Quality of learning environments for students in healthcare professions -- Requirements for healthcare education providers in care settings

This document specifies requirements for operational practices in care settings when a provider wishes to demonstrate its ability to consistently provide and improve healthcare education or training that meets the learning requirements of educational organizations. All the requirements in this document are intended to be applicable to any provider, regardless of its type, size or the healthcare services it offers.

Qualité des environnements d'apprentissage pour les étudiants en formation aux professions de santé -- Exigences pour les prestataires de formations aux professions de santé dans les établissements de soins

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Status
Published
Publication Date
05-Nov-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
07-Oct-2020
Completion Date
09-Oct-2020
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INTERNATIONAL IWA
WORKSHOP 35
AGREEMENT
First edition
2020-11
Quality of learning environments for
students in healthcare professions —
Requirements for healthcare
education providers in care settings
Reference number
IWA 35:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
IWA 35:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
IWA 35:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Governance ................................................................................................................................................................................................................. 3

4.1 Organizational culture ...................................................................................................................................................................... 3

4.2 Healthcare policy .................................................................................................................................................................................. 4

4.3 Legal requirements and other requirements ............................................................................................................... 4

4.4 Risk management ................................................................................................................................................................................. 4

4.5 Management of nonconformities and incidents ........................................................................................................ 5

5 Resources ..................................................................................................................................................................................................................... 5

5.1 Human resources .................................................................................................................................................................................. 5

5.2 Infrastructure ........................................................................................................................................................................................... 5

5.3 Financial resources ............................................................................................................................................................................. 5

5.4 Documented information ............................................................................................................................................................... 6

6 Planning and control ........................................................................................................................................................................................ 6

6.1 Partnerships between educational organizations and care settings ....................................................... 6

6.2 Determination of student requirements ........................................................................................................................... 6

6.3 Assignment of healthcare educators .................................................................................................................................... 7

6.4 Learning environment ...................................................................................................................................................................... 7

6.5 Assessment of learning .................................................................................................................................................................... 8

Annex A (informative) Workshop contributors ........................................................................................................................................ 9

Bibliography .............................................................................................................................................................................................................................12

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
IWA 35:2020(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

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

International Workshop Agreement IWA 35 was approved at a series of workshops hosted by the British

Standards Institution (BSI), in association with Nottingham University and the Knowledge Innovation

Center (Malta), held via video conferencing meetings in June to August 2020.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
IWA 35:2020(E)
Introduction

In healthcare studies which include professional regulation, student learning in care settings is an

essential part of the curriculum. This education occurs when an organization provides structured

arrangements, such as student teacher relationships and/or interactions, in care settings. Curricula are

designed with close input from national health services and, when they graduate, students are expected

to have sufficient experience to practice independently within their profession. Simultaneously, a

shortage of healthcare professionals in certain countries is stimulating mobility. However, healthcare

professionals who are educated or trained in the systems in which they intend to work are more likely

to be capable of immediate integration into that system, unlike professionals from other systems who

can require extra time and resources for a similar integration.

The intent of this document is, therefore, to provide a set of requirements that support educational and

healthcare institutions in offering and directing high-quality international learning opportunities and

in simplifying the processes involved in organizing these for students.
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.
[4]
This document is based on the HEALINT Protocol .
© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
International Workshop Agreement IWA 35:2020(E)
Quality of learning environments for students in
healthcare professions — Requirements for healthcare
education providers in care settings
1 Scope

This document specifies requirements for operational practices in care settings when a provider wishes

to demonstrate its ability to consistently provide and improve healthcare education or training that

meets the learning requirements of educational organizations.

All the requirements in this document are intended to be applicable to any provider, regardless of its

type, size or the healthcare services it offers.
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.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
legal requirements and other requirements

legal requirements that an organization (3.8) has to comply with and other requirements that an

organization has to, or chooses to, comply with

Note 1 to entry: Legal requirements and other requirements can arise from mandatory requirements, such as

applicable laws and regulations, or voluntary commitments, such as organizational and industry standards,

contractual relationships, codes of practice and agreements with community groups or non-governmental

organizations.

[SOURCE: ISO 45001:2018, 3.9, modified — The original notes to entry have been removed and a new

note to entry has been added.]
3.2
documented information

information required to be controlled and maintained by an organization (3.8) 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:
— management systems and related processes;
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records).
© ISO 2020 – All rights reserved 1
---------------------- Page: 6 ----------------------
IWA 35:2020(E)

Note 3 to entry: This constitutes one of the common terms and core definitions of the high level structure for ISO

management system standards. The original definition has been modified by replacing “the management system,

including related processes” with “management systems and related processes” in Note 2 to entry.

3.3
infrastructure

system of facilities, equipment and services needed for the operation of an

organization (3.8)
[SOURCE: ISO 9000:2015, 3.5.2]
3.4
interested party

person or organization (3.8) that can affect, be affected by, or perceive itself to be affected by a decision

or activity

Note 1 to entry: Customers, owners, people in an organization, providers (3.11), bankers, regulators, unions,

partners or society that can include competitors or opposing pressure groups.

Note 2 to entry: This constitutes one of the common terms and core definitions of the high level structure for

ISO management system standards. The original definition has been modified by deleting the admitted term

"stakeholder" and by adding the Example.
3.5
nonconformity
non-fulfilment of a requirement

Note 1 to entry: This constitutes one of the common terms and core definitions of the high level structure for ISO

management system standards.
3.6
incident

occurrence arising out of, or in the course of, work that could or does result in injury and ill health

Note 1 to entry: An incident where injury and ill health occurs is sometimes referred to as an “accident”.

Note 2 to entry: An incident where no injury and ill health occurs, but has the potential to do so, may be referred

to as a “near-miss”, “near-hit” or “close call” and can also include omission of care.

Note 3 to entry: Although there can be one or more nonconformities (3.5) related to an incident, an incident can

also occur where there is conformity to requirements.

[SOURCE: ISO 45001:2018, 3.35, modified — Notes 2 and 3 to entry have been modified.]

3.7
healthcare educator
person responsible for providing learning experiences in a care setting

Note 1 to entry: Depending on the context, there can be one or more healthcare educators.

Note 2 to entry: Depending on the context, other terms can be used in place of “healthcare educator”, e.g. practice

supervisor, clinical instructor, preceptor, monitor, mentor, tutor.

Note 3 to entry: Depending on the context, healthcare educators can originate from a care setting, an education

organization (3.8), or both.
3.8
organization

person or group of people that has its own functions with responsibilities, authorities and relationships

to achieve its objectives

Note 1 to entry: This constitutes one of the common terms and core definitions of the high level structure for ISO

management system standards. The original definition has been modified by deleting the original Note to entry.

2 © ISO 2020 – All rights reserved
---------------------- Page: 7 ----------------------
IWA 35:2020(E)
3.9
service user
person to which the care service is delivered

Note 1 to entry: Depending on the nature and culture of the organization (3.8), other terms can be used in place

of “service user”, e.g. patient, customer, client, among others.
3.10
healthcare education

learning facilitated by a provider (3.11) that is part of a recognized qualification

Note 1 to entry: Healthcare education is sometimes referred to as healthcare training.

3.11
provider

organization (3.8) offering healthcare education (3.10) or training in a care setting

Note 1 to entry: The provider can differ substantially according to the services offered (hospital, clinic, care

home, hospice, etc.); their financial nature (public, private, etc.) and their size (micro, small or large), among

other characteristics.
4 Governance
4.1 Organizational culture

The provider shall determine its purpose, scope and aspirations for healthcare education and maintain

this as documented information. This documented information shall be communicated to relevant

interested parties.

The provider shall determine, implement and promote a positive culture that demonstrates knowledge

of the service users’ needs and expectations and reflects cultural sensitivity, effective practice and

continual improvement.

When identifying this culture, the provider should consider elements including, but not limited to:

a) person-centred approach and care;
b) anti-discrimination;
c) cultural integration;
d) data protection;
e) ethical practice;
f) occupational health and safety;
g) dedication to healthcare professional development;
h) digital literacy;
i) innovation;
j) sustainability;

k) commitment to continuous improvement supported by evidence-based practice and reflection on

lessons learned.

NOTE 1 Cultural integration can include the recognition, respect and fulfilment of cultural and language

needs of service users as appropriate.
© ISO 2020 – All rights reserved 3
---------------------- Page: 8 ----------------------
IWA 35:2020(E)

NOTE 2 A positive culture can include sensitivity towards all cultures; mutual respect; empathy; compassion;

motivation; confidence; patient safety.
4.2 Healthcare policy

The provider shall establish, implement and periodically review a healthcare policy that reflects its

purpose, scope, aspirations and culture through a set of organizational commitments for the delivery

of care.

The healthcare policy shall be maintained as documented information and available to interested

parties.
4.3 Legal requirements and other requirements

The provider shall identify the applicable legal requirements and other requirements for delivery of

safe and effective care, and for safe and effective education within that care setting, considering, as a

minimum:
a) clinical practice;
b) data protection;
c) occupational health and safety;

d) appropriate insurance arrangements to protect patients and their care providers, employees,

visitors and students in the workplace (this can include group or individual insurance for stude

...

INTERNATIONAL IWA
WORKSHOP 35
AGREEMENT
First edition
2020-11
Quality of learning environments for
students in healthcare professions
– requirements for healthcare
education providers in care setting
PROOF/ÉPREUVE
Reference number
IWA 35:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
IWA 35:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
IWA 35:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Governance ................................................................................................................................................................................................................. 3

4.1 Organizational culture ...................................................................................................................................................................... 3

4.2 Healthcare policy .................................................................................................................................................................................. 4

4.3 Legal requirements and other requirements ............................................................................................................... 4

4.4 Risk management ................................................................................................................................................................................. 4

4.5 Management of nonconformities and incidents ........................................................................................................ 5

5 Resources ..................................................................................................................................................................................................................... 5

5.1 Human resources .................................................................................................................................................................................. 5

5.2 Infrastructure ........................................................................................................................................................................................... 5

5.3 Financial resources ............................................................................................................................................................................. 5

5.4 Documented information ............................................................................................................................................................... 6

6 Planning and control ........................................................................................................................................................................................ 6

6.1 Partnerships between educational organizations and care settings ....................................................... 6

6.2 Determination of student requirements ........................................................................................................................... 6

6.3 Assignment of healthcare educators .................................................................................................................................... 7

6.4 Learning environment ...................................................................................................................................................................... 7

6.5 Assessment of learning .................................................................................................................................................................... 8

Annex A (informative) Workshop contributors ........................................................................................................................................ 9

Bibliography .............................................................................................................................................................................................................................12

© ISO 2020 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
IWA 35:2020(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

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

International Workshop Agreement IWA 35 was approved at a workshop hosted by the British

Standards Institution (BSI), in association with Nottingham University and the Knowledge Innovation

Centre, held via a video conferencing meeting, in June 2020.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
IWA 35:2020(E)
Introduction

In healthcare studies which include professional regulation, student learning in care settings is an

essential part of the curriculum. This education occurs when an organization provides structured

arrangements, such as student teacher relationships and/or interactions, in care settings. Curricula are

designed with close input from national health services and, when they graduate, students are expected

to have sufficient experience to practice independently within their profession. Simultaneously, a

shortage of healthcare professionals in certain countries is stimulating mobility. However, healthcare

professionals who are educated or trained in the systems in which they intend to work are more likely

to be capable of immediate integration into that system, unlike professionals from other systems who

can require extra time and resources for a similar integration.

The intent of this document is, therefore, to provide a set of requirements that support educational and

healthcare institutions in offering and directing high-quality international learning opportunities and

in simplifying the processes involved in organizing these for students.
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.
© ISO 2020 – All rights reserved PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
International Workshop Agreement IWA 35:2020(E)
Quality of learning environments for students in
healthcare professions – requirements for healthcare
education providers in care setting
1 Scope

This document specifies requirements for operational practices in care settings when a provider wishes

to demonstrate its ability to consistently provide and improve healthcare education or training that

meets the learning requirements of educational organizations.

All the requirements in this document are intended to be applicable to any provider, regardless of its

type, size or the healthcare services it offers.
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.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
legal requirements and other requirements

legal requirements that an organization (3.8) has to comply with and other requirements that an

organization has to, or chooses to, comply with

Note 1 to entry: Legal requirements and other requirements can arise from mandatory requirements, such as

applicable laws and regulations, or voluntary commitments, such as organizational and industry standards,

contractual relationships, codes of practice and agreements with community groups or non-governmental

organizations.

[SOURCE: ISO 45001:2018, 3.9, modified — The original notes to entry have been removed and a new

note to entry has been added.]
3.2
documented information

information required to be controlled and maintained by an organization (3.8) 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:
— management systems and related processes;
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records).
© ISO 2020 – All rights reserved PROOF/ÉPREUVE 1
---------------------- Page: 6 ----------------------
IWA 35:2020(E)

Note 3 to entry: This constitutes one of the common terms and core definitions of the high level structure for ISO

management system standards. The original definition has been modified by replacing “the management system,

including related processes” with “management systems and related processes” in Note 2 to entry.

3.3
infrastructure

system of facilities, equipment and services needed for the operation of an

organization (3.8)
[SOURCE: ISO 9000:2015, 3.5.2]
3.4
interested party

person or organization (3.8) that can affect, be affected by, or perceive itself to be affected by a decision

or activity

Note 1 to entry: Customers, owners, people in an organization, providers (3.11), bankers, regulators, unions,

partners or society that can include competitors or opposing pressure groups.

Note 2 to entry: This constitutes one of the common terms and core definitions of the high level structure for

ISO management system standards. The original definition has been modified by deleting the admitted term

"stakeholder" and by adding the Example.
3.5
nonconformity
non-fulfilment of a requirement

Note 1 to entry: This constitutes one of the common terms and core definitions of the high level structure for ISO

management system standards.
3.6
incident

occurrence arising out of, or in the course of, work that could or does result in injury and ill health

Note 1 to entry: An incident where injury and ill health occurs is sometimes referred to as an “accident”.

Note 2 to entry: An incident where no injury and ill health occurs, but has the potential to do so, may be referred

to as a “near-miss”, “near-hit” or “close call” and can also include omission of care.

Note 3 to entry: Although there can be one or more nonconformities (3.5) related to an incident, an incident can

also occur where there is conformity to requirements.

[SOURCE: ISO 45001:2018, 3.35, modified — Notes 2 and 3 to entry have been modified.]

3.7
healthcare educator
person responsible for providing learning experiences in a care setting

Note 1 to entry: Depending on the context, there can be one or more healthcare educators.

Note 2 to entry: Depending on the context, other terms can be used in place of “healthcare educator”, e.g. practice

supervisor, clinical instructor, preceptor, monitor, mentor, tutor.

Note 3 to entry: Depending on the context, healthcare educators can originate from a care setting, an education

organization (3.8), or both.
3.8
organization

person or group of people that has its own functions with responsibilities, authorities and relationships

to achieve its objectives

Note 1 to entry: This constitutes one of the common terms and core definitions of the high level structure for ISO

management system standards. The original definition has been modified by deleting the original Note to entry.

2 PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 7 ----------------------
IWA 35:2020(E)
3.9
service user
person to which the care service is delivered

Note 1 to entry: Depending on the nature and culture of the organization (3.8), other terms can be used in place

of “service user”, e.g. patient, customer, client, among others.
3.10
healthcare education

learning facilitated by a provider (3.11) that is part of a recognized qualification

Note 1 to entry: Healthcare education is sometimes referred to as healthcare training.

3.11
provider

organization (3.8) offering healthcare education (3.10) or training in a care setting

Note 1 to entry: The provider can differ substantially according to the services offered (hospital, clinic, care

home, hospice, etc.); their financial nature (public, private, etc.) and their size (micro, small or large), among

other characteristics.
4 Governance
4.1 Organizational culture

The provider shall determine its purpose, scope and aspirations for healthcare education and maintain

this as documented information. This documented information shall be communicated to relevant

interested parties.

The provider shall determine, implement and promote a positive culture that demonstrates knowledge

of the service users’ needs and expectations and reflects cultural sensitivity, effective practice and

continual improvement.

When identifying this culture, the provider should consider elements including, but not limited to:

a) person-centred approach and care;
b) anti-discrimination;
c) cultural integration;
d) data protection;
e) ethical practice;
f) occupational health and safety;
g) dedication to healthcare professional development;
h) digital literacy;
i) innovation;
j) sustainability;

k) commitment to continuous improvement supported by evidence-based practice and reflection on

lessons learned.

NOTE 1 Cultural integration can include the recognition, respect and fulfilment of cultural and language

needs of service users as appropriate.
© ISO 2020 – All rights reserved PROOF/ÉPREUVE 3
---------------------- Page: 8 ----------------------
IWA 35:2020(E)

NOTE 2 A positive culture can include sensitivity towards all cultures; mutual respect; empathy; compassion;

motivation; confidence; patient safety.
4.2 Healthcare policy

The provider shall establish, implement and periodically review a healthcare policy that reflects its

purpose, scope, aspirations and culture through a set of organizational commitments for the delivery

of care.

The healthcare policy shall be maintained as documented information and available to interested

parties.
4.3 Legal requirements and other requirements

The provider shall identify the applicable legal requirements and other requirements for delivery of

safe and effective care, and for safe and effective education within that care setting, considering, as a

minimum:
a) clinical practice;
b) data protection;
c) occupational health and safety;

d) appropriate insurance arrangements to protect patients and their care providers, employees,

visitors and students in the workplace (this can
...

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