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Product Safety Assurance Policy and Structure

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 and repair products, in addition to taking other actions regarding any product-related issues.

■Ensuring product safety
Each company in the HOYA Group provides, where appropriate, 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 assurance structure

At the HOYA Group, under the supervision of the executive officer in charge, each business division has product safety assurance functions. For businesses falling under the Life Care segment, which handles healthcare and medical products, we have established a division at the head office in charge of regulations, quality, and government affairs across these businesses.

■Quality management system for healthcare and medical products
In the operation of our divisions that manufacture and sell healthcare and medical products, we implement a quality management system based on ISO 13485 to ensure quality control. Additionally, the Division in charge of regulations, quality and government affairs oversees the appropriateness and effectiveness of the quality and safety of healthcare and medical products in each division, in accordance with the Japanese Pharmaceutical Affairs Law, European and U.S. laws and regulations, and risk management systems. The HOYA Group continuously reviews and improves its management systems, monitoring organizations, and internal training programs as needed.

■Healthcare Compliance Committee
The HOYA Group established the Healthcare Compliance Committee with the objective of obtaining the thorough compliance with laws, ordinances, standards and norms, both in Japan and overseas, required of healthcare products. Composed of three independent directors who are knowledgeable about the healthcare field, the Healthcare Compliance Committee conducts monitoring of the status of the relevant business divisions’ responses to regulations and other matters. Obtaining advice as necessary from specialists with expert knowledge of the laws and ordinances in each country with respect to healthcare products, each member of the Healthcare Compliance Committee offers proposals and advice to each business division for whose regulatory response he or she is responsible.

Quality Management System

The HOYA Group has acquired international quality management system ISO9001 (mainly for the Information Technology business) or ISO13485 (mainly for the Life Care business) focusing on major production bases in each business and is making efforts to improve the safety and quality of its products.

*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.