[Quality standards for medical laboratories].
In France, medical laboratories must engage a quality approach according to the standard guide de bonne exécution des analyses (GBEA) and, for hospital laboratories, according to the Agence nationale d'évaluation en santé (Anaes). Except the GBEA and the Anaes handbook, which are obligatory standards by regulations, the biologists can choose, for a complementary and voluntary quality process, between the standards ISO 9001, ISO 17025 or ISO 15189. Our aim is to shed light on the advantages of these five standards by realizing a comparative study of their requirements. This work enabled us to highlight a great number of similarities and to raise the characteristics of these five standards. According to their objectives, the biologists will choose a recognition of their quality management system with an ISO 9001 certification or a recognition extended to the technical skills with an ISO 17025 or ISO 15189 accreditation. The contents of these last two documents are rather close and both integrate requirements of the standard ISO 9001. The standard ISO 17025 is, at first sight, rather distant from the biological analysis, requiring many efforts of adaptation, just like the ISO 9001 standard. The standard ISO 15189 seems to be well adapted but more constraining seeing the details requirements level needed. It necessitates a perfect control of the preanalytical phase, which is difficult to acquire in a clinical framework where the biological fluids are not taken by the laboratory staff.
Pascal
P
P
Banque de tissus et cellules des hospices civils de Lyon, hôpital Edouard-Herriot, Lyon, France.
Beyerle
F
F
D001695:Biology / Q000592:standards; D005602:France; D006296:Health Services / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007753:Laboratories / Q000331:legislation & jurisprudence* / Q000592:standards*; D011786:Quality Control