Introduction
In today’s complex regulatory environment, organisations are expected to operate with integrity, accountability, and transparency. ISO 37301:2021, the international standard for compliance management systems (CMS), helps organisations meet these expectations. One of the foundational requirements of ISO 37301 is understanding the ‘organisation and its context’ — a critical step in designing an effective and resilient compliance framework.
Why Context Matters in Compliance
Before implementing any system, it’s vital to understand the landscape in which the organisation operates. The compliance risks, opportunities, and obligations an organisation faces depend heavily on its internal and external context. ISO 37301 ensures organisations take a thoughtful and structured approach to evaluating their environment.
Clause 4.1 – Understanding the Organisation and its Context
Clause 4.1 requires organisations to determine external and internal issues relevant to their purpose and that affect their ability to achieve the intended outcomes of the compliance management system.
This includes:
External Issues such as:
– Legal and regulatory developments
– Political, economic, social, technological, environmental factors (PESTLE analysis)
– Industry trends and stakeholder expectations
– Third-party relationships and global supply chains
Internal Issues such as:
– Organisational structure and governance
– Mission, vision, and strategic objectives
– Culture, values, and ethics
– Internal policies, processes, and resource capabilities
Clause 4.2 – Understanding the Needs and Expectations of Stakeholders
This clause complements the previous one by ensuring that stakeholder requirements — including those of regulators, employees, shareholders, customers, and the broader community — are identified and considered. These needs often form the basis for compliance obligations that the organisation must fulfil.
Practical Application
A practical way to apply these clauses is to conduct a context and stakeholder analysis during the early stages of CMS design. Tools like SWOT analysis, stakeholder mapping, and risk assessments can be used to document these insights.
For example:
– A healthcare provider may identify strict data protection regulations and rising patient expectations for ethical conduct as key external issues.
– Internally, the company might face challenges related to staff awareness of compliance policies and limited digital infrastructure.
Conclusion
Understanding the organisation and its context is not a one-time task — it’s a continuous process that enables a proactive and dynamic approach to compliance. By embedding these principles from ISO 37301, organisations can better anticipate changes, manage risks, and foster a culture of integrity.
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.