What is ISO 13485?

Kid is doing a diabetes glucose level finger blood test. In background there are older, bigger devices. Modern, mini monitor in her hands. ISO 13485 is an international standard that outlines the requirements for a quality management system (QMS) for medical device manufacturers. The standard was first introduced in 1996 and has since been revised in 2003, 2016, and most recently in 2021. ISO 13485 is used by medical device companies worldwide to ensure that their products are safe and effective, and meet regulatory requirements.

The standard provides a framework for the development, implementation, and maintenance of a QMS that is specific to the medical device industry. ISO 13485 covers all aspects of the medical device lifecycle, from design and development to production, installation, and servicing. It also includes requirements for post-market surveillance, risk management, and documentation.

One of the key features of ISO 13485 is its focus on risk management. The standard requires companies to identify, assess, and mitigate risks associated with their medical devices throughout their lifecycle. This includes risks related to product design, production, and use, as well as risks associated with the supply chain and distribution.

ISO 13485 also requires companies to have a comprehensive quality manual that outlines their quality policies and procedures. The quality manual must be regularly reviewed and updated to ensure that it remains relevant and effective.

In addition, ISO 13485 requires companies to establish and maintain a document control system that ensures that all documents related to the QMS are controlled, distributed, and maintained properly. The standard also requires companies to maintain records related to the QMS, including records related to product design, production, and servicing.

Overall, ISO 13485 is a critical standard for medical device manufacturers who want to ensure that their products meet regulatory requirements and are safe and effective for use. By implementing a QMS that meets the requirements of ISO 13485, companies can demonstrate their commitment to quality and continuous improvement, which can help them gain a competitive advantage in the marketplace.

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