Norme 15189 cofrac pdf download

Espace documentaire accueil cofrac comite francais d. Les indispensables pratiques pour etre accredites cofrac l. Since its introduction in 2003 iso 15189 1 has become the most important standard for accreditation of medical laboratories 2. Iso 15189 est une norme internationale publiee par liso en 2012 qui specifie les exigences.

This document is applicable to all organizations performing laboratory activities, regardless of the number of personnel. Total 170 files quick download in editable form by e delivery chapter1. Every care has been taken to ensure that the file is suitable for use by iso member bodies. Details of the software products used to create this pdf file can be found in the general info relative to the file. International recognition of accreditation facilitates access to the export markets. Pdf metrology in an iso 15189 accredited medical biology. Iso 15189 documents with manual, procedures, audit checklist. Download editable iso 15189 manual, procedures, forms, audit checklists are written in plain english.

Iso 15189 documents editable templates for medical laboratory qms certification. Documents sold on the ansi standards store are in electronic adobe acrobat pdf format, however some iso and iec standards are available from amazon in hard copy format. Iso 15189 documents editable manual, procedures, forms. Document cofrac sh inf 50 porteestypes daccreditation rev. Delivrer des accreditations cofrac normes et referentiels daccreditation obtenir laccreditation. Are the documents at the ansi webstore in electronic adobe acrobat pdf format only. In belgium it is mandatory for certain disciplines. Iso 15189 when carrying out work at its permanent facilities andor associated facilities. This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories. Thanks to the multilateral arrangements to which cofrac is signatory, accreditation obtained in france can be recognised in europe and worldwide. The standard was developed by the international organisation for standardizations technical committee 212. Les normes nf en iso 15189 et nf en isocei 17025 definissent les. Ukas accreditation covers the following disciplines.

Norme europeenne europaische norm en iso 15189 november 2012 ics 03. Isocd 15189 medical laboratories requirements for quality and competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. Since january 16th 2010, the french legislation requires that the. Iso 15189 can be used by medical laboratories in developing their quality management systems and assessing their own competence. Ukas provides accreditation to the internationally recognised standard iso 15189 medical laboratories requirements for quality and competence. 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. Cette accreditation est delivree par le comite francais daccreditation cofrac et repose sur des normes europeennes harmonisees. Elle doit satisfaire a des exigences normatives norme 15189, des documents d application du cofrac sh ref 02 et des dispositions legislatives et.