ISO 13485 (Clause 6.3) - Key Infrastructure Log Template

Maintain compliance and operational efficiency with our ISO 13485:2016 Clause 6.3 Key Infrastructure Log Template. Properly managing your organization’s key infrastructure, such as facilities, equipment, and other critical resources, is essential for ensuring product quality and regulatory compliance. This ready-to-use template provides a systematic approach for documenting and tracking infrastructure components that directly impact the performance of your Quality Management System (QMS), in alignment with ISO 13485:2016 requirements.

✔ Pre-Formatted Key Infrastructure Log Template – Covers key ISO 13485:2016 Clause 6.3 requirements.
✔ Infrastructure Identification & Classification – Record key assets such as facilities, equipment, and technology.
✔ Maintenance & Calibration Tracking – Ensure critical infrastructure is properly maintained and calibrated.
✔ Resource Allocation & Utilization – Monitor usage and ensure resources meet operational needs.
✔ Performance Monitoring & Risk Assessment – Track the performance and potential risks associated with infrastructure.
✔ Compliance with Regulatory & Safety Standards – Ensure infrastructure meets applicable industry and regulatory standards.
✔ Audit-Ready Documentation & Compliance Tracking – Maintain structured records for internal audits and inspections.
✔ Editable Digital Format – Fully customizable for various business models and infrastructure needs.

This key infrastructure log template is ideal for quality managers, facilities teams, and compliance officers, ensuring a structured, compliant, and efficient infrastructure management system.

Download the ISO 13485:2016 Key Infrastructure Log Template today and strengthen your infrastructure management and compliance strategy!