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QSR to QMSR Gap Assessment Tool

This gap assessment tool provides a view of the quality system requirements of the QSR, ISO 13485:2016, and the QMSR. You'll be able to see where to find each requirement in each document, as well as the differences between requirements in the QSR and the QMSR. Use the tool to identify gaps within your QMS processes and track changes throughout implementation. 

Features & Benefits
✓   Helpful overview between the gaps and your processes
✓   Shows location of requirements in QSR, ISO 13485:2016, and QMSR

✓   Descriptions of any differences between requirements
✓   Color-coded status tracking during the implementation phase

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