How to Get ISO 14971 Certification

Globally Recognized Standard

ISO 14971 is recognized in over 100 countries, making it the most widely accepted risk management standard for medical devices globally. It provides a common framework for risk management across international medical device supply chains.

Regulatory Compliance

ISO 14971 is a prerequisite for CE marking under the EU MDR and IVDR, and is a key requirement for FDA QSR (21 CFR 820). Certification supports compliance with global regulatory requirements and streamlines market access.

Lifecycle Risk Management

ISO 14971 provides a systematic framework for managing risks throughout the entire device lifecycle, from design and development through production, post-production, and eventual decommissioning, ensuring ongoing patient safety.

Patient Safety & Trust

Certification signals to regulators, healthcare providers, and patients that your organization has robust risk management controls and a commitment to patient safety, building trust and strengthening market position.

1. Risk Analysis

Identify and describe hazards, estimate risks for each hazardous situation, and evaluate risks to determine which require treatment. This is the foundation of the risk management process and requires systematic hazard identification.

2. Risk Evaluation

Compare estimated risks against risk acceptability criteria. Determine if risks are acceptable without further controls, or if risk control measures are required. Document the risk evaluation for each hazardous situation.

3. Risk Control

Implement risk control measures to reduce risks to acceptable levels. Verify the effectiveness of controls and evaluate residual risk. Conduct a risk/benefit analysis if residual risks remain unacceptable.

4. Overall Residual Risk Evaluation

Evaluate the overall residual risk after all risk control measures have been implemented. Determine if the overall residual risk is acceptable based on criteria established in the risk management plan.

5. Risk Management Report

Document the results of the risk management process in a comprehensive risk management report. This report summarizes all activities and findings and is a key document for regulatory submissions.

6. Production & Post-Production Activities

Monitor and review risk management information throughout the device lifecycle. Use feedback from production and post-market surveillance to identify new hazards, update risk assessments, and improve the device.

Inherent Safety by Design

Eliminate or reduce hazards through design changes. This is the most effective risk control measure. Examples: using low-voltage components, eliminating sharp edges, or designing failsafe mechanisms.

Protective Measures

Implement protective measures in the device or manufacturing process to reduce risk. Examples: guards, shields, alarms, software interlocks, or process controls that prevent or detect hazards.

Information for Safety

Provide information to users about residual risks and how to avoid them. Examples: warnings in labeling, instructions for use, training requirements, or contraindications.

Verification of Controls

Verify that each risk control measure is effective and does not introduce new hazards. Verification can include testing, inspection, analysis, or other appropriate methods. Document verification results.

Residual Risk Evaluation

For each hazard, evaluate the residual risk after risk control measures have been implemented. Determine if the residual risk is acceptable based on the risk acceptability criteria.

Risk/Benefit Analysis

If residual risk remains unacceptable, conduct a risk/benefit analysis to weigh the benefits of the device against the residual risk. Document the analysis and justification for accepting the risk.

Set Up the Audit Program

Develop an audit schedule and methods for planning and preparing your audits. Create documents, forms, and checklists that support the audit process. Consider using lead auditor training that includes a module on managing the audit program.

Appoint Qualified Auditors

Auditors should be objective and impartial, they cannot audit their own work. They should have knowledge of ISO 14971, medical device risk management, and auditing techniques. Consider using external auditors with medical device experience.

Provide Auditor Training

Auditors must be familiar with the ISO 14971:2019 standard, possess strong auditing skills, be capable of reporting findings and following up on corrective actions, and ideally, promote best practices and add operational value.

Start Audits Early

Use internal audits as training tools to support implementation. You can start auditing during implementation, focusing on specific requirements or processes initially, and expanding the scope as the system matures. This early start helps identify and fix issues before the formal certification audit.

Conduct a Complete Internal Audit

To be eligible for ISO 14971 certification, you must complete a comprehensive internal audit covering your entire risk management system. The audit can be divided into multiple partial audits, focusing on specific devices or processes at a time. Address all identified nonconformities before proceeding to the certification audit.

Outsource If Needed

If you lack internal audit expertise, you can outsource the pre-certification internal audit to experienced auditors. This ensures that all issues with your risk management system are identified and addressed, increasing confidence in passing the certification audit.

Accreditation Status

Ensure the registrar is accredited by a recognized national accreditation body (e.g., UKAS, ANAB, DAKKS, JAS-ANZ). Accreditation ensures the registrar follows international standards for certification and is competent to audit medical device risk management systems.

Medical Device Experience

Choose a registrar with auditors who have specific experience in the medical device industry and ISO 14971 auditing. They will understand your device types, regulatory requirements, and risk management challenges, leading to a more relevant and valuable audit.

Regulatory Recognition

Consider whether the registrar is recognized by your regulatory authorities (e.g., Notified Bodies under MDR, FDA) and whether their certificates are accepted by your customers and regulators. In some markets, specific registrars are preferred or required.

Cost & Value

Compare quotes from multiple registrars. The cheapest option is not always the best, consider the value of the audit, the auditor’s expertise, and the registrar’s reputation. Ensure you understand what is included in the quoted fee (e.g., travel expenses, annual surveillance audits).

Global Capability

If you have or plan to have multiple sites in different countries, choose a registrar that can audit all sites consistently. This simplifies the management of your certification across locations and avoids the need to work with multiple registrars.

Relationship & Support

Choose a registrar you feel comfortable working with. The relationship should be collaborative, not adversarial. A good auditor will help you improve your risk management system, not just find faults. Assess their responsiveness and communication during the quoting process as an indicator.

Incomplete Hazard Identification

Failing to identify all potential hazards, especially those related to use errors, software failures, or combination products. This leads to incomplete risk analysis and regulatory compliance issues.

Avoid: Use systematic hazard identification methods (e.g., checklist, FMEA, FTA). Involve the full multidisciplinary team. Consider the entire device lifecycle, including manufacturing and disposal. Use ISO/TR 24971:2020 guidance.

Unjustified Risk Acceptability Criteria

Setting risk acceptability criteria without proper justification, or using criteria that are not aligned with regulatory expectations. This undermines the credibility of the risk management system.

Avoid: Document the basis for your risk acceptability criteria. Consider industry norms and regulatory guidance. Review criteria periodically and update as needed.

Lack of Traceability

Failing to maintain traceability from hazard identification through risk control to the risk management report. This makes it difficult to demonstrate compliance and can be a focus of regulatory audits.

Avoid: Use a traceability matrix to link hazards, risk controls, and verification activities. Maintain clear documentation that connects all elements of the risk management process.

Neglecting Post-Market Risk Management

Failing to conduct production and post-production risk management activities, including monitoring feedback, identifying new hazards, and updating risk assessments.

Avoid: Establish a process for collecting and analyzing post-market data. Integrate risk management with your post-market surveillance system. Update the risk management file based on new information.

Lack of Management Commitment

When leadership does not actively support the risk management system, it becomes a compliance exercise rather than a strategic initiative, leading to poor implementation and audit failures.

Avoid: Secure top management commitment from the start. Ensure they understand the business case for certification and communicate their support visibly to the organization.

Inadequate Documentation

Creating documentation that is incomplete, poorly organized, or lacks sufficient detail for regulatory submissions. This can lead to delays and non-conformities during certification audits.

Avoid: Use templates and standardized formats. Ensure documentation is complete, clear, and well-organized. Maintain the risk management file as a controlled document with proper version control. For documentation best practices, see our ISO 9001 guide.

Ignoring Risk/Benefit Analysis

Failing to conduct a risk/benefit analysis when residual risks are not acceptable based on criteria, or not documenting the justification for accepting residual risks.

Avoid: Establish a clear process for risk/benefit analysis. Document the analysis and justification. Consider clinical data and patient outcomes in the analysis.