Manage Risk Effectively

First, ISO 9001:2015 promotes using the process approach. Using the departmental approach is not wrong, but it is not the most effective approach.

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
• Results 

For example, 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, its quality, 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 a 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)