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The EC4 quality manual model.

J M Queraltó1

  • 1Servei de Bioquímica, Hospital de la Santa Creu i Sant Pau, Av. Sant Antoni M. Claret, 167, E-08025, Barcelona, Spain. jqueralto@hsp.santpau.es

Clinica Chimica Acta; International Journal of Clinical Chemistry
|July 5, 2001
PubMed
Summary

The European Confederation of Clinical Chemistry (EC4) developed essential criteria and a quality manual model to harmonize clinical laboratory quality systems across Europe. This initiative aims to facilitate laboratory accreditation and certification against international standards.

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Clinical chemistry and laboratory medicine·2001

Area of Science:

  • Clinical Chemistry
  • Laboratory Quality Management

Background:

  • Harmonisation of the clinical laboratory profession in Europe is a key priority for the European Confederation of Clinical Chemistry (EC4).
  • Establishing harmonised quality systems is a crucial first step towards professional harmonisation in clinical laboratories.

Purpose of the Study:

  • To present the "EC4 Essential Criteria" for developing or updating clinical laboratory quality systems.
  • To introduce a Quality Manual Model designed to align with the "EC4 Essential Criteria" and facilitate accreditation/certification.
  • To support clinical laboratory professionals by providing a free, accessible Quality Manual Model.

Main Methods:

  • Publication of the "EC4 Essential Criteria" by the Working Group on Harmonisation of Quality Systems.
  • Development of a Quality Manual Model based on the "EC4 Essential Criteria", including sample quality policy documents and operational guidance.

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  • Making the Quality Manual Model freely available to clinical laboratory professionals.

    • Main Results:

    • The "EC4 Essential Criteria" provide a framework for laboratory quality system development and update.
    • The Quality Manual Model offers practical guidance and a template for creating compliant quality systems.
    • The availability of the model aims to streamline the accreditation and certification process for clinical laboratories.

    Conclusions:

    • The EC4 initiative provides essential tools for harmonising clinical laboratory quality systems in Europe.
    • The developed criteria and manual model support laboratories in achieving accreditation and certification.
    • This work facilitates the standardisation of quality management in European clinical laboratories.