This Change Control Order (ECO) Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines the process for initiating, reviewing, approving, implementing, and documenting engineering and quality changes. Ensures controlled updates to products, documents, and processes. Digital delivery within 24 business hours.
This procedure establishes a structured method for managing engineering changes, document revisions, and controlled updates to design, manufacturing, and quality records. It covers ECO initiation, impact assessment, approval routing, implementation, verification, and documentation retention. 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.