Maximum permissible day-to-day imprecision and ISO 15189
- 294 Downloads
The standard ISO 15189:2003  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 . 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,...
KeywordsDay-to-day imprecision Maximum permissible imprecision metrological requirements Standard ISO 15189 Accreditation Metrology
- 1.International Organization for Standardization (2003) Medical laboratories – Particular requirements for quality and competence. ISO 15189. ISO, Geneva, SwitzerlandGoogle Scholar
- 2.International Organization for Standardization (2000) Quality management systems – Fundamentals and vocabulary. ISO 9000. ISO, Geneva, SwitzerlandGoogle Scholar
- 3.Bundersärztekammer. Richtlinie der Bundesärztekammer zur Qualitätssicherung quantitativer laboratoriumsmedizinischer Untersuchungen. Beschluss des Vorstandes der Bundesärztekammer vom 24.08.2001 <http://www.bundesaerztekammer.de/ 30/Richtlinien/Richtidx/Labor2002> [Accessed 2006-03-13]Google Scholar
- 4.Centers for Medicare & Medicaid Services. Clinical Laboratory Improvement Amendments. <http://www.cms.hhs.gov/clia> [Accessed 2006-03-13]Google Scholar
- 5.ISO/DIS 15196 (2001) Technical report: determination on analytical performance goals for laboratory procedures based on medical requirements. ISO, Geneva, SwitzerlandGoogle Scholar
- 7.Fuentes-Arderiu X, Miró-Balagué J (2000) Clin Chem 46:1715–1716Google Scholar