This Process Monitoring & Measurement 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 monitoring, measuring, and evaluating manufacturing and quality processes to ensure consistent product conformity. Digital delivery within 24 business hours.
This procedure outlines methods for selecting process indicators, establishing acceptance criteria, monitoring process performance, and documenting results. It supports trend analysis, CAPA inputs, and management review. 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.