ISO 13485 Requirements

Medical devices are key to helping improve the quality of life for millions of people. As governments around the world begin to prioritize health care expenditures, it’s no surprise that medical device manufacturers are also expecting their regulatory requirements to become more stringent over time. The International Organization for Standardization (ISO) has developed a comprehensive set of guidelines referred to as ISO 13485 which would provide an efficient and cost-effective way for medical device manufacturers to meet market requirements. Continue reading this blog to find out more about the ISO 13485 requirements.

ISO 13485 Requirements

About the ISO 13485 Standard

Before going into detail about the ISO 13485 requirements, let us first examine the ISO 13485 standard. The ISO 13485 standard is a quality management system standard that is specifically designed for medical device manufacturers. The standard helps these manufacturers to ensure that their devices are safe and effective. The ISO 13485 standard is not just for large medical device manufacturers. It is also applicable to small and medium-sized businesses. In fact, the standard is designed to be scalable, so that it can be tailored to meet the needs of any size business.

ISO 13485 Requirements – Defined

The ISO 13485 requirements are extensive, and they cover all aspects of the manufacturing process of medical devices. In order to achieve ISO 13485 certification, a medical device manufacturer must demonstrate that it meets all ISO 13485 requirements. The ISO 13485 requirements may be used by medical device manufacturers worldwide to integrate an effective Quality Management System (QMS).

ISO 13485 Requirements – A Breakdown

The ISO 13485 requirements are divided into two main sections:

  • Management requirements – The management requirements cover topics such as organizational structure, risk management, and quality management system.
  • Technical requirements – The technical requirements focus on areas such as design and development, production and quality assurance, and post-market surveillance.

ISO 13485 Requirements – Risk Management

One of the most important aspects of the ISO 13485 standard is its emphasis on risk management. Risk management is a critical part of any quality management system, and it is especially important in the medical device industry. The ISO 13485 requirements mandate that medical device manufacturers identify and assess all risks associated with their devices. They must then put in place controls to mitigate these risks.

ISO 13485 Requirements – Quality Management

Another key area of the ISO 13485 standard is quality management. The standard requires medical device manufacturers to establish and implement a quality management system that meets the requirements of the standard. This system must be designed to ensure that all devices are safe and effective.

ISO 13485 Requirements – Design and Development

One of the most important aspects of the ISO 13485 standard is its emphasis on design and development. The standard includes requirements that ensure that design and development processes are effective. These requirements help to ensure that medical devices adhere to all applicable regulations, as well as any industry standards, throughout the entire product life cycle.

ISO 13485 Requirements – Outputs

There are several key outputs of an ISO 13485 compliant Quality Management System (QMS). These include:

  • Written procedures – The ISO 13485 requirements ensure that all businesses develop and maintain written procedures. These procedures must be documented in a systematic manner, and they should provide step-by-step instructions for completing tasks throughout the business process.
  • Training records – Under the ISO 13485 standard, medical device manufacturers must keep records of any training that they provide to their employees.
  • Controlled documents – The ISO 13485 requirements mandate that medical device manufacturers control all documentation throughout the entire product life cycle. This means that necessary documentation must be reviewed and approved before it is used in order to reduce the chance of errors.

Overview of ISO 13485 Requirements to Achieve ISO 13485 Certification

Medical devices manufacturers who want to have their products certified to ISO 13485 must comply with a number of requirements. The most important ISO 13485 requirements are listed below.

  • Establish and maintain a quality management system (QMS) that meets the ISO 13485 requirements.
  • Design and manufacture products that meet the relevant regulatory requirements and customer requirements.
  • Have a process in place for verifying that the product meets ISO 13485 requirements.
  • Ensure that all personnel involved in the design and manufacture of medical devices are trained on the relevant aspects of ISO 13485.
  • Establish and maintain effective processes for corrective and preventive action.
  • Maintain records of the design and manufacture of products, and the results of any verification and validation activities.
  • Periodically review the QMS to ensure that it continues to meet the ISO 13485 requirements.

ISO 13485 Requirements – Conclusion

As can be seen, the ISO 13485 requirements are extensive. All medical device manufacturers are expected to comply with these requirements in order to receive ISO Certification. The ISO 13485 requirements are rigorous, but they are also essential for ensuring the safety and effectiveness of medical devices. Achieving certification is not easy, but it is well worth the effort. By complying with the ISO 13485 requirements, medical device manufacturers can be confident that their products meet the highest standards of quality.

Contact IAS today to learn more about the ISO 13485 requirements or visit our ISO 13485 requirements frequently asked questions page!