ISO 7101:2023

INTERNATIONAL ISO
STANDARD 7101
First edition
2023-10
Healthcare organization
management — Management systems
for quality in healthcare organizations
— Requirements
Management des organisations de soins de santé — Systèmes de
management pour la qualité dans les organisations de soins de santé
— Exigences
Reference number
© 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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 . 10
5.3 Roles, responsibilities and authorities . 10
5.4 Service user focus . 10
5.5 Access to care . 11
6 Planning .11
6.1 Actions to address risks and opportunities . 11
6.1.1 General . 11
6.1.2 Risk culture .12
6.1.3 Risk management processes .12
6.2 Healthcare quality objectives and planning to achieve them .12
6.3 Planning of changes .13
7 Support .13
7.1 Resources . 13
7.2 Competence . 14
7.3 Awareness . 14
7.4 Communication . 14
7.4.1 General . 14
7.4.2 Service user communication . 15
7.4.3 Clinical communication . .15
7.4.4 External communications . 15
7.5 Documented information . 15
7.5.1 General .15
7.5.2 Creating and updating documented information . 16
7.5.3 Control of documented information . 16
7.5.4 Information management systems . 16
7.5.5 Control and management of electronic information . 17
7.5.6 Audit of records . 17
8 Operation .18
8.1 Operational planning and control . 18
8.2 Healthcare facilities management and maintenance . 18
8.2.1 General . 18
8.2.2 Contingency planning for facilities and services . 19
8.2.3 Equipment . 19
8.3 Waste management . 20
8.3.1 General .20
8.3.2 Waste reduction . 20
8.3.3 Environmental responsibility . 20
8.4 Handling and storage of materials . 20
iii
8.5 Service user belongings . 21
8.6 Emerging technologies . 21
8.7 Service design in healthcare . 21
8.8 Supplies and services from external providers. 22
8.9 Provision of services .23
8.10 People-centred care . 23
8.10.1 General .23
8.10.2 Service user experience . 23
8.10.3 Compassionate care . 24
8.10.4 Inclusivity and diversity . 24
8.10.5 Health literacy .25
8.10.6 Co-production . 25
8.10.7 Workforce wellbeing . 25
8.11 Ethics . 26
8.12 Patient safety . 26
8.12.1 General . 26
8.12.2 Knowledge and learning in safety . 26
8.12.3 Patient identification . 26
8.12.4 Medication safety. 27
8.12.5 Surgical safety . 27
8.12.6 Infection prevention and control (IPC) . 27
8.12.7 Prevention of falls, pressure ulcers and thromboembolism .28
8.12.8 Diagnostic safety .28
8.12.9 Blood transfusions .
...