ISO Total Quality Systems

While the risks are inherently related, their treatment can be significantly different between the standards. ISO 9001:2015 explains some of this in both clause 0.3.3 and the Annex A.4 where it concedes that risk was always inherent in the standard, but not overtly stated. The idea that organizations must have risk-based thinking to fulfill their mandates and the amount of risk assessed was based on their context. ISO 9001:2015 states that risk-based thinking is essential in all forms of planning and execution of the quality management system. A formal and documented risk management process