This Equipment Process Validation & Qualification 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 IQ/OQ/PQ of equipment and processes to ensure validated, controlled operations. Digital delivery within 24 business hours.
This procedure outlines installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), requalification, calibration, maintenance, and documentation requirements. It ensures equipment and processes consistently meet predetermined specifications. 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.