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Product Responsibility

Basic Approach and Policy

In response to the growing social demand for high-quality and safe products and services, the Olympus Group is working to improve the quality and safety of its products and services and provide reliable services that satisfy our customers.

Quality Assurance

The Olympus Group has established the Olympus Global Quality Policy based on its corporate philosophy. We continue to implement measures to instill quality policy in our daily operations for all members to foster a mindset that emphasizes safety and quality.

Olympus Global Quality Policy

Promotion Structure

Quality Management System

The Olympus Group, with its Chief Quality Officer (CQO) and QARA division members of each region, review and improve their worldwide work processes. As a result, the Olympus Group business divisions and subsidiaries have actively been obtaining and maintaining the international quality control standards, such as ISO 13485 certification. Based on the global management rules, QARA members regularly report to executive officers and CQO who are top of quality and regulatory functions, to clarify companywide issues. In addition, we conduct group internal quality audits aimed at monitoring the status of each quality management system from an objective perspective to get hold of the status of each organization to promote improvement.

Initiatives

Creating a Safety- and Quality-Oriented Corporate Culture

Olympus Group recognizes that it is essential for Olympus employees to act with a mindset to always prioritize customers and patient's safety and security by implementing activities to foster an organizational culture that emphasizes safety and security of our customers and patients. As examples of these activities, the Olympus Group implements a Quality Month initiative and various seminars and e-learning programs, actively creating opportunities for employees to reaffirm the fact that their day-to-day work leads to the safety and security of Olympus Group customers and patients.

Appropriate Communication

(Case 1)

In order to comply with the Laws concerning environmentally related substances for Olympus Group Products and to reduce environmental impact, we collect information on handling of environmentally related substances and trends in laws and regulations in each country, As a consequence, we have established the "Control Rules for Environment-related Substances Used in Product" in our group products. The rules are published on our website.

(Case 2)

Olympus offers advanced information on endoscopes, and diagnostic test using endoscopes and techniques through a membership website "Medical Town" for medical professionals. Medical safety information, such as corrective actions, recall letters regarding Olympus equipment and warnings are available to non-members to ensure greater transparency.

Valuing Bioethics in Evaluating Product Efficacy and Safety

At Olympus, our purpose is to make people’s lives healthier, safer, and more fulfilling. In line with this mission, we are committed to the safe and ethical use of animals in our research and development processes. By adhering to industry standards and regulatory requirements, we ensure that our medical devices are rigorously tested for safety and efficacy. This responsible approach not only minimizes risks to patients but also upholds the highest ethical standards in animal welfare. Through these efforts, we strive to advance medical technology while maintaining our dedication to ethical practices and patient safety.

When the use of animals is necessary, Olympus supports a replacement, reduction, and refinement strategy as outlined by Russell & Burch’s seminal 3R’s Principle.1,2

  • Replacement is the preferred use of non-animal methods over animal methods whenever it is possible to achieve the same scientific aims.
  • Reduction is the use of methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.
  • Refinement is the use of methods that alleviate or minimize potential pain, suffering or distress, and enhance animal welfare for the animals used.

All research activities involving animals are conducted in accordance with the respective country rules such as requisite approval from the relevant Institutional Animal Care and Use Committee (IACUC) and in accordance with the United States Animal Welfare Act, the National Academy of Sciences Guide for the Care and Use of Laboratory Animals, the Accreditation of Laboratory Animal Care and Use by the Japan Pharmaceutical Information Center, the Act on Welfare and Management of Animals, the Basic Guidelines for Animal Research in Institutions under Management of the Ministry of Health, Labour and Welfare, and other related laws and guidelines.

In terms of training, our mission to improve patient outcomes necessitates comprehensive training for healthcare professionals. Whenever possible, we use inanimate methods such as simulation systems, tissue models, and extensive didactic instruction. When alternatives are not available or adequate, we adhere to the same rigorous ethical and quality standards for animals used in research and development. We comply with international guidelines, including the World Medical Association’s Declaration of Helsinki, which stipulates the need for animal studies before any human exposure.

Through these efforts, we strive to advance medical technology while maintaining our dedication to ethical practices and patient safety.

＊１ Russell, W M. S, and Rex L. Burch. The Principles of Humane Experimental Technique. London: Methuen, 1959. Print.

＊２ National Research Council. 2011. Guide for the Care and Use of Laboratory Animals: Eighth Edition. Washington, DC: The National Academies Press.