ISO 45001:2018 Clause 4.1 Understanding the organization and its context

ISO 45001:2018 Requirement

The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s) of its OH&S management system.

As per Annex A (Guidance on the use of ISO 45001:2018 standard) of ISO 45001:2018 standard it further explains:

An understanding of the context of an organization is used to establish, implement, maintain and continually improve its OH&S management system. Internal and external issues can be positive or negative and include conditions, characteristics or changing circumstances that can affect the OH&S management system, for example:
a) external issues, such as:
1) the cultural, social, political, legal, financial, technological, economic and natural surroundings and market competition, whether international, national, regional or local;
2) introduction of new competitors, contractors, subcontractors, suppliers, partners and providers, new technologies, new laws and the emergence of new occupations;
3) new knowledge on products and their effect on health and safety;
4) key drivers and trends relevant to the industry or sector having impact on the organization;
5) relationships with, as well as perceptions and values of, its external interested parties;
6) changes in relation to any of the above;
b) internal issues, such as:
1) governance, organizational structure, roles and accountabilities;
2) policies, objectives and the strategies that are in place to achieve them;
3) the capabilities, understood in terms of resources, knowledge and competence (e.g. capital, time, human resources, processes, systems and technologies);
4) information systems, information flows and decision-making processes (both formal and informal);
5) introduction of new products, materials, services, tools, software, premises and equipment;
6) relationships with, as well as perceptions and values of, workers;
7) the culture in the organization;
8) standards, guidelines and models adopted by the organization;
9) the form and extent of contractual relationships, including, for example, outsourced activities;
10) working time arrangements;
11) working conditions;
12) changes in relation to any of the above

Determining external and internal issues relevant to an organization’s Occupational Health and Safety (OH&S) management system is a crucial step in complying with ISO 45001:2018. Here’s a step-by-step guide on how an organization can go about this process:

  1. Establish a Cross-Functional Team: Create a team comprising individuals from various departments and levels of the organization to ensure a comprehensive understanding of both internal and external issues. This team should include OH&S professionals, management representatives, and relevant stakeholders.
  2. Identify Internal Issues: Examine existing documentation, such as policies, procedures, and previous assessments, to identify internal issues that are relevant to OH&S management. This can include past incident reports, risk assessments, and performance data Perform internal audits or assessments to identify potential gaps or areas of improvement in your existing OH&S practices and procedures.Consult with employees and worker representatives to gather their insights and concerns regarding workplace safety and health. Employees often have valuable information about day-to-day safety issues.d. Evaluate the availability of resources, including personnel, equipment, and financial resources, that are allocated to OH&S activities.
  3. Identify External Issues: Identify and engage with external stakeholders who may have an interest in or impact on your organization’s OH&S performance. This can include regulatory agencies, customers, suppliers, and local communities. Stay informed about relevant OH&S laws, regulations, and standards applicable to your industry and location. Identify any upcoming changes or developments in the regulatory landscape. Monitor industry trends and best practices in occupational health and safety. This includes staying updated on emerging technologies, methodologies, and benchmarks.Consider economic, social, and environmental factors that may impact your organization’s OH&S performance. These could include economic conditions, societal expectations, and environmental factors like climate change.
  4. Analyze and Prioritize Issues: Once you’ve identified internal and external issues, analyze them to determine their significance and potential impact on your OH&S management system and performance. Prioritize these issues based on their importance and relevance to your organization’s goals and objectives.
  5. Document Findings: Document the results of your analysis in a systematic manner. Create a record of the identified issues, their potential impact, and how they relate to the purpose and intended outcomes of your OH&S management system.
  6. Integrate into OH&S Management System: Integrate the identified issues into your OH&S management system. This may involve updating your OH&S policy, objectives, and action plans to address the prioritized issues.
  7. Regular Review and Updates: Continually monitor and review these issues to ensure that your OH&S management system remains responsive to changes in the internal and external environment. Update your system as needed to address new challenges or opportunities.

Remember that this process should be iterative and ongoing. By regularly reviewing and addressing internal and external issues, organizations can adapt to changing circumstances and maintain a proactive approach to occupational health and safety management. Some examples of External and Internal issues are

External Issues:

  1. Regulatory Changes: New occupational health and safety laws or regulations introduced by government authorities that affect the organization’s compliance requirements.
  2. Market Trends: Shifting industry standards or trends in safety practices and technologies that impact how the organization manages safety.
  3. Competitive Landscape: Actions and safety initiatives taken by competitors that may require the organization to adapt its own OH&S strategies.
  4. Customer Requirements: Changes in customer expectations or contract requirements related to safety and health performance.
  5. Supply Chain Issues: Safety risks or vulnerabilities within the organization’s supply chain, such as suppliers not meeting safety standards or disruptions in the supply of safety-critical materials.
  6. Environmental Factors: Environmental changes, like extreme weather events, that could increase safety risks for employees or affect the organization’s ability to operate safely.
  7. Community Concerns: Concerns or expectations of the local community regarding the organization’s impact on their safety and well-being.
  8. Economic Conditions: Economic downturns that might affect the organization’s financial resources available for safety programs and initiatives.
  9. Technological Advancements: New technologies or processes that could enhance or change how safety is managed within the organization.

Internal Issues:

  1. Safety Culture: The organization’s internal safety culture, including the commitment of leadership and the behavior of employees regarding safety.
  2. Resource Allocation: The availability and allocation of resources, such as budget, personnel, and equipment, for managing safety effectively.
  3. Incident History: Past safety incidents, near misses, or accident trends within the organization that indicate areas needing improvement.
  4. Training and Competence: The level of training and competence of employees and management in terms of safety practices and procedures.
  5. Workflow and Processes: The efficiency and effectiveness of safety-related processes and workflows within the organization.
  6. Equipment Maintenance: The condition and reliability of safety-critical equipment and machinery.
  7. Communication: The effectiveness of internal communication regarding safety issues, including reporting mechanisms and feedback loops.
  8. Employee Engagement: The level of employee engagement and participation in safety programs and initiatives.
  9. OH&S Policy: The organization’s OH&S policy and objectives and how well they align with actual practices.
  10. Workplace Design: The layout and design of the workplace, including ergonomic considerations and safety features.
  11. Supply Chain Control: The organization’s control over its supply chain in terms of safety standards and practices.
  12. Emergency Response Preparedness: The organization’s readiness to respond to emergencies or crises, such as fire drills and evacuation plans.

H&S Conditions Affecting External Issues:

  1. Regulatory Compliance: The organization’s compliance with OH&S regulations and standards can be an external issue. Non-compliance can lead to legal penalties, damage to reputation, and loss of business opportunities.
  2. Incident Reporting and Transparency: How the organization handles and reports workplace incidents can affect its external image. Poor incident management can lead to negative publicity and damage to the organization’s reputation.
  3. Safety Performance: The organization’s safety performance, including accident rates and injury statistics, can impact its relationships with customers, suppliers, and stakeholders. A history of frequent accidents may deter business partners.
  4. Community Relations: The organization’s relationship with the local community can be affected by its OH&S practices. Incidents or perceived risks to the community can lead to public concern and pressure on the organization to improve safety.
  5. Supplier and Contractor Relations: If the organization relies on suppliers or contractors, their safety practices can become an external issue. Poor safety records among suppliers or contractors may lead to concerns from customers or regulatory authorities.
  6. Legal and Regulatory Environment: Changes in OH&S regulations and government policies can significantly impact the external issues facing an organization. Compliance with new requirements may require significant resources and changes to operations.

OH&S Conditions Affecting Internal Issues:

  1. Safety Culture: The internal safety culture within the organization, including attitudes, beliefs, and behaviors related to safety, can directly impact internal issues. A strong safety culture promotes proactive safety measures.
  2. Incident Management: How the organization responds to and manages workplace incidents internally can affect its internal issues, including the morale and confidence of employees.
  3. Employee Health and Well-being: The health and well-being of employees, including physical and mental health, can be internal issues. These conditions can impact productivity, absenteeism, and overall workplace morale.
  4. Training and Competence: The organization’s commitment to providing adequate training and ensuring employee competence in safety procedures can influence internal issues. Well-trained employees are more likely to follow safety protocols.
  5. Resource Allocation: The allocation of resources within the organization for OH&S initiatives is an internal issue. Sufficient budget, personnel, and equipment dedicated to safety can improve internal safety conditions.
  6. Safety Policies and Procedures: The effectiveness and enforcement of internal safety policies and procedures directly impact internal OH&S issues. Clear and well-communicated policies promote safer work environments.
  7. Continuous Improvement: The organization’s commitment to continuous improvement in OH&S practices can influence internal issues. A culture of continuous improvement encourages the identification and mitigation of safety risks.
  8. Emergency Preparedness: How well the organization is prepared to respond to emergencies internally, such as fires or chemical spills, is an internal issue. Proper planning and training are crucial.
  9. Risk Assessment: The organization’s ability to identify, assess, and control occupational health and safety risks is an internal issue. A proactive approach to risk management can prevent incidents.

Methodologies to determine external and internal issues

  1. SWOT Analysis (Strengths, Weaknesses, Opportunities, Threats):
    • Strengths: Identify internal factors that contribute positively to OH&S, such as a strong safety culture, well-trained staff, or effective safety procedures.
    • Weaknesses: Identify internal factors that hinder OH&S, like inadequate resources, insufficient training, or outdated procedures.
    • Opportunities: Identify external factors that could positively impact OH&S, such as new safety technologies, regulatory changes that favor safety, or emerging best practices.
    • Threats: Identify external factors that could negatively impact OH&S, such as changing regulations, natural disasters, supply chain disruptions, or increased competition.
  2. PESTLE Analysis (Political, Economic, Social, Technological, Legal, Environmental):
    • Political: Consider political factors, such as government regulations and policies related to OH&S, which can have a significant impact on the organization.
    • Economic: Analyze economic conditions, like economic downturns, budget constraints, or financial stability, which may affect resource allocation for safety.
    • Social: Examine societal factors, including employee attitudes toward safety, public perception, and community expectations regarding safety.
    • Technological: Assess technological factors that influence OH&S, like advancements in safety equipment or digital tools for safety management.
    • Legal: Review legal factors, including changes in OH&S regulations, compliance requirements, and potential legal risks.
    • Environmental: Consider environmental factors, such as climate-related risks or environmental hazards, which may affect safety conditions.
  3. Stakeholder Engagement: Engage with internal and external stakeholders, including employees, customers, suppliers, regulatory agencies, and local communities. Collect their input and feedback on OH&S issues that matter to them and affect the organization.
  4. Data Analysis:Analyze historical data related to OH&S incidents, near misses, safety audits, and compliance records to identify trends and patterns that may reveal internal issues.
  5. Benchmarking: Compare the organization’s OH&S performance against industry benchmarks and best practices to identify gaps and areas for improvement.
  6. Internal Audits and Assessments: Conduct internal audits and assessments specifically focused on OH&S management. These audits can uncover weaknesses and areas for improvement within the organization.
  7. Brainstorming and Workshops:Facilitate brainstorming sessions and workshops involving cross-functional teams to discuss and identify both internal and external issues that impact OH&S.
  8. Risk Assessment:Perform OH&S risk assessments to identify and evaluate potential hazards and risks within the organization. This can help pinpoint internal issues related to safety.
  9. Scenario Planning: Develop scenarios based on potential future changes in the internal and external environment. This can help identify how the organization would respond to various OH&S-related challenges or opportunities.
  10. Regular Review and Updates: Ensure that the process of identifying internal and external issues is ongoing and integrated into the organization’s OH&S management system. Regularly review and update the analysis to adapt to changing conditions.

Documented Information required:

  1. Legal and Regulatory Requirements: Document a list of applicable OH&S legal and regulatory requirements. This should include relevant laws, regulations, and standards that the organization must comply with.
  2. Identification of Internal Issues: Document the internal issues that are relevant to the organization’s OH&S management system. This may include factors such as organizational culture, resources, structure, and internal safety performance data.
  3. Identification of External Issues: Document the external issues that are relevant to the organization’s OH&S management system. This may include factors such as changes in OH&S regulations, market conditions, customer requirements, and emerging safety trends.
  4. Methods Used for Identification: Document the methods and processes used to identify and assess internal and external issues. This could include the results of SWOT analyses, PESTLE analyses, stakeholder consultations, and risk assessments.
  5. Periodic Review: Document the organization’s process for periodically reviewing and updating its understanding of internal and external issues to ensure its OH&S management system remains relevant and effective.
  6. Communication and Documentation of Information: Document how the organization communicates this understanding of its context to relevant parties, including employees, and how it ensures that this information is maintained and made available as necessary.
  7. Integration with Other Management Systems: If the organization has other management systems (e.g., quality or environmental management systems), document how the understanding of its context is integrated with those systems to ensure alignment and consistency.

Example of procedure of identifying internal and external issues in OH&S MS.

Objective: To establish a systematic process for identifying and assessing internal and external issues that are relevant to the organization’s OH&S management system.

Scope: This procedure applies to all personnel responsible for managing and maintaining the OH&S management system.


  • Top Management: Responsible for overseeing the identification and assessment of internal and external issues and ensuring that the OH&S management system is aligned with these issues.
  • OH&S Team: Responsible for conducting assessments and providing recommendations based on the identified issues.
  • Relevant Personnel: Responsible for providing input and feedback as needed during the identification process.

Procedure Steps:

  1. Context Establishment: Top management shall establish the context of the organization, including its internal and external environment. Define the scope of the OH&S management system, including boundaries, activities, and locations covered.
  2. Identification of Interested Parties: Compile a list of interested parties relevant to the OH&S management system. This may include employees, contractors, regulatory authorities, customers, and other stakeholders. Document the methods used to identify these interested parties, which may involve stakeholder analysis and consultations.
  3. Needs and Expectations Assessment: For each identified interested party, assess their needs and expectations related to OH&S. Document the results of this assessment, including the specific OH&S-related needs and expectations of each party.
  4. Legal and Regulatory Requirements: Maintain an up-to-date list of all applicable OH&S legal and regulatory requirements. Ensure that these requirements are regularly reviewed for changes and updates. Document the sources and references for these requirements.
  5. Identification of Internal Issues:
    • Conduct a review of internal factors that could affect the OH&S management system. This may include:
      • Organizational culture and values
      • Resources dedicated to OH&S
      • Previous safety incidents and trends
      • OH&S performance data .
    • Document the results of this review.
  6. Identification of External Issues:
    • Conduct a review of external factors that could affect the OH&S management system. This may include:
      • Changes in OH&S regulations
      • Market conditions
      • Customer expectations
      • Emerging safety technologies or trends
    • Document the results of this review.
  7. Assessment Methods: Document the methods and tools used to assess and prioritize the identified issues. This may include SWOT analysis, PESTLE analysis, and risk assessments.
  8. Periodic Review: Establish a schedule for periodic review and updating of the identification process to ensure ongoing relevance. Document the process for reviewing and updating the identification of issues.
  9. Communication and Integration: Ensure that the documented information regarding identified issues is communicated to relevant parties within the organization. Document how this understanding of context is integrated into the OH&S management system to inform objectives, policies, and procedures.
  10. Record Keeping: Maintain records of the identified issues, assessments, and any actions taken to address them.
  11. Continuous Improvement: Use the information about internal and external issues to drive continuous improvement in the OH&S management system.
  12. Training and Awareness: Ensure that personnel involved in the identification process are trained and aware of their roles and responsibilities.
  13. Documentation Control: Maintain and control the documentation related to this procedure in accordance with the organization’s document control procedures.
  14. Review and Approval: Periodically review and update this procedure to ensure its effectiveness. Obtain approval from top management or relevant authorities for any changes to this procedure.

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