Pursuit of Quality and Trust

At Sysmex, under the supervision and management of the President, the quality assurance divisions play a central role in maintaining and improving our quality management system. More specifically, we hold a monthly quality meeting where the managers of our development, production, marketing, and customer care divisions explore what we can do to monitor the quality, effectiveness, and safety of our products and customer care, along with improvement measures. We also hold Quality System Committee meetings regularly to review responses to inspections by regulatory bodies, quality objectives, and actions arising from management reviews. This is part of our efforts to maintain the Group's quality management system and promote activities for improvement.
Furthermore, all manufacturing bases for final products¹ have obtained ISO 9001 certification, the international standard for general quality management, or ISO 13485 certification, the international standard for medical device quality management systems. Of the 83 companies in the Sysmex Group, 38 have been ISO 9001 certified and 21 have been ISO 13485 certified. In fiscal 2025, three cases of nonconformity were identified in an internal quality audit and two cases during an external quality audit, and corrective action is being taken.
We have also set a quality objective for fiscal 2026 of zero major or recurring nonconformities annually in external audits, working continuously toward ongoing improvement. 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.

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Used in laboratory testing, Sysmex's products play a vital role in protecting human life and health. In its product development, manufacturing, and procurement activities, Sysmex operates a quality management system to comply with the laws and regulations of countries worldwide, including Japan’s PMD Act, the EU’s IVDR, the U.S. FDA’s Quality Management System Regulation, and China’s Regulations on the Supervision and Administration of Medical Devices. We also manage regulatory requirements across every process of development, manufacturing, and procurement.
Furthermore, we strive to maintain and improve product safety and quality through internal audits, supplier audits, employee training, and continuous improvement activities.

In the product development process leading up to market launch, Sysmex verifies product quality by setting up five “quality gates.”¹ Furthermore, we continuously conduct quality and safety risk assessments² throughout the entire product lifecycle, not just during design and development, and implement appropriate mitigation measures for high-risk events. For products where Sysmex holds responsibility as a marketing authorization holder, we strive to ensure quality by performing manufacturing site management and quality verifications based on our quality management system. In the unlikely event that a product defect occurs, we have frameworks in place to promptly assess the situation and take appropriate action.
At factory sites, in addition to conducting regular quality audits, we continuously monitor the progress of manufacturing processes and any deviations. We also perform incoming inspections and in-process tests on materials purchased from suppliers to verify their quality. For suppliers with high nonconformity rates, we maintain a system to ensure quality by providing guidance and support for quality improvement. Moreover, when corrective and preventive actions are required, we promptly formulate plans based on internal regulations and consistently execute them through to the verification of the action’s validity and effectiveness. To ensure quality and traceability, we use RFID³ and introduce GPS and temperature loggers⁴ for the transportation of certain reagents for testing, enabling high-level quality assurance required during the transport of reagent products.

Sysmex is advancing the use of quality data obtained from post-market surveillance and manufacturing processes, working to strengthen the preventive quality assurance system by feeding this data back into the design and development stages.
Specifically, we use our global quality complaint handling system to collect quality information from the market on a global and timely basis. When product malfunction reports are received, we promptly investigate the root cause and strive to prevent defective products from entering or circulating in the market.
Furthermore, based on regular information review and ongoing information gathering by the quality assurance divisions, we centrally manage malfunction data from both the market and pre-shipping stages in a Group-wide database.
This quality information is reliably fed back into the design and development stages. By linking this data with risk assessment, we aim to enhance hazard identification and the development of preventive measures for similar products.

The reliability of testing results is indispensable for patients to receive appropriate diagnoses and treatment. Sysmex has established an accuracy assurance system based on international standards to ensure that testing results can be trusted and used seamlessly across different medical institutions and regions.
In the field of hematology, Sysmex has established and maintained metrological traceability—a framework that links measurement results to international reference standards—for over 30 years, in accordance with standardization guidelines from the ICSH¹ and CLSI.²
This reliability is sustained throughout the entire testing process. Sysmex has developed a comprehensive accuracy assurance framework that connects everything from the starting point of testing to medical settings, and ultimately to patients.
We secure the “foundation of accuracy” in testing through reference materials (samples that serve as benchmarks for testing results), holding ISO 17034 accreditation in the field of hematology. Furthermore, our metrological traceability links measurement values to international standards, ensuring that testing results carry the same clinical significance across different medical institutions. (In Japan, we have obtained ISO/IEC 17025 and ISO 15195 accreditations.)
We also provide external quality assessment (EQA) services based on ISO/IEC 17043, supporting quality improvement in clinical laboratories through inter-laboratory comparisons and evaluations. These initiatives underpin quality management systems grounded in standards such as ISO 15189 and CAP accreditation, enabling the delivery of highly reliable testing data. (In Japan, we also assist laboratories in obtaining and operating ISO 15189 accreditation.)
Ultimately, these interconnected frameworks empower physicians to make appropriate clinical decisions, leading to accurate diagnoses and treatment for patients.
Through its integrated accuracy assurance framework—comprising reference materials, metrological traceability, and external quality assessment—Sysmex contributes to improving the quality of healthcare and delivering value to patients.

To provide safe and highly reliable products and services to patients and healthcare professionals, Sysmex conducts Quality Policy training, as well as regular quality management training for relevant divisions and specialized training on laws and regulations for specific divisions and job functions.
In fiscal 2025, we provided training on the topic of quality to approximately 3,000 employees, covering all employees across development, production, marketing, and service divisions, as well as ISO-certified business offices of our domestic Group companies. At overseas Group companies, we also held training regarding quality at all manufacturing bases for final products and ISO-certified business offices. Through these initiatives, we aim to raise quality awareness and ensure strict compliance with laws and regulations, thereby fostering a culture of quality throughout the entire Group.

Sysmex has established the Quality Assurance division, which controls information regarding the quality and safety of its products. We investigate and analyze information received from medical institutions and sales distributors and share it among relevant divisions—including design, manufacturing, and quality assurance—to drive quality improvement and prevent recurrences. Furthermore, we leverage the knowledge gained to develop new products and enhance existing ones, striving to deliver safer and more reliable products and services.

Sysmex Corporation posts information about product recalls and repairs on its website under “Important Product Notices.” By providing prompt and transparent information to our customers and medical institutions, we are committed to ensuring product safety and maintaining and improving reliability.

To ensure accurate testing results, Sysmex asks healthcare providers to use Sysmex-branded instruments and reagents together. In recent years, however, counterfeit reagents that mimic the names and container shapes of Sysmex products have been identified in circulation in some regions. These counterfeit reagents may compromise the reliability of testing results and could interfere with appropriate diagnosis and treatment. For this reason, Sysmex continuously monitors the market for counterfeit reagents. When they are identified, we take swift and thorough action based on our intellectual property rights, collaborating closely with local government institutions and judicial bodies.

Sysmex conducts customer satisfaction surveys in various countries and regions. To deliver better customer care, we set evaluation metrics tailored to each country and region in accordance with the characteristics of the products and services we offer.
Sysmex America has won awards for eight consecutive years in all three categories—customer satisfaction, overall service, and system performance—in the hematology analyzer manufacturer segment of the 2025 ServiceTrak^TM Clinical Laboratory Award, organized by IMV, a specialist provider of market research in medical imaging and clinical diagnostic instruments. In addition, Sysmex America has maintained the No. 1 ranking for system reliability for 26 consecutive years and has received industry-leading evaluations in areas that reflect strong customer trust, including repurchase intention and Net Promoter Score (NPS^®)
Furthermore, Sysmex Shanghai achieved the highest rating across all five categories—market share, comprehensive customer satisfaction, repurchase intention, NPS, and training system satisfaction—at the 2025 China Medical Industry Data Survey, receiving the Grand Prize.
Through these internal surveys and third-party evaluations, Sysmex routinely monitors whether it continues to provide high-quality products and services that satisfy customers, leveraging these insights for ongoing improvement.

Stakeholder's Voice

How Testing Empowers Healthcare: Sysmex’s New Challenges in Hemostasis Testing Across EMEA

To address diverse healthcare challenges across the EMEA region, we have shifted our approach beyond merely providing instruments. We have transformed into an organization that stays closely aligned with frontline professionals, offering continuous support throughout every stage—from system installation and operation to training.
By supporting testing consolidation and operational improvements, we enhance both the quality and speed of diagnoses, creating environments where patients are connected to appropriate treatment more rapidly. This is the value we strive to deliver.

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• How Testing Empowers Healthcare: Sysmex’s New Challenges in Hemostasis Testing Across EMEA

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 relevant divisions to use them in the development of new products and in operational improvements. In fiscal 2025, we gathered approximately 15,000 customer feedback responses from the Japanese market and many from European and other foreign markets.
Products equipped with functions or features developed or improved based on customer feedback display a VOC Mark in our product catalog. By continuously translating customer feedback into improvement, Sysmex is committed to enhancing customer value.

Sysmex provides a variety of training programs covering instrument operation, maintenance, and application support as part of its customer care, using a globally consistent digital platform called Caresphere^TM Academy. Through these training programs, we support customers in ensuring the proper use of our products and improving testing quality, thereby contributing to the realization of safer and more reliable healthcare. In recent years, we have established new training centers in Brazil and Turkey to strengthen and enhance customer care by offering high-quality face-to-face training tailored to local needs.
We are also developing and expanding environments that enable online training in regions around the world. In addition to e-learning, which enables customers to acquire skills anytime and anywhere at their own convenience, we also offer highly immersive virtual training through full-scale online studios. This ensures that customers in regions located far from training centers can also receive standardized, high-quality product training.

Sysmex was a pioneer in the industry to introduce network solutions that connect testing instruments to a network and remotely monitor their operating status, leading to preventative maintenance. Today, a global team of experts regularly monitors data collected from products provided in more than 190 countries and regions, including instrument failure trends and service response status. This data is used to help improve product quality, accelerate service improvement processes, and reduce instrument failure rates.
Furthermore, we have established a market support escalation system to ensure that customer issues and inquiries from any region of the world are shared with our headquarters in a timely manner and resolved swiftly. This system is used to continuously maintain and improve the quality and response speed of our customer care. We are also advancing the development of an online application to support overall customer care activities by assessing instrument status using AI models and visualizing instrument log data.
Through these initiatives, we are driving the evolution toward a more proactive service model by combining accumulated digital information assets with advanced technologies such as AI.

Sysmex has built and is operating a system to centralize the knowledge, experience, skills, and know-how accumulated through its customer care activities worldwide, sharing and using them across the entire Group.
Knowledge gained through frontline customer care activities is applied to provide high-quality and efficient customer support that does not rely on individual personnel, regions, or levels of experience. Furthermore, by centrally aggregating and sharing various resources—such as product information, case studies of inquiries, and academic literature—we are enhancing the academic knowledge of our application support staff while improving the efficiency of customer support delivery.

Sysmex Corporation provides a wide range of support information for customers in Japan through the Support Information section of its website. By featuring comprehensive FAQs related to product usage, we assist customers in resolving their inquiries and challenges swiftly.
In addition, we provide a customer portal (“My Page”) that allows customers to review their online inquiry history, establishing an environment where they can easily access the information they need. We are committed to continuously expanding these functions to enhance customer convenience and ensure the smooth use of our products.

Sysmex has established regional customer support centers to ensure rapid and reliable responses to customer inquiries while striving to build frameworks that respond promptly to customer requests.
In Japan, we have established a Customer Support Center, where experienced staff members with expert knowledge respond to customer inquiries 24 hours a day, 365 days a year (separate contract required for use). The center maintains and uses records of past customer inquiries and maintenance histories to ensure accurate and tailored resolutions. Furthermore, by using data transmitted from instruments via our network, we monitor instrument status in real time, enabling more accurate and faster responses to customer inquiries. Through these initiatives, we support our customers’ business continuity and ensure stable laboratory operations.

Responding to Inquiries at the Customer Support Center
Other 12.1%
Complaints such as defective products 0.1%
Inquiries regarding data 2.7%
Inquiries regarding operating procedures 3.0%
Inquiries regarding quality control 2.3%
Inquiries regarding products 9.2%
Repairs and maintenance 70.5%
Total inquiries received in fiscal 2025: 79,857

For testing data to be used appropriately in medical settings, it is essential that evidence demonstrating its clinical utility is accumulated and widely understood by healthcare professionals. Sysmex works to promote understanding and raise awareness of the utility of testing data. We achieve this by publishing scientific papers in collaboration with research institutions and healthcare professionals, as well as by generating evidence and providing information that assists in diagnostic and treatment decision-making. Through these efforts, we support the proper use of testing data, contributing to the improvement of healthcare quality, including the early detection of diseases and the early initiation of treatment.