How to Conduct Effective Risk Assessments Under ISO 45001: A Complete Guide

by | Dec 13, 2025 | ISO 13485

Workplace safety has become a critical priority for organizations worldwide, and ISO 45001 provides a comprehensive framework for managing occupational health and safety. At the heart of this international standard lies risk assessment, a systematic process that helps organizations identify, evaluate, and control workplace hazards before they result in injuries or illnesses.

Understanding how to conduct effective risk assessments under ISO 45001 is essential for any organization committed to creating a safer work environment. This guide walks you through the entire process, from initial planning to continuous improvement, ensuring your organization meets compliance requirements while genuinely protecting your workforce. You might also enjoy reading about Understanding ISO Standards: A Complete Guide to International Quality Management Systems.

Understanding ISO 45001 and Its Risk Assessment Requirements

ISO 45001 represents the first global standard for occupational health and safety management systems. Published in March 2018, it replaced the previous OHSAS 18001 standard and introduced a more proactive approach to preventing work-related injuries and illnesses. The standard emphasizes risk-based thinking, making risk assessment a fundamental requirement rather than an optional activity. You might also enjoy reading about Building a Safety Culture Through ISO 45001 Implementation: A Complete Guide.

The standard requires organizations to establish, implement, and maintain processes for hazard identification and risk assessment on an ongoing basis. This means risk assessment is not a one-time exercise but a continuous activity that evolves with your organization. The assessment must consider routine and non-routine activities, human factors, emerging hazards, and changes in the organization or its activities. You might also enjoy reading about ISO 45001 vs OHSAS 18001: Understanding the Critical Changes in Workplace Safety Standards.

The Core Elements of Risk Assessment Under ISO 45001

Before diving into the practical steps, it is important to understand the core elements that make up an effective risk assessment process under ISO 45001. These elements form the foundation of your occupational health and safety management system.

Hazard Identification

Hazard identification involves systematically recognizing sources of potential harm in the workplace. A hazard can be anything with the potential to cause injury or illness, including physical agents, chemical substances, work methods, equipment, or even organizational factors like work pressure or inadequate training.

Under ISO 45001, hazard identification must be proactive and ongoing. Organizations need to look beyond obvious hazards and consider less apparent risks, such as ergonomic issues, psychosocial factors, and potential emergency situations.

Risk Evaluation

Once hazards are identified, the next step involves evaluating the risks associated with each hazard. This means determining the likelihood of the hazard causing harm and the potential severity of that harm. Risk evaluation helps prioritize which risks need immediate attention and which can be managed through routine controls.

Risk Control

After evaluating risks, organizations must implement appropriate control measures following the hierarchy of controls. This hierarchy, which ISO 45001 explicitly requires, ensures that the most effective controls are considered first, moving from elimination of hazards to administrative controls and personal protective equipment as a last resort.

Step-by-Step Process for Conducting Risk Assessments

Conducting an effective risk assessment under ISO 45001 requires a structured approach. The following steps provide a practical roadmap for organizations at any stage of their occupational health and safety journey.

Step 1: Establish the Context and Scope

Begin by clearly defining what you intend to assess. This includes determining the boundaries of your risk assessment, which departments or processes will be included, and who needs to be involved. Consider the nature of your operations, the people who may be affected, and the legal and regulatory requirements that apply to your organization.

Establishing context also means understanding your organization’s internal and external factors that might influence occupational health and safety. External factors could include weather conditions, local emergency services, or nearby industrial activities. Internal factors might include your organizational culture, shift patterns, or contractor management practices.

Step 2: Assemble a Competent Risk Assessment Team

Effective risk assessments require input from people with appropriate knowledge and experience. Your team should include individuals who understand the work being assessed, have technical expertise in health and safety, and represent the workers who will be affected by the assessment.

ISO 45001 emphasizes worker participation and consultation throughout the risk assessment process. Workers often have the most detailed understanding of day-to-day operations and can identify hazards that may not be apparent to managers or safety professionals. Including workers also increases buy-in and compliance with subsequent control measures.

Step 3: Identify Hazards Systematically

Use multiple methods to ensure comprehensive hazard identification. Walk through the workplace observing activities, equipment, and environmental conditions. Review incident records, near-miss reports, and health surveillance data to identify patterns or recurring issues. Consult manufacturers’ safety data sheets for chemical hazards and equipment manuals for machinery risks.

Consider different categories of hazards to ensure nothing is overlooked. These include:

  • Physical hazards such as noise, vibration, temperature extremes, and radiation
  • Chemical hazards including toxic substances, irritants, and sensitizers
  • Biological hazards like bacteria, viruses, and fungi
  • Ergonomic hazards related to manual handling, repetitive movements, and awkward postures
  • Psychosocial hazards such as work-related stress, violence, and harassment
  • Safety hazards including slips, trips, falls, and contact with moving machinery

Do not limit your assessment to routine activities. Consider maintenance tasks, emergency procedures, changes in weather or season, and potential equipment failures. Think about who might be at risk, including employees, contractors, visitors, and even members of the public who might be affected by your operations.

Step 4: Assess and Evaluate Risks

For each identified hazard, evaluate the associated risk by considering both likelihood and severity. Likelihood refers to how probable it is that the hazard will cause harm, while severity relates to how serious the consequences would be if harm occurred.

Many organizations use risk matrices to support this evaluation, rating likelihood and severity on scales (such as 1 to 5) and calculating a risk score. However, ISO 45001 does not prescribe a specific method, so you can choose an approach that suits your organization’s size and complexity.

When evaluating risks, consider both the current situation and any existing control measures. This gives you a realistic picture of the residual risk that remains even with current controls in place. If existing controls are inadequate or poorly implemented, the actual risk may be higher than initially appears.

Step 5: Determine and Implement Control Measures

Based on your risk evaluation, determine what additional controls are needed to eliminate hazards or reduce risks to an acceptable level. ISO 45001 requires organizations to follow the hierarchy of controls when selecting measures:

  • Elimination: Remove the hazard entirely, which is the most effective control but not always feasible
  • Substitution: Replace the hazard with something less dangerous, such as using a less toxic chemical
  • Engineering controls: Isolate people from the hazard through physical means like machine guards or ventilation systems
  • Administrative controls: Change how people work through procedures, training, or reduced exposure times
  • Personal protective equipment: Provide equipment to protect workers when other controls cannot sufficiently reduce risk

Often, a combination of controls at different levels provides the most effective risk management. Document your chosen controls clearly, specifying who is responsible for implementation, what resources are needed, and the timeline for completion.

Step 6: Document the Assessment

ISO 45001 requires organizations to maintain documented information about their risk assessment processes and results. Your documentation should be sufficient to demonstrate that you have systematically identified hazards, evaluated risks, and determined appropriate controls.

Effective documentation includes details of the assessment methodology, who was involved, what hazards were identified, how risks were evaluated, what controls are in place or planned, and who is responsible for implementation. Keep records accessible to relevant workers and managers, ensuring that information flows to those who need it.

Step 7: Monitor, Review, and Update

Risk assessments are not static documents that sit on a shelf gathering dust. ISO 45001 requires regular review and updates to ensure assessments remain relevant and effective. Reviews should occur at planned intervals, after significant changes, following incidents, or when monitoring reveals that controls are inadequate.

Changes that trigger review include introduction of new equipment or substances, changes in work processes, organizational restructuring, new information about hazards, or changes in legal requirements. Even when no changes occur, periodic reviews help verify that controls remain effective and workers continue to follow established procedures.

Common Challenges and How to Overcome Them

Organizations frequently encounter obstacles when implementing risk assessment processes. Recognizing these challenges and knowing how to address them can significantly improve the effectiveness of your risk management efforts.

Challenge 1: Lack of Worker Engagement

Workers may be reluctant to participate in risk assessments due to fear of blame, skepticism about whether their input matters, or simply not understanding the purpose. Overcome this by clearly communicating that risk assessment aims to improve safety, not apportion blame. Demonstrate that you act on worker feedback by implementing suggested controls and reporting back on changes made.

Challenge 2: Focusing Only on Obvious Hazards

Organizations often identify physical safety hazards while overlooking ergonomic or psychosocial risks. Combat this tendency by using structured checklists covering all hazard categories, providing training on less visible risks, and including diverse perspectives in assessment teams.

Challenge 3: Inadequate Resources or Competence

Some organizations struggle with risk assessment because they lack people with appropriate knowledge and skills. Address this through targeted training for risk assessment team members, engaging external expertise where needed, and using industry-specific guidance to supplement internal knowledge.

Challenge 4: Treating Risk Assessment as a Paper Exercise

Perhaps the most significant challenge is when risk assessments become disconnected from reality, with documented controls that exist on paper but not in practice. Prevent this by involving frontline workers who know what actually happens, monitoring implementation of controls, and holding people accountable for risk management responsibilities.

Integrating Risk Assessment into Business Operations

For risk assessment to be truly effective, it must become part of how your organization operates rather than a separate compliance activity. This integration happens when risk assessment influences decision-making across the organization.

Include risk assessment in your change management processes so that health and safety implications are considered before changes are implemented. Incorporate risk information into work instructions and procedures so that workers understand the hazards they face and the controls they must follow. Link risk assessment results to your training programs, ensuring that training addresses the actual risks workers encounter.

Leadership plays a crucial role in integration. When senior managers actively participate in risk assessments, question risk management decisions, and allocate resources to control implementation, they send a powerful message about the importance of occupational health and safety.

Using Technology to Enhance Risk Assessment

Modern technology offers tools that can make risk assessment more efficient, consistent, and accessible. Digital platforms allow teams to conduct assessments on mobile devices in the workplace, automatically route assessments for approval, and link hazards to control measures across multiple assessments.

Risk assessment software can provide templates and prompts that improve consistency, generate reports for management review, and track implementation of controls. However, technology should support rather than replace the human judgment and worker consultation that are essential to effective risk assessment.

Data analytics can reveal patterns across multiple assessments, highlighting common hazards or areas where controls are frequently inadequate. This insight helps organizations target improvement efforts where they will have the greatest impact on worker safety.

Measuring the Effectiveness of Your Risk Assessment Process

ISO 45001 requires organizations to monitor and measure the performance of their occupational health and safety management system, including risk assessment processes. Effectiveness can be measured through both leading and lagging indicators.

Leading indicators might include the number of risk assessments completed, percentage of identified actions implemented on time, worker participation rates in risk assessments, or the proportion of changes subjected to risk assessment before implementation. These indicators help predict future performance and identify process improvements.

Lagging indicators such as incident rates, near-miss reports, and occupational illness statistics reveal the ultimate impact of your risk management efforts. While lagging indicators show what has already happened, they provide valuable feedback on whether your risk assessments are identifying the right hazards and implementing effective controls.

Regular management review of these indicators, as required by ISO 45001, ensures that risk assessment processes receive ongoing attention and continuous improvement.

Conclusion

Conducting effective risk assessments under ISO 45001 requires more than simply filling out forms or checking boxes. It demands a systematic, ongoing commitment to identifying hazards, evaluating risks, and implementing controls that genuinely protect workers from harm.

The most successful organizations treat risk assessment as a collaborative process that engages workers at all levels, integrates with business operations, and drives continuous improvement in occupational health and safety performance. By following the structured approach outlined in this guide and avoiding common pitfalls, your organization can develop a risk assessment process that meets ISO 45001 requirements while creating a genuinely safer workplace.

Remember that the ultimate goal is not compliance with a standard but prevention of work-related injuries and illnesses. When risk assessment becomes embedded in your organizational culture, it transforms from a compliance burden into a valuable tool that protects your most important asset: your people.

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