Address risk and opportunities regarding ISO 9001:2015 - I am very confused regarding implementation this topic. Because my understandings regarding this new approach, differs a lot from all implementations and guidance of reputable experts. a lot of them go to risk assessment against each activity using FMEA!! and others transform it to strategic business risk without touching the opportunities any more. Please, I need reasonable discussion regarding this wonderful approach which considered now to me as a nightmare.”
ISO 9001:2015 gives a lot of freedom in treating risks and opportunities. So, you will see different possible approaches.
First, what is a risk or an opportunity? A negative/positive deviation from an expected due to uncertainty is a risk/opportunity. The expected are desired results, are the outcomes of a QMS.
Second, ISO 9001 mentions risks/opportunities at three levels (clause 5.1.2b – risks about products and services. Clause 4.4.1f – risks about process outcomes. Clause 6.1.1 – risks about QMS over all results)
Third, with FMEA, with a conversation/discussion about internal and external issues, or with performance analysis one organization can determine relevant risks and opportunities and then evaluate them and decide what to do with them.
The following material will provide you information about risks and opportunities