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Accreditation and Quality Assurance

, Volume 11, Issue 8–9, pp 451–454 | Cite as

Calibration services in the frame of accredited coagulation EQA schemes – Meeting the IVD directive

  • Ulf Örnemark
  • Elisabeth Nilsson
  • Gunnar Nordin
  • Nils Egberg
  • Tomas L Lindahl
  • Andreas Hillarp
  • Lennart Stigendahl
  • Inger Fagerberg
Practitioner's Report
  • 55 Downloads

Abstract

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.

Keywords

In vitro diagnostic medical devices Calibration External quality assessment Coagulation 

References

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Copyright information

© Springer-Verlag 2006

Authors and Affiliations

  • Ulf Örnemark
    • 1
  • Elisabeth Nilsson
    • 1
  • Gunnar Nordin
    • 1
  • Nils Egberg
    • 2
    • 3
  • Tomas L Lindahl
    • 2
    • 4
  • Andreas Hillarp
    • 2
    • 5
  • Lennart Stigendahl
    • 2
    • 6
  • Inger Fagerberg
    • 2
    • 6
  1. 1.EQUALISUppsalaSweden
  2. 2.EQUALIS' expert group for coagulationUppsalaSweden
  3. 3.Karolinska University HospitalStockholmSweden
  4. 4.Linköping University HospitalLinköpingSweden
  5. 5.Malmö University HospitalMalmöSweden
  6. 6.Sahlgrenska University HospitalGothenburgSweden

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