ISO 13485:2003

Who can apply for ISO 13485 certification?


ISO 13485 is applicable to all manufacturers and suppliers of medical devices, components, contract services and distributors of medical devices. For a number of markets ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices.


What is an ISO 13485 Quality Management System?

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.


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    What are the benefits of being certified to ISO 13485?

    Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.


    • Increase access to more markets worldwide with certification
    • Outline how to review and improve processes across your organization
    • Increase efficiency, cut costs and monitor supply chain performance
    • Demonstrate that you produce safer and more effective medical devices
    • Meet regulatory requirements and customer expectations

    Requirements of the ISO 13485 standard

    The ISO 13485 standard contains specific requirements for manufacture, installation and servicing and requires:


    • Risk management approach to product development and product realisation
    • Validation of processes
    • Compliance with statutory and regulatory requirements
    • Effective product traceability and recall systems
    • Implementation of a quality management system with several enhancements.