Why Risk-Based Thinking Should Be Part of Your Quality Management System

While the concept of risk is easy enough to understand, figuring out how to apply it to your organization can be somewhat more complicated. Learning how to manage the effect of uncertainty in such a way as to determine the impact on how value is created and sustained requires a deep understanding of your organization’s processes. Many organizations are tempted to avoid these difficulties by ignoring risk management altogether, which can lead to cost overruns, time delays, waste, rework, or even to more serious problems that have an impact on health and safety or the environment.

Fortunately, ISO 9001:2015 for quality management systems (QMS) can provide some much-needed guidance on how to make risk-based thinking the cornerstone of your QMS. ISO 9001:2015 incorporates risk-based thinking throughout to help your organization make better quality decisions that anticipate and prevent process problems. It also incorporates the high-level structure of Annex SL to create consistency with other standards for management systems such as ISO 14001:2015 for environmental management systems and ISO 45001:2018 for safety management systems. This allows you to create an integrated management system that emphasizes risk-based thinking across the organization and contributes to continuous improvement and satisfying your customer requirements.

ISO 9001:2015 doesn’t tell you how to run your business, but there are many options for processes and tools to support your quality management system. You can use some of the many quality tools for risk management to identify and analyze risk in your organization, including Failure Mode Effect Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Fault Tree Analysis (FTA), and Control Plans. In addition, QMS software can provide the risk management and document control applications you can use to demonstrate your risk-based thinking to auditors.

Risk-Based Thinking in ISO 9001:2015: How Understanding Risk Improves Quality in Your Organization is the second in our three-part series of Insight Reports dedicated to risk. Nicole Radziwill, SVP Quality & Strategy at Ultranauts, Inc, shows you how the inclusion of risk-based thinking in ISO 9001:2015 can help you master the pitfalls and opportunities risk presents to your organization. You’ll learn about the following:

• How the high-level structure of Annex SL can help you incorporate risk-based thinking into your integrated management system.
• How to establish, assess, and treat risk.
• How to use your quality management system software to demonstrate your understanding of risk-based thinking to quality auditors.
• Which quality tools are most useful for risk management.


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