The latest version of ISO 9001: Quality Management Systems (November 2015) for the first time links quality and risk. Introductory clause 0.3.3 notes: “Risk-based thinking is essential for achieving an effective quality management system.” This clause goes on to correctly describe that opportunities can be achieved, because the uncertainty in risk can have both positive and negative outcomes.
Risk-based thinking is discussed in clause A.4, which notes that by applying this kind of thinking in the Standard, some reduction in prescriptive requirements was found, and in their place more performance-based requirements were introduced, thus giving more flexibility in the way the Standard can be implemented. This is good news for design professionals.
Clause 6.1 specifies that “the organization shall plan actions to address risks”, there is no formal requirement for risk management procedures. It’s left up to the firm. The firm is responsible to implement risk-based thinking, but does not have to produce a risk management plan, or retain records of its risk management activities.
The DesignRisk app is fully founded in risk-based thinking, and using it fully satisfies ISO 9001 in regard to this requirement.
