- Quality Assurance
- Quality Management System
- Appropriate Communication
- Valuing Bioethics in Evaluating Product Efficacy and Safety
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.
The Olympus Group has established the Olympus Global Quality Policy based on its corporate philosophy. We continue to implement measures to instill quality policy standards in our daily operations for all members to foster a mindset that emphasizes safety and quality.
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 revised in fiscal year 2021, 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.
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.
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.
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
Olympus and its Japan subsidiaries may conduct animal research to develop medical equipment, assess product efficacy and safety, and promote the correct usage of the products. We are keen to ensure that the research we carry out is ethical from both the scientific and animal welfare viewpoints, because we value the lives of animals.
Olympus and its Japan subsidiaries introduced their animal research corporate rules based on the Act on Welfare and Management of Animals, Basic Guidelines for Animal Research in Institutions under Management of the Ministry of Health, Labour and Welfare and other related laws and guidelines. We established the Institutional Animal Care and Use Committee (IACUC) based on the animal research corporate rules to rigorously review all our animal research plans and ensure that they are based on the 3Rs of animal testing —Replacement (of animal testing with alternative methods), Reduction (of the number of animals to be used), and Refinement (of the testing method to minimize animals' suffering).
We are committed to the ethical and humane handling of the animals used in our research, paying extra attention to their physical and psychological wellbeing. Self-inspections are also conducted, verifying our compliance with the research corporate rules for animal research. Our practice is accredited under the Accreditation of Laboratory Animal Care and Use by the Japan Pharmaceutical Information Center.