Clause 4 of ISO 45001:2018 establishes the foundation for the entire OH&S management system. Before designing the system, organizations must understand their context — internal and external issues, interested parties, and the boundaries of their OHSMS. This ensures the system is tailored to your specific circumstances rather than being a generic template.
Clause 4.1: Understanding Internal and External Issues
Organizations must determine the external and internal issues relevant to their purpose that affect their ability to achieve the intended outcomes of the OH&S management system. External issues include regulatory environment (OSHA, state safety codes), economic conditions, technology changes, labor market conditions, and community expectations. Internal issues include organizational culture, governance structure, workforce demographics, competence levels, existing safety practices, and shift patterns.
Clause 4.2: Understanding Needs and Expectations of Workers and Other Interested Parties
Identify the interested parties relevant to the OH&S management system and determine their needs and expectations. ISO 45001 specifically names workers as the primary interested party, but others include contractors, temporary workers, visitors, regulators, trade unions, suppliers, neighboring communities, insurance providers, and shareholders. Determine which needs and expectations become legal or other requirements.
Best Practices for Clause 4.2
- Create a stakeholder register listing each interested party and their OH&S-related needs
- Engage workers directly through surveys, safety committees, and toolbox talks
- Include contractor and temporary worker perspectives
- Determine which needs become compliance obligations per Clause 6.1.3
- Review and update the register at least annually or when circumstances change
Clause 4.3: Determining the Scope of the OH&S Management System
Define the boundaries and applicability of your OHSMS. The scope must consider the issues from 4.1, the requirements from 4.2, and planned or performed work-related activities. It should cover all activities, products, and services within the organization’s control or influence that can affect OH&S performance.
Best Practices for Clause 4.3
- Be specific about physical locations, activities, and processes included
- Include all workers under your control (employees, contractors, temporary workers)
- Avoid excluding high-risk activities; auditors will challenge unjustified exclusions
- Make the scope available as documented information to all interested parties
Clause 4.4: OH&S Management System
Establish, implement, maintain, and continually improve the OHSMS, including the processes needed and their interactions, in accordance with ISO 45001 requirements. This clause is the commitment to build and sustain the system as a whole.
Common Pitfalls
- Treating context analysis as a one-time exercise rather than ongoing awareness
- Excluding significant activities or locations from the OHSMS scope without justification
- Not connecting identified issues to actual planning and risk assessment
- Failing to consider worker perspectives when determining context
- Overlooking contractor and temporary worker needs in interested party analysis
