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Clause 4 of ISO 9001:2015 states that the organization to assess itself in regards to the organizations' context and how this context may affect the QMS.
Organization need to study:  

Influences of various elements on the organization.
How elements reflect on the QMS 
Risks and opportunities regarding the business

Internal Context

The company's culture
Objectives and goals
Complexity of the products
Flow of processes
Organization knowledge
Size of the organization

External Context


Markets
Customers 
Regulatory Bodies & Government Organization