Risk-Based vs Clause-Based Audits

Published on: December 13, 2024

Audits are assessments of an organisation against a set of criteria. In the ISO context, audits are conducted against the requirements of the organisation’s own processes and the chosen ISO Management System Standards, such as ISO 9001:2015 or ISO 45001:2018.

Traditionally, these audits have been conducted taking a clause-based approach, focusing on adherence to specific requirements set by the ISO Standards. However, with the release of ISO 19011:2018 (Guidelines for auditing management systems) in 2018, there has been a significant shift towards a more dynamic method known as risk-based auditing

This approach emphasises evaluating potential risks that could impact the management system’s performance and effectiveness, aligning more closely with the business’s strategic goals and the risk-based approach outlined in the ISO Standards.

Despite this change, it’s still common to find that many auditors continue to rely on traditional clause-based auditing methods. In this blog post, we will delve into the distinctions between risk-based and clause-based auditing. You’ll learn:

What is Risk-based Auditing?

Risk-based auditing represents a more dynamic and strategic approach to auditing that focuses on identifying and evaluating the risks that could impact the effectiveness and performance of a management system. Unlike the traditional clause-based auditing, risk-based auditing prioritises areas that are of greatest risk to the organisation’s objectives and goals not being achieved. Here’s an in-depth look at risk-based auditing:

Definition and Process

  • Risk-based auditing involves assessing the potential risks associated with a business’s processes and determining the likelihood and impact of these risks on achieving the objectives of the management system. This approach requires auditors to have an understanding of the organisation’s industry, operations, and the specific challenges it faces.
  • Auditors using this approach focus on critical risk areas, evaluating the effectiveness of the controls in place to manage these risks and suggesting improvements to enhance risk mitigation strategies.

Advantages of Risk-Based Auditing

  • Enhanced Focus on Critical Areas: By prioritising areas with higher risks, businesses can allocate resources more effectively and address potential issues before they escalate. Main advantages of this approach:
  • Focuses efforts on processes that are most vulnerable to disruptions.
  • Aligns audit activities with strategic business objectives, increasing their relevance and value.
  • Proactive Problem Solving: This approach encourages identifying and resolving issues that could impede the organisation’s ability to meet its goals. Consequently, it promotes a proactive culture within the organisation, aiming to prevent problems rather than react to them. It also helps build a robust system that can withstand, improve, and adapt to changes and challenges.
  • Strategic Value Addition: Risk-based auditing focuses on enhancing operational and strategic decision-making by providing insights that help in planning and risk management. It also supports continual improvement by focusing on areas that can significantly impact performance and customer satisfaction.

Challenges of Risk-Based Auditing

  • Requires Specialised Knowledge: Auditors need to have strong business acumen, to better understand the context of operational processes and their potential risks, which can require extensive managing experience.
  • Potentially More Time-Consuming: Identifying and evaluating risks can be more time-consuming than checking against a fixed set of clauses, as it involves process analysis and possibly more extensive consultations with various stakeholders.

What is Clause-Based Auditing?

Clause-based auditing is a traditional approach in which auditors focus on verifying conformance against the specific clauses of the relevant ISO Standard. This method is straightforward and systematic, as it clearly defines the requirements that a business must meet to achieve and maintain certification.

Did you know? 

In the past, organisations often structured their Management Systems to directly align with the specific clauses of the relevant ISO standards. This was done to meet the expectations of auditors, who typically followed a clause-based auditing approach and expected systems to mirror this structure. However, the ISO standards changed to be more flexible and less prescriptive, now requiring organisations to develop their Management System in a way that suits their needs, industry, and operations, not the clauses of a Standard.

Here’s an expanded look at clause-based auditing:

Definition and Process

  • Clause-based auditing involves a detailed examination of the organisation’s documented procedures and practices against the specific clauses of an ISO Standard.
  • The process is generally linear and prescriptive, focusing primarily on whether the business has adhered to the written standards and implemented them as described.

Advantages of Clause-Based Auditing

  • Clear Conformance Criteria: The main strength of clause-based auditing is its clarity and simplicity for the auditor. Auditors have specific criteria to evaluate, making it straightforward to determine whether the organisation meets requirements.
  • Ease of Training: Auditors can be trained more easily to look for specific criteria from the standard, making this approach easier to standardise across different auditors and audit teams.

Limitations of Clause-Based Auditing

  • Lack of Flexibility: Clause-based auditing tends to be rigid, focusing solely on meeting Standard requirements without considering the effectiveness or efficiency of the processes in place.
  • Potential for Missed Opportunities: By concentrating only on whether the Management System meets the Standard’s clauses, auditors may overlook opportunities for process improvements or innovative practices that could add value beyond conformance.
  • Surface-Level Analysis: This method might not adequately address the underlying issues that could lead to non-conformance or inefficiencies, as it does not typically assess the effectiveness of the implemented processes.

What is the best approach – Risk-Based vs Clause-Based Auditing?

In the comparative analysis between risk-based and clause-based auditing, each approach offers distinct advantages and encounters specific challenges.

Clause-based auditing has served as the backbone of ISO audits due to its structured approach and clear benchmarks. However, the clause-based approach is dated and no longer suits the current business environment. As organisations and the ISO standards evolve, there is a growing recognition of the need for a more dynamic and results-oriented approach that not only ensures the standards requirements are met, but also promotes continual improvement, effectiveness in meeting organisational goals and providing real business benefits out of the auditing process.

The risk-based auditing better suits modern business practices, where flexibility and adaptability are key to success. By focusing on risk and its management, organisations can ensure they meet the requirements of the ISO Standards for Certification while also enhancing their strategic operations and resilience against disruptions.

Businesses are increasingly recognising the benefits of adopting a risk-based approach as recommended by ISO 19011:2018, as it empowers organisations to not just survive but thrive in today’s fast-paced and often unpredictable business environment.

Our Management System Internal Auditor Training is a practical eLearning course that teaches how to conduct effective Internal Audits taking a risk-based approach in accordance with the main ISO Management System Standards. Delivered via video lessons, this training combines theory, practical real-life examples, and templates, so even those new to the internal audit world can succeed when performing management system Internal Audits. Click here to find out more, or give us a call at 1300 614 897 for more details.

Managing Director at ICExperts Academy and ISO Certification Experts

Erica is the Managing Director of ISO Certification Experts and ICExperts Academy. She has been helping businesses with their ISO Certification needs for over 20 years. Erica is also a Certified trainer, implementer and auditor for ISO 9001, ISO 14001, ISO 45001 and ISO 27001 standards. Erica primarily heads up the day-to-day operations of the businesses, and is also a current member of the Australian Organisation for Quality and Brand Integrity Committee.

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