Compliance management systems - Requirements with guidance for use

This document specifies requirements and provides guidelines for establishing, developing, implementing, evaluating, maintaining and improving an effective compliance management system within an organization.
This document is applicable to all types of organizations regardless of the type, size and nature of the activity, as well as whether the organization is from the public, private or non-profit sector.
All requirements specified in this document that refer to a governing body apply to top management in cases where an organization does not have a governing body as a separate function.

Systèmes de management de la conformité - Exigences et recommandations pour la mise en oeuvre

Sistemi za upravljanje skladnosti - Zahteve z napotki za uporabo

General Information

Status
Published
Public Enquiry End Date
31-Jan-2021
Publication Date
28-Apr-2021
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
12-Apr-2021
Due Date
17-Jun-2021
Completion Date
29-Apr-2021

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SLOVENSKI STANDARD
SIST ISO 37301:2021
01-junij-2021
Sistemi za upravljanje skladnosti - Zahteve z napotki za uporabo
Compliance management systems - Requirements with guidance for use
Systèmes de management de la conformité - Exigences et recommandations pour la
mise en oeuvre
Ta slovenski standard je istoveten z: ISO 37301:2021
ICS:
03.100.01 Organizacija in vodenje Company organization and
podjetja na splošno management in general
03.100.70 Sistemi vodenja Management systems
SIST ISO 37301:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST ISO 37301:2021
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SIST ISO 37301:2021
INTERNATIONAL ISO
STANDARD 37301
First edition
2021-04
Compliance management systems —
Requirements with guidance for use
Systèmes de management de la conformité — Exigences et
recommandations pour la mise en oeuvre
Reference number
ISO 37301:2021(E)
ISO 2021
---------------------- Page: 3 ----------------------
SIST ISO 37301:2021
ISO 37301:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
SIST ISO 37301:2021
ISO 37301:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

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

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

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

4 Context of the organization ....................................................................................................................................................................... 5

4.1 Understanding the organization and its context ....................................................................................................... 5

4.2 Understanding the needs and expectations of interested parties .............................................................. 5

4.3 Determining the scope of the compliance management system ................................................................. 5

4.4 Compliance management system ........................................................................................................................................... 6

4.5 Compliance obligations ................................................................................................................................................................... 6

4.6 Compliance risk assessment ....................................................................................................................................................... 6

5 Leadership .................................................................................................................................................................................................................. 6

5.1 Leadership and commitment ..................................................................................................................................................... 6

5.1.1 Governing body and top management .......................................................................................................... 6

5.1.2 Compliance culture ........................................................................................................................................................ 7

5.1.3 Compliance governance ............................................................................................................................................. 7

5.2 Compliance policy ................................................................................................................................................................................ 8

5.3 Roles, responsibilities and authorities ............................................................................................................................... 8

5.3.1 Governing body and top management .......................................................................................................... 8

5.3.2 Compliance function ..................................................................................................................................................... 9

5.3.3 Management .....................................................................................................................................................................10

5.3.4 Personnel .............................................................................................................................................................................10

6 Planning ......................................................................................................................................................................................................................10

6.1 Actions to address risks and opportunities ................................................................................................................10

6.2 Compliance objectives and planning to achieve them .......................................................................................11

6.3 Planning of changes .........................................................................................................................................................................11

7 Support ........................................................................................................................................................................................................................12

7.1 Resources ..................................................................................................................................................................................................12

7.2 Competence ............................................................................................................................................................................................12

7.2.1 General...................................................................................................................................................................................12

7.2.2 Employment process .................................................................................................................................................12

7.2.3 Training .................................................................................................................................................................................12

7.3 Awareness ................................................................................................................................................................................................13

7.4 Communication ...................................................................................................................................................................................13

7.5 Documented information ............................................................................................................................................................14

7.5.1 General...................................................................................................................................................................................14

7.5.2 Creating and updating documented information .............................................................................14

7.5.3 Control of documented information ............................................................................................................14

8 Operation ..................................................................................................................................................................................................................15

8.1 Operational planning and control .......................................................................................................................................15

8.2 Establishing controls and procedures .............................................................................................................................15

8.3 Raising concerns .................................................................................................................................................................................15

8.4 Investigation processes ................................................................................................................................................................15

9 Performance evaluation ............................................................................................................................................................................16

9.1 Monitoring, measurement, analysis and evaluation ............................................................................................16

9.1.1 General...................................................................................................................................................................................16

9.1.2 Sources of feedback on compliance performance ............................................................................16

9.1.3 Development of indicators ...................................................................................................................................16

9.1.4 Compliance reporting ...............................................................................................................................................16

9.1.5 Record-keeping ..............................................................................................................................................................17

© ISO 2021 – All rights reserved iii
---------------------- Page: 5 ----------------------
SIST ISO 37301:2021
ISO 37301:2021(E)

9.2 Internal audit .........................................................................................................................................................................................17

9.2.1 General...................................................................................................................................................................................17

9.2.2 Internal audit programme ....................................................................................................................................17

9.3 Management review ........................................................................................................................................................................17

9.3.1 General...................................................................................................................................................................................17

9.3.2 Management review inputs .................................................................................................................................18

9.3.3 Management review results ................................................................................................................................18

10 Improvement .........................................................................................................................................................................................................18

10.1 Continual improvement ...............................................................................................................................................................18

10.2 Nonconformity and corrective action ..............................................................................................................................19

Annex A (informative) Guidance for the use of this document ..............................................................................................20

Bibliography .............................................................................................................................................................................................................................40

iv © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
SIST ISO 37301:2021
ISO 37301:2021(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.

This document was prepared by Technical Committee ISO/TC 309, Governance of organizations.

This first edition of ISO 37301 cancels and replaces ISO 19600:2014, which has been technically revised.

The main changes compared to ISO 19600:2014 are as follows:

— this document now contains requirements with additional guidance for use based on those

requirements;

— this document follows ISO’s requirements for a harmonized structure for management system

standards.

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.
© ISO 2021 – All rights reserved v
---------------------- Page: 7 ----------------------
SIST ISO 37301:2021
ISO 37301:2021(E)
Introduction

Organizations that aim to be successful in the long term need to establish and maintain a culture of

compliance, considering the needs and expectations of interested parties. Compliance is therefore not

only the basis, but also an opportunity, for a successful and sustainable organization.

Compliance is an ongoing process and the outcome of an organization meeting its obligations.

Compliance is made sustainable by embedding it in the culture of the organization and in the behaviour

and attitude of people working for it. While maintaining its independence, it is preferable that

compliance management is integrated with the organization’s other management processes and its

operational requirements and procedures.

An effective, organization-wide compliance management system enables an organization to

demonstrate its commitment to comply with relevant laws, regulatory requirements, industry codes

and organizational standards, as well as standards of good governance, generally accepted best

practices, ethics and community expectations.

An organization’s approach to compliance is shaped by the leadership applying core values and

generally accepted good governance, ethical and community standards. Embedding compliance in the

behaviour of the people working for an organization depends above all on leadership at all levels and

clear values of an organization, as well as an acknowledgement and implementation of measures to

promote compliant behaviour. If this is not the case at all levels of an organization, there is a risk of

noncompliance.

In a number of jurisdictions, courts have considered an organization’s commitment to compliance

through its compliance management system when determining the appropriate penalty to be imposed

for contraventions of relevant laws. Therefore, regulatory and judicial bodies can also benefit from this

document as a benchmark.

Organizations are increasingly convinced that, by applying binding values and appropriate compliance

management, they can safeguard their integrity and avoid or minimize noncompliance with the

organization’s compliance obligations. Integrity and effective compliance are therefore key elements

of good and diligent management. Compliance also contributes to the socially responsible behaviour of

organizations.

One of the objectives of this document is to assist organizations to develop and spread a positive culture

of compliance, considering that an effective and sound management of compliance-related risks should

be regarded as an opportunity to pursue and take, due to the several benefits that it provides to the

organization such as:
— improving business opportunities and sustainability;
— protecting and enhancing an organization’s reputation and credibility;
— taking into account expectations of interested parties;

— demonstrating an organization’s commitment to managing its compliance risks effectively and

efficiently;

— increasing the confidence of third parties in the organization’s capacity to achieve sustained success;

— minimizing the risk of a contravention occurring with the attendant costs and reputational damage.

This document specifies requirements as well as provides guidance on compliance management

systems and recommended practices. Both the requirements and the guidance in this document are

intended to be adaptable, and implementation can differ depending on the size and level of maturity

of an organization’s compliance management system and on the context, nature and complexity of the

organization’s activities and objectives.
vi © ISO 2021 – All rights reserved
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SIST ISO 37301:2021
ISO 37301:2021(E)

This document is suitable to enhance the compliance-related requirements in other management

systems and to assist an organization in improving the overall management of all its compliance

obligations.

Figure 1 provides an overview on common elements of a compliance management system.

Figure 1 — Elements of a compliance management system
© ISO 2021 – All rights reserved vii
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SIST ISO 37301:2021
ISO 37301:2021(E)
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates permission;
— “can” indicates a possibility or a capability.

Information marked as “NOTE” is for guidance in understanding or clarifying the associated

requirements.
Annex A provides guidance for the use of this document.
viii © ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
SIST ISO 37301:2021
INTERNATIONAL STANDARD ISO 37301:2021(E)
Compliance management systems — Requirements with
guidance for use
1 Scope

This document specifies requirements and provides guidelines for establishing, developing,

implementing, evaluating, maintaining and improving an effective compliance management system

within an organization.

This document is applicable to all types of organizations regardless of the type, size and nature of the

activity, as well as whether the organization is from the public, private or non-profit sector.

All requirements specified in this document that refer to a governing body apply to top management in

cases where an organization does not have a governing body as a separate function.

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
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 compliance management system.
3.2
interested party (preferred term)
stakeholder (admitted term)

person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision

or activity
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.
© ISO 2021 – All rights reserved 1
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SIST ISO 37301:2021
ISO 37301:2021(E)

Note 3 to entry: For the purposes of this document, the term “top management” refers to the highest level of

executive management.
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

Note 1 to entry: A management 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)

Note 1 to entry: A policy can also be formally expressed by an organization’s governing body (3.21).

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, service or process (3.8)).

Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended result, a purpose, an operational

criterion, as a compliance (3.26) 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 compliance management systems (3.4), compliance objectives are set by the

organization (3.1), consistent with the compliance policy (3.5), to achieve specific results.

3.7
risk
effect of uncertainty on objectives (3.6)

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.

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 output, product or service depends on the context of the

reference.
3.9
competence
ability to apply knowledge and skills to achieve intended results
2 © ISO 2021 – All rights reserved
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SIST ISO 37301:2021
ISO 37301:2021(E)
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:
— the management system (3.4), including related processes (3.8);
— information created in order for the organization to operate (documentation);
— 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
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

interested parties (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).

3.15
conformity
fulfilment of a requirement (3.14)
3.16
nonconformity
non-fulfilment of a requirement (3.14)
Note 1 to entry: A nonconformity is not necessarily a noncompliance (3.27).
3.17
corrective action

action to eliminate the cause(s) of a nonconformity (3.16) and to prevent recurrence

3.18
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

(3.30)), 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.

© ISO 2021 – All rights reserved 3
---------------------- Page: 13 ----------------------
SIST ISO 37301:2021
ISO 37301:2021(E)
Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.

Note 4 to entry: Independence can be demonstrated by the freedom from responsibility for the activity being

audited or freedom from bias and conflict of interest.
3.19
measurement
process (3.8) to determine a value
3.20
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.

3.21
governing body

person or group of persons that has the ultimate responsibility and authority for an organization’s (3.1)

activities, governance and policies (3.5) and to which top management (3.3) reports and by which top

management is held accountable

Note 1 to entry: Not all organizations, particularly small organizations, will have a governing body separate from

top management.

Note 2 to entry: A governing body can include, but is not limited to, a board of directors, committees of the board,

a supervisory board or trustees.
3.22
personnel

individuals in a relationship recognized as a work relationship in national law or practice, or in any

contractual relationship that depends on its activity from the organization (3.1)

3.23
compliance function
person or group of persons with responsi
...

INTERNATIONAL ISO
STANDARD 37301
First edition
2021-04
Compliance management systems —
Requirements with guidance for use
Systèmes de management de la conformité — Exigences et
recommandations pour la mise en oeuvre
Reference number
ISO 37301:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 37301:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 37301:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

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

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

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

4 Context of the organization ....................................................................................................................................................................... 5

4.1 Understanding the organization and its context ....................................................................................................... 5

4.2 Understanding the needs and expectations of interested parties .............................................................. 5

4.3 Determining the scope of the compliance management system ................................................................. 5

4.4 Compliance management system ........................................................................................................................................... 6

4.5 Compliance obligations ................................................................................................................................................................... 6

4.6 Compliance risk assessment ....................................................................................................................................................... 6

5 Leadership .................................................................................................................................................................................................................. 6

5.1 Leadership and commitment ..................................................................................................................................................... 6

5.1.1 Governing body and top management .......................................................................................................... 6

5.1.2 Compliance culture ........................................................................................................................................................ 7

5.1.3 Compliance governance ............................................................................................................................................. 7

5.2 Compliance policy ................................................................................................................................................................................ 8

5.3 Roles, responsibilities and authorities ............................................................................................................................... 8

5.3.1 Governing body and top management .......................................................................................................... 8

5.3.2 Compliance function ..................................................................................................................................................... 9

5.3.3 Management .....................................................................................................................................................................10

5.3.4 Personnel .............................................................................................................................................................................10

6 Planning ......................................................................................................................................................................................................................10

6.1 Actions to address risks and opportunities ................................................................................................................10

6.2 Compliance objectives and planning to achieve them .......................................................................................11

6.3 Planning of changes .........................................................................................................................................................................11

7 Support ........................................................................................................................................................................................................................12

7.1 Resources ..................................................................................................................................................................................................12

7.2 Competence ............................................................................................................................................................................................12

7.2.1 General...................................................................................................................................................................................12

7.2.2 Employment process .................................................................................................................................................12

7.2.3 Training .................................................................................................................................................................................12

7.3 Awareness ................................................................................................................................................................................................13

7.4 Communication ...................................................................................................................................................................................13

7.5 Documented information ............................................................................................................................................................14

7.5.1 General...................................................................................................................................................................................14

7.5.2 Creating and updating documented information .............................................................................14

7.5.3 Control of documented information ............................................................................................................14

8 Operation ..................................................................................................................................................................................................................15

8.1 Operational planning and control .......................................................................................................................................15

8.2 Establishing controls and procedures .............................................................................................................................15

8.3 Raising concerns .................................................................................................................................................................................15

8.4 Investigation processes ................................................................................................................................................................15

9 Performance evaluation ............................................................................................................................................................................16

9.1 Monitoring, measurement, analysis and evaluation ............................................................................................16

9.1.1 General...................................................................................................................................................................................16

9.1.2 Sources of feedback on compliance performance ............................................................................16

9.1.3 Development of indicators ...................................................................................................................................16

9.1.4 Compliance reporting ...............................................................................................................................................16

9.1.5 Record-keeping ..............................................................................................................................................................17

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 37301:2021(E)

9.2 Internal audit .........................................................................................................................................................................................17

9.2.1 General...................................................................................................................................................................................17

9.2.2 Internal audit programme ....................................................................................................................................17

9.3 Management review ........................................................................................................................................................................17

9.3.1 General...................................................................................................................................................................................17

9.3.2 Management review inputs .................................................................................................................................18

9.3.3 Management review results ................................................................................................................................18

10 Improvement .........................................................................................................................................................................................................18

10.1 Continual improvement ...............................................................................................................................................................18

10.2 Nonconformity and corrective action ..............................................................................................................................19

Annex A (informative) Guidance for the use of this document ..............................................................................................20

Bibliography .............................................................................................................................................................................................................................40

iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 37301:2021(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.

This document was prepared by Technical Committee ISO/TC 309, Governance of organizations.

This first edition of ISO 37301 cancels and replaces ISO 19600:2014, which has been technically revised.

The main changes compared to ISO 19600:2014 are as follows:

— this document now contains requirements with additional guidance for use based on those

requirements;

— this document follows ISO’s requirements for a harmonized structure for management system

standards.

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.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO 37301:2021(E)
Introduction

Organizations that aim to be successful in the long term need to establish and maintain a culture of

compliance, considering the needs and expectations of interested parties. Compliance is therefore not

only the basis, but also an opportunity, for a successful and sustainable organization.

Compliance is an ongoing process and the outcome of an organization meeting its obligations.

Compliance is made sustainable by embedding it in the culture of the organization and in the behaviour

and attitude of people working for it. While maintaining its independence, it is preferable that

compliance management is integrated with the organization’s other management processes and its

operational requirements and procedures.

An effective, organization-wide compliance management system enables an organization to

demonstrate its commitment to comply with relevant laws, regulatory requirements, industry codes

and organizational standards, as well as standards of good governance, generally accepted best

practices, ethics and community expectations.

An organization’s approach to compliance is shaped by the leadership applying core values and

generally accepted good governance, ethical and community standards. Embedding compliance in the

behaviour of the people working for an organization depends above all on leadership at all levels and

clear values of an organization, as well as an acknowledgement and implementation of measures to

promote compliant behaviour. If this is not the case at all levels of an organization, there is a risk of

noncompliance.

In a number of jurisdictions, courts have considered an organization’s commitment to compliance

through its compliance management system when determining the appropriate penalty to be imposed

for contraventions of relevant laws. Therefore, regulatory and judicial bodies can also benefit from this

document as a benchmark.

Organizations are increasingly convinced that, by applying binding values and appropriate compliance

management, they can safeguard their integrity and avoid or minimize noncompliance with the

organization’s compliance obligations. Integrity and effective compliance are therefore key elements

of good and diligent management. Compliance also contributes to the socially responsible behaviour of

organizations.

One of the objectives of this document is to assist organizations to develop and spread a positive culture

of compliance, considering that an effective and sound management of compliance-related risks should

be regarded as an opportunity to pursue and take, due to the several benefits that it provides to the

organization such as:
— improving business opportunities and sustainability;
— protecting and enhancing an organization’s reputation and credibility;
— taking into account expectations of interested parties;

— demonstrating an organization’s commitment to managing its compliance risks effectively and

efficiently;

— increasing the confidence of third parties in the organization’s capacity to achieve sustained success;

— minimizing the risk of a contravention occurring with the attendant costs and reputational damage.

This document specifies requirements as well as provides guidance on compliance management

systems and recommended practices. Both the requirements and the guidance in this document are

intended to be adaptable, and implementation can differ depending on the size and level of maturity

of an organization’s compliance management system and on the context, nature and complexity of the

organization’s activities and objectives.
vi © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 37301:2021(E)

This document is suitable to enhance the compliance-related requirements in other management

systems and to assist an organization in improving the overall management of all its compliance

obligations.

Figure 1 provides an overview on common elements of a compliance management system.

Figure 1 — Elements of a compliance management system
© ISO 2021 – All rights reserved vii
---------------------- Page: 7 ----------------------
ISO 37301:2021(E)
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates permission;
— “can” indicates a possibility or a capability.

Information marked as “NOTE” is for guidance in understanding or clarifying the associated

requirements.
Annex A provides guidance for the use of this document.
viii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
INTERNATIONAL STANDARD ISO 37301:2021(E)
Compliance management systems — Requirements with
guidance for use
1 Scope

This document specifies requirements and provides guidelines for establishing, developing,

implementing, evaluating, maintaining and improving an effective compliance management system

within an organization.

This document is applicable to all types of organizations regardless of the type, size and nature of the

activity, as well as whether the organization is from the public, private or non-profit sector.

All requirements specified in this document that refer to a governing body apply to top management in

cases where an organization does not have a governing body as a separate function.

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
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 compliance management system.
3.2
interested party (preferred term)
stakeholder (admitted term)

person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision

or activity
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.
© ISO 2021 – All rights reserved 1
---------------------- Page: 9 ----------------------
ISO 37301:2021(E)

Note 3 to entry: For the purposes of this document, the term “top management” refers to the highest level of

executive management.
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

Note 1 to entry: A management 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)

Note 1 to entry: A policy can also be formally expressed by an organization’s governing body (3.21).

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, service or process (3.8)).

Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended result, a purpose, an operational

criterion, as a compliance (3.26) 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 compliance management systems (3.4), compliance objectives are set by the

organization (3.1), consistent with the compliance policy (3.5), to achieve specific results.

3.7
risk
effect of uncertainty on objectives (3.6)

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.

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 output, product or service depends on the context of the

reference.
3.9
competence
ability to apply knowledge and skills to achieve intended results
2 © ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
ISO 37301:2021(E)
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:
— the management system (3.4), including related processes (3.8);
— information created in order for the organization to operate (documentation);
— 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
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

interested parties (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).

3.15
conformity
fulfilment of a requirement (3.14)
3.16
nonconformity
non-fulfilment of a requirement (3.14)
Note 1 to entry: A nonconformity is not necessarily a noncompliance (3.27).
3.17
corrective action

action to eliminate the cause(s) of a nonconformity (3.16) and to prevent recurrence

3.18
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

(3.30)), 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.

© ISO 2021 – All rights reserved 3
---------------------- Page: 11 ----------------------
ISO 37301:2021(E)
Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.

Note 4 to entry: Independence can be demonstrated by the freedom from responsibility for the activity being

audited or freedom from bias and conflict of interest.
3.19
measurement
process (3.8) to determine a value
3.20
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.

3.21
governing body

person or group of persons that has the ultimate responsibility and authority for an organization’s (3.1)

activities, governance and policies (3.5) and to which top management (3.3) reports and by which top

management is held accountable

Note 1 to entry: Not all organizations, particularly small organizations, will have a governing body separate from

top management.

Note 2 to entry: A governing body can include, but is not limited to, a board of directors, committees of the board,

a supervisory board or trustees.
3.22
personnel

individuals in a relationship recognized as a work relationship in national law or practice, or in any

contractual relationship that depends on its activity from the organization (3.1)

3.23
compliance function

person or group of persons with responsibility and authority for the operation of the compliance (3.26)

management system (3.4)

Note 1 to entry: Preferably one individual will be assigned to the oversight of the compliance management system.

3.24
compliance risk

likelihood of occurrence and the consequences of noncompliance (3.27) with the organization’s (3.1)

compliance obligations (3.25)
3.25
compliance obligations

requirements (3.14) that an organization (3.1) mandatorily has to comply with as well as those that an

organization voluntarily chooses to comply with
3.26
compliance
meeting all the organization’s (3.1) compliance obligations (3.25)
3.27
noncompliance
non-fulfilment of compliance obligations (3.25)
3.28
compliance culture

values, ethics, beliefs and conduct (3.29) that exist throughout an organization (3.1) and interact with

the organization’s structures and control systems to produce behavioural norms that are conducive to

compliance (3.26)
4 © ISO 2021 – All rights reserved
---------------------
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 37301
ISO/TC 309
Compliance management systems —
Secretariat: BSI
Requirements with guidance for use
Voting begins on:
2021­01­01
Systèmes de management de la conformité — Exigences et
recommandations pour la mise en oeuvre
Voting terminates on:
2021­02­26
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 37301:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 37301:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
CH­1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 37301:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

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

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

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

4 Context of the organization ....................................................................................................................................................................... 5

4.1 Understanding the organization and its context ....................................................................................................... 5

4.2 Understanding the needs and expectations of interested parties .............................................................. 5

4.3 Determining the scope of the compliance management system ................................................................. 5

4.4 Compliance management system ........................................................................................................................................... 6

4.5 Compliance obligations ................................................................................................................................................................... 6

4.6 Compliance risk assessment ....................................................................................................................................................... 6

5 Leadership .................................................................................................................................................................................................................. 6

5.1 Leadership and commitment ..................................................................................................................................................... 6

5.1.1 Governing body and top management .......................................................................................................... 6

5.1.2 Compliance culture ........................................................................................................................................................ 7

5.1.3 Compliance governance ............................................................................................................................................. 7

5.2 Compliance policy ................................................................................................................................................................................ 8

5.3 Roles, responsibilities and authorities ............................................................................................................................... 8

5.3.1 Governing body and top management .......................................................................................................... 8

5.3.2 Compliance function ..................................................................................................................................................... 9

5.3.3 Management .....................................................................................................................................................................10

5.3.4 Personnel .............................................................................................................................................................................10

6 Planning ......................................................................................................................................................................................................................10

6.1 Actions to address risks and opportunities ................................................................................................................10

6.2 Compliance objectives and planning to achieve them .......................................................................................11

6.3 Planning of changes .........................................................................................................................................................................11

7 Support ........................................................................................................................................................................................................................11

7.1 Resources ..................................................................................................................................................................................................11

7.2 Competence ............................................................................................................................................................................................12

7.2.1 General...................................................................................................................................................................................12

7.2.2 Employment process .................................................................................................................................................12

7.2.3 Training .................................................................................................................................................................................12

7.3 Awareness ................................................................................................................................................................................................13

7.4 Communication ...................................................................................................................................................................................13

7.5 Documented information ............................................................................................................................................................14

7.5.1 General...................................................................................................................................................................................14

7.5.2 Creating and updating documented information .............................................................................14

7.5.3 Control of documented information ............................................................................................................14

8 Operation ..................................................................................................................................................................................................................15

8.1 Operational planning and control .......................................................................................................................................15

8.2 Establishing controls and procedures .............................................................................................................................15

8.3 Raising concerns .................................................................................................................................................................................15

8.4 Investigation processes ................................................................................................................................................................15

9 Performance evaluation ............................................................................................................................................................................16

9.1 Monitoring, measurement, analysis and evaluation ............................................................................................16

9.1.1 General...................................................................................................................................................................................16

9.1.2 Sources of feedback on compliance performance ............................................................................16

9.1.3 Development of indicators ...................................................................................................................................16

9.1.4 Compliance reporting ...............................................................................................................................................16

9.1.5 Record­keeping ..............................................................................................................................................................17

© ISO 2021 – All rights reserved iii
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ISO/FDIS 37301:2021(E)

9.2 Internal audit .........................................................................................................................................................................................17

9.2.1 General...................................................................................................................................................................................17

9.2.2 Internal audit programme ....................................................................................................................................17

9.3 Management review ........................................................................................................................................................................17

9.3.1 General...................................................................................................................................................................................17

9.3.2 Management review inputs .................................................................................................................................18

9.3.3 Management review results ................................................................................................................................18

10 Improvement .........................................................................................................................................................................................................18

10.1 Continual improvement ...............................................................................................................................................................18

10.2 Nonconformity and corrective action ..............................................................................................................................19

Annex A (informative) Guidance for the use of this document ..............................................................................................20

Bibliography .............................................................................................................................................................................................................................40

iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 37301:2021(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 non­governmental, 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.

This document was prepared by Technical Committee ISO/TC 309, Governance of organizations.

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.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO/FDIS 37301:2021(E)
Introduction

Organizations that aim to be successful in the long term need to establish and maintain a culture of

compliance, considering the needs and expectations of interested parties. Compliance is therefore not

only the basis, but also an opportunity, for a successful and sustainable organization.

Compliance is an ongoing process and the outcome of an organization meeting its obligations.

Compliance is made sustainable by embedding it in the culture of the organization and in the behaviour

and attitude of people working for it. While maintaining its independence, it is preferable that

compliance management is integrated with the organization’s other management processes and its

operational requirements and procedures.

An effective, organization-wide compliance management system enables an organization to

demonstrate its commitment to comply with relevant laws, regulatory requirements, industry codes

and organizational standards, as well as standards of good governance, generally accepted best

practices, ethics and community expectations.

An organization’s approach to compliance is shaped by the leadership applying core values and

generally accepted good governance, ethical and community standards. Embedding compliance in the

behaviour of the people working for an organization depends above all on leadership at all levels and

clear values of an organization, as well as an acknowledgement and implementation of measures to

promote compliant behaviour. If this is not the case at all levels of an organization, there is a risk of

noncompliance.

In a number of jurisdictions, courts have considered an organization’s commitment to compliance

through its compliance management system when determining the appropriate penalty to be imposed

for contraventions of relevant laws. Therefore, regulatory and judicial bodies can also benefit from this

document as a benchmark.

Organizations are increasingly convinced that, by applying binding values and appropriate compliance

management, they can safeguard their integrity and avoid or minimize noncompliance with the

organization’s compliance obligations. Integrity and effective compliance are therefore key elements

of good and diligent management. Compliance also contributes to the socially responsible behaviour of

organizations.

One of the objectives of this document is to assist organizations to develop and spread a positive culture

of compliance, considering that an effective and sound management of compliance­related risks should

be regarded as an opportunity to pursue and take, due to the several benefits that it provides to the

organization such as:
— improving business opportunities and sustainability;
— protecting and enhancing an organization’s reputation and credibility;
— taking into account expectations of interested parties;

— demonstrating an organization’s commitment to managing its compliance risks effectively and

efficiently;

— increasing the confidence of third parties in the organization’s capacity to achieve sustained success;

— minimizing the risk of a contravention occurring with the attendant costs and reputational damage.

This document specifies requirements as well as provides guidance on compliance management

systems and recommended practices. Both the requirements and the guidance in this document are

intended to be adaptable, and implementation can differ depending on the size and level of maturity

of an organization’s compliance management system and on the context, nature and complexity of the

organization’s activities and objectives.
vi © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
ISO/FDIS 37301:2021(E)

This document is suitable to enhance the compliance-related requirements in other management

systems and to assist an organization in improving the overall management of all its compliance

obligations.

Figure 1 provides an overview on common elements of a compliance management system.

Figure 1 — Elements of a compliance management system
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
© ISO 2021 – All rights reserved vii
---------------------- Page: 7 ----------------------
ISO/FDIS 37301:2021(E)
— “should” indicates a recommendation;
— “may” indicates permission:
— “can” indicates a possibility or a capability.

Information marked as “NOTE” is for guidance in understanding or clarifying the associated

requirements.
Annex A provides guidance for the use of this document.
viii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 37301:2021(E)
Compliance management systems — Requirements with
guidance for use
1 Scope

This document specifies requirements and provides guidelines for establishing, developing,

implementing, evaluating, maintaining and improving an effective compliance management system

within an organization.

This document is applicable to all types of organizations regardless of the type, size and nature of the

activity, as well as whether the organization is from the public, private or non-profit sector.

All requirements specified in this document that refer to a governing body apply to top management in

cases where an organization does not have a governing body as a separate function.

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
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 compliance management system.
3.2
interested party (preferred term)
stakeholder (admitted term)

person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision

or activity
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.
© ISO 2021 – All rights reserved 1
---------------------- Page: 9 ----------------------
ISO/FDIS 37301:2021(E)

Note 3 to entry: For the purposes of this document, the term “top management” refers to the highest level of

executive management.
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

Note 1 to entry: A management 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)

Note 1 to entry: A policy can also be formally expressed by an organization’s governing body (3.2).

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, service or process (3.8)).

Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended result, a purpose, an operational

criterion, as a compliance (3.7) 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 compliance management systems (3.4), compliance objectives are set by the

organization (3.1), consistent with the compliance policy (3.5), to achieve specific results.

3.7
risk
effect of uncertainty on objectives

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.

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 output, product or service depends on the context of the

reference.
3.9
competence
ability to apply knowledge and skills to achieve intended results
2 © ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
ISO/FDIS 37301:2021(E)
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:
— the management system (3.4), including related processes (3.8);
— information created in order for the organization to operate (documentation);
— 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
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

interested parties (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).

3.15
conformity
fulfilment of a requirement (3.14)
3.16
nonconformity
non-fulfilment of a requirement (3.14)
Note 1 to entry: A nonconformity is not necessarily a noncompliance (3.27).
3.17
corrective action

action to eliminate the cause(s) of a nonconformity (3.16) and to prevent recurrence

3.18
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

(3.30)), 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.

© ISO 2021 – All rights reserved 3
---------------------- Page: 11 ----------------------
ISO/FDIS 37301:2021(E)
Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.

Note 4 to entry: Independence can be demonstrated by the freedom from responsibility for the activity being

audited or freedom from bias and conflict of interest.
3.19
measurement
process (3.8) to determine a value
3.20
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.

3.21
governing body

person or group of persons that has the ultimate responsibility and authority for an organization’s (3.1)

activities, governance and policies (3.5) and to which top management (3.3) reports and by which top

management is held accountable

Note 1 to entry: Not all organizations, particularly small organizations, will have a governing body separate from

top management.

Note 2 to entry: A governing body can include, but is not limited to, a board of directors, committees of the board,

a supervisory board or trustees.
3.22
personnel

individuals in a relationship recognized as a work relationship in national law or practice, or in any

contractual relationship that depends on its activity from the organization (3.1)

3.23
compliance function

person or group of persons with responsibility and authority for the operation of the compliance (3.26)

management system (3.4)

Note 1 to entry: Preferably one individual will be assigned to the oversight of compliance management system.

3.24
compliance risk

likelihood of occurrence and the consequences of noncompliance (3.27) with the organization’s (3.1)

compliance obligations (3.25)
3.25
compliance obligations

requirements (3.14) that an organization (3.1) mandatorily has to comply with as well as those that an

organization voluntarily chooses to comply with
3.26
compliance
meeting all the organization’s (3.1) compliance obligations (3.25)
3.27
noncompliance
non-fulfilment of compliance obligations (3.25)
3.28
compliance culture
values, ethics, beliefs and conduct
...

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