ISO 13485 (Clause 8.2) - Enquiries, Feedback, Complaints & Returns Procedure Template
ISO 13485 (Clause 8.2) - Enquiries, Feedback, Complaints & Returns Procedure Template
Template Overview
Template Overview
Ensure compliance with ISO 13485:2016 Clause 8.2 – Monitoring & Measurement by implementing a structured process for handling customer enquiries, feedback, and product returns. This Enquiries, Feedback & Returns Procedure Template provides a clear framework for managing and documenting customer interactions, ensuring regulatory compliance and continuous improvement in medical device quality and performance.
Key Features
Key Features
✔ Pre-Formatted Procedure Document – Covers key ISO 13485:2016 Clause 8.2 requirements.
✔ Customer Enquiry Management Process – Standardized steps for handling product and regulatory queries.
✔ Feedback & Complaint Handling Section – Ensure systematic documentation and resolution of customer concerns.
✔ Product Returns & Investigation Process – Define criteria for return acceptance, evaluation, and corrective actions.
✔ Regulatory Compliance & Reporting – Ensure compliance with post-market surveillance and vigilance requirements.
✔ Traceability & Record-Keeping Requirements – Maintain audit-ready documentation.
✔ Editable Digital Format – Fully customizable to align with your quality management system (QMS).
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is ideal for medical device manufacturers, customer service teams, and quality managers, ensuring efficient complaint handling, customer satisfaction, and regulatory compliance.
Download the ISO 13485:2016 Enquiries, Feedback & Returns Procedure Template today and enhance your customer communication process!
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Additional information
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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