Usefulness of EC4 essential criteria for quality systems of medical laboratories as guideline to the ISO 15189 and ISO 17025 documents

Many medical laboratories have made a start with the introduction of qualit y management systems. However, it is still not clear against which standard s such systems should be measured. The existing ISO and CEN standards do no t cover essential aspects of medical laboratories. The publication of the E C4 Essential Criteria has stimulated the development of the ISO/Draft Inter national Standard 15189. This standard seems adequate for our type of labor atories. 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 m anagement and budget management as required in the EFQM model, that are not (yet) included in the ISO standard. In the present article the EC4 Essenti al Criteria are cross-referenced with two new international ISO standards, ISO/FDIS 15189 and ISO/FDIS 17025. the latter being the successor of ISO gu ide 25 and EN 45000. Both new ISO documents are in compliance with the new ISO 9000:2000 standard.