This JIS standard specifies quality management system (QMS) requirements for medical devices across their entire lifecycle, from design and development through manufacturing, storage, distribution, installation, servicing, and disposal, corresponding to ISO 13485:2016. The document establishes the foundational QMS framework required for medical device manufacturers to obtain manufacturing and sales licenses and manufacturing registration under Japan's Pharmaceutical Affairs Law (Yakuhin Kikai Hou). Manufacturers must establish documented procedures for design control, risk management, supplier management, production and process controls, verification and validation, nonconforming product management, corrective and preventive actions, and post-market surveillance. The standard emphasizes management responsibility, resource provision, competence and training, and management review to ensure consistent product quality and safety. Organizations must maintain traceability, manage changes, and implement effective management of product recalls. This QMS standard serves as the regulatory foundation integrating all other technical standards (IEC 62304, ISO 14971, IEC 62366-1) into a coordinated governance structure.