A specialized audit checklist designed to assess the completeness, accuracy, and compliance of risk analysis documentation for medical devices as per ISO 14971 standards, ensuring robust record-keeping of the risk management process.
ISO 14971 Risk Analysis Documentation Audit Checklist
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About This Checklist
The ISO 14971 Risk Analysis Documentation Audit Checklist is an essential tool for healthcare organizations and medical device manufacturers to ensure comprehensive and compliant documentation of the risk analysis process. This checklist guides auditors and quality professionals through the critical examination of risk analysis records, ensuring that all aspects of risk identification, estimation, and evaluation are properly documented as per ISO 14971 standards. By implementing this checklist, organizations can enhance the transparency, traceability, and defensibility of their risk management decisions, ultimately contributing to improved product safety and regulatory compliance.
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Ensures completeness and accuracy of risk analysis documentation
Facilitates regulatory compliance and audit readiness
Improves traceability of risk management decisions
Enhances the quality and consistency of risk analysis across products
Supports continuous improvement of the risk management process
