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ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry, including in vitro diagnostics (IVDs). This chapter outlines its regulatory relevance, structure, and implementation requirements, emphasizing risk management, documentation, and process control across the product lifecycle. It details the roles of legal manufacturers, suppliers, and service providers, and explains certification procedures and benefits. Practical guidance is provided on aligning ISO 13485 with other standards, managing outsourced processes, and ensuring compliance with EU regulations such as IVDR. The chapter serves as a comprehensive resource for establishing and maintaining a robust, audit-ready QMS.

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ISO 13485: The Mandatory Quality System for IVD Manufacturers

  • 章节

  • 发表日期：

    2026年

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  • Sven Hoffmann

摘要

ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry, including in vitro diagnostics (IVDs). This chapter outlines its regulatory relevance, structure, and implementation requirements, emphasizing risk management, documentation, and process control across the product lifecycle. It details the roles of legal manufacturers, suppliers, and service providers, and explains certification procedures and benefits. Practical guidance is provided on aligning ISO 13485 with other standards, managing outsourced processes, and ensuring compliance with EU regulations such as IVDR. The chapter serves as a comprehensive resource for establishing and maintaining a robust, audit-ready QMS.