ISO 15189 Accreditation
Certificate nr. 141-MED
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The embryology and andrology labs at UZ Brussel are the first in the Benelux countries to be awarded the internationally recognized ISO Norm 15189 label. |
On April 5th, 2005, the ISO Norm 15189 Accreditation was awarded to the laboratory for Clinical Biology and to the care programme of reproductive medicine at UZ-Brussel (then still AZ-VUB).
The accreditation for the clinical biology laboratory encompasses all microbiological examinations, bacteriology, virology (including HIV), and
serology.
For the reproductive medicine care programme, all laboratory procedures in the following areas were included; sperm examinations, IVF, ICSI, up to and including embryo biopsy for pre implantation diagnosis (PGD).
ISO Norm 15189 is a measurement of quality which was specifically developed for medical laboratories. It goes much deeper than the better known ISO Norm 9001-2000 which alone certifies that a laboratory or institution has developed a certain quality control system and that it adheres to it in practice.
In order to obtain an ISO 15189 certificate, a laboratory must prove to an external independent auditor, that it is competent and consistent in generating correct laboratory results. This competence must be coupled with a high level of patient care. It goes without saying that the laboratory must additionally reside over a formulated quality control system. In other words, the ISO Norm 15189 accreditation confirms that the laboratory also complies to all ISO Norm 9001-2000 requirements.
The previously mentioned laboratories at UZ Brussel received the accreditations from Belac (then still Beltest). This Belgian institution, which is a department of the FOD Economy KMO Middle class and energy, is part of the European Union of National Accreditation Committees of the EA ( European Co-operation for Accreditation) and from the International Co-operation for Laboratory Accreditation (ILAC).
In practice, this means that the issued ISO 15189 certificate is internationally recognised and that the lab results of the clinical biology laboratory and the reproductive medicine care programme at UZ Brussel are internationally accepted. The care programme is the first in the Benelux to be recognised.