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Context, risks and preventive actions

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Guest user Created:   Jan 22, 2018 Last commented:   Jan 22, 2018

Context, risks and preventive actions

"1. How to identify the context of the organization in ISO 9001:2015? 2. How to identify risks and opportunities? 3. Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits?”
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Carlos Pereira da Cruz Jan 22, 2018

Answer:

1. ISO 9001:2015 requires that an organization determines the internal and external issues that can affect its intended results. The other word for the external issue is: context. ISO 9001:2015 does not prescribe any method to determine context. You can use, for example: Opportunities and threats taken from the SWOT analysis and/or you can brainstorm external issues using the PESTEL framework.
2. If you check the ISO definition for risk, “effect of uncertainty on an expected result”, you can start by determining what are the expected results from your management system, from your products and services and from your processes. Then, for each determined expected result, you can start listing positive (opportunities) and negative (risks) deviations that can occur because of the uncertainty that exists in the world
3. Here, I can just give you my guess. According to my experience organizations had some difficulties in developing preventive actions. I believe that the risk-based approach makes it easier:
to look forward and think about what can happen and if we should do anything about it;
to apply preventive actions at a more strategic level of an organization

The following material will provide you information about the risk-based approach and the context of an organization:

- 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 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/
ISO 9001:2015 Case study: Context of the organization as a success factor in manufacturing company - https://advisera.com/9001academy/blog/2016/10/11/iso-90012015-case-study-context-of-the-organization-as-a-success-factor-in-manufacturing-company/
How to identify the context of the organization in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
- 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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Jan 22, 2018

Jan 22, 2018