Risk-Based Thinking and the IATF 16949 Requirements Related to Risk

• A major revision to the ISO 9001:2015 standard incorporates risk-based thinking.
• Risk is defined as the “effect of uncertainty on objectives,” which is the potential for deviation from expected outcomes. The deviation could be positive or negative.
• The 2015 standard spans quality management, leadership, customer focus, the relationship between risk and opportunity, and the analysis and evaluation of preventive and corrective actions.

Risk-based thinking is one of the more significant additions to ISO 9001:2015’s list of quality management principles. Risk-based thinking involves incorporating risk analysis in an organizational quality management system, including certain risks’ opportunities, probability, and consequences. The goal is to prevent identifiable problems before they happen, evaluating risks according to their likelihood and consequences should they occur. 

Risk is defined as the “effect of uncertainty on objectives,” which is the potential for deviation from expected outcomes due to any cause and can be either positive or negative. Uncertainty refers to a need for knowledge or understanding about an event, including its probability of occurrence and/or its consequences.

ISO 9001’s 2015 standard utilizes risk-based thinking for quality management, leadership, customer focus, the relationship between risk and opportunity, analysis and evaluation of preventive actions, and corrective actions if risks occur. 

The article also compares risk-based thinking in ISO 9001:2015 and how IATF 16949:2016, a technical standard guiding quality management in automotive development, uses risk-based thinking, including preventive actions, contingency plans, design and development, and more.

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