ISO 7101:2023

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 7101
ISO/TC 304
Healthcare organization
Secretariat: ANSI
management — Management systems
Voting begins on:
2023-06-30 for quality in healthcare organizations
— Requirements
Voting terminates on:
2023-08-25
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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 7101:2023(E)
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 2023

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ISO/FDIS 7101:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 7101
ISO/TC 304
Healthcare organization
Secretariat: ANSI
management — Management systems
Voting begins on:
for quality in healthcare organizations
— Requirements
Voting terminates on:
COPYRIGHT PROTECTED DOCUMENT
© ISO 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
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 7101:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

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ISO/FDIS 7101:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization .7
4.1 Understanding the organization and its context . 7
4.2 Understanding the needs and expectations of stakeholders . 8
4.3 Determining the scope of the management system for quality in healthcare
organizations . 8
4.4 Management system for quality in healthcare organizations. 8
5 Leadership . 9
5.1 Leadership and commitment . 9
5.2 Healthcare quality policy .
...

DRAFT INTERNATIONAL STANDARD
ISO/FDIS 7101
ISO/TC 304
Date: 2023-08-05
Secretariat: ANSI
Date: 2023-06-16
Healthcare organization management — Management systems for
quality in healthcare organizations –— Requirements
FDIS stage

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DRAFT INTERNATIONAL STANDARD ISO/FDIS 7101:2022(E)

© ISO 2022 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 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
Fax: +41 22 749 09 47
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved 2

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ISO/FDIS 7101:20222023(E)
Contents
Foreword . viii
Introduction . ix
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 8
4.1 Understanding the organization and its context . 8
4.2 Understanding the needs and expectations of stakeholders . 8
4.3 Determining the scope of the management system for quality in healthcare organizations . 9
4.4 Management system for quality in healthcare organizations . 9
5 Leadership . 9
5.1 Leadership and commitment . 9
5.2 Healthcare quality policy . 10
5.3 Roles, responsibilities and authorities . 11
5.4 Service user focus . 11
5.5 Access to care. 12
6 Planning . 12
6.1 Actions to address risks and opportunities . 12
6.1.1 General . 12
6.1.2 Risk culture . 12
6.1.3 Risk management processes . 13
6.2 Healthcare quality objectives and planning to achieve them . 13
6.3 Planning of changes .
...