ISO 13485 (Clause 6.4) - Contamination Control Procedure Template
ISO 13485 (Clause 6.4) - Contamination Control Procedure Template
Template Overview
Template Overview
Maintain a controlled and contamination-free environment for medical device manufacturing with our ISO 13485:2016 Clause 6.4 Contamination Control Procedure Template. Contamination control is essential for ensuring product safety, regulatory compliance, and quality assurance in cleanrooms, controlled environments, and production areas. This structured procedure template helps organizations implement and document best practices in hygiene, cleanliness, and contamination prevention, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA regulations.
Key Features
Key Features
✔ Pre-Formatted Contamination Control Procedure – Covers key ISO 13485:2016 Clause 6.4 requirements.
✔ Contamination Risk Assessment & Mitigation – Identify potential contamination sources and preventive actions.
✔ Cleanroom & Controlled Environment Guidelines – Define cleaning protocols, air quality control, and gowning requirements.
✔ Personnel Hygiene & Training Requirements – Ensure employees follow best practices to prevent contamination.
✔ Monitoring & Compliance Checks – Establish inspection routines and corrective actions for non-conformities.
✔ Traceability & Documentation – Maintain audit-ready contamination control records.
✔ Editable Digital Format – Fully customizable for different medical device manufacturing settings.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is ideal for manufacturers, quality managers, and compliance teams, ensuring consistent, effective, and audit-ready contamination control.
Download the ISO 13485:2016 Contamination Control Procedure Template today and safeguard your medical device production 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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