ISO and CEN documents on quality in medical laboratories

The forthcoming international standard ISO 15189 “Quality management in the medical laboratory” is a document of great importance for the development of quality systems and accreditation for medical/clinical laboratories. For the first time, there will be an internationally recognized standard desig...

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Bibliographic Details
Published in:Clinica chimica acta 2001-07, Vol.309 (2), p.121-125
Main Author: Kenny, Desmond
Format: Article
Language:English
Subjects:
Accreditation
Biological and medical sciences
Chemistry, Clinical - standards
Clinical laboratories
Documentation
Europe
Health participants
Investigative techniques, diagnostic techniques (general aspects)
Laboratories - standards
Medical laboratories
Medical sciences
Miscellaneous. Technology
Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques
Public health. Hygiene
Public health. Hygiene-occupational medicine
Quality Assurance, Health Care
Quality management
Societies, Scientific
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Summary:The forthcoming international standard ISO 15189 “Quality management in the medical laboratory” is a document of great importance for the development of quality systems and accreditation for medical/clinical laboratories. For the first time, there will be an internationally recognized standard designed specifically for the accreditation of medical laboratories. The document takes into account the special requirements imposed by the medical environment and by the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories must provide not only testing of patient samples, but also advisory, interpretative and educational services. A further document, still in draft form (ISO/DIS 15190), deals with safety management for medical laboratories. ISO 15189 (and probably 15190 also) are expected be adopted by CEN as a European Standard (EN).
ISSN:0009-8981
1873-3492
DOI:10.1016/S0009-8981(01)00508-3