ISO 13485 (Clause 7.5) - Installation Work Instruction Template
ISO 13485 (Clause 7.5) - Installation Work Instruction Template
Template Overview
Template Overview
Achieve compliance with ISO 13485:2016 Clause 7.5 – Production and Service Provision with our Installation Work Instruction Template. This document provides a structured format to ensure medical devices are installed correctly, consistently, and in compliance with regulatory requirements, minimizing errors and improving customer satisfaction.
Key Features
Key Features
✔ Pre-Formatted Installation Procedure – Covers key ISO 13485:2016 Clause 7.5 requirements.
✔ Step-by-Step Installation Instructions – Ensures standardized processes for all installations.
✔ Roles & Responsibilities Section – Defines accountability for personnel involved.
✔ Equipment & Environmental Requirements – Document tools, conditions, and safety considerations.
✔ Testing & Verification Checklist – Ensures installation is correctly performed and validated.
✔ Customer Handover & Documentation Section – Confirm compliance and end-user training completion.
✔ Editable Digital Format – Fully customizable for different medical devices and company processes.
Why choose a QMS Template?
Why choose a QMS Template?
This Installation Work Instruction Template is ideal for medical device manufacturers, quality teams, and service providers, ensuring compliance with ISO 13485 and EU MDR/IVDR requirements while maintaining high-quality installation standards.
Download the ISO 13485:2016 Installation Work Instruction Template today and streamline your installation processes with confidence!
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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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