ISO 13485 Quality Management System Made Simple

ISO 13485 is the international standard outlining the quality management criteria medical device manufacturers must meet to demonstrate compliance with regulatory requirements. Developed by the International Organization for Standardization (ISO), compliance with ISO 13485 demonstrates a company’s commitment to ensuring the consistent safety, effectiveness and compliance of its medical devices.

ISO 13485:2016 is the latest iteration of the 13485 standard and is the version currently used for compliance purposes. ISO standards are reviewed every five years to ensure relevance to the current market.

ISO 13485 certification is a voluntary process that requires an organization’s quality management system to pass a third-party Medical Device Single Audit Program (MDSAP) audit. Being officially certified for ISO 13485 demonstrates to customers and regulators that your medical device products reliably meet stringent quality standards.

ISO 13485 is not mandatory in the United States; however it is mandatory in several other countries, including most of Europe, Canada, Japan and Australia. The U.S. FDA also recently published a final rule amending its medical device quality requirements to bring them more in line with ISO 13485, effective February 2026.

ISO 13485 is a quality standard specific to medical devices. It is based on the more general quality management standard of ISO 9001, however ISO 13485 is a more stringent guideline with a greater focus on patient safety. The major differences between ISO 13485 and ISO 9001 include:

• Framework for implementing risk management procedures
• Rigorous document control throughout product lifecycle
• Greater environmental safety and prevention of contamination
• Required clinical and performance evaluations
• Methods for collecting customer feedback
• Product realization has a more significant impact in 13485 and greater record requirements