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Accreditation and Quality Assurance

, Volume 11, Issue 11, pp 593–594 | Cite as

Maximum permissible day-to-day imprecision and ISO 15189

  • Xavier Fuentes-Arderiu
  • Raül Rigo-Bonnin
Discussion Forum
  • 294 Downloads

The standard ISO 15189:2003 [1] specifies particular requirements about validation and quality of the examination procedures, mainly in subclauses 5.3.2, 5.5.1, 5.5.2, 5.5.4 and 5.5.6. These requirements indicate that clinical laboratories seeking accreditation shall comply with specifications relevant to the examinations concerned and shall use validated examination procedures, it is to say for these procedures there is objective evidence that the requirements for a specific intended use or application have been fulfilled [2]. In the clinical laboratory, many of these requirements are metrological ones.

In real life, clinical laboratories mostly use commercial validated examination procedures, generally without modification; in-house examination procedures are less used that the commercial ones. Logically, when a clinical laboratory use a commercial validated examination procedure without modification, it is only necessary to have a copy of the manufacturer's validation documentation,...

Keywords

Day-to-day imprecision Maximum permissible imprecision metrological requirements Standard ISO 15189 Accreditation Metrology 

References

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Copyright information

© Springer-Verlag 2006

Authors and Affiliations

  1. 1.Laboratori ClínicIDIBELL-Hospital Universitari de BellvitgeCataloniaSpain

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