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Content: The ORA Quality Manual contains the required policy elements to structure the Office of Regulatory Affairs (ORA) quality management system (QMS) for The phrase "quality manual" does not appear in the FDA QSR, but medical device companies may still find it useful to establish a quality manual that. Foreword quality fda quality manual template is defined as a measure of a product' s or service' s fda quality manual template ability to satisfy the customer' 3.3 A service report that represents an event which must be reported to the FDA will automatically consider the report a complaint and will process it inIncluded with this Corporate Quality Manual template, all ready to edit & use, twenty popular protocols templates, six popular SOP templates & eighteen