What is the latest version of ISO 13485?

ISO 13485:2016 is the third and current edition of the international medical-device quality-management-system standard. It was published in March 2016 and was most recently reviewed and confirmed in 2025, meaning ISO determined that it remained suitable without issuing a replacement edition.

The edition should be written as ISO 13485:2016 in quality manuals, certification statements, supplier requirements, audit reports, and contracts. A company should not describe itself simply as “ISO certified,” because this does not identify either the standard or edition.

The 2016 edition strengthened attention to:

• Regulatory requirements across multiple jurisdictions
• Risk-based control of quality-system processes
• Supplier and outsourced-process controls
• Design transfer and product realization
• Process, software, sterilization, and packaging validation
• Complaint handling and regulatory reporting
• Traceability and post-production activities

Regional adoptions may use different prefixes or include regional amendments. For example, an EN adoption used in Europe may contain European annexes addressing relationships with EU regulatory requirements. These regional documents should not be confused with a new international ISO edition.

ISO’s official listing confirms that ISO 13485:2016 remains current. Organizations should monitor ISO, their national standards body, regulators, accreditation bodies, and certification bodies for future revisions or transition instructions. At present, references to “ISO 13485:2026” as a replacement edition would be incorrect.