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Licensed Unlicensed Requires Authentication Published by De Gruyter June 1, 2005

Usefulness of EC4 Essential Criteria for Quality Systems of Medical Laboratories as Guideline to the ISO 15189 and ISO 17025 Documents

  • Rob T.P.Jansen , Desmond Kenny , Vic Blaton , David Burnett , Wim Huisman , Mario Plebani , Josep M. Queraltó , Simone Zérah and Joep van Lieshout


Many medical laboratories have made a start with the introduction of quality management systems. However, it is still not clear against which standards such systems should be measured. The existing ISO and CEN standards do not cover essential aspects of medical laboratories. The publication of the EC4 Essential Criteria has stimulated the development of the ISO/Draft International Standard 15189. This standard seems adequate for our type of laboratories. However, it is not easy to read. The EC4 Essential Criteria could well serve as a guide, covering additional aspects, e.g. on total quality management and budget management as required in the EFQM model, that are not (yet) included in the ISO standard. In the present article the EC4 Essential Criteria are cross-referenced with two new international ISO standards, ISO/FDIS 15189 and ISO/FDIS 17025, the latter being the successor of ISO guide 25 and EN 45000. Both new ISO documents are in compliance with the new ISO 9000:2000 standard.

Published Online: 2005-06-01
Published in Print: 2000-10-16

Copyright © 2000 by Walter de Gruyter GmbH & Co. KG

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