What is the meaning of risk and opportunities in QMS?
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Let us start with ISO 9000:2015 risk definition.
risk = effect of uncertainty
It's important to higlight the word "uncertainty". Something that we cannot control, something that it is outside of our level of control.
And an effect is a deviation from the expected — positive or negative.
So, one can say that risk is a deviation from the expected (positive or negative) resulting from a trigger event that we cannot control. By the way, the ability to control the trigger event is what separates a positive risk from an improvement opportunity.
ISO 9001:2015 about risks mentions: risks and opportunities related with the context of the organization; risks and opportunities related with products and services and risks and opportunities related with processes.
What are we talking about when we talk about "the expected"? What are the expected results of a Purchasing process or of a Production process? Its objectives.
What are the expected results of products and services? The ability to comply with specifications, orders or contracts.
The following material will provide you more information about risks and opportunities:
- How to address risks and opportunities in ISO 9001 - https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
- Please check this free webinar on demand - Free webinar – How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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Jan 13, 2020