This Unannounced Audits Procedure complies with EU MDR 2017/745, ISO 13485:2016, and Notified Body requirements. Delivered in editable Word format, it defines requirements for managing and supporting unannounced audits to ensure readiness and regulatory compliance. Digital delivery within 24 business hours.
This procedure outlines preparation steps, audit response protocols, facility access rules, documentation availability, and staff responsibilities during unannounced audits. It includes requirements for product availability, subcontractor readiness, and immediate cooperation with auditors. Delivered in editable Word format for easy customization. Consultancy support is available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are available for an additional fee.