Atrys renews and extends the scope of accreditation
March 5, 2014
The National Accreditation Entity (ENAC) has decided to renew and expand the accreditation scope of Althia Health, S.L. (Althia) in recognition of the quality and technical competence in accordance with the criteria set out in the UNE-EN ISO 15189: 2007 standard for conducting tests on Pathology and Molecular Pathology.
The ISO 15189 is an internationally recognized standard, specifically designed for the establishment of quality management in a clinical laboratories, and the evaluation of the technical capacity of a laboratory to provide reliable and accurate results. It is a critical initiative that provides quality standards of best practices and competencies for the harmonization of global practices towards a common measure of quality and safety assurance.
Althia (now Atrys) was the first laboratory in Spain accredited according to ISO 15189 to determine the overexpression of the HER2 protein by immunohistochemistry (IHC) and the amplification of the HER2 gene by fluorescence in situ hybridization (FISH) in breast cancer.
Recently Atrys has extended its reach to all IHC and FISH tests listed on the ENAC Accredited Analysis List, including more than 70 markers. However, having opted for a flexible range mode, this list will be expanded while Althia incorporates new IHC and FISH markers into its catalog.
UNE-EN ISO 15189 accreditation, unlike ISO 9001 certification for quality management, ensures the technical competence of clinical laboratories, and is the standard recommended by the Spanish Society of Pathological Anatomy (SEAP) for the laboratories of Pathological anatomy.
With this recognition, Atrys has fulfilled the objective of extending the scope of its technical competence, and confirms its commitment to the highest levels of quality in the diagnosis service, R&D services and collaborations, as well as in the field of Clinical trials.