The EC4 Quality Manual Model

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, proced...

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Bibliographic Details
Published in:Clinica chimica acta 2001-07, Vol.309 (2), p.127-136
Main Author: QUERALTO, Josep M
Format: Article
Language:English
Subjects:
Accreditation
Accreditation and certification
Biological and medical sciences
Chemistry, Clinical - organization & administration
Chemistry, Clinical - standards
Confidentiality
EC4
Europe
European Union
Humans
Investigative techniques, diagnostic techniques (general aspects)
Laboratories - organization & administration
Laboratories - standards
Laboratory management
Manuals as Topic
Medical sciences
Miscellaneous. Technology
Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques
Quality Assurance, Health Care
Quality management
Quality Manual
Quality System
Safety
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Summary: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.
ISSN:0009-8981
1873-3492
DOI:10.1016/S0009-8981(01)00510-1