Establishment of a Company-Wide Quality Management System

「Corrective actions in response to observations received from the U.S. Food and Drug Administration (FDA) in the second half of 2025 are making steady progress globally, and we continue constructive and highly transparent dialogue with the FDA. We are also making progress in resuming shipments of products affected by voluntary shipment suspensions.」

「To comply with quality and regulatory requirements for medical devices imposed by authorities in various countries and to strengthen quality assurance functions, we recorded ¥5,407 million in expenses for improvement activities, including complaint handling, medical device reporting (MDR), and process and design verification, under “Other expenses.”」

「Our Group will continue to improve operational quality globally and contribute to patient safety and peace of mind.」

「In April 2025, we established the Innovation & Safety (I&S) Committee as a new voluntary committee that also assumes the roles of the former Quality Assurance and Regulatory Affairs (QA&RA) Committee.」

「To comply with each country's quality regulations for medical devices and strengthen quality assurance functions, the company recorded ¥10,998 million under Other expenses for improvement activities including complaint handling, medical device reporting (MDR), and process and design validation.」

「We also integrated corrective actions in response to observations from the U.S. Food and Drug Administration (FDA) and the quality transformation project into a single comprehensive program and named it “Elevate.”」

「To comply with quality and regulatory requirements for medical devices imposed by authorities in various countries and to strengthen quality assurance functions, we recorded ¥16,989 million in expenses for improvement activities, including complaint handling, medical device reporting (MDR), and process and design verification, under “Other expenses.”」

「To comply with quality and regulatory requirements for medical devices imposed by authorities in various countries, including the U.S. FDA, and to strengthen quality assurance functions, we recorded ¥11,938 million in expenses for improvement activities, including complaint handling, medical device reporting (MDR), and process and design verification, under “Other expenses.”」

「To comply with quality and regulatory requirements for medical devices imposed by authorities in various countries, including the U.S. FDA, and to strengthen quality assurance functions, we recorded ¥5,013 million in expenses for improvement activities, including complaint handling, medical device reporting (MDR), and process and design verification, under “Other expenses.”」

「Since April 2023, we have established the Quality Assurance and Regulatory Affairs (QA&RA) Committee as a voluntary committee. The committee oversees and reports on progress in building the quality assurance and regulatory affairs (QA&RA) framework required of a global medtech company, from the perspectives of compliance with relevant laws and regulations, collaboration among internal functions, and securing resources, including personnel.」

「Across the Group, we will improve processes for corrective and preventive actions so that we can respond promptly to market changes while continuing regular audit and verification procedures, through the development of personnel and strengthening of capabilities in internal departments related to quality and regulatory affairs. We also conduct regular monitoring of medical policy and regulatory matters, provide management with status updates, ensure a thorough understanding of applicable laws and regulations, and provide regular training to employees engaged in related operations, including by sharing best practices.」

「Costs associated with sales growth in the medical field and outsourcing expenses related to strengthening the business operating infrastructure, including QARA, increased.」

「By appointing Global Process Owners to important quality processes, we began conducting quality activities consistently across regions based on global SOPs (Standard Operating Procedures).」

「In the medical field, we are hiring physicians in the United States, Europe, and Japan and continuing to improve our processes so that we can incorporate the opinions of experts, including physicians, globally and at an earlier stage regarding product safety and customer needs.」

「On 1 April 2020, through a company split, we transferred certain functions, including research and development, manufacturing, and repair planning, to Olympus Medical Systems Corporation, our wholly owned subsidiary, in order to strengthen the structure for maintaining effective governance and appropriate quality in our quality and regulatory affairs functions.」

「To strengthen our quality and regulatory affairs functions, our Representative Executive Officer, President and CEO decided on 20 December 2019 to have certain functions, including research and development, manufacturing, and repair planning, transferred to Olympus Medical Systems Corporation, our wholly owned subsidiary, and to enter into an absorption-type company split agreement with OMSC.」

「In addition, based on the medium-term management plan (16CSP), we advanced the strengthening of quality and regulatory affairs functions in terms of both organizational structure and systems. Globally, we further increased staffing in the quality and regulatory affairs division, particularly for the medical business, and strengthened regulatory compliance, product registration functions, and post-market safety management.」

「During the consolidated fiscal year, we revised the Olympus Group Quality Policy so that it would serve as a code of conduct prioritizing quality with a greater emphasis on safety, and took steps to ensure that quality management systems in all businesses and regions were maintained and improved in accordance with the policy. In addition, based on 16CSP, we advanced the strengthening of quality and regulatory affairs functions in terms of both organizational structure and systems. Globally, we significantly increased staffing in the quality and regulatory affairs divisions, particularly for the medical business, and strengthened regulatory compliance, product registration functions, and post-market safety management.」

「Under the medium-term management plan that began in April 2016, we are working to strengthen our company-wide quality management system and quality assurance framework in anticipation of expanding our medical business, in order to realize our management vision of “contributing to society by realizing the health, security and peace of mind, and spiritual richness of people around the world.”」

「In April 2015, we established the Quality and Product Regulatory Affairs Division by consolidating the quality assurance functions of our internal business divisions. To support the realization of “One Olympus” through the matrix-style business operations launched in April of the same year, we are advancing the development of a company-wide quality management system.」