Management system guidance
4.0 Context of the Organization
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4.1 Understanding the organization and its context
Clause 4.1 of ISO 45001:2018 requires your organization to determine the external and internal issues that are relevant to its purpose and that can affect its ability to achieve the intended outcomes of its OH&S management system. Amendment 1:2024 added one further requirement: your organization must also determine whether climate change is a relevant issue.
An OH&S management system exists to stop workers being harmed by their work and to give them safe and healthy places to work. Its intended outcomes also include continual improvement of OH&S performance, fulfilment of legal requirements and other requirements, and achievement of OH&S objectives. An issue is relevant if it can help or hinder any of these.
What are internal and external issues?
Internal and external issues are conditions, characteristics or changing circumstances that can influence the OH&S management system, either positively or negatively. Annex A.4.1 of ISO 45001 gives examples, which can be summarized as follows:
- External issues – the legal, political, economic, financial, social, cultural, technological and natural setting in which you operate, from local to international level; market competition; new contractors, suppliers, partners or technologies; new laws and emerging occupations; new knowledge about products and their health effects; trends in your sector; and your relationships with external interested parties;
- Internal issues – governance, structure, roles and accountabilities; policies, objectives and strategies; resources, knowledge and competence; information systems and how decisions are made; new products, materials, tools, software, premises and equipment; relationships with workers; the culture of the organization; standards and guidelines you have adopted; contractual and outsourcing arrangements; working time arrangements; and working conditions.
A change in any of these is also an issue. Typical OH&S examples include an ageing workforce, high staff turnover, reliance on agency labor, lone or remote working, shift and overtime patterns, new legislation, a move to new premises, a strong or weak incident-reporting culture, and the introduction of new machinery or chemicals.
Climate change (Amendment 1:2024)
Since February 2024 your organization must decide whether climate change is relevant to its OH&S management system. This is a determination, not an automatic obligation to act. If you conclude it is relevant, the issue is carried into your planning for risks and opportunities (6.1.1) like any other issue; if you conclude it is not, you should be able to explain why.
For OH&S, climate change is most often relevant through its effects on workers and workplaces, for example:
- Heat stress and UV exposure for outdoor workers, drivers and people working in poorly ventilated buildings;
- Storms, flooding and other extreme weather affecting site access, travel, structures and emergency arrangements (8.2);
- Poor air quality from wildfire smoke, or changes in the spread of vector-borne diseases;
- New hazards introduced by low-carbon technologies, such as battery storage, electric vehicles, heat pumps or hydrogen;
- Supply chain disruption affecting the availability of PPE, spare parts or specialist contractors.
The relevance of climate change will vary greatly with the size and sector of your organization, its activities, its geography and the scope of its OH&S management system. Record your conclusion, for example in your context analysis or management review minutes, and revisit it when circumstances change.
How to determine your issues
ISO 45001 does not prescribe a method. A workshop approach often allows ideas to be shared and provides an effective and efficient way of reaching a valuable outcome. Cross-functional input is essential: operations, maintenance, HR, procurement, finance and engineering will each see different issues. Workers and their representatives often know about issues that managers do not, so use your consultation and participation arrangements (5.4) to gather their views.
Use the Context & Interested Parties Matrix to document the external and internal issues relevant to your organization’s purpose that may affect its ability to achieve the intended outcomes of the OH&S management system. A SWOT analysis works well for internal issues and a PESTLE analysis for external issues.
Internal issues – SWOT analysis
Use a SWOT analysis template to identify your organization’s strengths, weaknesses, opportunities and threats in relation to health and safety. The prompts below are typical; each organization’s issues will be different.
Strengths are characteristics that help you manage health and safety well. We consider:
- What does our organization do well in health and safety?
- Do we have an open reporting culture, competent supervisors and an active safety committee?
- Are our facilities, equipment and safe systems of work in good condition?
Weaknesses are areas that need improvement. We consider:
- Where do incidents, near misses or audit findings keep recurring?
- What does root cause analysis of incidents tell us?
- Where are there gaps in competence, supervision or communication?
Opportunities are circumstances we could use to improve OH&S performance. We consider:
- Could new equipment or automation remove hazardous tasks?
- Are there wellbeing, ergonomic or health surveillance initiatives we could introduce?
- Could better data on incidents and exposures help us target resources?
Threats are anything internal that could undermine health and safety. We consider:
- Are there skill shortages, high turnover or increasing workloads?
- Is plant or equipment ageing, or is maintenance being deferred?
- Are budget pressures, restructuring or changes in working hours likely to affect safe working?
External issues – PESTLE analysis
A PESTLE (Political, Economic, Social, Technological, Legal and Environmental) analysis helps to structure the conversation about external issues. Typical OH&S prompts include:
- Political – government policy on health and safety enforcement, regulator priorities and campaigns, funding or grants for safety improvements;
- Economic – labor market conditions, the cost and availability of contractors and PPE, insurance premiums, and pressure on budgets or delivery times;
- Social – workforce demographics, attitudes to mental health and wellbeing, language and literacy differences, and public expectations of safe operations;
- Technological – new equipment, automation, remote monitoring and digital tools that can remove or introduce hazards;
- Legal – new or changing health and safety legislation, approved codes of practice, regulator guidance, and client or contract requirements;
- Environmental – local conditions such as heat, flooding or air quality, and whether climate change is a relevant issue (state your conclusion on its relevance here).
Recording and reviewing your issues
ISO 45001:2018 does not require documented information on context, so there may not be lists of issues or records of reviews. Information can also be obtained by interviewing top management about the organization’s context, strategic direction and the issues identified. However, most organizations find it helpful to keep some of the following to demonstrate conformity:
- SWOT and PESTLE analyses, or a context and interested parties matrix;
- A statement on the relevance of climate change;
- Business plans and strategy reviews;
- Management review and safety committee minutes;
- Risk and opportunity registers that reference the issues identified;
- Process maps, tables, spreadsheets or mind maps.
Issues change, so review them at planned intervals and when significant changes occur. Changes in internal and external issues are a required input to management review (9.3), and the issues you identify feed directly into the scope of the OH&S management system (4.3) and into planning for risks and opportunities (6.1.1). The needs and expectations of workers and other interested parties are covered next, in 4.2.
You should seek and record evidence that your organization has a process for identifying the internal and external issues relevant to its OH&S management system, that the issues identified are specific to its activities and workforce, that it has decided whether climate change is a relevant issue, and that issues are reviewed regularly and used as an input to scope, planning and management review.
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