Internal and external issues for processes

Answer:

Internal and external issues don't have to be determined on the process level, they should be determined on the global level for the entire company and QMS. What can be determined for each process are risks and opportunities and those should be related to quality of process outputs. For example you can determine what are the risks for nonconformities to occur in the process or what are opportunities to improve the process performances.

For more information, see:
- ISO 9001:2015 Case study: Context of the organization as a success factor in manufacturing company https://advisera.com/9001academy/blog/2016/10/11/iso-90012015-case-study-context-of-the-organization-as-a-success-factor-in-manufacturing-company/