April 13, 2024

What is the difference between ISO 13485 and ISO 14971?

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The main difference between ISO 13485 and ISO 14971 is that ISO 13485 is a series of standards developed by the International Organization for Standardization for Medical Device Quality Management Systems. Whereas ISO 14971 is a set of guidelines developed by the ISO for the Application of Risk Management in Medical Devices.

ISO 13485 is focused on regulatory and customer requirements and for medical devices. As ISO 13485 requires risk analysis and record keeping pertaining to any risk, ISO 13485 looks to ISO 14971 for guidance. ISO 14971 is more detailed when it comes to risk management requirements.

ISO 14791 and ISO 13485:2016 are related because they work together to create a QMS that is functional and addresses risk. ISO 13485 is focused on regulatory and customer requirements and for medical devices. As ISO 13485 requires risk analysis and record keeping pertaining to any risk, ISO 13485 looks to ISO 14971 for guidance. ISO 14971 is more detailed when it comes to risk management requirements.

The main difference between ISO 13485 and ISO 14971 is that ISO 13485 is a series of standards developed by the International Organization for Standardization for Medical Device Quality Management Systems. The ISO released the first edition of ISO 13485 in 1996, which was restricted by numerous standardization standards. Whereas ISO 14971 is a set of guidelines developed by the ISO for the Application of Risk Management in Medical Devices. Since 1998, ISO 14971 has been around. The application of ISO 14971, however, did not begin until the year 2000.

ISO 13485 Foundation

ISO (International Organisation for Standardisation) is an independent, non-governmental, international organisation that develops standards to improve the quality, safety, and efficiency of products or services. ISO 13485 is an international standard that outlines the quality standards for organisations that design, develop, and manufacture medical devices. ISO 13485 Medical Devices Quality Management System allows organisations to demonstrate their ability to provide medical devices and related services that consistently meet their customers’ and regulatory requirements. Our ISO 13485 Foundation course also includes the exam to allow learners to test and establish their knowledge of the ISO 13485 standard learned during this course.

In our ISO 13485 Foundation course, learners will become familiar with the ISO 13485 standard, its importance in organisations, requirements, management responsibilities, risk management, etc. Learners will also get familiar with the implementation stages of ISO 13485, process mapping, the relationship between ISO 13485 and ISO 9001, among other important topics that will help learners get accustomed to the ISO 13485 standard. Our ISO 13485 Foundation Training course is designed by industry experts. Learners will get a thorough overview of the standard so they can easily pass their exam in the first attempt.

The new revision of ISO 13485 expands risk management to include processes such as purchasing and training. Section 4.2.1 states that, “The organization shall apply a risk-based approach to the control of the appropriate processes needed for the quality management system.” In other words, anything that affects the quality system needs to be viewed from that risk perspective. Although this may not be new, it is a reminder that risk is a major part of your QMS and needs to be addressed to achieve ISO 13485:2016 certification.

 

ISO 13485 is an international Quality Management System (QMS) standard that helps organisations to efficiently design and manufacture various medical devices. This standard allows professionals to ensure the quality of medical devices and related services that can continuously meet client needs and appropriate administrative requirements. Requirements of ISO 13485 can be applied to organisations regardless of their type and size. ISO 13485 training enables individuals to plan, lead, and report audits within their organisation successfully.

 

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What is the difference between ISO 13485 and ISO 14971?
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What is the difference between ISO 13485 and ISO 14971?
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The main difference between ISO 13485 and ISO 14971 is that ISO 13485 is a series of standards developed by the International Organization for Standardization for Medical Device Quality Management Systems. Whereas ISO 14971 is a set of guidelines developed by the ISO for the Application of Risk Management in Medical Devices.
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