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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

Workspaces

Medical Device Manufacturing Facility

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
Medical Device Engineer
Risk Management Specialist
Healthcare Auditor

Medical Device Risk Management Questions

(0 / 4)

1
How frequently are risk assessments conducted?

Select the frequency of risk assessments.

To determine if risk assessments are performed regularly to ensure patient safety.
2
Are all risk management documents up to date?

Provide details of the documentation review.

To ensure that all documentation reflects current practices and regulations.
3
How many risk control measures have been implemented?

Enter the number of measures.

To verify the adequacy of risk control measures in place.
Min: 0
Target: 5
Max: 100
4
Is the risk management process compliant with ISO 14971?

Select compliance status.

To ensure adherence to international standards for risk management.
5
On a scale of 1-5, how effective are the implemented risk control measures?

Rate the effectiveness of risk control measures.

To assess the effectiveness of the control measures in place.
Min: 1
Target: 4
Max: 5
6
Has user feedback been incorporated into the risk management process?

Indicate if user feedback has been included.

To ensure that the perspectives of users are considered in risk management.
7
What is the classification of the highest risk identified?

Select the classification of the highest risk.

To ensure that the highest risk is adequately classified and prioritized.
8
Please provide a summary of the latest risk assessment conducted.

Enter a detailed summary of the risk assessment.

To document and evaluate the outcomes of the most recent risk assessment.
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9
What improvements have been suggested by participants for the risk communication training?

List any suggested improvements.

To gather insights for enhancing the training program.
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10
What was the average feedback score from participants in the latest training session?

Enter the average feedback score (1-5).

To evaluate the effectiveness of the training program based on participant feedback.
Min: 1
Target: 4
Max: 5
11
How often is the risk communication training conducted?

Provide details on the frequency of training.

To ensure that training is conducted regularly to keep staff updated.
12
Is there a training program in place for risk communication related to medical devices?

Select the training program status.

To ensure that all relevant personnel are trained in risk communication practices.
13
How many outstanding risk issues are currently unresolved?

Enter the number of unresolved risk issues.

To assess the backlog of unresolved risks that need attention.
Min: 0
Target: 2
Max: 100
14
Have corrective actions been implemented for any identified risks?

Indicate if corrective actions have been implemented.

To verify that appropriate measures are taken to mitigate identified risks.
15
What is the established frequency for monitoring identified risks?

Select the frequency of risk monitoring.

To confirm that there is a defined schedule for ongoing risk monitoring.
16
When was the last risk review conducted?

Select the date of the last risk review.

To ensure that risk reviews are performed regularly as part of the risk management process.
17
Has management actively participated in quality assurance reviews?

Indicate if management has participated.

To confirm that top management is engaged in the quality assurance process.
18
Provide a summary of recent non-conformance reports.

Detail the non-conformance reports and their status.

To review and analyze non-conformance issues for continuous improvement.
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19
How many internal audits are conducted per year?

Enter the number of internal audits conducted annually.

To ensure that internal audits are performed regularly to assess compliance and quality.
Min: 1
Target: 4
Max: 12
20
Is there an active quality assurance program in place for the medical devices?

Select the status of the quality assurance program.

To ensure that a quality assurance program is established and maintained to meet compliance requirements.

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

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