Risks assessment in ISO 9001

I would like to discuss some important things regarding ISO 9001:2015 documentation as I am working on Risk Assessment Matrix.
What I need to know is that is there need of formal documentation regarding risk assessment?
Because we have integrated management system and I think that we have already addressed many risks in the form of HAXCCP Matrix and Environmental Aspect & impact.
As per my understanding what additional thing we have to do in QMS is, that keeping in view the context of the Organization & needs and expectations of the interested parties existing risk assessment will be reviewed and revised accordingly.
Kindly guide me in this regard.
I would like to share the document on which I am working now a days.
I am interested to hear back from you.

Answer:

ISO 9001 does not require formal documentation regarding risk assessment, but it is beneficial to have at least the registry or list of risks and opportunities. HACCP and Environmental Aspect/Impact risk assessment are coveri ng different types of risks, one is for food safety and the other is for environment. ISO 9001 requires you to address risks and opportunities related to quality of products and services, achieving quality objectives and customer satisfaction.

The risk and opportunities assessment for ISO 9001 can be done in more simple way than those to above mentioned methodologies. You can conduct SWOT analysis or arrange a brainstorming session with relevant people in the company and talk about the risks. 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/