Compliance management systems — Requirements with guidance for use Systèmes de management de la conformité — Exigences et recommandations pour la mise en oeuvre © ISO 2021Reference number ISO/FDIS 37301:2021(E)INTERNATIONAL STANDARDISO/FDIS 37301FINAL DRAFT 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 SUPPOR TING DOCUMENTATION. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­ LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STAN­ DARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.ISO/TC 309 Secretariat: BSI Voting begins on: 2021 ­01­01 Voting terminates on: 2021 ­02­26 ISO/FDIS 37301:2021(E) ii © ISO 2021 – All rights reservedCOPYRIGHT PROTECTED DOCUMENT © ISO 2021 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 CH­1214 Vernier, Geneva Phone: +41 22 749 01 11 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ISO/FDIS 37301:2021(E) Foreword .......................................................................................................................................................................................................................................... v Introduction ................................................................................................................................................................................................................................ vi 1 Scope ................................................................................................................................................................................................................................. 1 2 Normati ve references ...................................................................................................................................................................................... 1 3 Terms and definitions ..................................................................................................................................................................................... 1 4 C ontext of the organization ....................................................................................................................................................................... 5 4.1 Understanding the or ganization and its context ....................................................................................................... 5 4.2 Understanding the needs and e xpectations of interested parties .............................................................. 5 4.3 Det ermining the scope of the compliance management system ................................................................. 5 4.4 Compliance management s ystem ........................................................................................................................................... 6 4.5 Compliance oblig ations ................................................................................................................................................................... 6 4.6 Compliance risk assessment ....................................................................................................................................................... 6 5 Leadership ......................................................................