Take little steps to reach your goal, the key is “thinking risks” every day using different points of view.
Explore the most suitable way of adapting concepts to your QMS, and start acting!
Risk management is a concept that is generally understood and used across industries, however, risk-based thinking is something that’s not broadly well-defined or practiced. To fill this void,
According to ISO 9001:2015 - Clause 0.3.3 and Annex A Clause A.4, Risk-Based Thinking is;
Risk has been always implicit and addressed in ISO 9001. Many of the requirements are constituted to prevent risks. ISO 9001 had included a clause on preventive action, which aimed to prevent the occurrence of nonconformities. On the contrary, according to the latest version of ISO 9001, Risk-based thinking considers both risks and opportunities.
The Introduction (clause Clause 0.3.3) and Annex A (Annex A Clause A.4) of ISO 9001:2015 explain risk-based thinking, including clarification on risk and opportunity concepts. A piece of thorough information can be found in this ISO paper that is related to Risk-based thinking.
Organizations should determine their risks and opportunities using a risk-based thinking mindset. Here are some areas that could help to implement this mindset.
If you need further information about risk-based thinking, read the article "Using risk-based thinking to manage nonconformities and deviations"
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