ISO 37301:2021 is an international standard developed by the ISO Technical Committee ISO/TC 309, Governance of Organizations, to provide organizations with a robust framework for compliance management. Published in April 2021, the standard specifies requirements and offers guidance for establishing, implementing, evaluating, maintaining, and improving a Compliance Management System (CMS). It replaces ISO 19600:2014, transitioning from a guidance document to a certifiable standard, reflecting ISO’s harmonized structure for management system standards.

Purpose and Scope

ISO 37301 applies to organizations of all types, sizes, and sectors—public, private, or non-profit. It helps organizations ensure adherence to their compliance obligations, including legal, regulatory, and contractual requirements, as well as voluntary commitments and ethical standards. Compliance management, as outlined in the standard, is integral to organizational governance and sustainability, contributing to enhanced operational efficiency and a culture of integrity.

The standard emphasizes compliance as a continuous process that integrates with other management systems and organizational practices. It highlights the role of leadership in embedding compliance within organizational culture and aligning it with stakeholder expectations and broader governance practices.

Key Features of ISO 37301

ISO 37301 provides a systematic framework for managing compliance risks. It includes:

• Policy Development: Establishing a clear compliance policy aligned with organizational goals.

• Risk Assessment: Identifying, evaluating, and addressing compliance risks proactively.

• Controls and Monitoring: Implementing measures to prevent, detect, and respond to non-compliance.

• Continuous Improvement: Regularly updating the CMS to adapt to evolving regulatory landscapes and organizational needs.

Unlike ISO 19600, ISO 37301 includes specific "shall" requirements, making it suitable for external certification. This allows organizations to formally demonstrate their commitment to compliance to stakeholders, customers, and regulators.

The standard is designed to integrate with existing systems such as ISO 9001 (Quality Management), ISO 14001 (Environmental Management), and ISO 37001 (Anti-Bribery Management). It adapts to the size, nature, and complexity of the organization, ensuring its relevance across industries and organizational contexts.

Recent Amendment: Climate Action
In February 2024, ISO released Amendment 1:2024 to ISO 37301, introducing climate change considerations into compliance management. The amendment adds:

• A requirement for organizations to determine whether climate change is a relevant issue.

• A note highlighting that stakeholders may have compliance-related requirements concerning climate change.

Benefits of ISO 37301

By implementing ISO 37301, organizations can:

• Enhance governance and reduce compliance risks.

• Foster a culture of ethical behavior and integrity.

• Build trust with customers, regulators, and investors.

• Improve operational efficiency and stakeholder confidence.

• Support sustainable development by aligning with SDG 8 (Decent Work and Economic Growth), SDG 11 (Sustainable Cities and Communities), and SDG 16 (Peace, Justice, and Strong Institutions).

Background and Development

The development of ISO 37301 was overseen by ISO/TC 309, which focuses on governance of organizations. The committee ensures that the standard reflects global best practices in compliance management, drawing on contributions from experts across industries and countries.

The publication of ISO 37301 marked a significant advancement in compliance management, offering a universal framework applicable across diverse regulatory and cultural contexts. It reflects the growing importance of compliance as a strategic organizational function, influencing reputation, legal standing, and operational success.

Steps to Implement ISO 37301

To implement ISO 37301 effectively, organizations should:

• Define compliance obligations and establish a compliance policy.

• Conduct risk assessments to identify and prioritize compliance risks.

• Develop and implement controls, monitoring processes, and corrective actions.

• Provide regular training and clear communication to employees and stakeholders.

• Continuously monitor, evaluate, and improve the CMS to address new challenges and opportunities.

Comparison with Related Standards

ISO 37301 builds on the foundation of ISO 19600 and complements ISO 37001, which focuses specifically on anti-bribery management. While ISO 37001 addresses a narrow scope, ISO 37301 provides a comprehensive framework for managing a wide range of compliance obligations.

Why ISO 37301 Matters

Compliance is a cornerstone of good governance and sustainable business practices. An effective CMS enables organizations to navigate complex regulatory environments, avoid penalties, and maintain their reputation. ISO 37301 empowers organizations to manage compliance as a strategic asset, turning challenges into opportunities for growth and trust-building.

For more information, visit the official ISO 37301 page.