ISO 13485 (Clause 8.2) - Enquiries, Feedback & Complaints Procedure Template
ISO 13485 (Clause 8.2) - Enquiries, Feedback & Complaints Procedure Template
Template Overview
Template Overview
Ensure compliance with ISO 13485:2016 Clause 8.2 – Monitoring & Measurement by implementing a structured process for managing customer enquiries and feedback. This Enquiries & Feedback Procedure Template provides a clear and standardized approach for handling product-related queries, customer feedback, and complaint resolution, ensuring compliance with regulatory requirements and continuous quality improvement.
Key Features
Key Features
✔ Pre-Formatted Procedure Document – Covers key ISO 13485:2016 Clause 8.2 requirements.
✔ Customer Enquiry Handling Process – Ensure prompt, professional, and documented responses.
✔ Feedback Collection & Complaint Management Section – Structured steps for gathering and addressing customer concerns.
✔ Escalation & Resolution Workflow – Define responsibilities for handling complex issues.
✔ Regulatory Compliance & Reporting – Ensure alignment with post-market surveillance (PMS) and vigilance reporting obligations.
✔ Traceability & Record-Keeping Requirements – Maintain audit-ready documentation for compliance.
✔ Editable Digital Format – Fully customizable to integrate with your quality management system (QMS).
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is essential for medical device manufacturers, customer service teams, and quality managers, ensuring effective communication, regulatory compliance, and continuous product improvement.
Download the ISO 13485:2016 Enquiries & Feedback Procedure Template today and enhance your customer interaction processes!
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Additional information
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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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