This document is applicable to all organizations performing laboratory activities, regardless of the number of personnel. Iso 15189 documents editable manual, procedures, forms. Iso 15189 documents with manual, procedures, audit checklist. Iso 15189 can be used by medical laboratories in developing their quality management systems and assessing their own competence. Every care has been taken to ensure that the file is suitable for use by iso member bodies. Iso 15189 medical laboratories requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. Les normes nf en iso 15189 et nf en isocei 17025 definissent les. Document cofrac sh inf 50 porteestypes daccreditation rev. The aabb a2la clinical accreditation program is a combined accreditation program for clinical laboratories, blood banks, and transfusion services. Retrouvez les documents cofrac nouvellement parus ou revises ces 30 derniers jours retour en haut. Download editable iso 15189 manual, procedures, forms, audit checklists are written in plain english. International recognition of accreditation facilitates access to the export markets. Presentation on iso 15189 documentation slideshare.
Espace documentaire accueil cofrac comite francais d. Isocd 15189 medical laboratories requirements for quality and competence. In belgium it is mandatory for certain disciplines. Details of the software products used to create this pdf file can be found in the general info relative to the file. Since its introduction in 2003 iso 15189 1 has become the most important standard for accreditation of medical laboratories 2. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. Are the documents at the ansi webstore in electronic adobe acrobat pdf format only.
Pdf all french medical biology laboratories must be accredited according to iso. Isocen standards wgaiso of the eflm flexible scope. This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories. Iso 15189 est une norme internationale publiee par liso en 2012 qui specifie les exigences. Total 170 files quick download in editable form by e delivery chapter1. Norme europeenne europaische norm en iso 15189 november 2012 ics 03. Elle doit satisfaire a des exigences normatives norme 15189, des documents d application du cofrac sh ref 02 et des dispositions legislatives et. The standard was developed by the international organisation for standardizations technical committee 212. Transition to isoiec 17025 main changes in the version 2017. Thanks to the multilateral arrangements to which cofrac is signatory, accreditation obtained in france can be recognised in europe and worldwide. Iso 15189 when carrying out work at its permanent facilities andor associated facilities. Delivrer des accreditations cofrac normes et referentiels daccreditation obtenir laccreditation. Les indispensables pratiques pour etre accredites cofrac l.
Pdf metrology in an iso 15189 accredited medical biology. Ukas accreditation covers the following disciplines. Ukas provides accreditation to the internationally recognised standard iso 15189 medical laboratories requirements for quality and competence. Cette accreditation est delivree par le comite francais daccreditation cofrac et repose sur des normes europeennes harmonisees. Updated 24 march 2020 given the spread of the coronavirus and taking into account the recommendations of the german federal government, the robert koch institute and other competent authorities, the dakks has taken measures to protect employees, assessors and clients. Iso 15189 documents editable templates for medical laboratory qms certification.