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ISO 14971 Medical Device Risk Management Audit Checklist

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

by: audit-now
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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.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Medical Device Manufacturing Facilities

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
Medical Device Engineer
Risk Management Specialist
Healthcare Auditor
1
Is the risk management process compliant with ISO 14971?
2
How many risk control measures have been implemented?
Min: 0
Target: 5
Max: 100
3
Are all risk management documents up to date?
4
How frequently are risk assessments conducted?
5
Please provide a summary of the latest risk assessment conducted.
6
What is the classification of the highest risk identified?
7
Has user feedback been incorporated into the risk management process?
8
On a scale of 1-5, how effective are the implemented risk control measures?
Min: 1
Target: 4
Max: 5
9
Is there a training program in place for risk communication related to medical devices?
10
How often is the risk communication training conducted?
11
What was the average feedback score from participants in the latest training session?
Min: 1
Target: 4
Max: 5
12
What improvements have been suggested by participants for the risk communication training?
13
When was the last risk review conducted?
14
What is the established frequency for monitoring identified risks?
15
Have corrective actions been implemented for any identified risks?
16
How many outstanding risk issues are currently unresolved?
Min: 0
Target: 2
Max: 100
17
Is there an active quality assurance program in place for the medical devices?
18
How many internal audits are conducted per year?
Min: 1
Target: 4
Max: 12
19
Provide a summary of recent non-conformance reports.
20
Has management actively participated in quality assurance reviews?

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