White Paper: Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers
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.
For medical device quality management system auditors, effectively communicating nonconformities to the auditee organization is essential. Without clearly written nonconformity statements, the potential for an auditee organization to misunderstand the nonconformity increases. This can lead to difficulty investigating the nonconformity and, in turn, difficulty implementing necessary containment, corrections, corrective actions and systemic corrective actions. However, it is possible to write effective nonconformity statements that are easy to read and easy to understand. In this informative paper, we have compiled a few simple tools and tips to help you consistently create clear, concise and precise nonconformity statements.