Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities. To conform to the requirements of this International Standard, an organization needs to plan and implement actions to address risks and opportunities. Riskbased thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise. Risk-based thinking is essential for achieving an effective quality management system.
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