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SPECIFICATION 17021-15
First edition
2023-12
Conformity assessment requirements
for bodies providing audit and
certification of management
systems —
Part 15:
Competence requirements for
auditing and certification of
management systems for quality in
healthcare organizations
Exigences relatives à l'évaluation de la conformité pour les
organismes procédant à l'audit et à la certification des systèmes de
management —
Partie 15: Exigences de compétence pour l'audit et la certification des
systèmes de management de la qualité dans les organismes de santé
Reference number
ISO/IEC TS 17021-15:2023(E)
© ISO/IEC 2023
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ISO/IEC TS 17021-15:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2023
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
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ISO copyright office
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Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii
© ISO/IEC 2023 – All rights reserved
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ISO/IEC TS 17021-15:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Generic competence requirements . 1
5 Competence requirements for auditors and audit teams in management systems
for quality in healthcare organizations . 2
5.1 General . 2
5.2 Knowledge of healthcare delivery requirements outlined in ISO 7101 . 2
5.3 Context of the organization . . 2
5.4 Client outcomes, services, processes and organization . 3
6 Competence requirements for other personnel . 3
6.1 General . 3
6.2 Competence of personnel reviewing audit reports and making certification
decisions . 3
Annex A (informative) Knowledge for auditing and certification of management systems
for quality in healthcare organizations . 4
Bibliography . 5
iii
© ISO/IEC 2023 – All rights reserved
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