Used in laboratory testing, Sysmex’s products play a vital role in protecting people’s lives and health. Being fully aware of this responsibility, Sysmex is making constant efforts to maintain and improve product quality by building a variety of systems, as well as complying with safety standards around the world in the design and development stages.
In the product development stage, we verify product quality by setting five “quality gates” in the processes leading up to market launch. We also conduct quality- and safety-related risk assessment during the design and development phases of a new product, as well as when changes are made to the design of an existing product. If any high-risk event is noted, we act to reduce that risk. Also, when we market products that are manufactured by others, we verify their quality by conducting audits of the manufacturers and meticulously inspecting their products. In addition to these efforts, in the unlikely event of a product defect, 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 conformity. We stipulate appropriate quality improvements for suppliers with high nonconformity rates, and we have a system to ensure quality through regular quality audits. In addition, our global quality complaint processing system allows us to gather quality information in a timely manner from markets around the world. When we receive information about a problem or malfunction, we immediately investigate the cause and cease distribution of the product. If we need to take any corrective or preventive action for a problem or malfunction, we promptly plan the action in accordance with the Group’s regulations, carry out the plan, and later verify the validity and effectiveness of the actions taken.