SIST ISO 37301:2021
(Main)Compliance management systems - Requirements with guidance for use
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
Le présent document spécifie des exigences et fournit des recommandations pour l’établissement, le développement, la mise en œuvre, l’évaluation, la tenue à jour et l’amélioration d’un système de management de conformité efficace au sein d’un organisme.
Le présent document s’applique à tous les types d’organismes, indépendamment du type, de la taille et de la nature de ses activités, qu’il appartienne au secteur public, privé ou à but non lucratif.
L’ensemble des exigences spécifiées dans le présent document qui font référence à un organe de gouvernance s’appliquent à la direction lorsque l’organe de gouvernance d’un organisme n’est pas distinct de la direction.
Sistemi za upravljanje skladnosti - Zahteve z napotki za uporabo
General Information
Relations
Buy Standard
Standards Content (Sample)
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.
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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
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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
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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
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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
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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
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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.
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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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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.
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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
---------------------
...
ISO/TC 309
Date : 2021-04
ISO 37301:2021(F)
ISO/TC 309
Secrétariat : BSI
Systèmes de management de la conformité — Exigences et recommandations
pour la mise en œuvre
Compliance management systems — Requirements with guidance for use
ICS : 03.100.01 ; 03.100.02 ; 03.100.70
Descripteurs :
Type du document : Norme internationale
Sous-type du document :
Stade du document : (60) Publication
Langue du document : F
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DOCUMENT PROTÉGÉ PAR COPYRIGHT
Type du document : Norme internationale
Sous-type du document :
Stade du document : (60) Publication
Langue du document : F
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ISO 37301:2021(F)
© ISO 2021, Publié en Suisse.
Droits de reproductionTous droits réservés. Sauf indication contraireprescription différente ou
nécessité dans le contexte de sa mise en œuvre, aucune partie de cette publication ne peut être
reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou
mécanique, y compris la photocopie, l’affichageou la diffusion sur l’internetl'internet ou sur un
Intranetintranet, sans autorisation écrite préalable. Les demandes d’autorisation peuventUne
autorisation peut être adresséesdemandée à l’ISOl'ISO à l’adressel'adresse ci-après ou au comité
membre de l’ISOl'ISO dans le pays du demandeur.
ISO copyright officeCopyright Office
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• CH-1214 Vernier, Geneva, SwitzerlandGenève
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E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse.
© ISO 2021 – Tous droits réservés
iii
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ISO 37301:2021(F)
Sommaire Page
Avant-propos . vii
Introduction . viii
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Contexte de l’organisme . 6
4.1 Connaissance de l’organisme et contexte . 6
4.2 Compréhension des besoins et des attentes des parties intéressées . 6
4.3 Détermination du périmètre d’application du système de management de conformité . 7
4.4 Système de management de conformité . 7
4.5 Obligations de conformité . 7
4.6 Appréciation du risque de conformité . 7
5 Leadership . 8
5.1 Leadership et engagement . 8
5.1.1 Organe de gouvernance et direction . 8
5.1.2 Culture de conformité. 9
5.1.3 Gouvernance de la fonction de conformité . 9
5.2 Politique de conformité . 9
5.3 Rôles, responsabilités et autorités . 10
5.3.1 Organe de gouvernance et direction . 10
5.3.2 Fonction de conformité . 11
5.3.3 Encadrement (Management) . 12
5.3.4 Personnel . 12
6 Planification . 12
6.1 Actions à mettre en œuvre face aux risques et opportunités. 12
6.2 Objectifs de conformité et planification des actions pour les atteindre . 13
6.3 Planification des changements . 14
7 Support . 14
7.1 Ressources . 14
7.2 Compétences . 14
7.2.1 Généralités . 14
7.2.2 Processus de recrutement . 14
7.2.3 Formation . 15
7.3 Sensibilisation . 15
7.4 Communication . 16
7.5 Informations documentées . 17
7.5.1 Généralités . 17
7.5.2 Création et mise à jour des informations documentées . 17
7.5.3 Maîtrise des informations documentées . 17
8 Réalisation des activités opérationnelles . 18
8.1 Planification et maîtrise opérationnelles . 18
8.2 Établissement des dispositifs de maîtrise . 18
8.3 Signalement des inquiétudes . 18
8.4 Processus d’enquête. 19
9 Évaluation des performances . 19
9.1 Surveillance, mesure, analyse et évaluation . 19
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ISO 37301:2021(F)
9.1.1 Généralités . 19
9.1.2 Sources de retour d’informations sur les performances de conformité . 20
9.1.3 Mise en place des indicateurs . 20
9.1.4 Mécanisme de rapports (reporting) de conformité . 20
9.1.5 Conservation d’éléments probants . 20
9.2 Audit interne . 20
9.2.1 Généralités . 20
9.2.2 Programme d’audit interne . 21
9.3 Revue de direction . 21
9.3.1 Généralités . 21
9.3.2 Données d’entrée de la revue de direction. 21
9.3.3 Résultats de la revue de direction . 22
10 Amélioration . 22
10.1 Amélioration continue . 22
10.2 Non-conformité et actions correctives . 22
Annexe A (informative) Recommandations relatives à l’utilisation du présent document . 24
Bibliographie . 49
Avant-propos . vii
Introduction . viii
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Contexte de l’organisme . 6
4.1 Connaissance de l’organisme et contexte . 6
4.2 Compréhension des besoins et des attentes des parties intéressées . 6
4.3 Détermination du périmètre d’application du système de management de conformité . 7
4.4 Système de management de conformité . 7
4.5 Obligations de conformité . 7
4.6 Appréciation du risque de conformité . 7
5 Leadership. 8
5.1 Leadership et engagement . 8
5.1.1 Organe de gouvernance et direction . 8
5.1.2 Culture de conformité . 9
5.1.3 Gouvernance de la fonction de conformité . 9
5.2 Politique de conformité . 9
5.3 Rôles, responsabilités et autorités . 10
5.3.1 Organe de gouvernance et direction . 10
5.3.2 Fonction de conformité . 11
5.3.3 Encadrement (Management) . 12
5.3.4 Personnel . 12
6 Planification . 12
6.1 Actions à mettre en œuvre face aux risques et opportunités . 12
6.2 Objectifs de conformité et planification des actions pour les atteindre . 13
6.3 Planification des changements . 14
7 Support . 14
7.1 Ressources . 14
7.2 Compétences . 14
7.2.1 Généralités . 14
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ISO 37301:2021(F)
7.2.2 Processus de recrutement . 14
7.2.3 Formation . 15
7.3 Sensibilisation . 15
7.4 Communication . 16
7.5 Informations documentées . 17
7.5.1 Généralités . 17
7.5.2 Création et mise à jour des informations documentées . 17
7.5.3 Maîtrise des informations documentées . 17
8 Réalisation des activités opérationnelles . 18
8.1 Planification et maîtrise opérationnelles . 18
8.2 Établissement des dispositifs de maîtrise . 18
8.3 Signalement des inquiétudes . 18
8.4 Processus d’enquête. 19
9 Évaluation des performances . 19
9.1 Surveillance, mesure, analyse et évaluation . 19
9.1.1 Généralités . 19
9.1.2 Sources de retour d’informations sur les performances de conformité . 20
9.1.3 Mise en place des indicateurs . 20
9.1.4 Mécanisme de rapports (reporting) de conformité . 20
9.1.5 Conservation d’éléments probants . 20
9.2 Audit interne . 20
9.2.1 Généralités . 20
9.2.2 Programme d’audit interne . 21
9.3 Revue de direction . 21
9.3.1 Généralités . 21
9.3.2 Données d’entrée de la revue de direction . 21
9.3.3 Résultats de la revue de direction . 22
10 Amélioration . 22
10.1 Amélioration continue . 22
10.2 Non-conformité et actions correctives . 22
Annexe A (informative) Recommandations relatives à l’utilisation du présent document . 24
Bibliographie . 49
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ISO 37301:2021(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en
général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit
de faire partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales
et non gouvernementales, en liaison avec l’ISO participent également aux travaux. L’ISO collabore
étroitement avec la Commission électrotechnique internationale (IEC) en ce qui concerne la
normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directiveswww.iso.org/directives).
L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable de
ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant les
références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de l’élaboration
du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de brevets reçues par
l’ISO (voir www.iso.org/brevetswww.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion
de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir le lien suivant : www.iso.org/iso/fr/avant-
proposwww.iso.org/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 309, Gouvernance des organisations.
Cette première édition de l’ISO 37301 annule et remplace l’ISO 19600:2014, qui a fait l’objet d’une
révision technique.
Les principales modifications par rapport à l’ISO 19600:2014 sont les suivantes :
— le présent document contient désormais des exigences et recommandations supplémentaires pour
la mise en œuvre basées sur ces exigences ;
— le présent document suit les exigences de l’ISO pour une structure harmonisée des normes de
systèmes de management.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www.iso.org/fr/members.htmlwww.iso.org/fr/members.html.
© ISO 2021 – Tous droits réservés
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ISO 37301:2021(F)
Introduction
Les organismes qui aspirent à garantir leur réussite sur le long terme doivent établir et entretenir une
culture de conformité, en prenant en compte les besoins et attentes des parties intéressées. Le dispositif
de conformité ne constitue donc pas seulement un prérequis, mais également une opportunité pour un
organisme qui souhaite se développer de façon durable.
La (mise/maintien en) conformité est un processus continu et le résultat d’un organisme qui exécute ses
obligations. Le meilleur moyen de permettre l’instauration durable d’un dispositif de conformité est de
l’intégrer à la culture de l’organisme ainsi que dans les attendus de l’organisme en matière de
comportement et conduite du personnel. Tout en gardant son indépendance, il est préférable que la
gestion du dispositif de conformité soit intégrée aux autres processus de l’organisme ainsi qu’à ses
exigences et procédures opérationnelles.
L’existence d’un système de management de conformité, à l’échelle d’un organisme dans son ensemble,
permet à ce dernier de démontrer son engagement vis-à-vis du respect de la législation en vigueur,
y compris les exigences réglementaires, les codes industriels et les normes organisationnelles, ainsi que
les normes de bonne gouvernance, les meilleures pratiques communément admises, l’éthique et les
attentes des parties intéressées.
La démarche de (mise/maintien en) conformité d’un organisme est orientée par un leadership qui
applique ses valeurs fondamentales et les principes communément admis de bonne gouvernance,
d’éthique et communautaires. Intégrer la (mise/maintien en) conformité dans le comportement des
personnes qui travaillent pour un organisme dépend avant tout d’une mission et d’une exemplarité à tous
les niveaux et de valeurs claires pour cet organisme, ainsi que de la reconnaissance et de la mise en œuvre
de mesures pour promouvoir une attitude de conformité. Si cela n’est pas le cas à tous les niveaux d’un
organisme, un risque de défaut de conformité existe.
Dans plusieurs juridictions, pour déterminer la sanction appropriée à prononcer en cas de violation des
lois en vigueur, les tribunaux ont tenu compte de l’engagement de l’organisme pour la (mise/maintien en)
conformité soutenu par son système de management de conformité. Par conséquent, les autorités
réglementaires/de régulation et les instances judiciaires peuvent également tirer parti du présent
document comme référence.
Les organismes sont de plus en plus convaincus du fait qu’en appliquant des valeurs engageantes et une
gestion appropriée de conformité, elles peuvent préserver leur intégrité et éviter ou de réduire le plus
possible les cas de manquement aux obligations de conformité de l’organisme. L’intégrité et l’effectivité
du dispositif de conformité sont donc des éléments clés pour une gestion saine et diligente de l’organisme.
La (mise/maintien en) conformité contribue également au comportement socialement responsable des
organismes.
L’un des objectifs du présent document est d’assister les organismes dans l’élaboration et la diffusion
d’une culture positive de conformité, en considérant qu’il convient qu’une gestion efficace et saine des
risques de conformité soit perçue comme étant une opportunité à saisir en raison des divers bénéfices
qu’il procure à l’organisme, comme :
— l’amélioration des opportunités commerciales et de la viabilité économique/sociale/
environnementale ;
— la protection et l’amélioration de la réputation et de la crédibilité d’un organisme ;
— la prise en compte des attentes des parties intéressées ;
viii © ISO 2021 – Tous droits réservés
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ISO 37301:2021(F)
— la démonstration de l’engagement d’un organisme vis-à-vis de la gestion effective de ses risques de
conformité de manière efficace ;
— l’accroissement de la confiance des tierces parties dans la capacité de l’organisme à atteindre des
objectifs sur le long terme ;
— la réduction au minimum de la violation ou de la menace de violation des lois, des coûts afférents
et de l’atteinte à la réputation qui en découlent.
Le présent document spécifie des exigences relatives aux systèmes de management de conformité et
fournit des recommandations et pratiques recommandées. Les exigences et les recommandations
fournies dans le présent document se veulent flexibles et leur mise en œuvre peut être différente selon
la taille et le niveau de maturité du système de management de conformité de l’organisme et selon le
contexte, la nature et la complexité des activités de l’organisme et de ses objectifs.
Le présent document est à même d’améliorer les exigences de conformité dans d’autres systèmes de
management et d’aider un organisme à améliorer la gestion dans son ensemble de toutes ses obligations
de conformité.
La Figure 1 donne une vue d’ensemble des éléments les plus courants d’un système de management de
conformité.
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ISO 37301:2021(F)
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ISO 37301:2021(F)
Figure 1 — Éléments d’un système de management de conformité
Dans le présent document, les fo
...
NORME ISO
INTERNATIONALE 37301
Première édition
2021-04
Systèmes de management de
la conformité — Exigences et
recommandations pour la mise en
oeuvre
Compliance management systems — Requirements with guidance for
use
Sistemas de gestión del compliance — Requisitos con orientación
para su uso
Numéro de référence
ISO 37301:2021(F)
©
ISO 2021
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ISO 37301:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2021 – Tous droits réservés
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ISO 37301:2021(F)
Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Contexte de l’organisme . 5
4.1 Connaissance de l’organisme et contexte . 5
4.2 Compréhension des besoins et des attentes des parties intéressées . 6
4.3 Détermination du périmètre d’application du système de management de conformité. 6
4.4 Système de management de conformité . 6
4.5 Obligations de conformité . 6
4.6 Appréciation du risque de conformité. 7
5 Leadership . 7
5.1 Leadership et engagement. 7
5.1.1 Organe de gouvernance et direction . 7
5.1.2 Culture de conformité . . 8
5.1.3 Gouvernance de la fonction de conformité . 8
5.2 Politique de conformité . 8
5.3 Rôles, responsabilités et autorités . 9
5.3.1 Organe de gouvernance et direction . 9
5.3.2 Fonction de conformité .10
5.3.3 Encadrement (Management) .11
5.3.4 Personnel .11
6 Planification .11
6.1 Actions à mettre en œuvre face aux risques et opportunités .11
6.2 Objectifs de conformité et planification des actions pour les atteindre .12
6.3 Planification des changements .12
7 Support .13
7.1 Ressources .13
7.2 Compétences .13
7.2.1 Généralités .13
7.2.2 Processus de recrutement .13
7.2.3 Formation . .13
7.3 Sensibilisation .14
7.4 Communication .14
7.5 Informations documentées .15
7.5.1 Généralités .15
7.5.2 Création et mise à jour des informations documentées .15
7.5.3 Maîtrise des informations documentées .16
8 Réalisation des activités opérationnelles .16
8.1 Planification et maîtrise opérationnelles .16
8.2 Établissement des dispositifs de maîtrise .17
8.3 Signalement des inquiétudes .17
8.4 Processus d’enquête .17
9 Évaluation des performances .17
9.1 Surveillance, mesure, analyse et évaluation .17
9.1.1 Généralités .17
9.1.2 Sources de retour d’informations sur les performances de conformité .18
9.1.3 Mise en place des indicateurs .18
9.1.4 Mécanisme de rapports (reporting) de conformité .18
9.1.5 Conservation d’éléments probants .18
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ISO 37301:2021(F)
9.2 Audit interne .19
9.2.1 Généralités .19
9.2.2 Programme d’audit interne .19
9.3 Revue de direction .19
9.3.1 Généralités .19
9.3.2 Données d’entrée de la revue de direction .19
9.3.3 Résultats de la revue de direction .20
10 Amélioration .20
10.1 Amélioration continue .20
10.2 Non-conformité et actions correctives .20
Annexe A (informative) Recommandations relatives à l’utilisation du présent document .22
Bibliographie .44
iv © ISO 2021 – Tous droits réservés
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ISO 37301:2021(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www
.iso .org/ directives).
L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www .iso .org/ brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion
de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir www .iso .org/ avant -propos.
Le présent document a été élaboré par le comité technique ISO/TC 309, Gouvernance des organisations.
Cette première édition de l’ISO 37301 annule et remplace l’ISO 19600:2014, qui a fait l’objet d’une
révision technique.
Les principales modifications par rapport à l’ISO 19600:2014 sont les suivantes:
— le présent document contient désormais des exigences et recommandations supplémentaires pour
la mise en œuvre basées sur ces exigences;
— le présent document suit les exigences de l’ISO pour une structure harmonisée des normes de
systèmes de management.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www .iso .org/ fr/ members .html.
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ISO 37301:2021(F)
Introduction
Les organismes qui aspirent à garantir leur réussite sur le long terme doivent établir et entretenir une
culture de conformité, en prenant en compte les besoins et attentes des parties intéressées. Le dispositif
de conformité ne constitue donc pas seulement un prérequis, mais également une opportunité pour un
organisme qui souhaite se développer de façon durable.
La (mise/maintien en) conformité est un processus continu et le résultat d’un organisme qui exécute
ses obligations. Le meilleur moyen de permettre l’instauration durable d’un dispositif de conformité
est de l’intégrer à la culture de l’organisme ainsi que dans les attendus de l’organisme en matière de
comportement et conduite du personnel. Tout en gardant son indépendance, il est préférable que la
gestion du dispositif de conformité soit intégrée aux autres processus de l’organisme ainsi qu’à ses
exigences et procédures opérationnelles.
L’existence d’un système de management de conformité, à l’échelle d’un organisme dans son ensemble,
permet à ce dernier de démontrer son engagement vis-à-vis du respect de la législation en vigueur,
y compris les exigences réglementaires, les codes industriels et les normes organisationnelles, ainsi
que les normes de bonne gouvernance, les meilleures pratiques communément admises, l’éthique et les
attentes des parties intéressées.
La démarche de (mise/maintien en) conformité d’un organisme est orientée par un leadership qui
applique ses valeurs fondamentales et les principes communément admis de bonne gouvernance,
d’éthique et communautaires. Intégrer la (mise/maintien en) conformité dans le comportement des
personnes qui travaillent pour un organisme dépend avant tout d’une mission et d’une exemplarité à
tous les niveaux et de valeurs claires pour cet organisme, ainsi que de la reconnaissance et de la mise
en œuvre de mesures pour promouvoir une attitude de conformité. Si cela n’est pas le cas à tous les
niveaux d’un organisme, un risque de défaut de conformité existe.
Dans plusieurs juridictions, pour déterminer la sanction appropriée à prononcer en cas de violation
des lois en vigueur, les tribunaux ont tenu compte de l’engagement de l’organisme pour la (mise/
maintien en) conformité soutenu par son système de management de conformité. Par conséquent, les
autorités réglementaires/de régulation et les instances judiciaires peuvent également tirer parti du
présent document comme référence.
Les organismes sont de plus en plus convaincus du fait qu’en appliquant des valeurs engageantes et
une gestion appropriée de conformité, elles peuvent préserver leur intégrité et éviter ou de réduire
le plus possible les cas de manquement aux obligations de conformité de l’organisme. L’intégrité et
l’effectivité du dispositif de conformité sont donc des éléments clés pour une gestion saine et diligente
de l’organisme. La (mise/maintien en) conformité contribue également au comportement socialement
responsable des organismes.
L’un des objectifs du présent document est d’assister les organismes dans l’élaboration et la diffusion
d’une culture positive de conformité, en considérant qu’il convient qu’une gestion efficace et saine des
risques de conformité soit perçue comme étant une opportunité à saisir en raison des divers bénéfices
qu’il procure à l’organisme, comme:
— l’amélioration des opportunités commerciales et de la viabilité économique/sociale/
environnementale;
— la protection et l’amélioration de la réputation et de la crédibilité d’un organisme;
— la prise en compte des attentes des parties intéressées;
— la démonstration de l’engagement d’un organisme vis-à-vis de la gestion effective de ses risques de
conformité de manière efficace;
— l’accroissement de la confiance des tierces parties dans la capacité de l’organisme à atteindre des
objectifs sur le long terme;
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ISO 37301:2021(F)
— la réduction au minimum de la violation ou de la menace de violation des lois, des coûts afférents
et de l’atteinte à la réputation qui en découlent.
Le présent document spécifie des exigences relatives aux systèmes de management de conformité
et fournit des recommandations et pratiques recommandées. Les exigences et les recommandations
fournies dans le présent document se veulent flexibles et leur mise en œuvre peut être différente selon
la taille et le niveau de maturité du système de management de conformité de l’organisme et selon le
contexte, la nature et la complexité des activités de l’organisme et de ses objectifs.
Le présent document est à même d’améliorer les exigences de conformité dans d’autres systèmes de
management et d’aider un organisme à améliorer la gestion dans son ensemble de toutes ses obligations
de conformité.
La Figure 1 donne une vue d’ensemble des éléments les plus courants d’un système de management de
conformité.
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ISO 37301:2021(F)
Figure 1 — Éléments d’un système de management de conformité
Dans le présent document, les formes verbales suivantes sont utilisées:
— «doit» indique une exigence;
— «il convient de/que» indique une recommandation;
— «peut/il est admis» («may» en anglais) indique une autorisation;
— «peut/il est possible» («can» en anglais) indique une possibilité ou une capacité.
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ISO 37301:2021(F)
Les informations sous forme de «NOTE» sont fournies pour clarifier l’exigence associée ou en faciliter la
compréhension.
L’Annexe A donne des recommandations relatives à l’utilisation du présent document.
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NORME INTERNATIONALE ISO 37301:2021(F)
Systèmes de management de la conformité — Exigences et
recommandations pour la mise en oeuvre
1 Domaine d’application
Le présent document spécifie des exigences et fournit des recommandations pour l’établissement,
le développement, la mise en œuvre, l’évaluation, la tenue à jour et l’amélioration d’un système de
management de conformité efficace au sein d’un organisme.
Le présent document s’applique à tous les types d’organismes, indépendamment du type, de la taille et
de la nature de ses activités, qu’il appartienne au secteur public, privé ou à but non lucratif.
L’ensemble des exigences spécifiées dans le présent document qui font référence à un organe de
gouvernance s’appliquent à la direction lorsque l’organe de gouvernance d’un organisme n’est pas
distinct de la direction.
2 Références normatives
Le présent document ne contient aucune référence normative.
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions suivants s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l’adresse https:// www .electropedia .org/
3.1
organisme
personne ou groupe de personnes ayant un rôle avec les responsabilités, l’autorité et les relations lui
permettant d’atteindre ses objectifs (3.6)
Note 1 à l'article: Le concept d’organisme englobe sans s’y limiter, les travailleurs indépendants, les compagnies,
les sociétés, les firmes, les entreprises, les administrations, les partenariats, les organisations caritatives ou les
institutions, ou bien une partie ou une combinaison des entités précédentes, à responsabilité limitée ou ayant un
autre statut, de droit public ou privé.
Note 2 à l'article: Si l’organisme fait partie d’une entité plus grande, le terme «organisme» se réfère uniquement
à la partie de l’entité plus grande qui est couverte par le périmètre du système de management de conformité.
3.2
partie intéressée (terme préféré)
partie prenante (terme admis)
personne ou organisme (3.1) qui peut soit influer sur une décision ou une activité, soit être influencé(e)
ou s’estimer influencé(e) par une décision ou une activité
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ISO 37301:2021(F)
3.3
direction
personne ou groupe de personnes qui oriente et dirige un organisme (3.1) au plus haut niveau
Note 1 à l'article: La direction a le pouvoir de déléguer son autorité et de fournir des ressources au sein de
l’organisme.
Note 2 à l'article: Si le périmètre du système de management (3.4) ne couvre qu’une partie de l’organisme, alors la
direction s’adresse à ceux qui gouvernent et contrôlent cette partie de l’organisme.
Note 3 à l'article: Pour les besoins du présent document, le terme «direction» fait référence au plus haut niveau de
direction exécutive.
3.4
système de management
ensemble d’éléments corrélés ou en interaction d’un organisme (3.1), utilisés pour établir des politiques
(3.5) et des objectifs (3.6), ainsi que des processus (3.8) de façon à atteindre lesdits objectifs
Note 1 à l'article: Un système de management peut traiter d’un seul ou de plusieurs domaines.
Note 2 à l'article: Les éléments du système de management comprennent la structure, les rôles et responsabilités,
la planification et le fonctionnement de l’organisme.
3.5
politique
intentions et orientations d’un organisme (3.1), telles qu’elles sont officiellement formulées par sa
direction (3.3)
Note 1 à l'article: Une politique peut également être officiellement formulée par l’organe de gouvernance (3.21)
d’un organisme.
3.6
objectif
résultat à atteindre
Note 1 à l'article: Un objectif peut être stratégique, tactique ou opérationnel.
Note 2 à l'article: Les objectifs peuvent se rapporter à différents domaines (tels que finance, ventes et marketing,
achats, santé, sécurité, et environnement). Ils peuvent s’appliquer, par exemple, à l’organisme dans son ensemble
ou à un projet, un produit, un service ou un processus (3.8).
Note 3 à l'article: Un objectif peut être exprimé de différentes manières, par exemple par un résultat escompté,
un besoin, un critère opérationnel, en tant qu’objectif de conformité (3.26) ou par l’utilisation d’autres termes
ayant la même signification (par exemple finalité, but ou cible).
Note 4 à l'article: Dans le contexte des systèmes de management (3.4) de conformité, les objectifs de conformité
sont fixés par l’organisme (3.1), en cohérence avec sa politique (3.5) de conformité, en vue d’obtenir des résultats
spécifiques.
3.7
risque
effet de l’incertitude sur l’atteinte des objectifs (3.6)
Note 1 à l'article: Un effet est un écart, positif ou négatif, par rapport à une attente.
Note 2 à l'article: L’incertitude est l’état, même partiel, de manque d’information qui entrave la compréhension ou
la connaissance d’un événement, de ses conséquences ou de sa vraisemblance.
Note 3 à l'article: Un risque est souvent caractérisé par référence à des événements potentiels (tels que définis
dans le Guide ISO 73) et à des conséquences également potentielles (telles que définies dans le Guide ISO 73), ou
par référence à une combinaison des deux.
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ISO 37301:2021(F)
Note 4 à l'article: Un risque est souvent exprimé en termes de combinaison des conséquences d’un événement
(y compris des changements de circonstances) et de la vraisemblance de son occurrence (telle que définie dans
le Guide ISO 73).
3.8
processus
ensemble d’activités corrélées ou en interaction qui transforme des éléments d’entrée en résultat
Note 1 à l'article: Le résultat d’un processus est appelé «résultat», «produit» ou «service» en fonction du contexte
de référence.
3.9
compétence
aptitude à mettre en pratique des connaissances et des savoir-faire pour obtenir les résultats escomptés
3.10
information documentée
information devant être maîtrisée et tenue à jour par un organisme (3.1) ainsi que le support sur lequel
elle figure
Note 1 à l'article: Les informations documentées peuvent se présenter sous n’importe quel format et sur tous
supports et peuvent provenir de toute source.
Note 2 à l'article: Les informations documentées peuvent se rapporter:
— au système de management (3.4), y compris les processus (3.8) connexes;
— aux informations créées en vue du fonctionnement de l’organisme (documentation);
— aux preuves des résultats obtenus (enregistrements).
3.11
performance
résultat mesurable
Note 1 à l'article: Les performances peuvent être liées à des résultats quantitatifs ou qualitatifs.
Note 2 à l'article: Les performances peuvent concerner le management d’activités, de processus (3.8), de produits,
de services, de systèmes ou d’organismes (3.1).
3.12
amélioration continue
activité récurrente menée pour améliorer les performances (3.11)
3.13
efficacité
niveau de réalisation des activités planifiées et d’obtention des résultats escomptés
3.14
exigence
besoin ou attente qui sont formulés, généralement implicites ou obligatoires
Note 1 à l'article: «Généralement implicite» signifie qu’il est habituel ou de pratique commune pour l’organisme
(3.1) et les parties intéressées (3.2) que le besoin ou l’attente à prendre en considération soit implicite.
Note 2 à l'article: Une exigence spécifiée est une exigence formulée, par exemple une information documentée
(3.10).
3.15
conformité
satisfaction d’une exigence (3.14)
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ISO 37301:2021(F)
3.16
non-conformité
non-satisfaction d’une exigence (3.14)
Note 1 à l'article: Une non-conformité n’est pas nécessairement un défaut de conformité (3.27).
3.17
action corrective
action visant à éliminer la ou les causes d’une non-conformité (3.16) et à éviter qu’elle ne réapparaisse
3.18
audit
processus (3.8) méthodique et indépendant permettant d’obtenir des preuves et de les évaluer de
manière objective pour déterminer dans quelle mesure les critères d’audit sont satisfaits
Note 1
...
NORMA ISO
INTERNACIONAL 37301
Primera edición
Traducción oficial
2021-04
Official translation
Traduction officielle
Sistemas de gestión del compliance —
Requisitos con orientación para su uso
Compliance management systems — Requirements with guidance for
use
Systèmes de management de la conformité — Exigences et
recommandations pour la mise en oeuvre
Publicado por la Secretaría Central de ISO en Ginebra, Suiza, como
traducción oficial en español avalada por el Grupo de Trabajo Spanish
Translation Task Force (STTF), que ha certificado la conformidad en
relación con las versiones inglesa y francesa.
Número de referencia
ISO 37301:2021 (traducción oficial)
© ISO 2021
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ISO 37301:2021 (traducción oficial)
DOCUMENTO PROTEGIDO POR COPYRIGHT
© ISO 2021
Reservados los derechos de reproducción. Salvo prescripción diferente, o requerido en el contexto de su implementación, no podrá
reproducirse ni utilizarse ninguna parte de esta publicación bajo ninguna forma y por ningún medio, electrónico o mecánico,
incluidos el fotocopiado, o la publicación en Internet o una Intranet, sin la autorización previa por escrito. La autorización puede
solicitarse a ISO en la siguiente dirección o al organismo miembro de ISO en el país solicitante.
ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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Publicada en Suiza
Versión española publicada en 2021
Traducción oficial/Official translation/Traduction officielle
ii © ISO 2021 – Todos los derechos reservados
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ISO 37301:2021 (traducción oficial)
Índice Página
Prólogo .v
Prólogo de la versión en español .vi
Introducción .vii
1 Objeto y campo de aplicación. 1
2 Referencias normativas . 1
3 Términos y definiciones . 1
4 Contexto de la organización . 5
4.1 Comprensión de la organización y de su contexto . 5
4.2 Comprensión de las necesidades y expectativas de las partes interesadas . 6
4.3 Determinación del alcance del sistema de gestión del compliance . 6
4.4 Sistema de gestión del compliance . 6
4.5 Obligaciones de compliance . 6
4.6 Evaluación de los riesgos de compliance . 6
5 Liderazgo . 7
5.1 Liderazgo y compromiso . 7
5.1.1 Órgano de gobierno y alta dirección . 7
5.1.2 Cultura de compliance . 8
5.1.3 Gobernanza del compliance . 8
5.2 Política de compliance . 8
5.3 Roles, responsabilidades y autoridades . 9
5.3.1 Órgano de gobierno y alta dirección . 9
5.3.2 Función de compliance . 9
5.3.3 Dirección .10
5.3.4 Personal .11
6 Planificación.11
6.1 Acciones para abordar los riesgos y oportunidades .11
6.2 Objetivos de compliance y planificación para lograrlos .11
6.3 Planificación de los cambios .12
7 Apoyo .12
7.1 Recursos.12
7.2 Competencia .12
7.2.1 Generalidades .12
7.2.2 Proceso de empleo .13
7.2.3 Formación .13
7.3 Toma de conciencia .13
7.4 Comunicación .14
7.5 Información documentada .14
7.5.1 Generalidades .14
7.5.2 Creación y actualización de la información documentada .15
7.5.3 Control de la información documentada .15
8
Operación .15
8.1 Planificación y control operacional .15
8.2 Establecimiento de controles y procedimientos .16
8.3 Planteamiento de inquietudes .16
8.4 Procesos de investigación .16
9 Evaluación del desempeño.17
9.1 Seguimiento, medición, análisis y evaluación .17
9.1.1 Generalidades .17
9.1.2 Fuentes de opinión sobre el desempeño del compliance .17
Traducción oficial/Official translation/Traduction officielle
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ISO 37301:2021 (traducción oficial)
9.1.3 Desarrollo de indicadores .17
9.1.4 Informes de compliance .17
9.1.5 Mantenimiento de registros .18
9.2 Auditoría interna .18
9.2.1 Generalidades .18
9.2.2 Programa de auditoría interna .18
9.3 Revisión por la dirección .18
9.3.1 Generalidades .18
9.3.2 Entradas para la revisión del sistema .18
9.3.3 Resultados de la revisión por la dirección .19
10 Mejora .19
10.1 Mejora continua .19
10.2 No conformidades y acciones correctivas .19
Anexo A (informativo) Guía para el uso de este documento .21
Bibliografía .43
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ISO 37301:2021 (traducción oficial)
Prólogo
ISO (Organización Internacional de Normalización) es una federación mundial de organismos
nacionales de normalización (organismos miembros de ISO). El trabajo de elaboración de las Normas
Internacionales se lleva a cabo normalmente a través de los comités técnicos de ISO. Cada organismo
miembro interesado en una materia para la cual se haya establecido un comité técnico, tiene el derecho
de estar representado en dicho comité. Las organizaciones internacionales, gubernamentales y no
gubernamentales, vinculadas con ISO, también participan en el trabajo. ISO colabora estrechamente
con la Comisión Electrotécnica Internacional (IEC) en todos los temas de normalización electrotécnica.
En la Parte 1 de las Directivas ISO/IEC se describen los procedimientos utilizados para desarrollar este
documento y aquellos previstos para su mantenimiento posterior. En particular debería tomarse nota
de los diferentes criterios de aprobación necesarios para los distintos tipos de documentos ISO. Este
documento ha sido redactado de acuerdo con las reglas editoriales de la Parte 2 de las Directivas ISO/
IEC (véase www .iso .org/ directives).
Se llama la atención sobre la posibilidad de que algunos de los elementos de este documento puedan
estar sujetos a derechos de patente. ISO no asume la responsabilidad por la identificación de alguno
o todos los derechos de patente. Los detalles sobre cualquier derecho de patente identificado durante
el desarrollo de este documento se indicarán en la Introducción y/o en la lista ISO de declaraciones de
patente recibidas (véase www .iso .org/ patents).
Cualquier nombre comercial utilizado en este documento es información que se proporciona para
comodidad del usuario y no constituye una recomendación.
Para una explicación de la naturaleza voluntaria de las normas, el significado de los términos específicos
de ISO y las expresiones relacionadas con la evaluación de la conformidad, así como la información
acerca de la adhesión de ISO a los principios de la Organización Mundial del Comercio (OMC) respecto a
los Obstáculos Técnicos al Comercio (OTC), véase www .iso .org/ iso/ foreword .html.
Este documento ha sido elaborado por el Comité Técnico ISO/TC 309, Gobernanza de las organizaciones.
Esta primera edición de la Norma ISO 37301 anula y sustituye a la Norma ISO 19600:2014, que ha sido
revisada técnicamente.
Los principales cambios respecto de la Norma ISO 19600:2014 son los siguientes:
— este documento contiene ahora requisitos y orientación adicional basada en los mismos;
— este documento sigue los requisitos de ISO para una estructura armonizada para las normas de
sistemas de gestión.
Cualquier comentario o pregunta sobre este documento deberían dirigirse al organismo nacional de
normalización del usuario. En www .iso .org/ members .html se puede encontrar un listado completo de
estos organismos.
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ISO 37301:2021 (traducción oficial)
Prólogo de la versión en español
Este documento ha sido traducido por el Grupo de Trabajo Spanish Translation Task Force (STTF) del
Comité Técnico ISO/TC 309, Gobernanza de las organizaciones, en el que participan representantes de
los organismos nacionales de normalización y representantes del sector empresarial de los siguientes
países:
Argentina, Bolivia, Chile, Colombia, Costa Rica, Ecuador, El Salvador, España, Guatemala, Panamá, Perú,
Uruguay.
Esta traducción es parte del resultado del trabajo que el Grupo ISO/TC 309/STTF, viene desarrollando
desde su creación en el año 2021 para lograr la unificación de la terminología en lengua española en el
ámbito del compliance.
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ISO 37301:2021 (traducción oficial)
Introducción
Las organizaciones que pretenden ser exitosas a largo plazo necesitan establecer y mantener una
cultura de cumplimiento, considerando las necesidades y expectativas de las partes interesadas. El
compliance, por tanto, no sólo es la base, sino también una oportunidad para una organización exitosa y
sostenible.
El compliance es un proceso continuo y el resultado de que una organización cumpla con sus obligaciones.
El compliance se hace sostenible a través de su integración en la cultura de una organización y
en el comportamiento y la actitud de las personas que trabajan para ella. Mientras mantenga su
independencia, es preferible que la gestión del compliance esté integrada con los demás procesos de
gestión de la organización y en sus requisitos y procedimientos operacionales.
Un sistema de gestión del compliance eficaz y que abarque a toda la organización permite que la
organización demuestre su compromiso de cumplir con las leyes, requisitos regulatorios, códigos de la
industria y las normas de la organización pertinentes, así como con las normas de buena gobernanza,
las mejores prácticas generalmente aceptadas, la ética y las expectativas de la comunidad.
El enfoque de una organización para el compliance consiste en que los líderes apliquen los valores
fundamentales y las normas generalmente aceptadas de buena gobernanza, de ética y de la comunidad.
Incorporar el compliance en el comportamiento de las personas que trabajan para una organización
depende, sobre todo, de sus líderes, en todos los niveles, y de que existan unos valores claros en la
organización, así como de la aceptación e implementación de medidas que promuevan una conducta
de cumplimiento. Si eso no sucede así en todos los niveles de la organización, existe riesgo de no
cumplimiento de compliance.
En varias jurisdicciones, a la hora de determinar la sanción a imponer por contravenir las leyes
pertinentes, los tribunales han tenido en cuenta el compromiso de cumplimiento de una organización a
través de su sistema de gestión del compliance. Por ello, los organismos regulatorios y judiciales también
se pueden beneficiar de tener este documento como punto de referencia.
Las organizaciones están cada vez más convencidas de que si aplican valores vinculantes y una gestión
adecuada del compliance, pueden salvaguardar su integridad y evitar o minimizar los no cumplimientos
de compliance con las obligaciones de compliance de la organización. Integridad y un compliance eficaz
son, por tanto, elementos clave para llevar una buena y diligente gestión. El compliance también
contribuye al comportamiento socialmente responsable de las organizaciones.
Uno de los objetivos de este documento es ayudar a las organizaciones a desarrollar y difundir una
cultura positiva de compliance, teniendo en cuenta que una gestión eficaz y sólida de los riesgos
relacionados con compliance debería considerarse como una oportunidad para perseguir y aprovechar,
debido a los diversos beneficios que proporciona a la organización, como, por ejemplo:
— mejorar las oportunidades de negocio y la sostenibilidad;
— proteger y mejorar la reputación y la credibilidad de una organización;
— tener en cuenta las expectativas de las partes interesadas;
— demostrar el compromiso de la organización en la gestión de sus riesgos de compliance de forma
eficaz y eficiente;
— aumentar la confianza de terceras partes en la capacidad de la organización para lograr un éxito
sostenido;
— minimizar el riesgo de que se produzca una infracción que conlleve costos y daños a la reputación.
Este documento especifica requisitos y, además, proporciona una guía de los sistemas de gestión del
compliance y prácticas recomendadas. Se pretende que tanto los requisitos como la guía que proporciona
este documento sean adaptables, y su aplicación puede diferir dependiendo del tamaño y el nivel de
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ISO 37301:2021 (traducción oficial)
madurez del sistema de gestión del compliance de una organización y del contexto, la naturaleza y la
complejidad de las actividades y los objetivos de la organización.
Este documento es adecuado para mejorar los requisitos relacionados con compliance en otros sistemas
de gestión y para ayudar a la organización a que mejore la gestión global de todas sus obligaciones de
compliance.
La Figura 1 proporciona una visión general de los elementos comunes de un sistema de gestión del
compliance.
Figura 1 — Elementos de un sistema de gestión del compliance
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ISO 37301:2021 (traducción oficial)
En este documento se utilizan las siguientes formas verbales:
— “debe” indica un requisito;
— “debería” indica una recomendación;
— “puede” indica un permiso, una posibilidad o una capacidad.
La información indicada como “NOTA” se presenta a modo de orientación para la comprensión o
clarificación del requisito correspondiente.
El Anexo A proporciona orientación para el uso de este documento.
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NORMA INTERNACIONAL ISO 37301:2021 (traducción oficial)
Sistemas de gestión del compliance — Requisitos con
orientación para su uso
1 Objeto y campo de aplicación
Este documento especifica los requisitos y proporciona directrices para establecer, desarrollar,
implementar, evaluar, mantener y mejorar un sistema de gestión del compliance eficaz dentro de una
organización.
Este documento es aplicable a toda clase de organizaciones independientemente del tipo, tamaño y
naturaleza de la actividad, así como a organizaciones del sector público, privado o sin fines de lucro.
Todos los requisitos especificados en este documento que hagan referencia a un órgano de gobierno se
aplican a la alta dirección en aquellos casos en los que una organización no tenga un órgano de gobierno
como función independiente.
2 Referencias normativas
No existen referencias normativas en este documento.
3 Términos y definiciones
Para los fines de este documento, se aplican los términos y definiciones siguientes.
ISO e IEC mantienen bases de datos terminológicas para su utilización en normalización en las siguientes
direcciones:
— Plataforma de búsqueda en línea de ISO: disponible en https:// www .iso .org/ obp
— Electropedia de IEC: disponible en https:// www .electropedia .org/
3.1
organización
persona o grupo de personas que tienen sus propias funciones con responsabilidades, autoridades y
relaciones para el logro de sus objetivos (3.6)
Nota 1 a la entrada: El concepto de organización incluye, entre otros, un trabajador independiente, compañía,
corporación, firma, empresa, autoridad, sociedad, organización benéfica o institución, o una parte o combinación
de estas, ya estén constituidas o no, públicas o privadas.
Nota 2 a la entrada: En el caso de que la organización forme parte de una entidad más grande, el término
“organización” se refiere solo a aquella parte de la organización que está dentro del alcance del sistema de gestión.
3.2
parte interesada
persona u organización (3.1) que puede afectar, verse afectada, o percibirse como afectada por una
decisión o actividad
3.3
alta dirección
persona o grupo de personas que dirigen y controlan una organización (3.1) al más alto nivel
Nota 1 a la entrada: La alta dirección tiene el poder de delegar autoridad y proporcionar recursos dentro de la
organización.
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ISO 37301:2021 (traducción oficial)
Nota 2 a la entrada: Si el alcance del sistema de gestión (3.4) comprende solo una parte de una organización,
entonces alta dirección se refiere a quienes dirigen y controlan esa parte de la organización.
Nota 3 a la entrada: Para los fines de este documento, el término “alta dirección” se refiere al más alto nivel de la
dirección ejecutiva.
3.4
sistema de gestión
conjunto de elementos de una organización (3.1) interrelacionados o que interactúan para establecer
políticas (3.5), objetivos (3.6) y procesos (3.8) para lograr esos objetivos
Nota 1 a la entrada: Un sistema de gestión puede tratar una sola disciplina o varias disciplinas.
Nota 2 a la entrada: Los elementos del sistema de gestión incluyen la estructura de la organización, los roles y las
responsabilidades, la planificación y la operación.
3.5
política
intenciones y dirección de una organización (3.1) como las expresa formalmente su alta dirección (3.3)
Nota 1 a la entrada: La política también puede ser expresada formalmente por el órgano de gobierno (3.21) de una
organización (3.1).
3.6
objetivo
resultado a lograr
Nota 1 a la entrada: Un objetivo puede ser estratégico, táctico u operativo.
Nota 2 a la entrada: Los objetivos pueden referirse a diferentes disciplinas (como las finanzas, la seguridad y
salud y el medio ambiente). Pueden ser, por ejemplo, objetivos que abarquen a toda la organización o específicos
para un proyecto, producto, servicio o proceso (3.8).
Nota 3 a la entrada: Un objetivo se puede expresar de otras maneras, por ejemplo, como un resultado previsto,
un propósito, un criterio operativo, un objetivo de compliance (3.26), o mediante el uso de términos con un
significado similar (por ejemplo, finalidad o meta).
Nota 4 a la entrada: En el contexto de sistemas de gestión (3.4) del compliance, la organización (3.1) establece los
objetivos de compliance, en concordancia con la política (3.5) de compliance, para lograr resultados específicos.
3.7
riesgo
efecto de la incertidumbre sobre los objetivos (3.6)
Nota 1 a la entrada: Un efecto es una desviación de lo esperado, ya sea positiva o negativa.
Nota 2 a la entrada: Incertidumbre es el estado, incluso parcial, de deficiencia de información relacionada con la
comprensión o conocimiento de un evento, su consecuencia o su probabilidad.
Nota 3 a la entrada: Con frecuencia el riesgo se caracteriza por referencia a “eventos” potenciales (como se define
en la Guía ISO 73) y “consecuencias” (como se define en la Guía ISO 73) , o a una combinación de estos.
Nota 4 a la entrada: Con frecuencia el riesgo se expresa en términos de una combinación de las consecuencias
de un evento (incluidos los cambios de las circunstancias) y la “probabilidad” (como se define en la Guía ISO 73)
asociada de que ocurra.
3.8
proceso
conjunto de actividades interrelacionadas o que interactúan, que emplean o transforman elementos de
entrada para obtener resultados
Nota 1 a la entrada: Que el resultado de un proceso se denomine salida, producto o servicio depende del contexto
de referencia.
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ISO 37301:2021 (traducción oficial)
3.9
competencia
capacidad para aplicar conocimientos y habilidades con el fin de lograr los resultados previstos
3.10
información documentada
información que una organización (3.1) tiene que controlar y mantener, y el medio en el que está
contenida
Nota 1 a la entrada: La información documentada puede estar en cualquier formato y medio, y puede provenir de
cualquier fuente.
Nota 2 a la entrada: La información documentada puede hacer referencia a:
— el sistema de gestión (3.4), incluidos los procesos (3.8) relacionados;
— la información creada para que la organización opere (documentación);
— la evidencia de los resultados alcanzados (registros).
3.11
desempeño
resultado medible
Nota 1 a la entrada: El desempeño se puede relacionar con hallazgos cuantitativos o cualitativos.
Nota 2 a la entrada: El desempeño se puede relacionar con actividades de gestión, procesos (3.8), productos,
servicios, sistemas u organizaciones (3.1).
3.12
mejora continua
actividad recurrente para mejorar el desempeño (3.11)
3.13
eficacia
grado en el que se re
...
SLOVENSKI STANDARD
oSIST ISO/DIS 37301:2021
01-januar-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/DIS 37301
ICS:
03.100.01 Organizacija in vodenje Company organization and
podjetja na splošno management in general
03.100.70 Sistemi vodenja Management systems
oSIST ISO/DIS 37301:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST ISO/DIS 37301:2021
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oSIST ISO/DIS 37301:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 37301
ISO/TC 309 Secretariat: BSI
Voting begins on: Voting terminates on:
2020-03-13 2020-06-05
Compliance management systems — Requirements with
guidance for use
ICS: 03.100.01; 03.100.02; 03.100.70
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 37301:2020(E)
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 SUPPORTING DOCUMENTATION. ISO 2020
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oSIST ISO/DIS 37301:2021
ISO/DIS 37301:2020(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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST ISO/DIS 37301:2021
ISO/DIS 37301:2020(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 . 6
4.4 Compliance management system . 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 Policy . 7
5.3 Roles, responsibilities and authorities . 8
5.3.1 Governing body and top management . 8
5.3.2 Compliance function . 8
5.3.3 Management . 9
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 .10
6.3 Compliance obligations .11
6.4 Compliance risk assessment .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 .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
9.2 Internal audit .17
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ISO/DIS 37301:2020(E)
9.3 Management review .17
10 Improvement .18
10.1 Nonconformity, noncompliance and corrective action .18
10.2 Continual improvement .19
Annex A (informative) Guidance for the use of this document .20
Bibliography .40
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oSIST ISO/DIS 37301:2021
ISO/DIS 37301:2020(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.
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.
This document cancels and replaces ISO 19600:2014-10.
In this International Standard, 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.
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oSIST ISO/DIS 37301:2021
ISO/DIS 37301:2020(E)
Introduction
Organizations that aim to be successful in the long term need to establish and maintain a culture of
integrity and compliance, considering the needs and expectations of interested parties. Integrity and
compliance are 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 if 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, including legislative requirements, industry
codes and organizational standards, as well as standards of good corporate governance, best practices,
ethics and community expectations.
An organization’s approach to compliance is shaped by the leadership applying core values and
generally accepted corporate 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.
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 the implementation of this 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.
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.
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ISO/DIS 37301:2020(E)
Figure 1 —
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oSIST ISO/DIS 37301:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 37301:2020(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 which 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 (3.8)
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.
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
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 and
interested parties 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.
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3.4
management system
set of interrelated or interacting elements of an organization (3.1) to establish policies (3.7) and
objectives (3.8) and processes (3.12) to achieve those objectives
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The system elements include the organization’s structure, roles and responsibilities, planning
and operation.
Note 3 to entry: The scope of a management system can include the whole of the organization, specific and
identified functions of the organization, specific and identified sections of the organization, or one or more
functions across a group of organizations.
3.5
top management
person or group of people who directs and controls an organization (3.1) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the
organization.
Note 2 to entry: If the scope of the management system (3.4) covers only part of an organization, then top
management refers to those who direct and control that part of the organization.
Note 3 to entry: For the purposes of this document, the term "top management" refers to the highest level of
executive management.
3.6
effectiveness
extent to which planned activities are realized and planned results achieved
3.7
policy
intentions and direction of an organization (3.1) as formally expressed by its top management (3.5)
and/or its governing body (3.22)
3.8
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 financial, health and safety, and
environmental goals) and can apply at different levels (such as strategic, organization-wide, project, product and
process (3.12).
Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an
operational criterion, as a compliance 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, compliance objectives are set by the
organization, consistent with the compliance policy, to achieve specific results.
3.9
risk
effect of uncertainty
Note 1 to entry: An effect is a deviation from the expected – positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or
knowledge of, an event, its consequence, or likelihood.
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.
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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.
3.10
competence
ability to apply knowledge and skills to achieve intended results
3.11
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 (3.12);
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records).
3.12
process
set of interrelated or interacting activities which transforms inputs into outputs
3.13
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 (3.12), products (including services),
systems or organizations (3.1)
3.14
outsource (verb)
make an arrangement where an external organization (3.1) performs part of an organization’s function
or process (3.11)
Note 1 to entry: An external organization is outside the scope of the management system (3.4), although the
outsourced function or process is within the scope.
3.15
monitoring
determining the status of a system, a process (3.12) or an activity
Note 1 to entry: To determine the status, there can be a need to check, supervise or critically observe.
3.16
measurement
process (3.12) to determine a value
3.17
audit
systematic, independent and documented process (3.12) for obtaining audit evidence and evaluating it
objectively to determine the extent to which the audit criteria are fulfilled
Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party),
and it can be a combined audit (combining two or more disciplines).
Note 2 to entry: An internal audit is conducted by the organization itself, or by an external party on its behalf.
Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.
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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.
3.18
conformity
fulfilment of a requirement (3.3)
3.19
nonconformity
non-fulfilment of a requirement (3.3)
Note 1 to entry: A nonconformity is not necessarily a noncompliance (3.28).
3.20
corrective action
action to eliminate the cause(s) of a nonconformity (3.19) or a noncompliance (3.28) and to prevent
recurrence
3.21
continual improvement
recurring activity to enhance performance (3.13)
3.22
governing body
person or group of persons that has the ultimate responsibility and authority for an organization's
(3.1) activities, governance and policies and to which top management (3.5) 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, board of directors, committees of the board,
supervisory board, or trustees.
3.23
personnel
individuals in a relationship recognized as work relationship in national law or practice, or in any
contractual relationship which depends on its activity from the organization (3.1)
3.24
compliance function
person or group of persons with responsibility and authority for the operation of the compliance (3.27)
management system (3.4)
Note 1 to entry: Preferably one individual will be assigned to the oversight of compliance management system.
3.25
compliance risk
likelihood of occurrence and the consequences of noncompliance (3.17) with the organization’s
compliance obligations (3.26)
3.26
compliance obligation
requirements (3.3) that an organization (3.1) mandatorily has to comply with as well as those that an
organization (3.1) voluntarily chooses to comply with
3.27
compliance
the outcome of meeting all the organization’s compliance obligations (3.26)
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3.28
noncompliance
non-fulfilment of a compliance obligation (3.26)
3.29
compliance culture
values, ethics and beliefs that exist throughout an organization (3.1) and interact with the organization’s
structures and control systems to produce behavioural norms that are c
...
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
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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.
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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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
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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
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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.
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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.
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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;
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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.
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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.
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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
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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.
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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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