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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
4.4

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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 - Medical Device Risk Management

Workspaces

Healthcare Facility
Clinics
Hospitals

Occupations

Risk Manager
Compliance Officer
Quality Assurance Specialist
Healthcare Administrator
Medical Device Engineer
1
Is the risk management policy compliant with ISO 14971?
2
What is the total number of identified risks?
Min: 0
Target: 0
Max: 100
3
List the risk mitigation strategies implemented.
4
How frequently are risk assessments conducted?
5
Have all relevant staff received training on risk management?
6
What is the implementation status of the risk control measures?
7
What is the assessed level of residual risk after controls?
Min: 1
Target: 1
Max: 5
8
Describe the documentation for risk control measures.
9
How often are the risk control measures reviewed?
10
Is there a mechanism to gather feedback on risk control measures?
11
How effective is the communication of risks to stakeholders?
12
What channels are used for risk communication?
13
What percentage of stakeholders are aware of the risks?
Min: 0
Target: 75
Max: 100
14
How often is risk information communicated to stakeholders?
15
Is there a mechanism for stakeholders to provide feedback on risks?
16
What risk analysis methodology is employed in the facility?
17
How many hours of training have staff received on risk analysis?
Min: 0
Target: 10
Max: 100
18
Describe how the results of the risk analysis are documented.
19
How often are the risk analysis techniques reviewed for effectiveness?
20
Is there a peer review process for the risk analysis conducted?
21
Is there a post-market surveillance process established for monitoring risks?
22
How many adverse events have been reported since the product launch?
Min: 0
Target: 5
Max: 1000
23
What actions have been taken in response to reported issues?
24
How often are post-market reviews conducted?
25
Are stakeholders involved in the post-market surveillance process?

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 of ISO 14971 Risk Management Audit Checklist

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.