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ISO 14971 Risk Management Audit Checklist

This checklist is designed to audit risk management processes in healthcare settings, ensuring compliance with ISO 14971 standards.

ISO 14971 Risk Management Audit Checklist
by: audit-now
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About This Checklist

The ISO 14971 Risk Management Audit Checklist is an essential tool for healthcare organizations to ensure compliance with international standards for risk management in medical devices. This checklist helps identify potential risks, assess their impact, and implement effective control measures. By using this checklist, healthcare facilities can enhance patient safety, improve regulatory compliance, and mitigate potential liabilities. Keywords: ISO 14971, risk management, healthcare compliance, medical device safety.

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Industry

Healthcare

Standard

ISO 14971

Workspaces

Hospital
Clinic
Healthcare Facility

Occupations

Risk Manager
Compliance Officer
Quality Assurance Specialist
Healthcare Administrator
Medical Device Engineer

Risk Management Process Evaluation

(0 / 5)

1
Have all relevant staff received training on risk management?

Indicate whether training has been completed.

To ensure that staff are adequately trained to manage risks.
2
How frequently are risk assessments conducted?

Select the frequency of risk assessments.

To ensure ongoing evaluation of risks in compliance with ISO 14971.
3
List the risk mitigation strategies implemented.

Provide a brief description of the strategies.

To evaluate the effectiveness of risk mitigation measures.
4
What is the total number of identified risks?

Enter the number of identified risks.

To assess the thoroughness of risk identification in the process.
Min: 0
Target: 0
Max: 100
5
Is the risk management policy compliant with ISO 14971?

Select the compliance status.

To ensure adherence to the standard for risk management in medical devices.
6
Is there a mechanism to gather feedback on risk control measures?

Indicate whether a feedback mechanism is in place.

To ensure a feedback loop exists for continuous improvement of risk controls.
7
How often are the risk control measures reviewed?

Select the review frequency for risk control measures.

To assess the regularity of reviews to maintain effective risk controls.
8
Describe the documentation for risk control measures.

Provide details regarding the documentation.

To ensure that adequate documentation exists for risk controls.
9
What is the assessed level of residual risk after controls?

Enter the level of residual risk (1-5 scale).

To determine the effectiveness of risk control measures in reducing risk.
Min: 1
Target: 1
Max: 5
10
What is the implementation status of the risk control measures?

Select the current status of risk control implementation.

To evaluate whether risk control measures are actively implemented.
11
Is there a mechanism for stakeholders to provide feedback on risks?

Indicate whether a feedback mechanism exists.

To ensure that stakeholders can voice their concerns or suggestions regarding risks.
12
How often is risk information communicated to stakeholders?

Select the frequency of risk communication.

To determine the regularity of risk updates provided to stakeholders.
13
What percentage of stakeholders are aware of the risks?

Enter the percentage of stakeholder awareness (0-100).

To measure the level of awareness among stakeholders regarding risks.
Min: 0
Target: 75
Max: 100
14
What channels are used for risk communication?

List the channels for risk communication.

To identify the methods employed for communicating risks.
15
How effective is the communication of risks to stakeholders?

Select the effectiveness level of risk communication.

To assess the clarity and impact of risk communication strategies.
16
Is there a peer review process for the risk analysis conducted?

Indicate whether a peer review process exists.

To ensure that risk analysis is subjected to peer evaluation for accuracy and completeness.
17
How often are the risk analysis techniques reviewed for effectiveness?

Select the frequency of reviewing analysis techniques.

To ensure that risk analysis methodologies remain current and effective.
18
Describe how the results of the risk analysis are documented.

Provide details on the documentation process.

To assess the thoroughness and accessibility of risk analysis documentation.
19
How many hours of training have staff received on risk analysis?

Enter the total hours of training on risk analysis.

To ensure that staff are adequately trained in risk analysis techniques.
Min: 0
Target: 10
Max: 100
20
What risk analysis methodology is employed in the facility?

Select the risk analysis methodology used.

To verify the use of appropriate risk analysis techniques according to ISO 14971.
21
Are stakeholders involved in the post-market surveillance process?

Indicate whether stakeholders are involved.

To ensure that feedback from users and stakeholders is integrated into risk monitoring.
22
How often are post-market reviews conducted?

Select the frequency of post-market reviews.

To ensure regular evaluation of product performance and safety.
23
What actions have been taken in response to reported issues?

Describe the actions taken for reported adverse events.

To evaluate the responsiveness of the organization to safety concerns.
24
How many adverse events have been reported since the product launch?

Enter the total number of adverse events reported.

To assess the safety and performance of the medical device based on real-world data.
Min: 0
Target: 5
Max: 1000
25
Is there a post-market surveillance process established for monitoring risks?

Select whether a post-market surveillance process is in place.

To ensure ongoing monitoring of risks associated with medical devices after market release.

FAQs

The purpose is to ensure compliance with ISO 14971 standards for risk management in medical devices.

Healthcare professionals involved in risk management and compliance should use this checklist.

It helps identify potential risks and implement control measures to mitigate them, enhancing patient safety.

Benefits include improved regulatory compliance, enhanced patient safety, and effective risk management.

This checklist can be applied in hospitals, clinics, and other healthcare facilities.

Benefits

Ensures compliance with ISO 14971 standards.

Enhances patient safety by identifying and mitigating risks.

Improves regulatory compliance and reduces potential liabilities.

Facilitates effective risk management processes.

Supports continuous improvement in healthcare safety.