Risks and opportunities - an approach
Assign topic to the user
Answer:
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
- ISO 9001 – Methodology for ISO 9001 Risk Analysis - https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/
- Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits - https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
- free online training 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/
Comment as guest or Sign in
Aug 10, 2018