Summary of clause 4 Context
Requirements
Determine external and internal issues
Monitor and review information about issues
Determine whether climate change is a relevant issue
Include nuclear safety considerations
Identify stakeholders
Clarify the requirements of the stakeholders
Monitor and review information about stakeholders and their requirements
Define the scope of the QSMS
Take into account the external and internal issues
Take into account the requirements of the stakeholders
Take into account the products and services
Apply any requirement of the ISO 9001 standard applicable within the scope of the QMS
Maintain the scope of the QSMS as documented information
Include in the scope of the QSMS justification for any requirements which cannot be met
Establish, implement, maintain and improve a process-based QSMS
Determine the needed processes and their application
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
Take into account the risks and opportunities for each process
Evaluate processes and if necessary modify them
Determine the improvement opportunities of processes and the QSMS
Maintain documented information on process operation
Retain documented information on process operation
Maintain documented information of how the requirements of the standard are met
Processess 
Maintain regulatory watch
Plan the QMS
Establish process ownership
Procedures 
Scope of the QSMS
Process control
Records 
External and internal issues
List of stakeholders
Process performance