Risks and opportunities and organizational knowledge

If you already have FMEA, you covered the risks for the main processes. All you need to do now is to identify risks for the rest of the internal (organizational structure, culture, competence of the employees, etc.) and external (legal requirements, competition, etc.) context and the opportunities. The easiest way to do this is to arrange a brainstorming session with the key people in the organization and make a list of risks and opportunities and to define actions to address them. All this information can be recorded in the same document and this can be sufficient evidence that you identified the risks and opportunities and planned actions to address them.

For more information, see: How to address risks and opportunities in ISO 9001

2) Organizational knowledge – what documents to support this clause 7.1.6?

This clause does not require any documented information, so you don't need to produce any additional procedures and records regarding it. Organizational knowledge is to some extent already documented through the organization's procedures and work instructions and the organization itself can decide to what level the knowledge of the organization should be documented.

For more information, see: How to manage knowledge of the organization according to ISO 9001 https://advisera.com/9001academy/blog/2016/08/30/how-to-manage-knowledge-of-the-organization-according-to-the-iso9001/

These materials will also help you regarding your questions:
- Book Discover ISO 9001:2015 through practical examples https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Free online training ISO 9001 Foundations Course https://advisera.com/training/iso-9001-foundations-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/