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  Process Audit

bullet-green-arrow-25documented internal audit process covers the entire quality management system including quality management system audits, manufacturing process audits, and product audits

bullet-green-arrow-25prioritized based upon risk, internal and external performance trends, and criticality of the process(es)

bullet-green-arrow-25frequency of audits shall be reviewed, adjusted based on occurrence of process changes, internal and external nonconformities, and/or customer complaints

bullet-green-arrow-25effectiveness of the audit program shall be reviewed as a part of management review