Sysmex has constructed a system to ensure compliance with laws and regulations around the world based on the Quality Policy, the Core Behavior and the Sysmex Corporation Quality Compliance Policy, and we act accordingly.
All of Sysmex’s production facilities* have obtained certification under the international standards ISO 9001 or ISO 13485.
In addition, we regularly hold the Global RAQA (regulatory affairs/quality assurance) Meeting, at which people in charge of quality assurance at Group companies in Japan and overseas gather. In this way, we are working to share quality information throughout the Group and reinforce our structure.
Used in laboratory testing, Sysmexʼs products play a vital role in protecting peopleʼs lives and good health. Being fully aware of this responsibility, Sysmex is making constant efforts to maintain and improve product quality by building various systems, not to mention complying with safety standards around the world at the design and development stages.
In the product development stage, we verify product quality by setting five "quality gates" in the process leading up to market launch. Also, when we market products that are manufactured by others, we verify their quality by conducting audits of the manufacturers and meticulously inspecting the products. As well as these efforts, in the unlikely event of a defective product we have systems in place to quickly identify and respond to the problem.
At factory sites, each month we monitor manufacturing processes and the status of supplier nonconformities. We designate appropriate quality improvements at suppliers with high nonconformity rates, and have a system of ensuring quality through regular quality audits. In addition, our global quality complaint processing system allows us to gather quality information in a timely way from markets around the world. When we receive information about a bug or malfunction, we immediately look into the cause and cease distribution of the product. Sharing information globally about bugs and malfunctions, as well as corrective and preventive actions, helps us maintain and enhance product quality.
In addition to quality policy education for all employees, Sysmex Corporation conducts basic and specialized quality education targeting specific departments and job types. In fiscal 2017, we conducted training on good vigilance practice (GVP) for safety management employees in charge of manufacturing and sales. This training was aimed at gathering safety management information related to the causes of health hazards and ensuring an accurate understanding of how to use this information. Being a company that provides products and services in more than 190 countries and regions around the world, we conduct education on individual countriesʼ regulatory systems for engineers in development divisions, making a thorough effort to develop products in accordance with laws and regulations.