Introduction

In an increasingly complex regulatory landscape, organisations must proactively identify and manage risks that could impact their ability to comply with legal, regulatory, and ethical obligations. ISO 37301:2021, the international standard for compliance management systems (CMS), emphasises the importance of compliance risk assessments as a core component of effective compliance management.

Why Compliance Risk Assessment Matters

Compliance risk assessments help organisations understand where they are most vulnerable to breaches in laws, regulations, or internal policies. These assessments enable prioritisation of compliance efforts and resources, supporting a more focused and efficient CMS.

Compliance Risk Assessment in ISO 37301

ISO 37301 integrates risk-based thinking throughout the compliance management system. Clause 6.1.2 requires organisations to assess risks related to compliance obligations and other identified requirements. The outcomes of these assessments should guide the development of controls, procedures, and monitoring mechanisms.

Key Steps in Compliance Risk Assessment

An effective compliance risk assessment typically includes the following steps:

1. Identify compliance obligations and areas of exposure.

2. Determine the likelihood and impact of potential non-compliance events.

3. Evaluate existing controls and their effectiveness.

4. Prioritise risks based on severity and probability.

5. Develop or update mitigation strategies and control measures.

6. Document and communicate the results to relevant stakeholders.

Tools and Techniques

Organisations can use various tools to support compliance risk assessments, including:

– Risk matrices and heat maps

– Compliance risk registers

– Internal audits and gap analyses

– Interviews and surveys with process owners

Example: Retail Company

A retail organisation might conduct a compliance risk assessment focused on data privacy laws, consumer protection regulations, and anti-bribery policies. By assessing the risks of non-compliance, the company can implement targeted training programs, enhance internal controls, and allocate resources where the risk is highest.

Conclusion

Compliance risk assessments are not just a regulatory requirement—they are a proactive strategy to safeguard an organisation’s reputation, operations, and legal standing. By aligning with ISO 37301, organisations can build a risk-aware culture and continuously improve their compliance performance through structured, data-driven assessments.

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.