1. Understanding the risks and opportunities approach

Risk is the "effect of uncertainty" and "An effect is a deviation, positive or negative, from an expectation" (ISO 9000:2015 § 3.7.9).

ISO 9001 requires us to determine the relevant external and internal issues (§ 4), and then to define objectives for our QMS, consistent with these issues. A challenge is what can be gained or lost by undertaking something...

The result is subject to hazards, influences and disturbances, which generate uncertainty, or in the case of repetitive activities, dispersion. Uncertainty is the consequence of ignorance and/or lack of control over factors that make a result...