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
The company's culture
Objectives and goals
Complexity of the products
Flow of processes
Size of the organization
Regulatory Bodies & Government Organization