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    Study Reminders

    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

    Regulatory Bodies & Government Organization