Risk-Based vs Clause-Based Audits: What You Need to Know
Audits are structured assessments that compare an organisation’s processes against established criteria. In the ISO framework, audits evaluate how well a business complies with its own procedures and the requirements of ISO Management System Standards, such as ISO 9001:2015 or ISO 45001:2018.
For many years, audits followed a clause-based approach, concentrating on compliance with specific clauses outlined in ISO Standards. However, since the introduction of ISO 19011:2018 (Guidelines for auditing management systems), there has been a shift towards risk-based auditing — a more strategic and flexible method that prioritises evaluating potential risks that could impact system performance and organisational goals.
Despite this evolution, clause-based audits are still widely used. In this article, we’ll explore the differences between these two approaches and highlight which might be best suited for your business.
What is Risk-Based Auditing?
Risk-based auditing is a forward-thinking approach that focuses on identifying and assessing risks that could affect the management system’s performance. Unlike clause-based audits, this method prioritises areas that pose the greatest risk to achieving business objectives, making audits more aligned with organisational strategy.
How It Works
Risk-based audits involve identifying potential risks in business operations, assessing their likelihood and impact, and reviewing the controls in place to manage them. Auditors need a deep understanding of the business, its challenges, and its industry-specific risks. The audit focuses on areas that matter most, providing actionable insights to improve processes and manage risks more effectively.
Benefits of Risk-Based Auditing
✔ Targeted Focus: Resources are directed to the areas with the highest potential risk, preventing issues before they escalate.
✔ Proactive Culture: Encourages early problem identification and promotes solutions that enhance resilience and adaptability.
✔ Strategic Insights: Helps improve decision-making and planning by aligning audit findings with organisational objectives and customer satisfaction.
Challenges of Risk-Based Auditing
⚠ Requires Expertise: Auditors must have in-depth knowledge of the industry and processes, which may require specialised training.
⚠ Time Intensive: Identifying risks and evaluating controls can take longer than a straightforward clause check.
What is Clause-Based Auditing?
Clause-based auditing is the traditional method where auditors assess whether an organisation’s documented processes meet the specific clauses of an ISO Standard. It’s structured, easy to follow, and focuses on verifying compliance against predefined requirements.
How It Works
Auditors review documented procedures and check conformance with each clause of the relevant ISO Standard. The process is systematic, ensuring that requirements are met in a linear fashion.
Benefits of Clause-Based Auditing
✔ Clear Benchmarks: Defined clauses make audits straightforward and easy to train auditors.
✔ Consistency: Auditors have specific guidelines to follow, ensuring uniformity across audits.
Limitations of Clause-Based Auditing
⚠ Rigid Framework: It focuses solely on compliance and misses out on identifying deeper inefficiencies or opportunities for improvement.
⚠ Surface-Level Findings: Auditors may overlook root causes or strategic enhancements, limiting the value beyond certification.
Which is Better – Risk-Based or Clause-Based Auditing?
Both approaches have their strengths and limitations. Clause-based auditing has long been the standard due to its structured nature and clarity. However, as businesses face increasingly complex and dynamic environments, organisations are recognising that audits need to go beyond mere compliance checks.
Risk-based auditing aligns more closely with today’s business realities. It encourages flexibility, focuses on strategic priorities, and supports continual improvement — helping organisations not just meet ISO requirements, but also enhance operational resilience and performance.
With ISO standards evolving to become less prescriptive, businesses that adopt a risk-based approach are better equipped to thrive in unpredictable markets.
