ISO 13485 (Clause 7.4) - Quality Inspection Goods Out (Medical Device Name) Template
ISO 13485 (Clause 7.4) - Quality Inspection Goods Out (Medical Device Name) Template
Template Overview
Template Overview
Ensure compliance with ISO 13485:2016 Clause 7.4 – Purchasing and 7.5 – Production and Service Provision by implementing a structured Goods Out Quality Inspection process. This Quality Inspection – Goods Out Template helps medical device manufacturers ensure that products leaving the facility meet regulatory, quality, and safety requirements before distribution.
Key Features
Key Features
✔ Pre-Formatted Quality Inspection Checklist – Covers key ISO 13485:2016 Clause 7.4 & 7.5 requirements.
✔ Final Product Verification Section – Ensure product conformity before dispatch.
✔ Packaging & Labeling Compliance – Verify correct labeling, UDI, and regulatory markings.
✔ Inspection Criteria & Acceptance Criteria – Standardized checks for product release.
✔ Defects & Non-Conformity Reporting Section – Identify and document any issues.
✔ Traceability & Documentation Requirements – Ensure full audit readiness.
✔ Editable Digital Format – Fully customizable for different medical devices and business processes.
Why choose a QMS Template?
Why choose a QMS Template?
This user-friendly template is essential for quality teams, warehouse staff, and regulatory personnel, ensuring product safety, compliance, and customer satisfaction before distribution.
Download the ISO 13485:2016 Quality Inspection – Goods Out Template today and implement a robust, compliant inspection 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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Contact Us
For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.