How to implement the risk-based thinking requirement in the new version of the ISO 9001:2015?

 ISO 9001:2015 standard requires us to take a “risk-based approach to quality management.” This involves taking a greater strategic view of risk within your business, and also ties in with the changes in leadership requirements.

So, given that your top management team should now be involved in the process of identifying, recording, removing, and mitigating risk, then you can see that from the start, using a risk-based thinking process should far surpass preventive action in terms of effectiveness. Ensuring that your management team has a forum for identifying risk at the regular management meetings can be a vital step toward this.

Risk is not a straightforward concept. Definitions of risk vary, even within documents published by the International Organizations for Standardization (ISO). One ISO definition indicates that risk is the “effect of uncertainty on an expected result.” Risk is now addressed by ISO 9001:2015, “Quality management systems—Requirements,” the international standard for quality management systems (QMS)