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ISO 13485 Quality Management System

Updated: Jan 12, 2023

Medical Devices

Why Medical Devices Need It

Companies that produce medical devices must have quality management systems in place. However, did you know that suppliers are required to do so as well? With the Medical Design & Manufacturing (MD&M) West Medtech just wrapped up, we thought it timely to share some vital information about ISO 13485 certification.

Medical Device ISO 13485 Certification

ISO 13485 certification crucial for medical device manufacturers

This standard provides guidance and tools for companies to manage the quality of their products. ISO 13485 certification shows that a company has met the rigorous standards set by the International Organization for Standardization (ISO) standard. It demonstrates that a manufacturer has implemented a comprehensive quality management system and can provide safe and effective products.

What is the significance of ISO 13485?

Significance of ISO 13485

ISO 13485 is the globally recognized quality management system standard for medical devices. Any company that manufactures, processes, assembles, or packages medical devices intended for human use must have ISO 13485 certification in order to sell their products in many countries.

Although ISO 13485 is based on ISO 9000 quality management principles, it has additional requirements that are specific to the medical device industry. These requirements cover aspects of product design, development, production, storage, and shipping. ISO 13485 also addresses issues such as customer satisfaction, post-market surveillance, and product liability.

Having ISO 13485 certification demonstrates to customers, suppliers, and regulators that a medical device company is committed to quality and patient safety.

ISO 13485 Trivia and Interesting Facts:

ISO 13485 Trivia

Did you know?

  • ISO 13485 was first published in 1996 and has been revised several times since then. The most recent revision was published in 2016.

  • ISO 13485 is based on the ISO 9000 quality management standard, but with additional requirements specific to the medical device industry.

  • This standard is recognized in over 60 countries, including the US, Canada, Europe, and Japan.

  • It is a voluntary standard in some countries, but many companies choose to pursue it in order to show their commitment to quality and patient safety.

  • Getting ISO 13485 certification can be a lengthy and expensive process, but it can pay off in terms of new business and market access.

Micro Weld Inc: The Safe Choice for Welding

Safe Choice for Welding

We understand the importance of selecting a dependable and trustworthy ISO 13485 supplier for your medical device welding projects. When turn-around times are urgent, you must make informed, smart decisions. We've earned our place as the "safe choice" among customers.

Do you want to learn more about our ISO 13485 certification?

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