This Work Environment & Clean Room Procedure complies with ISO 13485:2016, ISO 14644-1, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines requirements for controlling the work environment, including clean room operations, to ensure product quality and regulatory compliance. Digital delivery within 24 business hours.
This procedure outlines environmental controls, Sanitation & Hygiene, Structure Maintenance, Employees Safety & Work Tool Handling, Electricity Safety, Chemical Hazard Safety, Clean Room Behavior and Safety Instructions. Associated documents available for separate purchase include the clean room classifications, gowning requirements, cleaning schedules, monitoring activities, and documentation requirements. It includes temperature, humidity, particulate control, personnel practices, and contamination prevention measures. 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.