Risks and context

Answer:

Considering the strategic orientation of your organization, your top management team should determine internal and external issues that could affect the intended results of your QMS.

You can document that list of internal and internal issues.

Then, considering those issues, you should determine risks and opportunities. And you can list them. For example, if you determined as an external issue the possibility of competitors with new technology disrupt your market or determined the opportunity of opening a new geographical market your government negotiated for the opening of economic borders with other countries, those will be clearly good candidates for risks and opportunities determined considering clause 4.1.

You can make explicit connections between issues and risks and opportunities or not. They can only be implicit and your top man agement team can show to auditors the connections.

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 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 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/