Goods In, Goods Out & Preservation of Product Procedure - ISO 13485

Maintain full control over incoming and outgoing materials with our ISO 13485:2016 Clause 7.4 Goods In, Goods Out & Preservation of Product Procedure Template. Proper handling, storage, and traceability of medical device components and finished products are critical to ensuring product quality, regulatory compliance, and patient safety. This structured procedure template provides a standardized approach to managing goods receipt, shipment, and preservation, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Procedure for Goods In & Goods Out – Covers key ISO 13485:2016 Clause 7.4 & 7.5 requirements.

✔ Incoming Goods Inspection & Acceptance Criteria – Ensure supplier materials meet specifications before use.

✔ Storage & Handling Guidelines – Define temperature, humidity, and contamination controls for preservation.

✔ Goods Out Process & Shipping Verification – Maintain full traceability of outgoing medical devices.

✔ Non-Conformance & Rejection Process – Outline steps for handling defective or damaged goods.

✔ Record-Keeping & Audit Compliance – Maintain structured documentation for regulatory inspections.

✔ Editable Digital Format – Fully customizable for different supply chain and manufacturing environments.

This ready-to-use procedure template is essential for quality managers, warehouse teams, and regulatory professionals, ensuring structured, compliant, and effective material handling.

Download the ISO 13485:2016 Goods In, Goods Out & Preservation of Product Procedure Template today and enhance supply chain traceability and compliance!