ISO 13485 (Clause 6.3) - Cleaning Protocol Template
ISO 13485 (Clause 6.3) - Cleaning Protocol Template
Template Overview
Template Overview
Maintain regulatory-compliant cleanliness in your medical device production facility with our ISO 13485:2016 Clause 6.3 Cleaning Protocol Template. Proper cleaning and hygiene protocols are essential for ensuring product safety, quality, and compliance with ISO 13485:2016, MDR, IVDR, and FDA regulations. This structured template provides a standardized approach to cleaning and sanitation, ensuring consistent, documented, and audit-ready procedures for all controlled environments.
Key Features
Key Features
✔ Pre-Formatted Cleaning Protocol – Covers key ISO 13485:2016 Clause 6.3 requirements.
✔ Defined Cleaning Procedures – Step-by-step instructions for cleaning equipment, workspaces, and production areas.
✔ Cleaning Frequency & Responsibilities Section – Assign tasks to responsible personnel.
✔ Approved Cleaning Agents & Methods – Ensure safe and effective use of disinfectants.
✔ GMP & Contamination Control Compliance – Align with cleanroom and controlled environment best practices.
✔ Inspection & Verification Checklist – Confirm adherence to cleaning requirements.
✔ Editable Digital Format – Fully customizable for different medical device manufacturing environments.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is ideal for quality managers, facility teams, and compliance officers, ensuring consistent cleaning practices and regulatory compliance.
Download the ISO 13485:2016 Cleaning Protocol Template today and maintain a safe, hygienic, and audit-ready facility!
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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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