ISO 13485 (Clause 7.4) - Storage & Handling Protocol Template
ISO 13485 (Clause 7.4) - Storage & Handling Protocol Template
Template Overview
Template Overview
Maintain compliance with ISO 13485:2016 Clause 7.4 – Purchasing and 7.5 – Production and Service Provision with our Storage and Handling Protocol Template. Proper storage, handling, and transportation are critical to ensuring the safety, quality, and performance of medical devices and components throughout their lifecycle. This template provides a structured approach to documenting and implementing controlled storage and handling procedures, reducing risks of contamination, damage, or non-conformity.
Key Features
Key Features
✔ Pre-Formatted Storage & Handling Protocol – Covers key ISO 13485:2016 Clause 7.4 & 7.5 requirements.
✔ Environmental Conditions Guidelines – Define temperature, humidity, and other storage conditions.
✔ Inventory Management & FIFO/FEFO System – Ensure proper stock rotation and traceability.
✔ Handling & Transport Procedures – Minimize risks of contamination and physical damage.
✔ Inspection & Record-Keeping Requirements – Maintain regulatory compliance and audit readiness.
✔ Roles & Responsibilities Section – Clearly define personnel responsibilities for handling materials.
✔ Editable Digital Format – Fully customizable for different medical devices and storage needs.
Why choose a QMS Template?
Why choose a QMS Template?
This user-friendly template is ideal for manufacturers, distributors, and quality teams, ensuring compliance, product safety, and regulatory readiness.
Download the ISO 13485:2016 Storage and Handling Protocol Template today and protect your medical devices with a compliant system!
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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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