltó
mesh_terms: D000068:Accreditation; D002624:Chemistry, Clinical / Q000458:organization & administration / Q000592:standards*; D003219:Confidentiality; D005060:Europe; D005062:European Union; D006801:Humans; D007753:Laboratories / Q000458:organization & administration / Q000592:standards*; D008370:Manuals as Topic; D011785:Quality Assurance, Health Care; D012449:Safety