ISO 9001 Strategic risk assessment
Does ISO9001:2015 require risk assessment for change requests, non-conformances, complaints etc. or only the top-level risk assessment for the strategic business risks and opportunities? Do you have a form example for nonconformance risk assessment?
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ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
In this free webinar on-demand - How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/ - I show some examples of determining risks and then acting on them. ISO 9001:2015 mentions risk about:
- Context interacting with interested parties (clause 6.1)
- Products and services (clause 5.1.2 b))
- Processes (clause 4.4.1)
Your organization is a set of interrelated processes. Each process is a set of activities that transform inputs into desired outputs.
ISO 9000:2015 defines risk as to the effect of uncertainty. Because there is uncertainty, sometimes we don’t have the expected:
- Inputs
- Activities
- Outputs
What is a non-conformity? We don’t design processes to deliver non-conformities. So, when a non-conformity happens, we have the manifestation of risk. Non-conformities are potential risks that have materialized. Same for complaints.
Seen in this way, the risk-based approach is a very effective methodology for developing a plan to control a process and its results. The control will materialize, for example, in operations of control, verification, improvements in the process, in work instructions, in improvements in monitoring, in increasing the competence of the participants.
You can find more information below about risks.
- 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/
- How to identify risk significance in ISO 9001:2015 - https://advisera.com/9001academy/blog/2019/01/14/how-to-identify-risk-significance-in-iso-90012015/
- For a free preview of an example of the Registry of Key Risks and Opportunities - https://advisera.com/9001academy/documentation/registry-of-key-risks-and-opportunities/
- Enroll for the 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/ (I use a lot of examples based on the risk-based approach)
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May 17, 2021