Infrastructure, Work Environment and Contamination Control Procedure - ISO 13485

Maintain a controlled, compliant, and safe work environment with our ISO 13485:2016 Clause 6.3 Infrastructure, Work Environment & Contamination Control Procedure Template. Ensuring that the infrastructure, workspaces, and contamination control measures meet regulatory and quality standards is essential for medical device manufacturing, product safety, and compliance. This structured procedure template provides a clear framework for managing and monitoring the work environment, facility maintenance, and contamination control, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Infrastructure & Work Environment Procedure – Covers key ISO 13485:2016 Clause 6.3 requirements.

✔ Facility Management & Environmental Control Measures – Define cleanroom, temperature, and humidity control processes.

✔ Contamination Prevention & Cleanliness Guidelines – Ensure effective decontamination and sterile environments.

✔ Equipment & Maintenance Requirements – Outline scheduled maintenance for critical infrastructure.

✔ Employee Health, Safety & Training Procedures – Ensure safe working conditions and regulatory training.

✔ Audit-Ready Documentation & Record Keeping – Maintain structured facility and environmental records for inspections.

✔ Risk-Based Approach & ISO 14971 Integration – Identify and mitigate potential contamination risks.

✔ Editable Digital Format – Fully customizable for various manufacturing and work environments.

This ready-to-use infrastructure and contamination control procedure is ideal for quality managers, facility teams, and regulatory professionals, ensuring a structured, compliant, and effective work environment.

Download the ISO 13485:2016 Infrastructure, Work Environment & Contamination Control Procedure Template today and enhance your product safety and compliance strategy!