Summary of clause 4 Context
Requirements ISO 9001
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
Requirements IATF 16949
Include supporting functions, whether on-site or remote, in the scope for the quality management system (QMS)
Justify the exclusions and maintain as documented information
Never exclude manufacturing process design
Determine customer-specific requirements
Ensure conformity to all applicable customer, statutory and regulatory requirements
Define documented processes for the management of product-safety related products and manufacturing processes
Identify statutory and regulatory product-safety requirements
Notify customer of statutory and regulatory product-safety requirements
Realize special approvals for design FMEA
Identify product safety-related characteristics
Identify and control safety-related characteristics of product
Realize special approval
Realize reaction plans during monitoring and measurement
Define responsibilities, escalation process and flow of information
Identify training for product-safety related products and associated processes
Approve changes of product or process prior to implementation
Prepare for the transfer of product safety requirements throughout the supply chain
Prepare for product traceability by manufactured lot throughout the supply chain
Learn lessons from new product introduction
Processess 
Maintain regulatory watch
Plan the QMS
Establish process ownership
Guarantee product safety
Procedures 
Scope of the QMS
Process control
Records 
External and internal issues
List of stakeholders
Scope
Process performance