ISO 13485 (Clause 7.6) - Risk Identification, Analysis, and Control for Equipment Template
ISO 13485 (Clause 7.6) - Risk Identification, Analysis, and Control for Equipment Template
Template Overview
Template Overview
Ensure accurate, reliable, and compliant equipment management in medical device manufacturing with our ISO 13485:2016 Clause 7.6 Risk Identification, Analysis & Control for Equipment Template. Proper risk assessment and control of measuring and monitoring equipment are crucial for maintaining product quality, safety, and regulatory compliance with ISO 13485:2016, ISO 14971, FDA 21 CFR Part 820, MDR, and IVDR.
Key Features
Key Features
✔ Pre-Formatted Risk Identification & Analysis Template – Covers key ISO 13485:2016 Clause 7.6 requirements.
✔ Risk Identification Checklist – Assess potential failures in measurement, calibration, and equipment performance.
✔ Risk Analysis & Scoring Matrix – Evaluate severity, likelihood, and impact of identified risks.
✔ Risk Control & Mitigation Strategies – Define corrective actions, preventive measures, and verification steps.
✔ Traceability & Compliance Documentation – Maintain audit-ready records for regulatory inspections.
✔ Equipment Performance & Monitoring Logs – Ensure ongoing compliance and quality assurance.
✔ Editable Digital Format – Fully customizable for different medical device classifications and equipment types.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is ideal for quality managers, calibration teams, and regulatory professionals, ensuring a structured, compliant, and effective approach to equipment risk management.
Download the ISO 13485:2016 Risk Identification, Analysis & Control for Equipment Template today and improve compliance, safety, and reliability!
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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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