ISO 13485 vs ISO 14971: Difference and Comparison

In 1996, the ISO released the first edition of ISO 13485, which included various standardization parameters. The quality of medical devices is the primary focus of ISO 13485.

As a result, the emphasis is placed on quality. Since 1998, ISO 14971 has been in place. However, the ISO 14971 implementation procedure did not begin until 2000.

ISO 14971 is primarily concerned with the safety, security, and risk associated with the use of medical equipment.

Key Takeaways

  1. ISO 13485 is the international standard for medical device quality management systems, while ISO 14971 is the standard for risk management of medical devices.
  2. ISO 13485 focuses on quality management principles and regulatory compliance, while ISO 14971 provides guidelines for identifying, evaluating, and controlling risks associated with medical devices.
  3. Compliance with both standards is essential for ensuring the safety and effectiveness of medical devices.

ISO 13485 vs ISO 14971

ISO 13485 is an international standard that specifies the requirements for a quality management system specific to the medical device industry. ISO 14971, is a risk management standard for medical devices. It provides a framework and requirements for identifying, evaluating, and controlling risks.

ISO 13485 vs ISO 14971
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ISO 13485 is primarily concerned with medical equipment quality. As a result, the importance of quality is highlighted. ISO 13485 is an ISO 14971 subset.

For further clarity and advice, ISO 13485 relates to ISO 14971. The ISO 13485 standard highlights the need for certified firms to determine whether or not the quality system is being maintained and implemented properly.

ISO 13485 is used by enterprises involved in medical and associated services installation, manufacture, design, and service.

ISO 14971 focuses on medical device safety, security, and risk. ISO 14971 is a subset of ISO 13485 and is considered a parent set.

ISO 13485 includes some of the ISO 14971 norms and standards. The ISO 14971 standard provides a framework for evaluation, risk analysis, control, and review.

Production and post-production circumstances are also being monitored. ISO 14971 aids in the reduction of risk in medical equipment and management systems.

Comparison Table

Parameters of ComparisonISO 13485ISO 14971
TypeSubsetParent set
Refers toQuality management systemsApplication of risk management
Focuses uponQualitySafety, security
First publication1996 1998
PrinciplesA system approach to management, a process approach, fact-based decision-making process, continual improvement, people involvement, Customer focus.Risk management planning, risk evaluation, production & post-production activities, risk management review, risk control risk, risk analysis

What is ISO 13485?

The ISO 13485 standard is a subset of the ISO 14971 standard. For improved clarity and guidance, ISO 13485 relates to ISO 14971

According to ISO 13485, certified firms must assess if the quality system is being maintained and implemented successfully.

ISO 13485 is used by enterprises involved in the installation, manufacture, design, and servicing of medical and associated services.

The ISO released the first edition of ISO 13485 in 1996, which was bound with numerous standardization parameters. ISO 13485 is primarily concerned with the quality of medical devices.

As a result, the importance of quality is emphasized here.

ISO 13485 is a series of standards developed by the International Organization for Standardization for medical device quality management systems.

This certification, however, can be used by both external and internal parties.

What is ISO 14971?

ISO 14971 is a subset of ISO 13485 that is defined as a parent set. ISO 13485 incorporates some of the ISO 14971 regulations and requirements. ISO 14971 defines a framework for assessment, risk assessment, control, and review.

Production and post-production scenarios are also monitored.

The international standard ISO 14971 aids in the reduction of risk connected with medical equipment and management systems.

This certification recommends that to establish a successful risk management system, best practices should be followed.

ISO 14971 is a series of standards developed by the International Organization for Standardization (ISO) for risk management of medical devices.

Since 1998, ISO 14971 has been in use. The application of ISO 14971, on the other hand, did not begin until 2000.

The ISO 14971 standard is primarily concerned with the safety, security, and risk associated with the use of medical equipment.

Main Differences Between ISO 13485 and ISO 14971

  1. ISO 13485 refers to a set of standards set by the International Organization for standardization for the Quality management systems of medical devices. On the other hand, ISO 14971 refers to a set of standards set by the International Organization for standardization for the Application of risk management of medical devices.
  2. The first edition of ISO 13485, which was bound with several parameters of standardization, was published in the year 1996 by the ISO. On the other hand, ISO 14971 has been in existence since 1998. However, it was only in 2000 when the implementation process of ISO 14971 took place.
  3. ISO 13485 focuses mainly on the quality of medical devices. Hence, the quality is given emphasized here. On the other hand, ISO 14971 focuses mainly on the safety, security, and risk involved in the use of medical devices.
  4. ISO 13485 is defined as a subset of ISO 14971. ISO 13485 refers to ISO 14971 for better clarity and guidance. On the other hand, ISO 14971 is defined as a parent set of ISO 13485. Some of the rules and standards of ISO 14971 are available in ISO 13485.
  5. ISO 13485 emphasizes that certified organizations check if the maintenance and implementation of the quality system are done effectively or not. On the other hand, ISO 14971 establishes a framework for evaluation, risk analysis, control, review, monitoring of production and post-production scenarios as well.
  6. The organizations, which are involved in the installation, production, design, servicing of medical and related services make use of ISO 13485. However, external and internal parties can also make use of this certification as well. On the other hand, ISO 14971 helps in reducing the risk associated with medical devices and management systems. This certification suggests that best practices should be adopted to implement a successful risk management system.
References
  1. https://www.taylorfrancis.com/books/mono/10.1201/9781351000796/iso-13485-2016-complete-guide-quality-management-medical-device-industry-itay-abuhav
  2. https://search.proquest.com/openview/3dc123c21a9f07c03e3414b947059f0c/1?pq-origsite=gscholar&cbl=35812

Last Updated : 19 July, 2023

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