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Ch. R. Schweiger
Die Situation des Qualitätsmanagements in Österreich / Quality Management in Austria
This article deals with the situation of quality management in Austrian medical laboratories. Starting in 1994 after several rounds of discussion, the Society for Good Analytical und Laboratory Practise (GALP) was founded by the two major societies for laboratory medicine und clinical chemistry. This society had the purpose to work out strategies for quality management for Austrian medical laboratories. The major outcome of the activities was the adoption of ISO 9002:1994 as the model for quality management in medical laboratories and the publication of a guideline for the implementation of ISO 9002:1994 in the medical laboratories. This guideline was the basis for many medical laboratories in Austria to seek ISO 9001/2:1994 certification. Currently most medical laboratories (except those in hospitals, where certification is not so prevalent) are ISO 9000 certified. The next major development in quality management was the adoption of the third medical device guideline of the European Union (IVD-Guideline) and its national implementation in the Austrian Law on Medical Devices. This law includes several clauses, which can be used by the ministry of health to require quality management systems in medical laboratories and to establish rules for certification agencies in this field. However, the implementation of these clauses in the law is weak due to the lack of resources on side of the ministry. Nevertheless, European Union demands will lead to more effective measures as they did in the field of clinical studies. The development of EN ISO 15189:2003, which will be published in German language in December 2003, will lead to a change from certification to accreditation, at least in the high quality segment of medical laboratories. This will bring Austria in line with the international situation. Currently, quality does not have any impact on reimbursement of medical laboratories in Austria, so quality matters only in terms of cost but not in terms of higher earnings. Therefore quality is motivated by idealistic factors which tend to lose when economic pressures rise. In the future, changes in this field will be necessary too.
LaboratoriumsMedizin, Walter de Gruyter
Print ISSN: 0025-8466
Volume: 28, 02/2004
Pages: 85 - 90