ISO Published in Switzerland ISBN ISO copyright office CP 401 CH Vernier, Geneva Tel Fax Web 5:2016 Medical devices A practical guideĤ About this handbook All organizations face challenges when developing or updating their quality management system (QMS) and it is hoped that this handbook will be used to provide additional insight and understanding of the requirements in ISO ), Medical devices Quality management systems Requirements for regulatory purposes. Permission can be requested from either ISO at the address below or ISO s member body in the country of the requester. 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. 1 a practical guide ISO 13485:2016 Medical devices Advice from ISO/TC 210Ģ for SMEs a practical guide ISO 13485:2016 Medical devices Advice from ISO/TC 210ģ Copyright protected document All rights reserved.
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