Summary of clause 4 Context
Requirements
Determine external and internal issues
Monitor and review information about issues
Identify stakeholders
Clarify the requirements of the stakeholders
Monitor and review information about stakeholders and their requirements
Define the scope of the QMS
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
Processess 
Maintain regulatory watch
Plan the ISMS
Establish process ownership
Records 
External and internal issues
List of interested parties
Scope