Audit Readiness in Manufacturing

Navigating the complexities of manufacturing audits like IATF 16949, ISO 13485 for medical devices, and FDA regulations can be challenging. This session will delve into how Digital Calibration Certificates (DCC), alongside a robust Document Change Request (DCR) and Calibration Management and Maintenance System (CMMS), can significantly streamline audit preparedness. We’ll explore the tangible benefits of these digital tools in ensuring compliance, managing internal calibrations effectively, and proactively mitigating risks associated with out-of-tolerance equipment, potential recalls, and costly production line stoppages. Learn what a DCR entails, why it’s a cornerstone of audit readiness, and practical steps your organization can take to implement these powerful systems.