Module 17 2024

05/12/2024

Unannounced Audits in other systems

• The Medical Device Single Audit Program (MDSAP) requires unannounced audits if more than two grade-4 non-conformities or one or more grade-5 non-conformities are raised. The audit will be scheduled within 6-9 months and will verify the closure and effectiveness of the findings. • The grading system works on a point-based scale, where non-conformances are assigned points based on their impact on the Quality Management System (QMS) and the recurrence of the issue. • A Grade 5 non-conformance is considered very serious and indicates a high level of risk that requires immediate intervention. A Grade 5 non-conformance typically indicates a significant failure in the QMS that could potentially affect product safety and requires prompt corrective action(s). • A Grade 4 nonconformance is a serious issue that indicates a significant problem within the Quality Management System (QMS). A Grade 4 nonconformance requires prompt corrective action to address the identified issues and prevent recurrence

The Organisation for Professionals in Regulatory Affairs

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The Organisation for Professionals in Regulatory Affairs

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