Calibration services in the frame of accredited coagulation EQA schemes - Meeting the IVD directive
2006 (English)In: Accreditation and Quality Assurance, ISSN 0949-1775, Vol. 11, no 08-Sep, 451-454 p.Article in journal (Refereed) Published
Organisers of external quality assurance programmes may, for various reasons, also manufacture in vitro diagnostic medical devices, or provide calibration services. This paper describes measures taken by a Swedish organiser to meet the requirements of the European Commission's directive 98/79/EC for a national calibration of prothrombin time. Quality management system requirements and interactions with coagulation experts are summarised.
Place, publisher, year, edition, pages
2006. Vol. 11, no 08-Sep, 451-454 p.
in vitro diagnostic medical devices, calibration, external quality assessment, coagulation
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:liu:diva-45993DOI: 10.1007/s00769-006-0107-yOAI: oai:DiVA.org:liu-45993DiVA: diva2:266889