Risk-based thinking, or “actions to address risks and opportunities,” is among the most significant additions to ISO 9001:2015. This provision encompasses what we currently call preventive action, or proactive actions that prevent poor quality before it happens.

Corrective action for poor quality is mandatory, and preventive action is even better, but the predominant focus is still on only one of the Toyota Production System’s Seven Wastes, as seen in figure 1.

Figure 1: TPS Seven Wastes and other significant risks. (Original image: Iceberg in the Ross Sea, Michael Van Woert, National Oceanic and Atmospheric Administration. Public domain as work of U.S. government employee.)

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