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 — Systémes de
management pour la qualité dans les organisations de soins de santé
— Exigences

Reference number
ISO 7101:2023(E)

© ISO 2023
ISO 7101:2023(E)

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Published in Switzerland

ll © ISO 2023 - All rights reserved

 ISO 7101:2023(E)

Contents Page

Foreword... v
Introduction vi
1 Scope
2 Normative references 1
3 Terms and GefinitiiOMs ...0.....occccssssuessmsnnnsssmssnnineninnneesenansniunniansissntsnenasteuaneinstianttuaseuneeunneeanstnnneuneeuneesnteanesnneeuntennte 1
4 COMEEKE OF CIE OLEAN ACIO MN ssisssssssesscssisssisascsnsivssscoias
casts SSS Saas 7
4.1 Understanding the organization and its CONTEXE.....ccccseeen vf
4.2 Understanding the needs and expectations of stakeholders 8
4.3. Determining the scope of the management system for quality in healthcare
OT ATAT ZEN ONS ssscecscacnscssssanscaasiecncacsioisasesssansavsns
ci acntnsissauicvbbsabitasbinssosnsboabcasoicn ah aba easbuabsabcainb taba 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... cea iia i a 10
5.3 Roles, responsibilities and authorities ......ccccccscessesneeen 10
5.4 Service user focus... 10
SiG ACCRSS IO CAPE sscsssccscssscccssscsssancccesissatessiisecnssnsisttnascaac castes bee tc 11
6 Planning........... suonneoanotnsonnanetnantennnenseniantnannnssntisnsanntsentnsnttgnntaanenanttanttsnnegnnsnntsnsesnnnsnteageessneesneesntesnneenaeesneesn 11
6.1 Actions to address risks and opportunities 11
6.1.1 General 11
6.1.2 Risk culture SIS acnTiI aa Aaa 12
G13 Risk management Processes -sssisssccisssscccssasiscsassccaccssisssseev assests libessanccaipabeaniieoeteeciads 12
6.2 Healthcare quality objectives and planning to achieve theM........cccccccccessmnmennennsennnnennenneenn 12
6.3. Planning of changes 13
7 SUPPOTPEo. c c s s usiusmns n sena us uniuesn in insiuni siun se ais eu es en int aiunt gsan se ne sense n se 13
7.1 RESOULCES oesccssssesssssesssessssssessseennesnsnssesnnseseessenunsestnnsnisnssesnassennnsstnnsstunsssangseisnneningsensesestnsssenenestneestnanessnneseenseneeseeevneseea 13
Vz Competence 14
7.3 Awareness 14
74 Communication........... sees .14
7.4.1 General........... sessgnseeagnnesonsonnnsntegnsonangeennasoneggenennneeeanneennseneegsnnenseneganneenseenegasteneseeee 14
7.4.2 Service user communication 15
7.4.3 Clinical communication 15
744 ‘External communications [Link] 15
7.5 Documented INTOrmalianncsassxss nance en See Nea aaa NM INS 15
7.5.1 General SES 15
7.5.2 Creating and updating documented information 16
7.5.3 Control of documented information 16
[Link] InfOrmMatiON MANAGEMENE SYSTEMS scsisiissicscsistscicssrconsioasieanictinsSaciiaiiasscaiaulnecanliisansuasatshtit 16
7.5.5 Control and management of electronic information... 17
PSIG AUG OF PECOFAS sassstassssccsssccassesscssicctscssteessstcc
scree cesta otal 17
8 OPO abiOD i cccccssssssstsstuntnssnnestnsinasinsssninssiuesnstnssineesntnssneese 18
8.1 Operational planning and CONtLOL .......cccccsssmessnmsneesneemaneesnennsnennnetnntennnesnneenaeenntesnnenneenneesnneegnennneenneenneess 18
8.2 Healthcare facilities management and maintenance 18
8.2.1 General 18
8.2.2 Contingency planning for facilities and SePVICES........cccessmssunesennnsineneonneineneeseenunene 19
6.2:3 ‘BQUIPMeNt casecscncmsie onc eee 19
SiS: —§- Wa Ste mama semen tsscsssssscsssscsssastcacstiescctatacditclppbbunien esses npebabc asics ncedbes eases sandbags 20
8.3.1 General 20
8.3.2 Waste reduction 20
B.3:3 Environmental TESPOMSiility ssssccsiccsccicsiccssssnesstststiesstcoshostraaniutivsSacas issuance isis 20
8.4 Handling and storage of materials....0.0...cccccseesseeneeeninennine 20

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ISO 7101:2023(E)

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
BLO2A Service USE EXPETICHCE sssccccccssccceissceaoscoceccsvsssissssccaissnccnscios 23
8.10.3 Compassionate care. 24
8.10.4 Inclusivity and diversity 24
BLO) Healthy WCC PAC i sc nsi ens ins emsniesoncase ucarsn iones in 25
SLOG GOMPTO MU Cta Oe ase s n asunea rs veo sne aycse nicareisca ersntio 25
8.10.7 Workforce wellbeing 25
8.11 Ethics 26
8.12 Patient safety 26
BiL2Z.1 Gemeral ooocccccccccccccccccccscsssssssssssssssssssssosiusessussssssssesssessssssossesean 26
8.12.2 Knowledge and learning in safety 0. 26
8.12.3 Patient identification 26
8.12.4 Medication safety... 27
8.12.5 Surgical safety......... seonnennestnnnnnaneesentn 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... cocoons 28
8.12.9 Blood transfusions 28
Performance evaluation 29
9.1 Monitoring, measurement, analysis, and evaluation 29
9.1.1 General 29
9.1.2 Healthcare quality indicators... seen 30
9.1.3. Methods 30
9.1.4 Results 30
9.2 Tnternal Audit oncccccccccccccccssssssssssssssssssssssssssssssssssussunuussssssssssssssssesesseusssesssssesens 31
QZ Geme ral ooccocccccccccccccccccssssssssssssssssssssssssssssessnssnssssssvssssosssnsssssssessuisuessessounsee 31
9.2.2 Internal audit programme 31
9.3 Management review 31
QiBL — Ge@M@TAL cooccccccccccccccccccccssssssssossosssssssssssssssonussnusnssansavsgsensonsoussssoseuusisssnsnesnasngnasnsssensaneaseasesessonissussaaunasnnsansansensansaseaseueasensesese 31
9.3.2 Management review inputs 31
9.3.3. Management review results 32
10 IMPPOVEMENE........[Link] 32
10.1 Continual improvement 32
10.2 Nonconformity and corrective action... 33
10.2.1 General 33
10.2.2 Management of nonconformity and corrective action 33
Bibliography 35

lv © ISO 2023 - Allrights reserved

 ISO 7101:2023(E)

Foreword

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different types of ISO documents should be noted. This document was drafted in accordance with the
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This document was prepared by Technical Committee ISO/TC 304, Healthcare organization management.

Any feedback or questions on this document should be directed to the user’s national standards body. A
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© ISO 2023 - All rights reserved Vv

ISO 7101:2023(E)

Introduction

0.1 General

Healthcare systems and organizations of all sizes and structures embrace a culture of quality and
continual improvement with the objective of providing timely, safe, effective, efficient, equitable and
people-centred care. Given the current and future challenges in healthcare, more than ever it is vital to
improve service user experience, quality of care, and provide sustainable solutions.

Healthcare organizations around the world have been facing significant threats such as decreasing
financial resources, workforce shortages, increase in the number of people needing care as a result of
ageing populations, increasing rates of chronic disease, lack of shared data for decision making, scarcity
or inadequacy of medical equipment and medications, and an absence of clear healthcare system
governance. Many countries have embarked on universal health coverage, while others struggle with
rising healthcare costs. To compound this, a global pandemic has highlighted the importance of virtual
healthcare, new technologies, and the need to create and adapt approaches to healthcare management
and delivery. These health and organizational challenges require bold and innovative steps to improve
healthcare quality around the world.
This document provides requirements for management systems for quality in healthcare organizations.
As such, its target audience is broad, including any healthcare system, organization, or entity that aims
to increase the quality of its healthcare delivery and care outcomes. This includes ministries of health,
public and private healthcare systems, hospitals, clinics, non-governmental organizations and agencies
that provide healthcare services, and more.

This document conforms to I[SO’s requirements for management system standards. These requirements
include a harmonized structure, identical core text, and common terms with core definitions, designed
to benefit users implementing multiple ISO management system standards.
This document contains the requirements used to assess conformity. An organization that wishes to
demonstrate conformity with this document can do so by:

— makinga self-determination and self-declaration;

— seeking confirmation of its conformity by parties having an interest in the healthcare organization,
such as service users;

— seeking confirmation of its self-declaration by a party external to the organization; or

— seeking certification/registration of its management system for quality in the healthcare

organization by an external organization.

In this document, the following verbal forms are used:

— “shall” indicates a requirement;
— “should” indicates a recommendation;

— “may” indicates a permission;

— “can” indicates a possibility or a capability.

Information marked as “NOTE” is intended to assist the understanding or use of this document

0.2 Aim ofa management system for quality in healthcare organizations

The aims of a management system for quality in healthcare organizations include the following:

— create a culture of quality starting with strong top management;

— embrace a healthcare system based on people-centred care, respect, compassion, co-production,

equity and dignity;

vi © ISO 2023 - All rights reserved

 ISO 7101:2023(E)

— identify and address risks;

— ensure patient and workforce safety and wellbeing;

— control service delivery through documented processes and documented information;

— monitor and evaluate clinical and non-clinical performance;

— continually improve its processes and results.

0.3 Success factors

The success of a management system for quality in a healthcare organization depends on the
commitment from all levels and functions of the organization, led by top management. The top
management structure of the organization can create a culture of quality by including quality principles
in the organization's strategic direction, decision making, and aligning them with other operational
priorities. Successful implementation of this document can demonstrate to stakeholders that an
effective management system for quality in the healthcare organization is in place.
The level of detail and complexity of a management system for quality in the healthcare organization
varies depending on the context of the organization, the scope of its work, its regional, national, and
international conformity obligations, the nature of its activities, services provided, and resources
available.
0.4 Plan-Do-Study-Act model
The approach underlying a management system for quality in healthcare organizations is based on
the concept of Plan-Do-Study Act (PDSA) (see Figure 1). The PDSA model provides an iterative process
used by organizations to achieve continual improvement through cycles of ongoing measurement
of performance and assessment of changes. It can be applied to a management system for quality in
healthcare organizations and is briefly described as follows.

— Plan: establish healthcare quality objectives and processes necessary to deliver results in accordance
with the organization's healthcare quality policy (Clause 6).

— Do:implement the processes as planned (Clauses 7 and 8).

— Study: monitor, measure and assess processes against the organization’s policies, including its
commitments, objectives and operating criteria and report the results (Clause 9).

— Act: take actions to continually improve (Clause 10).

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Figure 1 — Elements of a management system for quality in healthcare organizations

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INTERNATIONAL STANDARD ISO 7101:2023(E)

Healthcare organization management — Management

systems for quality in healthcare organizations —
Requirements

1 Scope
The purpose of this document is to provide organizations with requirements to deliver high-quality
healthcare and specifies requirements for management systems for quality in healthcare organizations
when an organization desires to:

a) demonstrate its ability to consistently meet service user, stakeholder, and applicable statutory and
regulatory requirements;
b) enhance service user experience during the continuum of care and continually improve healthcare
quality; and

c) create and maintain processes that ensure timely, safe, effective, efficient, equitable, and people-
centred care.

The requirements of this document are based on recognized best practices and are intended to be
applicable to any organization providing healthcare services, regardless of its type, size, or the services
it provides.

2 Normative references

There are no normative references in this document.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

[SO and IEC maintain terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at [Link]

— IEC Electropedia: available at [Link]

3.1
organization
person or group of people that has its own functions with responsibilities, authorities and relationships
to achieve its objectives (3.6)
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm,
enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated
or not, public or private.

Note 2 to entry: If the organization is part of a larger entity, the term “organization” refers only to the part of the
larger entity that is within the scope of the healthcare (3.23) quality management system (3.4).

Note 3 to entry: In the case of healthcare (3.23), the organization is developed for the delivery of healthcare (3.23)
services by specialized workforces (3.30) to defined communities, populations, individuals or markets.

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ISO 7101:2023(E)

3.2
stakeholder
person or organization (3.1) that can affect, be affected by, or perceive itselfto be affected by a decision
or activity

Note 1 to entry: Stakeholders can include but are not limited to: Ministry or Department of Health, Finance,
Treasury, Education; non-governmental organizations and not-for-profit sector; community groups and civil
society organizations; local government, health insurance groups and other healthcare funders; donor and aid
agencies, UN agencies (including the WHO), health professions associations, regulatory bodies, health workers’
organizations and networks; patients, families, caregivers, and other health service users (3.28).

3.3
top management
person or group of people who directs and controls an organization (3.1) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the
organization.

Note 2 to entry: If the scope of the management system (3.4) covers only part of an organization, then top
management refers to those who direct and control that part of the organization.

Note 3 to entry: In some countries, and within differing organizational structures, additional terms can be used
such as “board”, “board of directors”, “trustees”, or “governance.”

3.4
management system
set of interrelated or interacting elements of an organization (3.1) to establish policies (3.5) and
objectives (3.6), as well as processes (3.8) to achieve those objectives (3.6)
Note 1 to entry: Amanagement system can address a single discipline or several disciplines.

Note 2 to entry: The management system elements include the organization's structure, roles and responsibilities,
planning and operation.

3.5
policy
intentions and direction of an organization (3.1) as formally expressed by its top management (3.3)
3.6
objective
result to be achieved

Note 1 to entry: An objective can be strategic, tactical, or operational.

Note 2 to entry: Objectives can relate to different disciplines (suchas finance, health and safety, and environment).
They can be, for example, organization-wide or specific to a project, product or process (3.8).

Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended result, as a purpose, as an
operational criterion, as a healthcare (3.23) quality objective or by the use of other words with similar meaning
(e.g. aim, goal, or target).

Note 4 to entry: In the context of healthcare (3.23) quality management systems (3.4), healthcare (3.23) quality
objectives are set by the organization (3.1), consistent with the healthcare (3.23) quality policy (3.5), to achieve
specific results.

3.7
risk
effect of uncertainty

Note 1 to entry: An effect is a deviation from the expected — positive or negative.

Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or
knowledge of, an event, its consequence, or likelihood.

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 ISO 7101:2023(E)

Note 3 to entry: Risk is often characterized by reference to potential events (as defined in ISO Guide 73) and
consequences (as defined in ISO Guide 73), or a combination of these.

Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including
changes in circumstances) and the associated likelihood (as defined in ISO Guide 73) of occurrence.

3.8
process
set of interrelated or interacting activities that uses or transforms inputs to deliver a result

Note 1 to entry: Whether the result of a process is called an output, a product or a service depends on the context
of the reference.

3.9
competence
ability to apply knowledge and skills to achieve intended results
3.10
documented information
information required to be controlled and maintained by an organization (3.1) and the medium on
which it is contained
Note 1 to entry: Documented information can be in any format and media and from any source.

Note 2 to entry: Documented information can refer to:

a) the management system (3.4), including related processes (3.8);

b) information created in order for the organization to operate (documentation);

c) evidence of results achieved (records).

3.11
performance
measurable result

Note 1 to entry: Performance can relate either to quantitative or qualitative findings.

Note 2 to entry: Performance can relate to managing activities, processes (3.8), products, services, systems or
organizations (3.1).

3.12
continual improvement
recurring activity to enhance performance (3.11)

3.13
effectiveness
extent to which planned activities are realized and planned results are achieved

3.14
effective
producing a desired or intended result

3.15
requirement
need or expectation that is stated, generally implied or obligatory
Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization (3.1) and
stakeholders (3.2) that the need or expectation under consideration is implied.

Note 2 to entry: A specified requirement is one that is stated, e.g. in documented information (3.10).

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ISO 7101:2023(E)

3.16
conformity
fulfilment of a requirement (3.15)

3.17
nonconformity
non-fulfilment of a requirement (3.15)

3.18
corrective action
action to eliminate the cause(s) of a nonconformity (3.17) and to prevent recurrence

3.19
audit
systematic and independent process (3.8) for obtaining evidence and evaluating it objectively to
determine the extent to which the audit criteria are fulfilled

Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party),
and it can be a combined audit (combining two or more disciplines).

Note 2 to entry: An internal audit is conducted by the organization (3.1) itself, or by an external party on its
behalf.

Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.

3.20
measurement
process (3.8) to determine a value

3.21
monitoring
determining the status of a system, a process (3.8) or an activity
Note 1 to entry: To determine the status, there can be a need to check, supervise or critically observe.

3.22
safe
free from risk (3.7) which is not tolerable
Note 1 to entry: In the healthcare (3.23) setting, "safe" refers to circumstances and services affecting all
stakeholders (3.2), not only patients.
[SOURCE: ISO/IEC Guide 51:2014, 3.14, modified — The term has been changed from "safety" to "safe";
in the definition, "freedom" has been changed to "free"; note 1 to entry has been added.]

3.23
healthcare
organized provision of services to individuals or a community in order to address, manage and improve
their physical, mental, and social wellbeing (3.24)

3.24
wellbeing
state of optimal physical, mental, emotional and social health (3.32)

[SOURCE: ISO 22886:2020, 3.11.4]

3.25
efficient
<healthcare> using inputs to the health (3.32) system (in the form of expenditure and other resources)
in a way to secure valued healthcare (3.23) system objectives (3.6)

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3.26
equitable
<healthcare> providing healthcare (3.23) ina manner that is fair and impartial

Note 1 to entry: Impartiality can relate to age, sex, gender, behavioural or clinical diagnosis, race, ethnicity,
geographical location, religion, socioeconomic status, linguistic or political affiliation.

3.27
people-centred care
approach to healthcare (3.23) delivery that engages patients, families, caregivers and communities,
incorporating their unique needs, experiences and preferences
3.28
service user
person or stakeholder (3.2) that could or does receive a service that is intended for, or required by, this
person or stakeholder (3.2)
Note 1 to entry: Similar terms include patient, healthcare (3.23) consumer, user, client, and end user.

Note 2 to entry: Service users can include a wide range of individuals including patients, families, caregivers, and
their support networks.

3.29
service user experience
perceptions and responses of a service user (3.28) that result from the use of a product, system, or
service

3.30
workforce
staff
personnel
all individuals employed by the organization (3.1)
Note 1 to entry: This concept includes full-time, part-time, casual or contract, clinical and non-clinical workers.

3.31
universal health coverage
all people having access to the health (3.32) services they need, when and where they need them,
without financial hardship

{[SOURCE: World Health Organization, Universal health coverage]

3.32
health
state of complete physical, mental and social wellbeing (3.24) and not merely the absence of disease or
infirmity
[SOURCE: Preamble to the Constitution of the World Health Organization, 1948]

3.33
co-production
practice of designing and implementing healthcare (3.23) service and delivery based on the
collaborative relationships and experiences between healthcare (3.23) providers, service users (3.28),
family members, caregivers and advocacy groups
3.34
health literacy
ability of individuals to gain access to, understand and use information in ways which promote and
maintain good health (3.32) for themselves, their families and their communities

{[SOURCE: World Health Organization, Health Literacy]

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ISO 7101:2023(E)

3.35
dignity
recognition by others of one’s inherent value, worth, and right to ethical treatment

3.36
risk assessment
overall process (3.8) of risk (3.7) identification, risk analysis and risk evaluation

[SOURCE: ISO 31073:2022, 3.3.8]

3.37
risk management
systematic application of management policies (3.5), procedures, and practices to the tasks of analysing,
evaluating, controlling and monitoring (3.21) risk (3.7)

[SOURCE: ISO/IEC Guide 63:2019, 3.15]

3.38
health indicator
measure designed to summarize information about a given priority topic in population health (3.32) or
healthcare (3.23) system performance (3.11)
Note 1 to entry: Health indicators provide comparable and actionable information across different geographic,
organizational or administrative boundaries and/or can track progress over time.

3.39
knowledge management
holistic, cross-functional discipline and set of practices focused on knowledge that improve
organizational performance (3.11)
Note 1 to entry: Knowledge management includes, but is not limited to, the creation, acquisition, application,
maintenance, sharing and protection of knowledge to create organizational value.

[SOURCE: ISO 30400:2022, 3.12.2]

3.40
just culture
atmosphere of trust in which healthcare (3.23) workers are supported and treated fairly when
something goes wrong in the delivery of care for service users (3.28)

3.41
patient safety
service user safety
framework of organized activities that creates cultures, processes (3.8), procedures, behaviours,
technologies and environments in healthcare (3.23) that consistently and sustainably lower risks (3.7),
reduce the occurrence of an avoidable harm (3.47), make an error (3.46) less likely and reduce its impact
when it does occur

Note 1 to entry: Activities can include the creation of cultures, processes and procedures, behaviours,
technologies, and environments in healthcare (3.23).

[SOURCE: Global Patient Safety Action Plan 2021-2030: Towards eliminating avoidable harm in health
care. (2021)]

3.42
incident
event or circumstance that has caused or could have caused unnecessary harm (3.47) to a patient
Note 1 to entry: Incidents include events, near misses, adverse events, and sentinel events.

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 ISO 7101:2023(E)

3.43
credentialing
process (3.8) of establishing the qualifications of licensed medical professionals and assessing their
background and legitimacy

3.44
privileging
granting permission to or authorizing an individual to perform specific activities in a hospital or
healthcare (3.23) organization (3.1)

3.45
compassionate care
manner of providing care that seeks to understand another's pain or suffering involving an authentic
desire to help

3.46
error
<healthcare> act of mistake or omission that contributes to an incident (3.42)
3.47
harm
injury or damage to the health (3.32) of people, or damage to property or the environment

3.48
environmentally friendly
pertaining to goods and services, guidelines and policies (3.5) that claim reduced, minimal, or no harm
(3.47) upon ecosystems or the environment

3.49
intelligent kindness
recognizing and bearing in mind the kinship of service users (3.28) - being of the same kind, depending
on each other for survival, wellbeing (3.24), and success - in relationships with each other and those
who work to heal or treat service users

{[SOURCE: Intelligent Kindness: Rehabilitating the Welfare State]

3.50
human factors
ergonomics
characteristics of individuals, teams, organizations (3.1) and systems used in the application of design
and evaluation to ensure the compatibility with needs, capabilities and limitations of people

3.51
healthcare associated infection
infection that occurs during the provision of care or during hospitalization that was not present at the
time of entry into the healthcare (3.23) system

4 Context ofthe organization

4.1 Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose and that
affect its ability to achieve the intended result(s) of the management system for quality in the healthcare
organization.

The organization shall determine whether climate change is a relevant issue.

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The organization shall be an entity that can be held legally responsible for its activities.
NOTE1 External context can include factors related to legal, political, technological, clinical, ethical, cultural,
religious, socioeconomic conditions, and social determinants of health, whether international, national, regional
or local.

NOTE2 — Internal context can include factors relating to the organizational vision, values, goals and objectives,
workforce values, culture, power structures, religion, knowledge, access to resources, and social determinants of
health.

4.2 Understanding the needs and expectations of stakeholders

The organization shall determine:

— the stakeholders that are relevant to the management system for quality in the healthcare
organization;

— the relevant requirements of these stakeholders;

— which of these requirements will be addressed through the management system for quality in the
healthcare organization.
NOTE Relevant stakeholders can have requirements related to climate change.

This shall include where applicable global financing partners, governmental, intergovernmental, and
non-governmental organizations with whom the organization has stated agreements.

The organization shall monitor stakeholder information and their requirements, maintain documented
information, and demonstrate accountability towards agreed-upon expectations of stakeholders.

4.3 Determining the scope of the management system for quality in healthcare
organizations
The organization shall determine the boundaries and applicability of the management system for
quality in the healthcare organization to establish its scope.
When determining this scope, the organization shall consider:

— the external and internal issues referred to in 4.1;

— the requirements referred to in 4.2;

— the organizational structure of the healthcare system, hospital, clinic or sites where services are
provided;
— services, including both clinical and non-clinical activities, that are included within the management
system for quality in the healthcare organization.

If items are not included within the scope of the management system for quality in the healthcare
organization, the organization shall indicate the reason why and provide this reasoning as documented
information.

The scope shall be available as documented information and made available to stakeholders.

4.4 Management system for quality in healthcare organizations

The organization shall establish, implement, maintain and continually improve a management system
for quality in the healthcare organization, including the processes needed and their interactions, in
accordance with the requirements of this document.

The organization shall have the systems, procedures and documented information as required by this
document and have evidence of implementation of the same.

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5 Leadership

5.1 Leadership and commitment

Top management shall demonstrate leadership and commitment with respect to the management
system for quality in the healthcare organization by:

a) defining its mission, vision, and values;

b) defining a code of conduct;

c) ensuring that the healthcare quality policy and objectives are established and are compatible with
the strategic direction of the organization;

d) creating a culture of quality by implementing, empowering and rewarding quality monitoring

across the organization;

e) establishing quality governance structures and accountabilities for the effective management of
the management system for quality across all levels of the organization (e.g. quality plan, quality
committees);
ensuring the integration of requirements from the management system for quality in the healthcare
organization into the organization’s services and processes;

8) ensuring that the resources needed for the management system for quality in the healthcare
organization are available, including required workforce in terms of numbers and skill levels
necessary to safely manage and perform its activities;

h) communicating the importance of effective healthcare quality management and of conforming to

the requirements of the management system for quality in the healthcare organization;

ensuring that the management system for quality in the healthcare organization achieves its
intended results;

i) assigning responsibilities and authorities for persons who contribute to the effectiveness of the
management system for quality in the healthcare organization;

k) directing and supporting persons to contribute to the effectiveness of the management system for
quality in healthcare organization;
promoting continual improvement;

supporting other relevant roles to demonstrate their leadership as it applies to their areas of
responsibility;

promoting risk-based thinking and risk assessment;

promoting safety for service users;

promoting safety and wellbeing of the workforce;

requesting evidence of compliance with legal and regulatory requirements;

ensuring transparency of communication and knowledge management;

ensuring impartiality, confidentiality and privacy are maintained and monitored;

adopting principles of cultural competence and aligning its services to meet the needs and
preferences of service users as to improve care, value diversity, and reduce disparity.

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5.2 Healthcare quality policy

Top management shall establish a healthcare quality policy that:

a) is appropriate to the purpose of the organization;

b) provides a framework for setting healthcare quality objectives;

c) includes a commitment to meet applicable requirements;

d) includes a commitment to continual improvement of the management system for quality in the
healthcare organization;

e) considers input from stakeholders;

f) expresses a commitment to people-centred care.

The healthcare quality policy shall:

— beavailable and maintained as documented information;

— becommunicated, understood and applied within the organization;

— be available to stakeholders, as appropriate.

Where services are provided at a distance, the healthcare quality policy shall also be communicated,
understood, and applied (e.g. mobile and satellite clinics, health outposts, and professionals providing
telehealth).

5.3 Roles, responsibilities and authorities

Top management shall ensure that the responsibilities, authorities and accountabilities for relevant
roles are assigned, communicated and understood within the organization.

Top management shall assign the responsibility, authority, and accountabilities for:

a) ensuring that the management system for quality in the healthcare organization conforms to the
requirements of this document;

b) reporting on the performance of the management system for quality in the healthcare organization
to top management;

c) reporting on the performance and status of quality objectives and health indicators at all levels
of the healthcare organization and/or healthcare system including primary, secondary, tertiary,
quaternary care, and private providers (as appropriate to the healthcare system structure);

d) ensuring the effective functioning of the risk management program;

e) ensuring transparency of reporting based on a just culture;

f) promoting and improving service user experience;

g) proposing and implementing modifications to improve the quality management system;

h) allocating resources and empowering the workforce to carry out their roles and responsibilities in
the quality management system.

5.4 Service user focus

Top management shall demonstrate leadership and commitment with respect to service user focus by:

a) meeting requirements of service users;

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b) ensuring the rights of service users are clearly known (e.g. patient bill of rights);

c) ensuring methods are in place to listen and respond to the service users’ voice;

d) assessing service user experience;

e) using lessons learned from service user experience to facilitate change;

f) creating an environment of co-production that encourages service users to participate in their
care.

5.5 Access to care

Top management shall ensure there is access to care in accordance with its defined mandate, taking
into consideration the laws and regulations by which it operates.

The organization shall address affordability and accessibility of its services, while minimizing financial
risks to service users. This includes consideration of economically challenged underprivileged and
vulnerable populations.

The organization should consider how it is working towards universal health coverage.
NOTE1 United Nations Sustainable Development Goal (SDG) 3, target 3.8 addresses universal health coverage.

NOTE2 Each country has an individualized path to achieving universal health coverage and deciding what to
cover based on the needs of their people and the resources at hand.

6 Planning

6.1 Actions to address risks and opportunities

6.1.1. General

When planning for the management system for quality in the healthcare organization, the organization
shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the
risks and opportunities that need to be addressed to:

— give assurance that the management system for quality in the healthcare organization can achieve
its intended result(s);

— prevent, or reduce, undesired effects;

— achieve continual improvement.

The organization shall plan:

a) actions to address these risks and opportunities in a timely manner;

b) howto

— integrate and implement the actions into its processes for the management system for quality
in the healthcare organization;
— evaluate the effectiveness of these actions.

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6.1.2. Risk culture

In order to create an organizational culture in which the values, beliefs, knowledge, attitudes and
understanding about risk are shared by everyone, the organization shall:

a) define a risk management program, which is consistent with the organizational vision, mission and
values;
demonstrate support from top management;

continually educate the workforce about the organization's risk management program;

develop and maintain documented information of risk management systems and make them
accessible as appropriate throughout the organization;

measure risk awareness culture at defined intervals.

6.1.3 Risk management processes

The organization shall have a documented system to identify risks and opportunities related to its
clinical and non-clinical activities, including environmental risks and unforeseen circumstances (e.g.
war, labour strikes, epidemics). Controls shall:

a) assess the risks and opportunities by identifying, analysing and evaluating each risk;

b) develop and maintain a register of risks and opportunities;

c) define a risk criterion that specifies how much risk it can or cannot accept in relation to meeting its
different types of clinical and non-clinical objectives;

rate risks based on severity, impact or importance;

develop risk assessment and treatment tools for monitoring and reporting;

define processes to capture and analyse patient safety incidents (near misses, adverse and sentinel
events);

g) define responsibilities, authorities and accountabilities for each step of the risk management
process;

h) develop risk mitigation plans that specify the options chosen, order of implementation, and how
the measures will be integrated into the organizational management plans and processes;
monitor and assess risk management interventions to ensure that they are effective and contribute
to patient safety and improved quality;

i) define appropriate improvement plans based on the assessments.

The risk management process and its results shall be documented and reported through appropriate
mechanisms and discussed during management review meetings.

6.2 Healthcare quality objectives and planning to achieve them

The organization shall establish healthcare quality objectives at relevant functions and levels.

The healthcare quality objectives shall:

a) be consistent with the healthcare quality policy;

b) be measurable (if practicable);

) take into account applicable requirements;

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d) be monitored;

e) be communicated;

f) be updated as appropriate at defined intervals;

g) be available as documented information;
h) include assessment of service user experience;

i) consider factors such as socio-economic status, culture, and diversity of service users;

j) use evidence-informed practice data and established indicators of health outcomes.

When planning how to achieve its healthcare quality objectives, the organization shall determine:

— what will be done;

— what resources will be required;

— who will be responsible;

— whenit will be completed;

— how the results will be evaluated.

The organization should consider the United Nations Sustainable Development Goals (SDGs) when
establishing healthcare quality objectives.

6.3 Planning of changes

When the organization determines the need for changes to the management system for quality in the
healthcare organization, the changes shall be carried out in a planned manner.

The organization shall consider:

a) the purpose of the changes and their potential consequences;

b) the replication of, and building infrastructure to support, full-scale implementation of best
practices beyond project mode;
c) the ability of the management system for quality in the healthcare organization to sustain the
changes;

d) the availability of resources;

e) the allocation or reallocation of responsibilities, authorities, and accountabilities;

f) how the changes will be documented, communicated, and implemented at all applicable systems
levels (top management, population-based services, preventive services, primary, secondary,
tertiary and quaternary care levels) as appropriate.

7 Support

7.1 Resources

The organization shall determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of the management system for quality in the
healthcare organization.

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7.2 Competence
The organization shall:

a) determine the necessary competence of person(s) doing work under its control that affects its
healthcare quality performance;

b) maintain a documented process for recruitment that defines the requirements for competence,
education, qualification, training, technical knowledge, skills, and experience;

c) ensure that these persons are competent on the basis of appropriate education, training, or
experience;

d) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness
of the actions taken;

e) provide orientation to all workforce at the time of joining the organization which shall include but
not be limited to organization’s services, rules and regulations, processes, policies and procedures;
f) provide integration into their appointed role and maintain documented procedures for
credentialing and privileging of healthcare professionals and support workforce as appropriate;

g) provide ongoing education and training necessary to maintain the required level of performance
and competency;
h) perform a documented performance evaluation at defined intervals;

i) provide training on respecting service users’ preferences and choices, including their options for
care and treatment, components of co-production and compassionate care, and obtaining informed
consent;

j) retain documented information as evidence of competence for all workforce members.

NOTE Applicable actions can include, for example: the provision of training to, the mentoring of, or the re-
assignment of currently employed persons; or the hiring or contracting of competent persons.

7.3 Awareness

Persons doing work under the organization's control shall be aware of:

the healthcare quality policy and the objectives applicable to their role;
their contribution to the effectiveness of the management system for quality in the healthcare
organization, including the benefits of improved healthcare quality performance;

the implications of not conforming with the requirements of the management system for quality in
the healthcare organization.

7.4 Communication

7.4.1 General

The organization shall determine the internal and external communications relevant to the management
system for quality in the healthcare organization, including:

on what it will communicate;

when to communicate;

with whom to communicate;

how to communicate.

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7.4.2 Service user communication

Communication processes with service users shall include:

a) providing information relating to services, rights and responsibilities;

b) handling enquiries, agreements or requests, including any actions taken;

c) obtaining service user feedback relating to services, including complaints;

d) ensuring that feedback mechanisms are accessible, understandable, and appropriate to the service
user’s education level and access to resources (e.g. computer, telephone, literacy level).

7.4.3 Clinical communication

The organization shall have processes in place to ensure effective clinical communication. These
processes shall:

a) safeguard the security and privacy of service users’ personal information during referrals and
transfers between healthcare workers, at shift change, between hospitals and care networks;
b) ensure that oral and telephone orders, and communication of clinical results, are controlled and
verified for accuracy;

c) demonstrate the use of comprehensive clinical records that allow for proper tracking of
communication between different professionals and service sites;

d) demonstrate that all communications containing personal health information follow national or
international standards of privacy;

e) maintain documented information as evidence of employee training on proper clinical

communication and privacy requirements.

7.4.4 External communications

The organization shall define communication channels with external parties including stakeholders,
global financing partners, government, intergovernmental and non-governmental organizations with
whom they have stated agreements.

7.5 Documented information

7.5.1 General

The management system for quality in the healthcare organization shall include:

a) documented information required by this document;

b) documented information determined by the organization as being necessary for the effectiveness
of the management system for quality in the healthcare organization.
NOTE The extent of documented information for a management system for quality in healthcare
organizations can differ from one organization to another due to:

— the size of organization and its type of activities, processes, and services;

— the complexity of processes and their interactions;

— the competence of persons.

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7.5.2 Creating and updating documented information

When creating and updating documented information, the organization shall ensure appropriate:

— identification and description (e.g. a title, date, author, or reference number);

— format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
— review and approval for suitability and adequacy.

7.5.3. Control of documented information

Documented information required by the management system for quality in the healthcare organization
and by this document shall be controlled to ensure:
a) itis available and suitable for use, where and when it is needed;

b) itis adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

For the control of documented information, the organization shall address the following activities, as
applicable:

— distribution, access, retrieval and use;

— storage and preservation, including preservation of legibility;

— control of changes (e.g. version control);

— periodic review and updating as necessary;

— retention and disposition.

Documented information of external origin determined by the organization to be necessary for the
planning and operation of the management system for quality in the healthcare organization shall be
identified as appropriate and controlled.
NOTE Access can imply a decision regarding the permission to view the documented information only, or
the permission and authority to view and change the documented information.

7.5.4 Information management systems

The organization’s information management system(s) shall be validated for its functionality, including
the proper functioning of interfaces within the organization information management system, by the
organization before use.
Whenever there are changes, including organization software configuration, they shall be authorized,
documented, tested, and validated before implementation.

The information management system shall:

a) be protected from unauthorized access;

b) be safeguarded against tampering and loss;

c) be maintained in a manner that ensures the integrity of data and information;
d) include incidents of any malfunctioning in the recording system;

e) have provisions for backup;

f) have contingency plans so that services are not disrupted;

g) address cybersecurity risk protections.

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When an organization’s information management system is managed and maintained off-site or

through an external provider, the organization shall ensure that the provider of the system conforms to
all applicable requirements of this document.
The organization shall have processes in place to consider how and when it will contribute data that
can be required for external databases and reporting.

7.5.5 Control and management of electronic information

The organization shall establish and maintain processes for using and safeguarding electronic health
information. Actions shall include requirements for:

a) naming files;

b) protection;
c) access;

d) back-up;

e) archive;

f) retrieval;

g) retention time;
h) deletion;

i) integration of documented information generated through different systems and interfaces;

j) maintaining the confidentiality of digital health information.

The organization shall define and document what constitutes a clinical record and maintain complete
clinical records for every service user.
The organization shall ensure that both workforce and service users have access to clinical records ina
timely manner.

Amendments to records shall be identified and dated, with the individual making the change identified.
NOTE International, national or regional regulations or requirements can also apply.

7.5.6 Audit of records

In order to ensure the integrity of documented information, the organization shall define what is
considered both clinical and non-clinical records.

To verify that records are maintained, complete, and accurate, the organization shall:

a) conduct audits of both clinical and non-clinical records periodically to ensure quality of care and
services;

b) ensure that clinical records contain the history, results, reports, and sufficient information to
facilitate clinical management of the service user;

c) verify that records include the date, time, and identity of the individual responsible for each
activity;

d) ensure that clinical records meet any legal requirements;

e) provide documented evidence of the audit of records and the results.

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8 Operation

8.1 Operational planning and control

The organization shall plan, implement and control the processes needed to meet requirements, and to
implement the actions determined in Clause 6, by:

— establishing criteria for the processes;

— implementing control of the processes in accordance with the criteria.

Documented information shall be available to the extent necessary to have confidence that the
processes have been carried out as planned.
The organization shall control planned changes and review the consequences of unintended changes,
taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that externally provided processes, products or services that are
relevant to the management system for quality in the healthcare organization are controlled. This
includes services provided by subcontractors, governmental and non-governmental agencies and relief
organizations.

8.2 Healthcare facilities management and maintenance

8.2.1 General

The organization shall determine, provide and maintain the facilities and associated resources
necessary to conform to its stated service offerings and the management system for quality in the
healthcare organization.

To ensure the safe, proper and continued use of facilities and resources, the organization shall:

a) maintain a scheduled maintenance plan of the facility that describes required facility inspection
rounds, including monitoring, inspection, and maintenance activities, and keep documented
information of activities and results;

b) monitor turnaround time for breakdown and repair of equipment that affects the provision of
uninterrupted service delivery;

c) align its infrastructural needs with possible plans for future expansion (when applicable);

d) maintain as-built drawings for future construction, renovation, and maintenance, as appropriate;
e) ensure that buildings are constructed and maintained per national or international guidelines and
provide reasonable access for individuals with disabilities;

f) perform and document preventive maintenance of buildings, firefighting systems, air-conditioning

systems, electrical systems, water supply systems and medical gas systems at specified intervals;

g) assess and document risks in terms of safety and infection control in case of renovation and
maintenance;

h) supply potable water with appropriate backup for continuous and uninterrupted water supply
(whenever possible);

i) adhere to applicable standards for water treatment (e.g. reverse osmosis, distilled water,
demineralized water, and soft water) used for clinical and support services;
j) demonstrate that water tanks and sumps are cleaned in accordance with regulatory requirements
and best practices;

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k) maintain processes to confirm the functionality and availability of ambulances and transport
vehicles with appropriate equipment, medications, and supplies for planned and unplanned
transfers of patients;

confirm the availability of appropriate emergency communication systems at defined intervals;

ensure an adequate power supply;

ensure airflow of the operating theatre, transplant rooms and other care areas where applicable,
meets defined requirements;
follow clean air standards with positive pressure and air exchanges to prevent infections;

provide negative pressure rooms with adequate air exchanges for isolation rooms (where applicable
and dependent on the reasonable resources of the organization);

post signs which will be understood by the service user, taking statutory and regulatory
requirements into consideration.

8.2.2 Contingency planning for facilities and services

In order to ensure continuation of its services, the organization shall:

a) maintain an emergency response plan that ensures business continuity to manage both natural
events and those caused by human beings which impact service delivery (e.g. earthquakes,
tornadoes, hurricanes, flooding, terrorism, pandemics, industrial accidents);

b) make adequate infrastructural provisions for early detection, abatement, and containment of fire
emergencies;

display exit plans and assembly sites taking relevant requirements into consideration, with regular
training and testing of emergency plans by conducting mock drills;

d) plan for possible power interruptions, including backup arrangements for continuous and
uninterrupted supply;

e) procure, store, handle and distribute medical gases in a safe manner with adequate back up that
includes colour coding of the pipelines, pipeline material, connectors, leak detection systems and
alarms;

f) have emergency evacuation plans for workforce and service users;

g) address the availability of nutrition and water for service users and workforce needed for survival
and continued provision of clinical services;

h) address safety measures that affect physical working conditions (e.g. war times, civil unrest,
outbreaks and pandemics, location of workplace).

8.2.3. Equipment

In order to ensure the safe and proper use of equipment required for its operations, and minimize the
risk of human factors and errors at the person-machine interface, the organization shall:

a) identify required equipment (including, but not limited to, biomedical equipment, measuring
instruments, apparatus, software, reagents, consumables and medical devices);

b) inspect, calibrate, and document relevant equipment traceable to national or international

measurement standards or other specified basis for calibration;

c) assess compatibility with existing equipment and devices, software systems and other
infrastructure when new procurements are being considered;

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d) maintain a list and usage log for identified equipment;

e) ensure that only qualified and trained workforce inspect, maintain, and operate equipment;

f) provide workforce with required personal protective equipment as required when working with
equipment.

Equipment and devices shall be identified and controlled for all levels of service delivery (labs, clinics,
hospitals, health outposts, diagnostic centres, home visits) as appropriate.

8.3. Waste management

8.3.1 General

The organization shall consider management and life cycle of all types of waste and shall:
a) collect, segregate, treat, store, transport and dispose of waste, taking local regulatory requirements
and applicable guidelines into consideration;

b) ensure that individuals responsible for waste disposal (both workforce and external providers) are
trained and knowledgeable of how to dispose of wastes and sharps;

c) identify, handle, and properly store hazardous material per safety data sheets or similar documents;
d) define a process for spill management.

8.3.2 Waste reduction

The organization shall have a waste reduction plan.

NOTE Areas of waste reduction can include, but are not limited to, physical wastes such as medical supplies
and clinical waste, and administrative wastes including unnecessary clinic visits, strategic employee scheduling,
time utilization, duplicate procedures, and reduction of corruption.

8.3.3. Environmental responsibility

The organization shall plan its processes and services in a manner to do the least possible harm to the
environment including:

a) take measures to use environmentally friendly chemicals;

b) aim to use environmentally friendly energy sources and monitor the consumption of electricity
and water;

c) select materials that are sustainable and environmentally friendly (whenever possible);

d) resell, recycle or donate equipment no longer in use to other facilities or stakeholders (where
permitted);
e) reduce, reuse, recycle, rethink, repurpose, and repair as possible;

f) take measures to raise the awareness of environmental responsibility.

8.4 Handling and storage of materials

To ensure the effective and safe preservation of materials incorporated into its process and services,
the organization shall have documented information describing how materials are controlled.

NOTE1 Materials can include, but are not limited to, medical devices and instruments, consumables,
medicines, chemicals, and reagents.

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NOTE2 Preservation can include identification, handling, contamination control, packaging, storage,
transmission or transportation, and protection.

8.5 Service user belongings

The organization shall have a process for managing property belonging to service users if the service
user brings it into the facility. The organization shall:

a) maintain a process for recording, storing and safeguarding medications brought by the service
user from home;
b) maintain a process for how and where service user items will be stored (e.g. personal wheelchair,
medical consumables, assistive breathing devices, linens, clothing);

c) ensure that personal devices requiring the use of electricity do not interfere with the facility’s
electrical system or capacity;

d) ensure that property does not pose a safety risk;

e) report property that is lost, damaged or found to be unsuitable for use to the service user and
document any actions taken.

The organization shall have a documented process for the handling of illegal property brought by the
service user, family and caregivers.

8.6 Emerging technologies

Where the organization uses new and emerging technologies to deliver various types of care, the
organization shall evaluate and mitigate risks, and define processes to ensure safe, proper, and effective
use of such technologies.
Where artificial intelligence is used in healthcare decision making and diagnosis, top management shall
ensure that these processes are tested, validated, and controlled.

Where new technologies are used to deliver patient care, the organization shall ensure that the user
experience is evaluated, and data used to continually improve user experience.
NOTE In the context of healthcare, emerging technologies include: surgical robots, service robots
(transportation and sanitation), social robots, cobots, robots that assist with procedures and assist service users
with tasks, wearable devices, communicating with healthcare providers via digital platforms, amongst other
emerging technologies.

8.7 Service design in healthcare

Service design process shall take a user-centric approach by considering the needs and requirements
of service providers, end users and stakeholders. In order to ensure that design results are user-centric
and are in accordance with the organization's mission, healthcare quality objectives and management
system, the organization shall:

a) define and document its process for designing or changing a service;

b) identify and engage key stakeholders throughout the process and shall:

— include multi-disciplinary teams in the process;

— define the responsibilities and authorities that will be involved in each design project;
— seek inputs and feedback from service users whenever possible;

c) identify tools and resources necessary to effectively address service design work;

d) adhere to standards or codes of practice that the organization has committed to implement;

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e) demonstrate or document compliance with legal or statutory requirements;

f) consider best available medical knowledge and scientific evidence in relation to the service being
designed or changed;
g) consider its current and future potential access to resources such as medical devices, medications,
vaccinations, adequate workforce, and sufficient space for service users and associated clinical
procedures;

h) identify level of risks and maintain a process to control for them;

i) consider workforce and patient safety in the design;

j) consider workforce wellbeing;

k) consider service user access to care settings;

1) consider the need for community outreach and education;

m) consider external and environmental factors.

The organization shall define the controls necessary to ensure all requirements have been adequately
addressed and shall retain all relevant documented information.

NOTE Given the challenge in seeking input from end users, it is important to leverage multiple channels or
efforts to gain this feedback at the convenience of the end users.

8.8 Supplies and services from external providers

The organization shall ensure that both clinical and non-clinical externally provided services and
products conform to stated requirements.

The organization shall:

a) define the criteria for evaluating, selecting, monitoring, and disqualifying its external providers;

b) consider how the product or service affects safety of both workforce and service users;

c) maintain processes in place for receiving and verifying that externally provided equipment,
devices, services materials and medications conform to agreed-upon requirements;

d) maintain processes to document and communicate any problems found with externally provided
products and services;

e) ensure that services provided externally align with the objectives of the management system for
quality in the healthcare organization; including principles of impartiality and confidentiality
where applicable;

f) ensure that records of external service provider performance, communications, and corrective
actions taken are maintained.
The organization shall document its expectations and agreed-upon contract requirements with
partnering stakeholders (governmental, non-governmental, and intergovernmental organizations,
funding partners, etc.). Where the stakeholder provides product or services and fails to meet established
criteria, the organization shall communicate this to the stakeholder through pre-defined methods.
NOTE Externally provided services and products can include medication, medical equipment and devices,
laboratory services, imaging services, consulting services, food and nutritional services, education programs,
amongst additional services.

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8.9 Provision of services

To ensure a safe, efficient, effective, and timely service, the organization shall define the controlled
conditions under which the service is provided. For this purpose, the organisation shall:
a) define and document its scope of services and make this available to service users;

b) provide documented information to service users of their rights and responsibilities;

c) define and document processes and procedures for registration, admission, and discharge of all
categories of service users;

d) maintain documented protocols and procedures for recording clinical findings, progress, care
provided, follow up details for all categories of service users;

e) maintain documented protocols and procedures for ordering diagnostic investigations,

medications, diet, and other clinical needs;

f) provide appropriate personal protective equipment to healthcare workers and service users;
g) use appropriate technology tools in delivery of care (e.g. digital health, telehealth, mobile health);
h) maintain documented processes for patients undergoing sedation, surgeries, and procedures;

i) maintain a documented process for obtaining informed consent in such a manner that the service
user clearly understands, and processes for when patients are unable to give verbal consent;

j) maintain documented protocols and procedures for referring service users to other specialists and
speciality departments;

k) maintain documented protocols for transfer of service users within the hospital and outside of the
hospital for diagnostic and clinical procedures, and for different levels of care;

1) provide a discharge summary, when applicable.

The organisation shall maintain and retain all relevant documented information which demonstrate
that all processes and activities have been carried out according to requirements.

8.10 People-centred care

8.10.1 General

Top management shall define the processes and procedures required to endorse and cultivate a
culture of people-centred care, taking into consideration the experience of service users, provision of
compassionate care, health literacy, as well as the principles of inclusivity and diversity.

8.10.2 Service user experience

[Link] General

The organization shall have a formal mechanism to routinely assess service user experience in all
service areas, including clinical and administrative services, and patient safety perceptions. The
organization shall:

a) use a validated and reliable methodology for assessing experience that includes a representative
sample of service users, ensuring that all groups are equitably included. This methodology should
include qualitative and quantitative components as appropriate;
b) include assessments of family and caregiver experience when possible;

c) encourage input from community groups and external service users;

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d) ensure that feedback mechanisms are accessible, understandable, and appropriate to the service
user's education level and access to resources (e.g. computer, telephone, literacy level).

[Link] Service user experience assessment

The service user experience assessment shall determine if:

a) service users, families, and caregivers feel they are treated with respect and dignity;

b) service users’ emotional needs, social and cultural needs, preferences, and values are considered;
c) privacy and confidentiality are maintained;

d) all people are treated equally, regardless of sex, gender, age, race, ethnicity, condition, or clinical
diagnosis;

e) service users, families and caregivers are included in shared decision making.

Organizational responses shall include action plans to address negative experiences. Actions shall
evaluate the need for process changes, corrective and preventive actions, and specify follow-up
communication with the service user.

The organization shall determine how experience data can be used to improve clinical outcomes, service
delivery, adherence to treatment, and as a mechanism to motivate service users to adopt positive health
behaviours.

Evaluation of user experience shall be included in the required management review meeting.

8.10.3 Compassionate care

The organization shall have a process in place to:

a) treat service users and workforce with respect and dignity;

b) foster and promote an environment of kindness among people, families and caregivers;

c) listen to service users and caregivers;

d) educate workforce on how to deliver compassionate care.

Relevant workforce shall be trained in, and aware of, the psychological, social and emotional issues
related to end-of-life care.

8.10.4 Inclusivity and diversity

In order to create and foster inclusivity and diversity, the organization shall:

a) adopt principles of cultural competence and align its services to meet the needs and preferences
of all people and families as to improve equity of care, value diversity, and reduce disparity for all
persons regardless of colour, gender, age, belief, languages, literacy level, racial, ethnic minority
groups and other vulnerable populations;

b) provide workforce training on cultural competence;

c) ensure that there is no bias or disparity that influence decision making between the workforce and
service users, or between workforce colleagues;
d) maintain processes in place to capture degrees of cultural competence in order to provide feedback
and opportunities for improvement.

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8.10.5 Health literacy

To foster service user and workforce healthcare literacy, the organization shall:

a) address and integrate health literacy into planning, evaluation measures, patient safety, and quality
improvement;

b) educate the workforce to be health literate;

c) include populations served in the design, implementation, and evaluation of health information and
services;

d) include caregiver support systems when the patient does not have the capacity to understand
information (e.g. paediatric, dementia, and special needs populations);

e) use health literacy strategies in communications and confirm understanding at all points of
contact;

f) address health literacy in high-risk situations, including detailed information before performing
procedures that require informed consents, care transitions and communications about medication;

g) emphasize people's ability to use health information and focus on the ability to make informed
decisions;

h) meet the needs of populations with a range of health literacy skills while avoiding stigmatization;

i) provide service users with education regarding prevention and management of their current or
potential conditions.
NOTE Education can be in the form of printed handouts, use of visual aids, verbal counselling, digital
platforms, amongst other methods.

8.10.6 Co-production

To co-produce health services the organization shall:

a) work to build trusting, respectful services in partnership with service users;

b) listen to service users and empower them and their support systems to become active in their care;
c) pay attention to service users’ lived realities, values, resources, social support, and objectives in
seeking care;

d) create a shared decision-making environment in which health professionals engage partners in

healthcare service delivery;

e) foster service users’ autonomy, identifying objectives that matter to the patient;
f) promote intelligent kindness and mindfulness regarding the kinship of service users and healthcare
providers.

8.10.7 Workforce wellbeing

In order to effectively maintain the wellbeing of its workforce, the organization shall:

a) maintain a documented plan to address workforce health and safety to include physical, chemical,
biological, ergonomic, and psychosocial components;
b) have processes in place to address workforce wellbeing including stress, burnout, and violence
received from service users or co-workers.

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8.11 Ethics

The organization shall have defined processes for identifying, investigating, analysing, and addressing
ethical dilemmas, including human subject research.
The workforce shall be trained as appropriate on the handling of ethical concerns.

Service users and their family, caregivers, and/or support systems shall be involved in ethical decision
making as agreed upon by the service user.

8.12 Patient safety

8.12.1 General

The organization shall have documented processes in place for ensuring patient safety in all healthcare
settings in which it provides services.

When deciding on which safety issues to address, the organization shall consider using nationally and
internationally recognized objectives and guidelines. To ensure safety in all settings, the organization
shall:
a) consider workforce ratios and balance of qualified workforce (interprofessional cadres of health
professionals) according to the workload and kind of work;

b) formulate team-based workflow including referral systems in which patients are appropriately
transferred to relevant clinical departments for hospitalization and other more specialized medical
institutions with corresponding flow of information;

c) assess the patient's experience/journey;

d) consider the existing expertise and capacity of the institutions referring and receiving the patient;

e) define a system for critical incident reporting (see 6.1).

NOTE Healthcare settings include hospitals, speciality clinics, community clinics, health posts, surgery
centres, health centres, and non-clinical settings in which health services are provided.

8.12.2 Knowledge and learning in safety

The organization shall:

a) establish an environment to promote continuous learning, knowledge sharing, training, and

deployment of relevant and competent workforce to ensure patient safety;
b) define a process for sharing lessons learned;

c) continually collect and analyse data on patient safety to implement improvements.

8.12.3 Patient identification

To ensure accuracy of patient identification, the organization shall develop and implement a process
that:

a) requires patient identification at all points of care, and before performing any diagnostic or
therapeutic procedure or intervention;

b) requires at least two unique patient identifiers;

c) does not use the patient’s room number, bed number or location in the healthcare facility for
identification;

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d) outlines processes for special circumstances when a patient is unable to confirm their identity (e.g.
comatose, disoriented, delirium, new-born that does not yet have a legal name, severe burns).

8.12.4 Medication safety

The organization shall have documented information regarding medication processes including
medication choice, prescribing, procurement, pharmacy validation, preparation, storage, dispensing,
and administration.

To ensure medication safety, the organization shall:

a) create a list and establish guidelines for the use of high-risk drugs, and implement an alert system
(e.g. look-alike and sound-alike drugs, concentrated electrolytes, insulin, antineoplastic drugs,
sedatives);

b) institute and enforce practices for rational antibiotics use according to evidence-based guidelines;

c) maintain protocols in place for patient and caregiver education regarding medication;

d) define mechanisms for monitoring and reporting medication errors and medication-related
adverse events.

8.12.5 Surgical safety

The organization shall implement systematic safety measures to promote surgical safety in the
operating theatre and other areas where a minor surgery is performed by:
a) deploying sufficient workforce considering the required occupational balance (ratio of nurses,
physicians, medical engineers and other healthcare workforce);

b) designing infrastructure and implementing a workflow based on human factors;

c) using evidence-based practice for the delivery and monitoring of anaesthesia;

d) ensuring communication and collaboration between surgeons and anaesthesiologists;

e) providing the necessary equipment for patient monitoring during surgery, periodically analysing
surgical interventions and related postoperative re-admissions;

f) maintaining processes to prevent wrong patient, wrong kind or wrong site of surgery errors.
NOTE Systematic measures to ensure surgical safety can include tools such as surgical safety checklists,
safe childbirth checklists, clinical algorithms and job aides.

8.12.6 Infection prevention and control (IPC)

The organization shall have documented and coordinated processes for an infection prevention and
control program that includes:

a) risk identification, setting priorities and definition of strategies;

b) developing and applying indicators, guidelines and operating procedures;

c) amonitoring/audit system for IPC practices, including the development of a tracking system such
as a dashboard designed to monitor and minimize impacts;

d) systemic measures for infection prevention and control: hand hygiene, prevention of the
emergence and transmission of microorganisms, surveillance of multi-resistant microorganisms,
device associated infection prevention, prevention of surgical site infection, isolation measures,
cleanliness of environment, and safe and rational use of antibiotics;

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ISO 7101:2023(E)

e) establishing a system such as committee on IPC to update technical guidance and address emerging
challenges by deliberation;

f) developing a surveillance program for healthcare associated infections, health workforce, including
the development and implementation of an immunization policy, coordination of biosafety policy,
and reporting and management of exposure accidents;

g) conducting annual workforce training program on IPC that reinforces the workforce’s critical role
in prevention strategies;

h) encouraging service users and their support systems to monitor and enforce compliance to IPC
guidelines and regulations;

i) instituting an organizational culture for IPC that can include multimodal strategies such as building
champions, feedback, and cross-pollination of best practices.

8.12.7 Prevention of falls, pressure ulcers and thromboembolism

The organization shall have processes in place to prevent patient falls, pressure ulcers and
thromboembolism and shall:

a) identify patients who are at risk of pressure injuries, and establish the necessary controls needed
to minimize the risk factors;

b) define interventions to maintain skin integrity, and periodically evaluate the implementation and
results of the interventions;

c) maintain a comprehensive fall prevention plan and whenever possible use the latest technologies
to assist in fall prevention;

d) identify patients who are at risk for thromboembolism and institute evidence-based protocols for
prevention and treatment;

e) maintain documented pharmacological protocols for the prevention of thromboembolism that are
evidence-based.

8.12.8 Diagnostic safety

To ensure diagnostic safety, the organization shall have processes in place to ensure:
a) accurate and timely laboratory testing, pathology and imaging services;

b) reporting of critical results of tests and diagnostic procedures;

c) timely communication of results to healthcare providers and service users;

d) compliance with applicable regulatory requirements;

e) comprehensive record keeping of diagnostic procedures and test results.

NOTE ISO 15189 provides specific requirements for quality and competence of medical laboratories, and can
effectively be applied to other healthcare services, such as diagnostic imaging, respiratory therapy, physiological
sciences, blood banks and transfusion services.

8.12.9 Blood transfusions

The organization shall have established procedures for blood transfusion safety. Documented
information shall include:

a) donor education and counselling;

b) cross-matching and typing;

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c) accurate, guideline-based protocols for administration of blood products;

d) confirmation of the blood type of the patient and the correct blood to be infused prior to the start
of transfusion;
e) screening for transfusion transmissible infections to include at a minimum HIV I/II, hepatitis B,
hepatitis C and syphilis;

f) appropriate collection, identification, storage, release, safe administration, assurance of blood and
blood products traceability;
g) training and education of workforce on transfusion procedures and the correct handling and
disposal of blood;

h) monitoring and reporting of adverse events and reactions.

Wastes and unused blood products generated from blood transfusions shall follow appropriate and
well-defined processes from the point of generation to final disposal site.

9 Performance evaluation

9.1 Monitoring, measurement, analysis, and evaluation

9.1.1 General

To evaluate its performance, the organization shall establish a healthcare quality monitoring system,
which is in accordance with the organization's healthcare quality policy and quality requirements.

Top management shall ensure that the quality monitoring system runs in an effective and efficient
manner, producing time-sensitive and usable results.
The organization shall assign responsibilities for the quality monitoring system including:

a) the overall organization as well as for individual departments and services;

b) specific projects identified by the quality monitoring system.

The organization shall define which indicators (clinical and non-clinical) it will use to measure
the effectiveness of its operations. Indicators shall be in alignment with recognized national and
international health indicators.

The organization shall determine:

— what needs to be monitored and measured;

— the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid
results;

— when the monitoring and measuring shall be performed;

— when the results from monitoring and measurement shall be analysed and evaluated.

Documented information shall be available as evidence of the results.

The organization shall evaluate the performance and the effectiveness of the management system for
quality in the healthcare organization.

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ISO 7101:2023(E)

9.1.2 Healthcare quality indicators

The organization shall identify what is to be monitored by the quality monitoring system and shall
include:

a) outcomes from clinical and non-clinical services, which examine effectiveness, efficiency and
continued appropriateness of the system and its offerings;
b) patient safety issues, risk reduction strategies, adverse events, and results of patient safety
interventions;

c) risk (clinical and non-clinical) identification, minimization and mitigation strategies and results;

d) the capacity of the organization to deliver the appropriate and required continuum of care to the
patient, including during transfer to other healthcare providers and facilities;
e) wait times as defined by the organization;

f) service user experience;

g) waste reduction efforts;

h) consideration and prioritization of those items that are most critical to the effective functioning of
the quality management system.

Where applicable, health indicators shall include morbidity, mortality and quality of life and wellbeing.

NOTE Wait times can include time to initial appointment, time for referrals to specialists, waiting time once
arrived for an appointment, amongst other measures.

9.1.3. Methods

The organization shall determine the methods which are to be used by the quality monitoring system,
which should include among other sources:

a) internal and external audits;

b) use of clinical and non-clinical indicators (system/organizational/service or program);

c) use of data from internal health information systems;
d) benchmarking.

The data shall be collected and obtained from reliable sources and based on statistical and scientific
criteria.

9.1.4 Results

The organization shall ensure that results of the healthcare quality monitoring system are reviewed,
analysed and used to inform strategic quality directions of the organization and shall:

a) express if the results meet the objectives set by the organization;

b) define an improvement plan to address cases of nonconformity with stated objectives;

c) share the results and proposals for improvement with appropriate internal and external
stakeholders.

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9.2 Internal audit

9.2.1 General

The organization shall conduct internal audits at planned intervals to provide information on whether
the management system for quality in the healthcare organization:

a) conforms to:
— the organization's own requirements for the management system for quality in the healthcare
organization;

— the requirements of this document;

b) is effectively implemented and maintained.

9.2.2 Internal audit programme

The organization shall plan, establish, implement and maintain (an) audit programme(s), including the
frequency, methods, responsibilities, planning requirements and reporting.

When establishing the internal audit programme(s), the organization shall consider the importance of
the processes concerned and the results of previous audits.

The organization shall:

a) define the audit objectives, criteria and scope for each audit;

b) select auditors and conduct audits as to ensure objectivity and impartiality of the audit process;

c) ensure that the results of audits are reported to relevant managers in a timely manner;
d) ensure that audits are conducted by trained and qualified individuals;

e) take appropriate corrective actions without undue delay.

Internal audits shall be performed at a minimum once every twelve months.

Documented information shall be available as evidence of the implementation of the audit programme(s)
and the audit results.

9.3 Management review

9.3.1 General

Top management shall review the organization’s healthcare quality management system, at planned
intervals, to ensure its continuing suitability, adequacy and effectiveness, and alignment with the
strategic direction of the organization.

9.3.2 Management review inputs

The management review shall include:

a) the status of actions from previous management reviews;

b) changes in external and internal issues that are relevant to the management system for quality in
the healthcare organization;

c) changes in needs and expectations of stakeholders that are relevant to the management system for
quality in the healthcare organization;

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ISO 7101:2023(E)

d) information on the performance of the management system for quality in the healthcare
organization, including trends in:

1) nonconformities and corrective actions;

2) monitoring and measurement results;
3) audit results;

4) service user experience and feedback from stakeholders;

5) the extent to which quality objectives have been met;

6) the extent to which established health indicators have been met;

7) process performance and conformity of services;
8) monitoring and measurement results;

9) patient safety;

10) waste management;

11) the performance of external providers;

e) the adequacy of resources (human and other);
f) internal finances and funding from external partners;

g) accessibility of health services for all people;

h) risk management;

i) opportunities for continual improvement.

9.3.3. Management review results

The results of the management review shall include decisions related to continual improvement
opportunities and any need for changes to the management system for quality in the healthcare
organization.

Documented information shall be available as evidence of the results of management reviews.

Information shall be provided to stakeholders as stated in agreements.

10 Improvement

10.1 Continual improvement

The organization shall continually improve the suitability, adequacy, and effectiveness of the
management system for quality in the healthcare organization.

The organization shall consider the results of analysis and evaluation, and the outputs from management
review to determine opportunities for improvement.

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10.2 Nonconformity and corrective action

10.2.1 General

The organisation shall define the process of identification, management and reporting of non-
conformities that could directly or indirectly negatively affect the management system for quality in
the healthcare organization. Such nonconformities arise from multiple sources including:
a) process deviations;

b) effectiveness of planning;

c) service user feedback;

d) workforce performance;

e) undesired clinical outcomes;

f) risk management;

g) patient safety incidents and near misses;

h) workforce complaints and grievances;

i) internal audits.

10.2.2 Management of nonconformity and corrective action

When a nonconformity occurs, the organization shall:

a) react to the nonconformity, and as applicable:

— take action to control and correct it;

— deal with the consequences;

b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not
recur or occur elsewhere, by:

— reviewing the nonconformity;

— determining the causes of the nonconformity;

— determining if similar nonconformities exist, or can potentially occur;
c) implement any action needed, and shall include:

1) correction, containment, delay or suspension of services;

2) informing the service user (required if the nonconformity affects the service user);

3) communicating with those involved with the nonconformity;

4) fail-proofing or installing equipment and devices that are oriented to quality and safety
improvements where feasible;

5) updating, controlling, and mitigating risks;

6) planning that considers service user and workforce perspectives;

7) communicating changes to affected members at all levels of the organization;

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ISO 7101:2023(E)

8) providing workforce with continued education on changes or new processes;

d) review the effectiveness of any corrective action taken;

e) make changes to the management system for quality in the healthcare organization, if necessary.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

Documented information shall be available as evidence of:

— the nature of the nonconformities and any subsequent actions taken;

— the responsibilities and authorities for the action;

— the results of any corrective action.

At all levels of the healthcare system (i.e. primary, secondary and tertiary), the organization shall
empower relevant stakeholders (e.g. healthcare workers, service users and caregivers) to report real
and potential nonconformities.

The organization shall consider how it will communicate lessons learned from nonconformities to its
workforce.

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Bibliography

{1] ISO/IEC Guide 51:2014, Safety aspects — Guidelines

for their inclusion in standards

[2] ISO/IEC Guide 63:2019, Guide to the development and inclusion of aspects of safety in International
Standards for medical devices
[3] ISO Guide 73, Risk management — Vocabulary

[4] [SO 15189, Medical laboratories — Requirements

for quality and competence

[5] ISO 19011, Guidelines

for auditing management systems

[6] [SO 22886:2020, Healthcare organization management — Vocabulary

[7] [SO 30400:2022, Human resource management — Vocabulary

[8] [SO 31073:2022, Risk management — Vocabulary

[9] BALLATT J., CAMPLING C., MALONEY C., 2020. Intelligent Kindness: Rehabilitating the Welfare
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{10} Global patient safety action plan 2021-2030: Towards eliminating avoidable harm in health care.
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[12] UNITED NATIONS SUSTAINABLE DEVELOPMENT GOALS, Available at: [Link]

[13] WorLpD HEALTH ORGANIZATION, 1946: Preamble to the Constitution of the World Health
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{14] WorLD HEALTH ORGANIZATION, Health Literacy. Available at: [Link]

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[15] WorLD HEALTH ORGANIZATION, Universal health coverage. Available at: [Link]
health-topics/universal-health-coverage#tab=tab 1

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ISO 7101:2023(E)

ICS 03.100.70; 11.020.01

Price based on 35 pages

© ISO 2023 - Allrights reserved