Summary of clause 4 Context
Requirements
Determine external and internal issues
Determine whether climate change is a relevant issue
Monitor and review information about issues
Identify stakeholders
Clarify the requirements of the stakeholders
Determine which of these requirements will be addressed
Monitor and review information about stakeholders and their requirements
Define the scope of the QMS
Take into consideration the external and internal issues
Take into consideration the requirements of the stakeholders
Take into consideration the products and services
Apply any requirement of the ISO 9001 standard applicable within the scope of the QMS
Keep the scope of the QMS available as documented information
Include in the scope of the QMS justification for any requirements which cannot be met
Keep the scope available
Establish, implement, maintain and improve a process-based QMS including process interactions
Determine the needed processes
Determine process inputs and outputs
Determine the sequence and interaction of processes
Determine the criteria and methods to control processes
Determine and ensure the resources
Assign process responsibilities and authorities
Address the risks and opportunities for each process
Evaluate processes and if necessary implement any changes needed
Determine the improvement opportunities of processes and the QMS
Keep documented information available to the extent necessary (procedures)
Keep documented information available to the extent necessary (records)
Processess 
Maintain regulatory watch
Plan the QMS
Establish process ownership
Procedures 
Scope of the QMS
Process control
Records 
Process performance
List of stakeholders