Transcription of Creating an Efficient Internal Audit Program
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Creating an Efficient Internal Audit Program Carol CekalaSusan ReillyTDC MedicalReilly & AssociatesPresentation topics What is an Audit ? Making it work Who audits? Selling to management Communicating resultsWhat is a quality Audit ?What is a quality Audit ? Objective assessment, performed at defined intervals and at sufficient frequency, of a company s quality system to operate against a given criteria{Systematic{Independent{Document edWhat is a quality Audit ? Provide factual, unfiltered information to manage the quality system A tool for use by management Regulatory requirement (FDA, ISO, etc.) Help minimize risk Close the loop for other elements of the quality systemWhat is a quality Audit ?}}}
Selling to management Efficient auditing can identify inadequate / ineffective / inefficient collection of data & measurements {Data not being used, not being used efficiently,
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SG4 - Guidelines for Regulatory Auditing of, Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers, MDSAP – Three Important Documents, MDSAP - Three Important Documents, Quality management, Medical device, Technicalities of a Quality Management, Technicalities of a . Quality Management System . under MDR, Nonconformity Grading System for Regulatory, Nonconformity Grading System for Regulatory Purposes and Information Exchange, Corrective and Preventive Action, Quality, The Transition to ISO 13485:2016, Transition to ISO 13485:2016, Temperature mapping of storage areas