ISO 37301:2021
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the compliance management system
4.4 Compliance management system
4.5 Compliance obligations
4.6 Compliance risk assessment
5 Leadership
5.1 Leadership and commitment
5.1.1 Governing body and top management
5.1.2 Compliance culture
5.1.3 Compliance governance
5.2 Compliance policy
5.3 Roles, responsibilities and authorities
5.3.1 Governing body and top management
5.3.2 Compliance function
5.3.3 Management
5.3.4 Personnel
6 Planning
6.1 Actions to address risks and opportunities
6.2 Compliance objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.2 Competence
7.2.1 General
7.2.2 Employment process
7.2.3 Training
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating documented information
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control
8.2 Establishing controls and procedures
8.3 Raising concerns
8.4 Investigation processes
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Sources of feedback on compliance performance
9.1.3 Development of indicators
9.1.4 Compliance reporting
9.1.5 Record-keeping
9.2 Internal audit
9.2.1 General
9.2.2 Internal audit programme
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review results
10 Improvement
10.1 Continual improvement
10.2 Nonconformity and corrective action
Annex A (informative) Guidance for the use of this document
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the compliance management system
4.4 Compliance management system
4.5 Compliance obligations
4.6 Compliance risk assessment
5 Leadership
5.1 Leadership and commitment
5.1.1 Governing body and top management
5.1.2 Compliance culture
5.1.3 Compliance governance
5.2 Compliance policy
5.3 Roles, responsibilities and authorities
5.3.1 Governing body and top management
5.3.2 Compliance function
5.3.3 Management
5.3.4 Personnel
6 Planning
6.1 Actions to address risks and opportunities
6.2 Compliance objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.2 Competence
7.2.1 General
7.2.2 Employment process
7.2.3 Training
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating documented information
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control
8.2 Establishing controls and procedures
8.3 Raising concerns
8.4 Investigation processes
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Sources of feedback on compliance performance
9.1.3 Development of indicators
9.1.4 Compliance reporting
9.1.5 Record-keeping
9.2 Internal audit
9.2.1 General
9.2.2 Internal audit programme
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review results
10 Improvement
10.1 Continual improvement
10.2 Nonconformity and corrective action
Annex A (informative) Guidance for the use of this document
Bibliography