ISO 9001:2015 Clause 6.1 requires attention to actions to address risks and opportunities. There really is little practical difference between the two, as failure to exploit an opportunity constitutes a risk.

To put this in perspective, recall that poor quality is only the tip of the iceberg when it comes to waste (muda). Among the Toyota Production System’s Seven Wastes—transportation, inventory, waste motion, waiting, overproduction, over-processing, and poor quality—the latter is the only waste that announces its presence and challenges the organization’s corrective and preventive action (CAPA) process to do something about it. If the organization has a decent CAPA process in place (I recommend AIAG’s Effective Problem Solving process (CQI-20), it almost certainly will.

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