Pursuit of Quality and Trust

At Sysmex, under the supervision and management of the President, the Quality Assurance Department leads our quality management efforts. More specifically, we hold a monthly quality meeting where the managers of our Development, Production, Marketing, and Service Departments explore what we can do to monitor the quality, effectiveness, and safety of our products and services, along with improvement measures. We also hold Quality System Committee meetings regularly to review quality targets, responses to inspections by regulatory bodies, and a management review of instructions for output. This is part of our efforts to maintain the Group’s quality management system and promote activities for improvement.
All our production facilities for final products* have obtained ISO 9001 or ISO 13485 certifications. Of the 79 companies in the Sysmex Group, 34 have been ISO 9001 certified and 21 have been ISO 13485 certified. In fiscal 2023, four cases of nonconformity were identified in an internal quality audit and five cases during an external quality audit. Remedial action is being taken. In addition, we have been making efforts to improve quality by setting the numbers of recalls and FDA warning letters as indicators for monitoring the progress of sustainability targets.

• Wholly owned subsidiaries

In the product development process leading up to market launch, Sysmex verifies product quality by setting up five "quality gates."¹ We also conduct quality and safety-related risk assessments when designing and developing new products, as well as when changes are made to the designs of existing products. If a high-risk event is noted, we act to eliminate it. In addition, when marketing products manufactured by other companies, we verify their quality by conducting audits of the manufacturers and meticulously inspecting their products. Moreover, in the unlikely event that a product defect occurs, we have systems in place to quickly identify the details and respond to any problems.
At factory sites, we conduct regular quality audits and monthly monitoring of manufacturing processes and supplier conformity to ensure quality. We appropriately instruct and support suppliers with high nonconformity rates to improve their quality. Our global quality complaint processing system allows us to gather quality information from markets around the world in a timely manner. When we receive information about a problem or malfunction, we immediately investigate the cause and cease distributing the product in question. If we need to take any corrective or preventive actions regarding a problem or malfunction, we promptly plan such actions in accordance with the Group’s regulations, carry out the plan, and later verify the validity and effectiveness of the actions taken.
In 2021, in order to ensure the quality and traceability of our products, we began to utilize a Global Positioning System (GPS) and temperature data loggers² for the transportation of some reagents used in testing. In the future, we will sequentially expand the use of these methods to include the transportation of diagnostic reagents that require high-quality assurance.

• 1 Product design assessment, process design assessment, evaluation by the Product Quality Control Department, quality management system (QMS) checks during the manufacturing process, and inspections for mass-produced items
• 2 A measurement device equipped with a thermometer and a data logger

Sysmex established the Quality Assurance Department, which controls information regarding the quality and safety of our products. Its function is to handle inquiries it receives from outside the Company, as well as to investigate and analyze the information it receives; to share this information with the Design, Manufacturing, and other divisions, and to improve quality. In addition, we have established a structure for incorporating this information in the next generation of products.

Requests and comments from customers are gathered by Sysmex’s Voice of the Customer (VOC) Team. After analyzing this information from various perspectives, the results are provided as feedback to related divisions in order to utilize them in the development of new products and in operational improvements. In fiscal 2023, we gathered approximately 13,500 customer feedback responses from the Japanese market and many from Europe and other foreign markets. We have received a positive response to instruments with new functions and equipment that we have added as a result of customer input, which is indicated by the VOC mark in our product catalog.