SS-EN-ISO-15189 › Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
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This International Standard specifes requirements for quality and competence in medical laboratories.This International Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confrming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.NOTE International, national or regional regulations or requirements may also apply to specifc topics covered in this International Standard.
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REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
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SS-EN ISO 15189:2012
Nov. 13, 2012
EN ISO 15189:2012(IDT); ISO 15189:2012(IDT)