ISO 14971 vs. ISO 24971

Attribute	ISO 14971	ISO 24971
Scope	Medical devices - Application of risk management to medical devices	Medical devices - Application of risk management to medical devices
Definition of risk	Potential for harm	Potential for harm
Risk management process	Systematic process for identifying, assessing, evaluating, and controlling risks	Systematic process for identifying, assessing, evaluating, and controlling risks
Risk analysis	Identification of hazards and estimation of risk	Identification of hazards and estimation of risk
Risk evaluation	Comparison of estimated risk against criteria	Comparison of estimated risk against criteria
Risk control	Implementation of measures to reduce risk	Implementation of measures to reduce risk

Introduction

ISO 14971 and ISO 24971 are both international standards that provide guidance on risk management for medical devices. While they share similar goals, there are some key differences between the two standards that are important for manufacturers to understand. In this article, we will compare the attributes of ISO 14971 and ISO 24971 to help clarify the distinctions between the two.

Scope

ISO 14971 is a standard specifically focused on the application of risk management to medical devices. It provides a framework for identifying, evaluating, and controlling risks throughout the entire lifecycle of a medical device. On the other hand, ISO 24971 is a more general standard that applies to any organization, regardless of industry, that wishes to implement a risk management system. While ISO 14971 is tailored specifically for medical devices, ISO 24971 can be applied to a wider range of products and services.

Requirements

ISO 14971 outlines specific requirements for risk management in the medical device industry. These requirements include conducting a risk analysis, evaluating the acceptability of risks, and implementing risk control measures. The standard also emphasizes the importance of documenting and reviewing risk management activities throughout the lifecycle of a medical device. In contrast, ISO 24971 provides a more general framework for risk management, with less prescriptive requirements. Organizations are encouraged to adapt the standard to their specific needs and context.

Integration with Quality Management Systems

ISO 14971 is designed to be compatible with ISO 13485, the international standard for quality management systems in the medical device industry. This integration allows manufacturers to align their risk management processes with their quality management systems, creating a more cohesive approach to product development. ISO 24971, on the other hand, does not have the same level of integration with quality management systems. While organizations can still integrate risk management with their quality processes, ISO 24971 does not provide specific guidance on how to do so.

Documentation

Both ISO 14971 and ISO 24971 emphasize the importance of documenting risk management activities. However, ISO 14971 provides more detailed guidance on the specific documentation requirements for risk management in the medical device industry. This includes documenting risk management plans, risk analyses, risk evaluations, and risk control measures. ISO 24971, on the other hand, is less prescriptive when it comes to documentation. Organizations are encouraged to document their risk management processes in a way that is appropriate for their specific context.

Implementation

ISO 14971 provides a structured approach to implementing risk management in the medical device industry. The standard outlines a series of steps that manufacturers should follow to identify, evaluate, and control risks associated with their products. This includes establishing a risk management process, conducting risk assessments, and monitoring the effectiveness of risk control measures. ISO 24971, on the other hand, takes a more flexible approach to implementation. Organizations are encouraged to adapt the standard to their specific needs and context, rather than following a strict set of guidelines.

Conclusion

While ISO 14971 and ISO 24971 both provide guidance on risk management, there are some key differences between the two standards. ISO 14971 is specifically tailored for the medical device industry, with detailed requirements for risk management in this context. ISO 24971, on the other hand, is a more general standard that can be applied to a wider range of products and services. Manufacturers should carefully consider the requirements and scope of each standard to determine which is most appropriate for their organization.