ISO 13485 (Clause 6.4) - Decontamination Record Template
ISO 13485 (Clause 6.4) - Decontamination Record Template
Template Overview
Template Overview
Maintain a clean and contamination-free environment with our ISO 13485:2016 Clause 6.4 Decontamination Record Template. Proper decontamination documentation is critical for ensuring product safety, compliance with regulatory standards, and contamination control in medical device manufacturing, storage, and handling. This structured template enables organizations to track, verify, and maintain decontamination records, ensuring compliance with ISO 13485:2016, MDR, IVDR, FDA, and GMP requirements.
Key Features
Key Features
✔ Pre-Formatted Decontamination Record Template – Covers key ISO 13485:2016 Clause 6.4 requirements.
✔ Decontamination Task Log – Track decontamination activities, dates, and responsible personnel.
✔ Equipment, Facility & Product Decontamination Records – Ensure all surfaces, tools, and workspaces meet hygiene standards.
✔ Approved Cleaning Agents & Methods Section – Record disinfectants, sterilization techniques, and procedures used.
✔ Risk Control & Contamination Prevention Section – Document safety measures and risk mitigations.
✔ Verification & Approval Sign-Off – Ensure compliance with internal quality control and regulatory inspections.
✔ Editable Digital Format – Fully customizable for different decontamination protocols and medical device classifications.
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 a structured, documented, and audit-ready decontamination process.
Download the ISO 13485:2016 Decontamination Record Template today and enhance contamination control and regulatory compliance!
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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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