Guest user Created: Jul 05, 2018 Last commented: Jul 05, 2018

Implementing risk-based thinking

"I plan to add a column in our Company Quality Activity plan to cover requirements related to risk based thinking. I am wondering if we need to have records of the full results of the risk Assessment (full description) or is a checkmark or "completed" remark sufficient. I also plan to have a written procedure of how the risk assessment shall be done when all planning activities handled on the Quality activity plan. Do you agree that this is required by the 2015 standard?”

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Carlos Pereira da Cruz Jul 05, 2018

Answer:

ISO 9001:2015 does not require neither procedures nor records about implementation of risk-based thinking. When I work with companies implementing a quality management system according to ISO 9001:2015 I recommend having a risk register and having a small instruction or procedure to assure a consistent procedure year after year. Attention, remember that my approach is not mandatory. So, your approach is acceptable, although I would like to work with recrds of the full risk assessment.

The following material will provide you information about risk -based thinking:

- 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/
- Free webinar – How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/
- - ISO 9001:2015 Risk Management Toolkit https://advisera.com/9001academy/iso-90012015-risk-management-toolkit/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

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Jul 04, 2018

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