Risk is the effect of uncertainty on the expected result, which encompasses any deviation whether it is negative or positive. The intent is for an approach to risk based thinking which promotes continual improvement and is proactive rather than reactive.
Risk based thinking is an important concept that forms the basis of ISO 9001:2015. This concept may seem to be new, but it has always been a part of ISO 9001 and at the same time, done by many organizations.
Any reference to ‘preventive action’ is removed but the concept of identifying and addressing potential mistakes before they occur remains the same.
ISO 9001:2015 requires an organization to determine the risks and opportunities affecting products and services, processes and the QMS as a whole and to take necessary action to address them.
Risk based thinking is determining the risk in qualitative terms as well as quantitatively defining the degree and rigor of formality needed to plan and check the quality management system and its activities.
Different processes have different levels of risk in terms of impact on customer satisfaction and results of the QMS. Also the results of non conformities are different for different organizations.
Risk-based thinking is prominent in Clause 6.1. The clause requires an organization to consider its context when planning the Quality Management System.
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