GlossaryEN1 min readUpdated: Jun 25, 2026
ISO 13485 Certification for Freight
Freight forwarders and warehouse operators handling medical devices are frequently required by their principals to hold ISO 13485 certification.
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Source: https://www.iso.org/standard/59752.html
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Definition & Explanation
Freight forwarders and warehouse operators handling medical devices are frequently required by their principals to hold ISO 13485 certification. ISO 13485 is an internationally recognised standard specifying quality management system requirements for organisations involved in the design, manufacture, or – extending into the supply chain – handling and transport of medical devices. For logistics providers, certification means demonstrating documented procedures for temperature control, safe handling, traceability, and risk management throughout the transport chain. Manufacturers of diagnostics, implants, and active medical devices regularly make the certification a contractual prerequisite for logistics partnerships and a tool for meeting regulatory expectations in destination markets. ISO 13485 complements general quality standards such as ISO 9001 but is not interchangeable with them: its scope is confined to the regulated medical device environment.
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