ISO 13485 (Clause 8.3) - Issue Report Form

Streamline your issue identification, documentation, and resolution processes with our ISO 13485:2016 Clause 8.3 Issue Report Form Template. Properly addressing issues is essential for maintaining the quality and safety of your medical devices and ensuring compliance with ISO 13485:2016. This ready-to-use form template provides a structured framework for recording issues, evaluating their impact, and taking appropriate actions, enabling efficient issue resolution and continuous improvement within your Quality Management System (QMS).

✔ Pre-Formatted Issue Report Form – Covers key ISO 13485:2016 Clause 8.3 requirements for issue documentation.
✔ Issue Identification & Description – Capture detailed information about the issue, including the origin, nature, and impact.
✔ Root Cause Analysis – Identify the underlying causes of the issue and evaluate its risk to product quality and safety.
✔ Corrective & Preventive Actions (CAPA) – Ensure appropriate corrective actions are implemented and preventative measures are taken.
✔ Resolution Tracking & Follow-Up – Track the progress of corrective actions and evaluate their effectiveness.
✔ Audit-Ready Documentation – Maintain comprehensive records for internal audits and regulatory reviews.
✔ Editable Digital Format – Fully customizable for various industries and QMS requirements.

This Issue Report Form Template is ideal for quality managers, regulatory teams, and compliance officers, ensuring a compliant and efficient process for managing issues.

Download the ISO 13485:2016 Issue Report Form Template today and improve your issue resolution process and compliance!