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Medical Device Risk Management Audit Checklist

A comprehensive checklist for auditing risk management processes in medical device development and production, ensuring compliance with ISO 13485 and ISO 14971 standards and improving overall product safety and effectiveness.

Medical Device Risk Management Audit Checklist

by: audit-now
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About This Checklist

The Medical Device Risk Management Audit Checklist is an indispensable tool for healthcare organizations to ensure compliance with ISO 13485 and ISO 14971 standards in risk management processes. This comprehensive checklist addresses crucial aspects of identifying, analyzing, evaluating, and controlling risks associated with medical devices throughout their lifecycle. By implementing robust risk management practices, manufacturers can enhance product safety, improve device reliability, and maintain regulatory compliance. This checklist aids in systematically evaluating risk assessment methodologies, risk control measures, and ongoing risk monitoring activities, ultimately contributing to improved patient safety and reduced potential for harm in the healthcare industry.

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Industry

Healthcare

Standard

ISO 13485 - Medical Device Quality Management

Workspaces

Medical Device Manufacturing Facilities

Occupations

Risk Management Specialist
Quality Assurance Manager
Design Engineer
Clinical Affairs Specialist
Regulatory Affairs Manager
1
Is there a documented process for hazard identification related to medical devices?

Please indicate if the process is documented.

To ensure all potential hazards are systematically identified.
2
How often is risk analysis conducted for medical devices?

Select the frequency of the risk analysis.

To determine if risk analysis is performed regularly.
3
Are appropriate risk control measures implemented for identified risks?

Select the status of risk control measures.

To ensure that identified risks are controlled effectively.
4
Is there a process in place to evaluate the impact of risks on patient safety?

Indicate if such a process exists.

To ensure patient safety is considered in risk management.
5
Is the risk management plan for the medical device readily available and up to date?

Select the availability status of the risk management plan.

To ensure that the plan is accessible and reflects current practices.
6
Are all risk assessments documented appropriately?

Indicate if all risk assessments are documented.

To ensure that there is a record of all risk assessments conducted.
7
Are there training records available for personnel involved in risk management processes?

Select the status of training records.

To verify that staff are adequately trained in risk management.
8
Is there a periodic review of risk management records conducted?

Select the review frequency.

To ensure that risk management practices are regularly evaluated.
9
Is risk management integrated into the product development lifecycle?

Indicate if risk management is integrated into development.

To assess whether risk management practices are embedded in development processes.
10
Are the implemented risk control measures effective in mitigating identified risks?

Rate the effectiveness of the risk control measures.

To evaluate the effectiveness of risk control measures.

1

2

3

4

5

11
Is there documented evidence of risk control plans for each identified risk?

Select the status of risk control plan documentation.

To ensure that there is a formal record for managing identified risks.
12
Are risks communicated effectively to all relevant stakeholders?

Select the effectiveness of risk communication.

To ensure that all stakeholders are informed about the risks.
13
Is the risk management process compliant with ISO 13485 and ISO 14971 standards?

Select the compliance status with ISO standards.

To confirm that the organization adheres to relevant ISO standards for risk management.
14
Are regular audits of the risk management process conducted?

Indicate whether regular audits are conducted.

To ensure that the risk management process is regularly reviewed and evaluated.
15
Are there documented corrective actions taken for any identified non-compliance issues?

Select the status of corrective actions.

To verify that appropriate actions are taken to address non-compliance.
16
Do all employees involved in risk management receive proper training?

Select the training compliance status.

To ensure that staff are adequately trained in risk management practices.
17
Are the objectives of the risk management process clearly defined and communicated?

Indicate if the objectives are defined and communicated.

To ensure that everyone understands the goals of the risk management process.
18
Is there a documented methodology for conducting risk assessments?

Select the documentation status of the risk assessment methodology.

To verify that a consistent approach is used for risk assessments.
19
Are relevant stakeholders involved in the risk management process?

Select the status of stakeholder involvement.

To ensure that all necessary perspectives are considered in risk management.
20
Is there a process in place to monitor identified risks over time?

Indicate if there is a monitoring process for risks.

To ensure that risks are actively monitored and managed.

FAQs

The checklist covers areas such as risk management planning, risk analysis techniques, risk evaluation criteria, risk control option analysis, residual risk assessment, risk management reporting, and post-production information handling.

It includes specific items to verify that all potential risks are identified, properly assessed, and effectively mitigated throughout the device lifecycle, from design and development to post-market surveillance.

The audit should involve cross-functional teams including risk management specialists, design engineers, clinical experts, quality assurance personnel, and regulatory affairs professionals to ensure a holistic approach to risk management.

Risk management audits should be performed at key milestones during product development, before major design changes, and at least annually for marketed devices to ensure ongoing effectiveness of risk control measures.

Inadequate risk management can lead to unforeseen device failures, patient injuries, product recalls, regulatory non-compliance, reputational damage, and significant financial losses for the manufacturer.

Benefits of Medical Device Risk Management Audit Checklist

Ensures compliance with ISO 13485 and ISO 14971 risk management requirements

Reduces potential for device-related adverse events and patient harm

Improves product design and performance through proactive risk mitigation

Enhances decision-making processes in medical device development and production

Facilitates regulatory approvals by demonstrating comprehensive risk management