IMHO, any changes in the system designed as per clauses 4 to 9 can be considered changes to QMS. The decisions and actions I came across include:
- Internal audit frequency changes (based on internal/external performance)
- Management review frequency change
- Changes in policy - based on changes in issues
- Addition of new remote support/location
- Addition of a new process
- Changes in KPI / Quality objective targets
- Changes in actions planned to achieve quality objectives
- Changes in the process interaction
- Changes in organizational structure
- Changes in outsourced processes
- Changes in controls over outsourced processes
- Addition of new manufacturing processes/products/services, hence change in scope
- Changes in procedures/addition of new procedures
- Changes in customer satisfaction evaluation methodology
- Implementation &/Or certification to other standards
- Adoption of technology for managing QMS / integration in technology e.g. SAP / SharePoint, etc.
- Changes in customer-specific requirements
- Changes in contingency plans
etc.