This Manufacturing Process 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 controlling and documenting manufacturing processes to ensure consistent product quality. Digital delivery within 24 business hours.
This procedure outlines process controls, work instructions, material handling, in‑process inspections, equipment use, operator qualifications, and documentation requirements. It ensures controlled, repeatable, and traceable manufacturing operations. 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.