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  QMS shall include:

bullet green arrow 25Documented information required by ISO 9001

bullet green arrow 25Documented information determined by the organization as necessary for the effectiveness of the QMS

Note: the extent of the information determined by:

bullet green arrow 25The size of organization and its type of activities, processes, products and services

bullet green arrow 25The complexity of processes and their interactions

bullet green arrow 25The competence of persons (greater training, education and experience required can be in inverse amount to work instructions.