Navigating Risk-Based Thinking in ISO 9001:2015

Since the release of ISO 9001:2015, which revised the 2008 version, there has been ongoing discussion and confusion regarding the documentation of risk management within Quality Management Systems (QMS). One of the most significant changes introduced by the 2015 revision is the emphasis on “risk-based thinking.” However, there remains some ambiguity around how thoroughly organizations need to document risks to comply with the standard.

ISO 9001:2015 does not explicitly require a documented risk registry in the QMS. The standard calls for organizations to identify and assess risks that could impact their ability to provide quality products and services. It also stresses the importance of understanding the needs and expectations of interested parties and evaluating risks associated with these factors. However, there is no “shall” statement demanding the creation or maintenance of a formal record of risks within the QMS. This absence of specific documentation requirements has led to uncertainty about what constitutes compliance.

The intent of ISO 9001:2015 is to foster “risk-based thinking” throughout the QMS, embedding it into processes, policies, and practices. This approach encourages organizations to consider risks at all levels, from high-level strategic decisions down to day-to-day tasks. The goal is for risk management to become an integral part of the QMS, much like DNA is to the structure of living organisms. While the standard does not mandate specific documentation, it does expect organizations to demonstrate that risks are being considered throughout the QMS and that appropriate measures are in place to mitigate those risks.

The challenge arises when organizations fail to document their risk management processes. Without clear documentation, it becomes difficult to prove that risks are being effectively managed, and different responses may be given during audits depending on who is asked. To address this, a more structured approach would involve documenting the risks identified, how they are addressed, and linking them to specific measures within the QMS. This documentation should be shared with relevant departments to ensure they are aware of the risks and understand how they are being controlled or mitigated.

In some cases, risks may be identified that are not adequately addressed by current measures. These can be flagged through management reviews, internal audits, or other evaluation mechanisms within the QMS. Once identified, corrective actions can be implemented to mitigate the risks. These actions should be documented and tracked to ensure they are effective.

The need for risk documentation depends on the size and complexity of the organization. For small organizations, risk management processes may be less formalized, but for larger organizations, especially those with multiple divisions, a comprehensive risk registry becomes essential. A risk registry allows the organization to track and manage risks across all operations, ensuring that risks are addressed consistently.

In large organizations, maintaining a centralized Quality Manual that covers overall risk management processes can be highly beneficial. This manual can serve as a reference for all divisions, helping ensure that risk management practices are aligned across the organization. Additionally, a strategic plan, which often includes risk assessments like SWOT (Strengths, Weaknesses, Opportunities, Threats) analyses, can help identify risks and opportunities in the organization’s context.

In conclusion, while ISO 9001:2015 does not require a formal risk registry, organizations should consider documenting their risk management processes. This ensures that risks are identified, assessed, and mitigated consistently, supporting the organization’s ability to meet its quality objectives and comply with the spirit of the standard.

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