BS EN IS0 22367:2020 BSl Standards Publication Medical laboratories - Application of risk management to medical laboratories bsi. BSENISO22367:2020 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN IS0 22367:2020.It isidenticaltoIS022367:2020.ItsupersedesDDCENISO/TS22367:2010 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/212,IVDs A list oforganizations represented on this committee can be obtained on requestto its secretary. This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. @TheBritishStandardsInstitution2020 Published by BSI Standards Limited 2020 ISBN9780539138368 ICS 11.100.01 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the StandardsPolicyandStrategyCommitteeon31March2020. Amendments/corrigendaissuedsincepublication Date Textaffected 31May2020 Implementation of CEN correctionnotice 8 April 2020: conflicting national standards date of withdrawal in Europeanforeword corrected EN ISO 22367 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHE NORM March 2020 ICS11.100.01 English Version Medical laboratories - Application of risk management to medicallaboratories (IS0 22367:2020) Laboratoires de biologie medicale-Application Medizinische Laboratorien -Fehlerverringerung durch Risikomanagement und standige de lagestion des risques auxlaboratoires de biologie médicale (IS0 22367:2020) Verbesserung (IS0 22367:2020) This European Standard was approved by CEN on 7February 2020. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language Management Centre has the same status astheofficial versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEEFURNORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2020CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22367:2020: E worldwide for CEN national Members