3. ESTABLISH RISK MANAGEMENT FRAMEWORK

• Establish a process to manage and control the risks associated with your organization’s medical devices.

• Document your organization’s medical device risk management process.             

• Apply your risk management process to your organization’s medical devices.            

• Maintain your risk management process for every medical device throughout its entire life-cycle.

• Check whether your risk management process complies with this standard by inspecting the appropriate documents.

• Make sure that top management demonstrates a commitment to medical device risk management.

• Make sure that top management defines and documents a policy that governs and controls how risk acceptability criteria are established.                                                           

• Make sure that top management reviews the suitability of your risk management process at planned intervals.

• Make sure that your organization complies with Part 3.2 by inspecting the appropriate documents.

• Make sure that the people who perform risk management tasks have the knowledge and experience they need to carry out the tasks that have been assigned to them.

• Make sure that records are kept that document the qualifications of your risk management personnel.

3.4 RISK MANAGEMENT PLAN

• Plan your organization’s risk management activities.

  • Establish a risk management plan for each particular medical device under consideration.

• Document your medical device risk management plan.

  • Define the scope of your risk management activities.

  • Assign risk management responsibilities and authorities.

  • Specify management review requirements.

  • Establish risk acceptability criteria for each plan.

  • Describe how verification activities will be done for each medical device.                  

  • Explain how you plan to collect and review production and post production information for each medical device.

3.5 RISK MANAGEMENT FILE

• Establish a risk management file for each medical device.

• Use your risk management file to facilitate traceability.

  • Use your risk management file to record risk analysis results for each identified hazard.

  • Use your risk management file to record risk evaluation results for each identified hazard.

  • Use your risk management file to record risk control measures and results for each identified hazard.

  • Use your risk management file to record residual risk evaluation results for each identified hazard.

• Maintain a risk management file for each medical device.

  • Make sure that you will be able to assemble all referenced information in a timely fashion.

4. PERFORM A RISK ANALYSIS FOR EACH MEDICAL DEVICE

4.1 RISK ANALYSIS PROCESS

• Perform a risk analysis for each medical device.

  • Document your medical device’s intended use.

  • Identify your medical device’s possible hazards.

  • Estimate the risk for each hazardous situation.

• Record your risk analysis activities and results.

  • Use your risk management file to document your analytical activities and results.

  • Check whether your organization complies with Part 4.1 by inspecting your risk management file.

4.2 INTENDED USE AND SAFETY

• Use your risk management file to document the intended use or purpose of each particular        medical device under consideration.                          

• Identify those medical device characteristics that could potentially affect safety.                       

• Check whether your organization complies with Part 4.2 by inspecting your risk management file.

4.3 IDENTIFICATION OF HAZARDS

• Identify the hazards that could possibly affect the safety of your medical device.

• Document the known and foreseeable hazards that could affect the safety of your medical device.

• Use your risk management file to maintain the documents that identify and describe the hazards that could affect the safety of your medical device.

4.4 RISK ESTIMATION PROCESS

• Estimate the risk for each hazardous situation.

  • Consider every reasonably foreseeable sequence or combination of events that could result in a hazardous situation.

• Use your risk management file to record the results of your risk estimation activities.

  • Use your risk management file to record each hazardous situation.            

  • Use your risk management file to record the process or system you use to estimate risk.

• Check whether your organization complies with Part 4.4 by inspecting your risk management file.

5. EVALUATE RISK FOR EACH IDENTIFIED HAZARDOUS SITUATION

RISK EVALUATION PROCESS

• Study each hazardous situation and then use your risk acceptability criteria to decide if risk reduction is required in each and every case.

  • Skip Parts 6.2 to 6.6 whenever risk reduction is not required for a particular hazardous situation.

RISK EVALUATION RECORDS

• Use your risk management file to record the results of your risk evaluation activities.

  • Check whether your organization complies with Part 5 by inspecting your risk management file.

6. DEVELOP RISK CONTROLS WHENEVER RISK MUST BE REDUCED

6.1 RISK REDUCTION PROCESS

• Reduce risk whenever your risk is unacceptable.

  • Identify your risk control options (see Part 6.2).

  • Implement appropriate risk control options (see Part 6.3).

  • Evaluate your residual (remaining) risks (see Part 6.4).

  • Decide if benefits exceed residual risks (see Part 6.5).

  • Identify risks arising from risk controls (see Part 6.6).

  • Ensure that all risks were considered (see Part 6.7).

6.2 RISK CONTROL OPTION ANALYSIS

• Identify risk control measures that reduce risk to an acceptable level.

  • Consider your organization’s risk control options.

  • Determine whether or not risk reduction is practicable.

  • Select the most appropriate risk control measures.

• Use your risk management file to record the risk control measures you have chosen to implement.

  • Check whether your organization complies with Part 6.2 by inspecting your risk management file.

6.3 RISK CONTROL IMPLEMENTATION

• Implement all of your risk control measures.

• Verify that each risk control was actually implemented.

• Use your risk management file to record the results of your risk control verification activities.

• Check whether your organization complies with Part 6.3 by inspecting your risk management file.

6.4 RESIDUAL RISK EVALUATION

• Evaluate your residual risk (the risk left over after you’ve implemented your risk control measures).

  • Use your risk acceptability criteria to evaluate whether or not your residual risk is acceptable.

  • Use your risk management file to record the results of your residual risk evaluation.         

• Check whether your organization complies with Part 6.4 by inspecting your risk management file and the accompanying residual risk disclosure documents.

6.5 RISK-BENEFIT ANALYSIS

• Conduct a risk-benefit analysis of your residual risk whenever your residual risk is unacceptable and further risk control is impractical.                            

• Use your risk management file to record the results of your risk benefit analysis.

• Check whether your organization complies with Part 6.5 by inspecting your risk management file.

6.6 RISKS CREATED BY CONTROLS

• Review your risk control measures to see if they generate unintended consequences.

• Manage and control all new or modified risks whenever your risk profile changes.

• Use your risk management file to record the results of your risk control review.

• Check whether your organization complies with Part 6.6 by inspecting your risk management file.

6.7 COMPLETENESS OF RISK CONTROL

• Make sure that all hazards and all identified hazardous situations have been considered.

• Use your risk management file to record the results of your hazard and risk control completeness review.

• Check whether your organization complies with Part 6.7 by inspecting your risk management file.

7. EVALUATE THE RESIDUAL RISK POSED BY EACH DEVICE

OVERALL RESIDUAL RISK EVALUATION

• Evaluate the acceptability of your device’s residual risk.

  • Use your risk acceptability criteria to decide if your medical device’s overall residual risk is acceptable.

• Use your risk management file to record the results of your overall residual risk acceptability evaluation.

• Check whether your organization complies with Part 7 by inspecting your risk management file and the medical device’s accompanying documents.

8. REVIEW RISK MANAGEMENT PROCESS AND PREPARE REPORT

RISK MANAGEMENT REVIEW

• Make sure that responsibility for carrying out              risk management reviews has been assigned.           

  • Make sure that your risk management plan indicates who is responsible for reviews.

• Carry out a risk management review before you release your medical device for commercial distribution.

  • Review your risk management process.

RISK MANAGEMENT REPORT

• Prepare a risk management report before you release your medical device for commercial distribution.

  • Use your report to record the results of your risk management review.                     

• Check whether your organization complies with Part 8 by inspecting your risk management file.

9. MONITOR DEVICE DURING PRODUCTION AND POST-PRODUCTION

MEDICAL DEVICE MONITORING

• Establish a system to monitor medical devices
  during production and post-production phases.

  • Develop your medical device monitoring system.

  • Use your medical device monitoring system.

  • Document your medical device monitoring system.

  • Maintain your medical device monitoring system.

MONITORING YOUR MONITORING

• Check whether your organization complies with Part 9 by inspecting your risk management file and other appropriate documents.

Also see the NEW ISO 13485 2016 Standard for Medical Devices.

MORE ISO 14971 PAGES

Introduction to ISO 14971 Risk Management Standard

Plain English Medical Device Risk Management Definitions

Overview of Medical Device Risk Management Standard

Our Plain English Approach to Risk Management

RELATED LIBRARIES

ISO 19011 Auditing Library

ISO 31000 Risk Management Library

ISO 9001 2015 Quality Management Library

ISO 14001 2015 Environmental Management Library

ISO 13485 2016 Medical Device Quality Management Library

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Updated on September 16, 2021. First published on February 28, 2011.

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