NSF International - the Public Health and Safety Organisation

White Paper

TOOLS AND TIPS FOR WRITING EFFECTIVE NONCONFORMITY STATEMENTS DURING QUALITY MANAGEMENT SYSTEM AUDITS OF MEDICAL DEVICE MANUFACTURERS

March 31, 2022

As a medical device quality management system auditor, one of the most important (if not the most important) responsibilities of your role is to effectively communicate identified nonconformities to the auditee organization. This allows the auditee organization to promptly investigate the cause of the nonconformity and implement any necessary containment, corrections, corrective actions and systemic corrective actions without undue delay. This will result in continued improvement of the suitability, adequacy and effectiveness of the auditee organization’s quality management system as well as of its product’s safety and performance.

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