ISO 13485 (Clause 6.3) - Cleaning Schedule and Record Template
ISO 13485 (Clause 6.3) - Cleaning Schedule and Record Template
Template Overview
Template Overview
Ensure a clean, hygienic, and compliant medical device manufacturing environment with our ISO 13485:2016 Clause 6.3 Cleaning Schedule & Record Template. Proper facility cleanliness is essential to maintaining product quality, safety, and regulatory compliance. This structured template helps organizations plan, document, and monitor cleaning activities, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA requirements.
Key Features
Key Features
✔ Pre-Formatted Cleaning Schedule & Record Template – Covers key ISO 13485:2016 Clause 6.3 requirements.
✔ Cleaning Task Schedule – Define daily, weekly, and monthly cleaning activities for different areas.
✔ Equipment & Facility Cleaning Log – Record cleaning dates, personnel, and cleaning agents used.
✔ GMP & Contamination Control Guidelines – Align with best practices for cleanroom environments and controlled areas.
✔ Inspection & Verification Section – Ensure cleaning activities are completed and signed off.
✔ Corrective Action Log – Document non-conformities and corrective actions taken.
✔ Editable Digital Format – Fully customizable for different medical device production facilities.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is ideal for facility managers, quality teams, and compliance officers, ensuring consistent, documented, and audit-ready cleaning practices.
Download the ISO 13485:2016 Cleaning Schedule & Record Template today and maintain a hygienic, compliant manufacturing environment!
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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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