Calibration services in the frame of accredited coagulation EQA schemes - Meeting the IVD directive
Författare
Summary, in English
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.
Avdelning/ar
Publiceringsår
2006
Språk
Engelska
Sidor
451-454
Publikation/Tidskrift/Serie
Accreditation and Quality Assurance
Volym
11
Issue
8-9
Dokumenttyp
Artikel i tidskrift
Förlag
Springer
Ämne
- Medicinal Chemistry
- Clinical Medicine
Nyckelord
- assessment
- external quality
- in vitro diagnostic medical devices
- calibration
- coagulation
Status
Published
Forskningsgrupp
- Clinical Chemistry, Malmö
ISBN/ISSN/Övrigt
- ISSN: 0949-1775