This Quality Audit Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines requirements for planning, conducting, reporting, and following up on internal audits to ensure the effectiveness of the Quality Management System. Digital delivery within 24 business hours.
This procedure outlines the internal audit program, auditor qualifications, audit planning, execution, reporting, and corrective action follow‑up. It includes audit schedules, checklists, audit trails, and documentation requirements to ensure regulatory compliance and continuous improvement. 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.