A comprehensive audit checklist designed to assess compliance with ISO 14971 standards for risk management in medical devices, covering all aspects of the risk management process from initial analysis to post-production monitoring.
ISO 14971 Medical Device Risk Management Audit Checklist
Get Template
About This Checklist
The ISO 14971 Medical Device Risk Management Audit Checklist is an essential tool for healthcare professionals and medical device manufacturers to ensure compliance with international standards for risk management in medical devices. This comprehensive checklist addresses the critical aspects of risk assessment, control, and monitoring throughout the product lifecycle. By implementing this checklist, organizations can effectively identify potential hazards, mitigate risks, and enhance patient safety. The systematic approach provided by this checklist helps streamline the audit process, ensuring thorough coverage of all relevant ISO 14971 requirements.
Learn moreIndustry
Standard
Workspaces
Occupations
FAQs
The primary purpose is to ensure compliance with ISO 14971 standards and facilitate a comprehensive risk management process for medical devices throughout their lifecycle.
This checklist should be used by quality assurance managers, regulatory affairs specialists, medical device engineers, and auditors in the healthcare and medical device manufacturing industries.
The frequency of audits may vary, but it is generally recommended to conduct a full ISO 14971 audit annually, with more frequent partial audits or reviews as needed, especially when introducing new products or significant changes.
The checklist covers key areas such as risk analysis, risk evaluation, risk control, overall residual risk acceptability, risk management review, and post-production information.
By ensuring a thorough risk management process, the checklist helps identify and mitigate potential hazards associated with medical devices, ultimately contributing to improved patient safety and reduced adverse events.
Benefits of ISO 14971 Medical Device Risk Management Audit Checklist
Ensures compliance with ISO 14971 standards for medical device risk management
Facilitates systematic identification and assessment of potential risks
Improves patient safety through comprehensive risk control measures
Streamlines the audit process for medical device manufacturers
Enhances documentation and traceability of risk management activities