Introduction

For a compliance management system (CMS) to be effective, everyone in the organisation must understand their role in ensuring compliance. ISO 37301:2021, the international standard for compliance management systems, places strong emphasis on clearly defined roles, responsibilities, and authorities to support ethical conduct and regulatory adherence. This blog explores how ISO 37301 helps organisations assign and manage compliance responsibilities across all levels.

The Importance of Defined Roles

Unclear or overlapping responsibilities can lead to gaps in compliance, increased risk, and a breakdown in accountability. By clearly outlining who is responsible for what, organisations can ensure that compliance obligations are met efficiently, and that ownership is embedded into everyday operations.

Clause 5.3 – Organisational Roles, Responsibilities and Authorities

According to Clause 5.3 of ISO 37301, top management must ensure that responsibilities and authorities for relevant roles are assigned, communicated, and understood. This includes:

– Assigning overall accountability for the compliance management system

– Designating a person or team with operational responsibility for compliance

– Ensuring all personnel are aware of their individual compliance responsibilities

– Empowering responsible persons with the authority to carry out their duties

Key Compliance Roles in an Organisation

Depending on the size and complexity of the organisation, typical compliance roles may include:

– **Board of Directors**: Provides oversight and ensures a culture of compliance at the highest level.

– **Top Management**: Demonstrates leadership and allocates resources for compliance efforts.

– **Compliance Officer/Function**: Develops, implements, and monitors the CMS; reports to senior management.

– **Department Managers**: Integrate compliance requirements into business processes.

– **Employees**: Understand and comply with applicable laws, policies, and procedures.

Building an Accountability Framework

To support strong compliance governance, organisations should:

1. Define and document compliance responsibilities for each role.

2. Communicate responsibilities through training, job descriptions, and internal policies.

3. Monitor performance and follow up on non-compliance.

4. Foster collaboration between compliance and other business functions.

Example: Healthcare Provider

A healthcare provider assigns a Chief Compliance Officer to oversee regulatory and ethical compliance. Department heads are responsible for implementing relevant policies in their areas, such as patient privacy and clinical standards. Staff receive regular training and are encouraged to report issues through a confidential whistleblower channel.

Conclusion

Clearly defined compliance roles and responsibilities are fundamental to an effective compliance management system. ISO 37301 helps organisations create a culture of accountability, ensuring that everyone—from senior leadership to front-line employees—understands their role in promoting ethical conduct and legal compliance.

For further information and to book your ISO37301compliance management systems survey please contact: Marcus J Allen at Thamer James Ltd. Email: [email protected]

Marcus has twenty years’ experience in delivering Governance, Risk and Compliance solutions to over two hundred organisations within the UK. Marcus holds the respected Diploma in Governance, Risk and Compliance from the International Compliance Association and holds a master’s degree in Management Learning & Change from the University of Bristol.

Marcus is a member of BSI G01 Governance Committee, this committee contributed to the formulation of the above Standard, in the UK.