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ISO 14971 Risk Analysis Documentation Audit Checklist

A specialized audit checklist designed to assess the completeness, accuracy, and compliance of risk analysis documentation for medical devices as per ISO 14971 standards, ensuring robust record-keeping of the risk management process.

ISO 14971 Risk Analysis Documentation Audit Checklist

by: audit-now
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About This Checklist

The ISO 14971 Risk Analysis Documentation Audit Checklist is an essential tool for healthcare organizations and medical device manufacturers to ensure comprehensive and compliant documentation of the risk analysis process. This checklist guides auditors and quality professionals through the critical examination of risk analysis records, ensuring that all aspects of risk identification, estimation, and evaluation are properly documented as per ISO 14971 standards. By implementing this checklist, organizations can enhance the transparency, traceability, and defensibility of their risk management decisions, ultimately contributing to improved product safety and regulatory compliance.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Medical Device Company Offices and Document Control Centers

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
Risk Management Auditor
Medical Device Documentation Specialist
Compliance Officer
1
Is the risk analysis documentation available for review?
2
Describe the process for verifying risk assessments.
3
What is the total number of risks identified in the documentation?
Min: 0
Target: 0
Max: 1000
4
Are the risk management records compliant with ISO 14971?
5
How frequently are the risk assessments reviewed?
6
What strategies are in place for risk mitigation?
7
How many training sessions are conducted on risk assessment per year?
Min: 0
Target: 0
Max: 100
8
When was the last risk assessment conducted?
9
Is the latest risk assessment approved by the designated authority?
10
What are the limitations identified in the risk assessment?
11
What is the total residual risk score calculated?
Min: 0
Target: 0
Max: 100
12
When is the next risk assessment scheduled?
13
Is the risk analysis documentation complete with all required sections?
14
Describe how stakeholders are involved in the risk assessment process.
15
How many risk control measures have been implemented?
Min: 0
Target: 0
Max: 100
16
When was the last review of the risk documentation conducted?
17
What methodology was used for the risk assessment?
18
What procedures are in place for communicating risks?
19
What is the acceptance criteria for remaining risk?
Min: 0
Target: 0
Max: 100
20
When is the next review scheduled for the risk management plan?

FAQs

The main objective is to verify that all required risk analysis documentation is complete, accurate, and compliant with ISO 14971 standards, ensuring a thorough record of the risk management process for medical devices.

Risk analysis documentation audits should be conducted at least annually, as well as before major regulatory submissions, product changes, or in response to significant field events or recalls.

The checklist covers elements such as hazard identification, risk estimation methodologies, risk evaluation criteria, risk control options considered, and the rationale for accepting or mitigating risks.

By ensuring comprehensive and compliant documentation, the checklist helps prepare organizations for regulatory scrutiny, facilitating smoother submissions and approvals for medical devices.

The audit should be conducted by qualified individuals such as quality assurance managers, regulatory affairs specialists, or independent auditors with expertise in ISO 14971 and medical device risk management.

Benefits of ISO 14971 Risk Analysis Documentation Audit Checklist

Ensures completeness and accuracy of risk analysis documentation

Facilitates regulatory compliance and audit readiness

Improves traceability of risk management decisions

Enhances the quality and consistency of risk analysis across products

Supports continuous improvement of the risk management process