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Answer:
ISO 9001:2015 recommends us to deal with risks and opportunities at three levels.
4.4.1 f) – risks about processes – Every process has intended outcomes and possible undesirable effects. What can affect negatively or positively the ability to meet those intended outcomes or to avoid those undesirable effects
5.1.2 b) – risks about products and services
6.1.1 a) – risks about intended outcomes of the QMS as a whole (quality objectives)
The following material will provide you information about the risk-based approach:
- ISO 9001 – 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/
- Risk-based thinking repl acing preventive action in ISO 9001:2015 – The benefits - https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
- ISO 9001:2015 Risk Management Toolkit - https://advisera.com/9001academy/iso-90012015-risk-management-toolkit/
- 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/
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Mar 12, 2018