FINAL INTERNATIONAL ISO/FDIS

DRAFT
STANDARD 7101

ISO/TC 304
Secretariat: ANSI Healthcare organization
Voting begins on:
management — Management systems
2023-06-30 for quality in healthcare organizations
Voting terminates on: — Requirements
2023-08-25

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Contents Page

Foreword...........................................................................................................................................................................................................................................v
Introduction............................................................................................................................................................................................................................... vi
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references...................................................................................................................................................................................... 1
3 Terms and definitions..................................................................................................................................................................................... 1
4 Context of the organization....................................................................................................................................................................... 7
4.1 Understanding the organization and its context...................................................................................................... 7
4.2 Understanding the needs and expectations of stakeholders......................................................................... 8
4.3 Determining the scope of the management system for quality in healthcare
organizations............................................................................................................................................................................................ 8
4.4 Management system for quality in healthcare organizations...................................................................... 8
5 Leadership................................................................................................................................................................................................................... 9
5.1 Leadership and commitment...................................................................................................................................................... 9
5.2 Healthcare quality policy............................................................................................................................................................ 10
5.3 Roles, responsibilities and authorities............................................................................................................................ 10
5.4 Service user focus.............................................................................................................................................................................. 10
5.5 Access to care........................................................................................................................................................................................ 11
6 Planning...................................................................................................................................................................................................................... 11
6.1 iTeh Standards
Actions to address risks and opportunities............................................................................................................... 11
6.1.1 General...................................................................................................................................................................................... 11
(https://standards.iteh.ai)
6.1.2 Risk culture........................................................................................................................................................................... 12
6.1.3 Risk management processes.................................................................................................................................. 12
6.2
6.3 Document Preview
Healthcare quality objectives and planning to achieve them..................................................................... 12
Planning of changes......................................................................................................................................................................... 13
7 Support.........................................................................................................................................................................................................................13
7.1 ISO 7101
Resources.................................................................................................................................................................................................. 13
7.2 Competence .............................................................................................................................................................................................
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7.3 Awareness................................................................................................................................................................................................. 14
7.4 Communication.................................................................................................................................................................................... 14
7.4.1 General...................................................................................................................................................................................... 14
7.4.2 Service user communication................................................................................................................................. 15
7.4.3 Clinical communication.............................................................................................................................................. 15
7.4.4 External communications........................................................................................................................................ 15
7.5 Documented information............................................................................................................................................................ 15
7.5.1 General...................................................................................................................................................................................... 15
7.5.2 Creating and updating documented information............................................................................... 16
7.5.3 Control of documented information............................................................................................................... 16
7.5.4 Information management systems.................................................................................................................. 16
7.5.5 Control and management of electronic information........................................................................ 17
7.5.6 Audit of records................................................................................................................................................................. 17
8 Operation................................................................................................................................................................................................................... 18
8.1 Operational planning and control....................................................................................................................................... 18
8.2 Healthcare facilities management and maintenance......................................................................................... 18
8.2.1 General...................................................................................................................................................................................... 18
8.2.2 Contingency planning for facilities and services................................................................................. 19
8.2.3 Equipment.............................................................................................................................................................................. 19
8.3 Waste management.......................................................................................................................................................................... 20
8.3.1 General...................................................................................................................................................................................... 20
8.3.2 Waste reduction................................................................................................................................................................ 20
8.3.3 Environmental responsibility.............................................................................................................................. 20
8.4 Handling and storage of materials...................................................................................................................................... 20

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ISO/FDIS 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
8.10.2 Service user experience............................................................................................................................................. 23
8.10.3 Compassionate care....................................................................................................................................................... 24
8.10.4 Inclusivity and diversity............................................................................................................................................ 24
8.10.5 Health literacy.................................................................................................................................................................... 25
8.10.6 Co-production..................................................................................................................................................................... 25
8.10.7 Workforce wellbeing..................................................................................................................................................... 25
8.11 Ethics............................................................................................................................................................................................................. 26
8.12 Patient safety......................................................................................................................................................................................... 26
8.12.1 General...................................................................................................................................................................................... 26
8.12.2 Knowledge and learning in safety.................................................................................................................... 26
8.12.3 Patient identification.................................................................................................................................................... 26
8.12.4 Medication safety............................................................................................................................................................ 27
8.12.5 Surgical safety.................................................................................................................................................................... 27
8.12.6 Infection prevention and control (IPC)........................................................................................................ 27
8.12.7 Prevention of falls, pressure ulcers and thromboembolism..................................................... 28
8.12.8 Diagnostic safety.............................................................................................................................................................. 28
8.12.9 Blood transfusions.......................................................................................................................................................... 28
9 iTeh Standards
Performance evaluation............................................................................................................................................................................ 29
9.1 Monitoring, measurement, analysis, and evaluation......................................................................................... 29
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9.1.1 General...................................................................................................................................................................................... 29
9.1.2 Healthcare quality indicators............................................................................................................................... 30
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9.1.3 Methods.................................................................................................................................................................................... 30
9.1.4 Results....................................................................................................................................................................................... 30
9.2 Internal audit......................................................................................................................................................................................... 31
ISO 7101
9.2.1 General...................................................................................................................................................................................... 31
9.2.2 Internal audit programme .......................................................................................................................................
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9.3 Management review........................................................................................................................................................................ 31
9.3.1 General...................................................................................................................................................................................... 31
9.3.2 Management review inputs.................................................................................................................................... 31
9.3.3 Management review results................................................................................................................................... 32
10 Improvement.......................................................................................................................................................................................................... 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

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 ISO/FDIS 7101:2023(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
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ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
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such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
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This document was prepared by Technical Committee ISO/TC 304, Healthcare organization management.
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ISO/FDIS 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.
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This document conforms to ISO’s requirements for management system standards. These requirements
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include a harmonized structure, identical core text, and common terms with core definitions, designed
to benefit users implementing multiple ISO management system standards.

Document
This document contains the requirements used to assessPreview
demonstrate conformity with this document can do so by:
conformity. An organization that wishes to

— making a self-determination and self-declaration;

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— 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 of a 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;

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 ISO/FDIS 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

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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
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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

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

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

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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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 system 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.

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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.
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2 Normative references
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There are no normative references in this document.
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3 Terms and definitions
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For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://​w ww​.iso​.org/​obp
— IEC Electropedia: available at https://​w ww​.electropedia​.org/​
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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3.2
stakeholder
person or organization (3.1) that can affect, be affected by, or perceive itself to 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
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set of interrelated or interacting elements of an organization (3.1) to establish policies (3.5) and
objectives (3.6), as well as processes (3.22) to achieve those objectives (3.6)
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Note 1 to entry: A management system can address a single discipline or several disciplines.

planning and operation.

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Note 2 to entry: The management system Preview
elements include the organization’s structure, roles and responsibilities,

3.5
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policy
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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 (such as 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/FDIS 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)
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the management system (3.4), including related processes (3.8);

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

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c) evidence of results achieved (records).

3.11
performance
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measurable result
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Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
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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/FDIS 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
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monitoring
determining the status of a system,Document Preview
a process (3.8) or an activity
Note 1 to entry: For determination of the status, there can be a need to check, supervise or critically observe.
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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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