Risks and opportunities and Leadership requiremnets

As a transition to ISO 9001:2015, how to address Risk based thinking? Do we need to have single process relating to risks planning OR every process should have "Risks and Opportunities" addressed in it ?
How to implement Clause 5 "Leadership"?

Looking forward to hear from you.

Answer:

Risks and opportunities to be addressed are the ones related to entire context of the organization, not only the processes. It is better to have single process for all risks and opportunities, the easiest way to address this requirement of the standard is to arrange a meeting with all relevant people in the company and discuss possible risks and opportunities related to all elements of your business and than to plan action to address those risks and opportunities. For more information, see: 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/

The management will d emonstrate leadership if all requirement from the clause 5 have been met. This means that the top management must, at least, approve the Quality Policy and conduct management reviews, along with other requirements such as providing resources, raising awareness, assigning responsibilities, etc. For more information about responsibilities to the top management, see: To what extent should top management be involved in your QMS? https://advisera.com/9001academy/blog/2016/11/22/to-what-extent-should-top-management-be-involved-in-your-qms/