What are the requirements of the ISO 14971 standard?
ISO 14971, Medical devices – Application of risk management to medical devices, specifies requirements for a risk management system (RMS) that allows medical device manufacturers (MDs):
- to identify
- to evaluate and
- to control the risks associated with medical devices
The requirements of the ISO 14971 standard are divided into 10 chapters (articles). The 134 requirements are in Chapters 4 through 10. The chapters cover the following areas:
1. Scope
The standard specifies requirements that apply to manufacturers at all stages of the life cycle of a medical device (MD). The standard applies to all MD manufacturers, regardless of their size, sector of activity or location.
2. Normative references
The standard references other relevant international standards and guidelines (such as ISO/TR 24971 and ISO/IEC Guide 63:2019).
3. Terms and definitions
The standard defines terms used in the context of ISO 14971.
4. General requirements for risk management system
Top management shall:
- Apply a risk management process
- Document the results of the risk management process. The documentation must include the following:
- the risk management policy
- the risk management process
- risk identification results
- the results of the risk evaluation
- risk control measures
- results of monitoring and review
- Provide proof of its commitment
- Determine necessary staff skills
- Plan the risk management plan
- Create the risk management file
5. Risk analysis
The manufacturer shall
- Apply the risk analysis process
- Document the intended use of the medical device and also any misuse
- Identify the characteristics likely to affect the safety of the MD
- Identify hazards and hazardous situations
- Estimate the risks
6. Risk evaluation
The manufacturer shall:
- Evaluate the risks for each hazardous situation
- Define if the risk is acceptable
- Carry out risk management activities
7. Risk management
The manufacturer shall:
- Analyze risk management options
- Implement risk control measures
- Evaluate residual risks
- Analyze the benefit-risk ratio
- Examine the effects of the control measures applied
- Review all risk control activities
8. Evaluation of overall residual risk
The manufacturer shall:
- Evaluate the overall residual risk of the MD
- Inform users of significant residual risks
9. Risk management review
The manufacturer shall:
- Review the execution of the risk management plan
- Entrust review to persons with appropriate authority
10. Production and post-production activities
The manufacturer shall:
- Collect the information:
- production and post-production
- monitoring the production process
- user-generated
- generated by maintenance
- generated by the supply chain
- accessible to the public
- relating to the state of the art
- Review the collected information
- Take appropriate actions
- Check the compliance of the risk management file
ISO 14971 certification offers many benefits to medical device manufacturers, including:
- Patient safety: ISO 14971 certification allows manufacturers to ensure that their products are safe for patients
- Effectiveness of medical devices: ISO 14971 certification allows manufacturers to ensure that their products are effective in meeting patient needs
- Compliance with regulatory requirements: ISO 14971 certification demonstrates that the manufacturer complies with applicable regulatory requirements
- Improved brand image: ISO 14971 certification can improve the manufacturer's brand image and enable it to gain the trust of patients, healthcare providers and other stakeholders
ISO 14971 certification is a valuable tool for medical device manufacturers. It allows manufacturers to ensure that their products are safe and effective.
