DRAFT INTERNATIONAL STANDARD ISO/DIS 22367 ISO/TC 212 Secretariat: ANSI Voting begins on: Voting terminates on: 2019-02-04 2019-04-29 Medical laboratories — Application of risk management to medical laboratories Laboratoires médicaux — Réduction d'erreurs par gestion du risque et amélioration continue ICS: 11.100.01 THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS This document is circulated as received from the committee secretariat. THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, ISO/CEN PARALLEL PROCESSING TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN Reference number NATIONAL REGULATIONS. ISO/DIS 22367:2019(E) RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION. © ISO 2019 ISO/DIS 22367:2019(E) ̹ ʹʹ͵͸͹– Contents Foreword ........................................................................................................................................................ 4 Introduction .................................................................................................................................................. 5 1 Scope ........................................................................................................................................................ 7 2 Normative references ........................................................................................................................ 7 3 Terms and definitions ........................................................................................................................ 7 4 Risk management .............................................................................................................................. 16 5 Risk analysis ........................................................................................................................................ 21 6 Risk evaluation ................................................................................................................................... 24 7 Risk control.......................................................................................................................................... 25 8 Risk/benefit analysis ....................................................................................................................... 27 9 Risk management review ............................................................................................................... 28 10 Risk monitoring, analysis and control of unanticipated risks .......................................... 29 Annex A Implementation of risk management within the quality management system .................................................................................................................. 31 ȋȌ Annex B Developing a risk management plan ..................................................... 43 Annex CȋȌ Risk acceptability considerations ........................................................... 45 Annex DȋȌ Identification of characteristics related to safety ............................. 48 Annex EȋȌ Examples of hazards, foreseeable sequences of events and hazardous situations .................................................................................................................. 56 ȋȌ Annex F Nonconformities potentially leading to significant risks ............... 64 Annex GȋȌ Risk analysis tools and techniques ......................................................... 73 Annex HȋȌ Risk analysis of foreseeable user actions ............................................ 79 Annex I ȋȌ Methods of risk assessment, including estimation of probability and severity of harm .................................................................................................................. 83 ȋȌ Annex J Overall residual risk evaluation and risk management review .... 89 Annex KȋȌ Conducting a risk/benefit analysis ........................................................ 92 Annex L ȋȌ Residual risk(s) .............................................................................................. 95 BibliographyȋȌ ................................................................................................................................................ 96 COPYRIGHT PROTECTED DOCUMENT © ISO 2019 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester. ISO copyright office CP 401 • Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 ͵ͻ͹ Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org iiPublished in Switzerland © ISO 2019 – All rights reserved ISO/DIS 22367:2019(E) © ISO 22367 – All rights reserved Contents Foreword ........................................................................................................................................................ 4 Introduction .................................................................................................................................................. 5 1 Scope ........................................................................................................................................................ 7 2 Normative references ........................................................................................................................ 7 3 Terms and definitions ........................................................................................................................ 7 4 Risk management .............................................................................................................................. 16 5 Risk analysis ........................................................................................................................................ 21 6 Risk evaluation ................................................................................................................................... 24 7 Risk control.......................................................................................................................................... 25 8 Risk/benefit analysis ....................................................................................................................... 27 9 Risk management review ............................................................................................................... 28 10 Risk monitoring, analysis and control of unanticipated risks .......................................... 29 Annex A (informative) Implementation of risk management within the quality management system .................................................................................................................. 31 Annex B (informative) Developing a risk management plan ..................................................... 43 Annex C (informative) Risk acceptability considerations ........................................................... 45 Annex D (informative) Identification of characteristics related to safety ............................. 48 Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous situations .................................................................................................................. 56 Annex F (informative) Nonconformities potentially leading to significant risks ............... 64 Annex G (informative) Risk analysis tools and techniques ......................................................... 73 Annex H (informative) Risk analysis of foreseeable user actions ............................................ 79 Annex I (informative) Methods of risk assessment, including estimation of probability and severity of harm .................................................................................................................. 83 Annex J (informative) Overall residual risk evaluation and risk management review .... 89 Annex K (informative) Conducting a risk/benefit analysis ........................................................ 92 Annex L (informative) Residual risk(s) .............................................................................................. 95 Bibliography ................................................................................................................................................ 96 Page 3 of 97 © ISO 2019 – All rights reserved ISO/DIS 22367:2019(E) ISO 22367 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the