ISO INTERNATIONAL STANDARD 10393 First edition 2013-04-15 Imperial College London, Version correct as of 24/12/2019 Consumer product recall Guidelines for suppliers Rappel de produits de consommation -Lignes directrices pour les fournisseurs Licensed copy: Imperial College, Reference number IS0 10393:2013(E) LSO @IS02013 IS0 10393:2013(E) , Imperial College London, Version correct as of 24/12/2019 Licensed copy: Imperial College , COPYRIGHTPROTECTEDDOCUMENT @ISO2013 All rights reserved. Unless otherwise specified, 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 Case postale 56:CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@iso.org Web www.iso.org Published in Switzerland ii @ IS0 2013 - All rights reserved IS0 10393:2013(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Terms and definitions 3 Purpose and principles ..4 4 General requirements. ..4 4.1 General .4 4.2 Policy .4 4.3 Documentation and record keeping ..5 4.4 Regulatory requirement. .5 4.5 Expertise required to manage a recall .5 4.6 Authorityforkeydecision .6 4.7 Training and recall simulation ..6 5 Assessing the need for a product recall .8 5.1 General .8 5.2 Incident notification. 9 5.3 Incident investigation .9 5.4 Assess the risk 10 5.5 Traceability .10 5.6 Product recall decision. .11 6 Implementing a product recall .11 6.1 General .11 6.2 Initiate the recall action .12 6.3 Communication ..14 6.4 Implement the recall. 16 6.5 Monitor and report.. .17 6.6 Evaluate effectiveness ..18 6.7 Review and adjust recall strategy ..19 Licensed copy: Imperial College , 7 Continual improvement of recall programme .20 7.1 General 20 7.2 Reviewing the recall 20 7.3 Corrective actions to prevent reoccurrence. .21 Annex A (informative) Hazard and risk evaluation. .22 Annex B (informative) Examples of product recall posters and press releases. ..27 Annex C (informative) Product recall checklist .31 Annex D (informative) Improving recall effectiveness - Examples ..32 Bibliography .38 @ IS0 2013 - All rights reserved iii