Product Safety
and
Quality

Product Safety Assurance Policy

Legal Compliance
Each company in the HOYA Group complies with the standards required of products in Japan and elsewhere around the world. We also comply with laws, regulations, and other standards related to product quality and safety.

Collecting and Responding to Product Incident Information
Each company in the HOYA Group collects information from customers and other sources related to product incidents and/or malfunctions. When necessary, we provide legally mandated reports to regulatory agencies and appropriate information to customers and others. We enact measures to recall products, repair products, in addition to taking other actions regarding any product-related issues.

Ensuring Product Safety
Each company in the HOYA Group provides user training, up-to-date user guides and documents, product warning labels, and other information for the effective, safe use of our products. We continue to seek opinions from users of our products and reflect this feedback in future products.

Training and Educational Systems to Improve Product Safety and Quality
Each company in the HOYA Group strives to improve product safety and quality. To accomplish this goal, we conduct ongoing education and training activities. At the same time, each Group company performs reviews and updates to product safety and quality management organizations and systems.

Product Safety and Quality Management Structure

Product safety and quality are managed by each business unit under the supervision of the Executive Officer responsible, with management systems tailored to the nature of each business. In the Life Care segment, the division at the head office in charge of regulations, quality, and government affairs oversees quality management and regulatory compliance across the businesses.

Healthcare Compliance Committee

The HOYA Group has established the Healthcare Compliance Committee to ensure thorough compliance with domestic and overseas laws, regulations, standards and other requirements applicable to its healthcare products (our Life Care product portfolio). The Committee is composed of Outside Directors with expertise in the healthcare field and monitors regulatory compliance within the relevant business divisions. Drawing on advice from specialists familiar with the laws and regulations applicable in the relevant countries when necessary, the Committee provides recommendations and guidance to the management teams responsible for regulatory compliance. In addition, the details of deliberations by the Committee are reported by the Committee Chairperson to the Board of Directors, thereby strengthening the governance framework.

Quality Management System

The HOYA Group positions product safety and quality as the foundation of its business activities and has established a management system based on international quality management systems, including ISO 9001 (mainly for the Information Technology business) and ISO 13485 (mainly for the Life Care business). We have obtained certifications mainly at major production sites and are working to strengthen our quality assurance systems across all processes, from product design and manufacturing to sales.

The Internal Audit Department conducts audits approximately once a year of the quality management systems of the Life Care businesses overseen by the division in charge of regulations, quality, and government affairs at the Group headquarters, evaluating their operational status and effectiveness. Based on audit findings, the business divisions implement continuous improvements. The audit results are reported by the Internal Audit Department to the Audit Committee and shared with the Board of Directors, ensuring monitoring from an independent perspective.

With regard to product safety, we comply with domestic and international laws and regulations and industry standards. We collect and analyze information regarding product accidents and defects and promptly take necessary measures, such as reporting to regulatory authorities and conducting product recalls or modifications. We also incorporate customer feedback and requests into product and service improvement activities, striving for continuous enhancement of quality.

To support these initiatives, we continuously provide education and training on product safety and quality management to improve employee awareness and expertise, while continuously reviewing and improving our quality management systems.

Status of ISO Certification

*1 The number in parentheses is the change from the previous fiscal year.

*2 Refers to the percentage of production sites eligible for certification that have completed certification.

For information on our acquisition status of ISO certification, please refer to this page.

Animal Experimentation

For some Life Care products, animal experimentation may be necessary during the development process. The HOYA Group has established internal policies and procedures for each business based on relevant laws, regulations and industry guidelines. Prior to conducting animal experiments, internal reviews are carried out in accordance with the 3Rs principles: Replacement (use of alternative methods), Reduction (reduction in the number of animals used), and Refinement (minimization of pain and distress to animals).