Pursuit of Quality and Trust

Quality Management

Group Quality Management System

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 certification. Of the 84 companies in the Sysmex Group, 34 have been ISO 9001 certified, and 21 have been ISO 13485 certified. In fiscal 2022, two 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
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Sustainable Improvement Programs

Compliance with Related Laws and Regulations in Each Country

Used in laboratory testing, Sysmexʼs products play a vital role in protecting human life and health. Sysmex has created a system that allows us to thoroughly comply with regulations worldwide, including the Japanese Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the In Vitro Diagnostic Medical Devices Regulation in the EU, the U.S. FDA’s Quality System Regulation, and the Regulations on the Supervision and Administration of Medical Devices in China, as well as maintaining and improving the safety and quality of our products.

Reinforcing Structures for Maintaining and Enhancing Quality

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 during a new product’s design and development phases, as well as when changes are made to the design of an existing product. If a high-risk event is noted, we act to eliminate it. Also, when marketing products manufactured by other companies, 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 any problems.
At factory sites, each month we monitor manufacturing processes and the status of supplier conformity. We instruct suppliers with high nonconformity rates to improve quality as needed, 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 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 started to utilize the 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 diagnostic reagents that require high quality assurance.

  • 1 Product design assessment, process design assessment, evaluation by 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

Providing High Quality Products and Services through Third-Party Certification

To enhance its credibility, Sysmex is strengthening its quality assurance system regarding product inspection results.
Our Ono Factory is ISO 17034 certified. This international standard relates to the competence of reference material producers. This was the first such certification granted in the hematology field in Japan. It recognizes a manufacturer’s ability to provide reference materials of the proper quality. This certification strengthens our credibility concerning the quality of data of our products and services, enabling our customers in global clinical laboratories to verify their own competence to provide proper test data.

Employee Training

Focusing on Specialized Quality and Safety Training

In addition to Quality Policy training, Sysmex provides regular quality management training for related departments, as well as specialized training on laws and regulations for employees in specific departments or job categories. In fiscal 2022, we provided quality training to a total of about 2,800 employees across Japan in the Group companies’ various development, production, and marketing and service departments, as well as in ISO-certified business offices. We also held quality training at all production facilities for final products and ISO-certified business offices managed by our Group companies overseas.

Quality and Safety Information

Sharing Customer Feedback within the Group

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.

Product Quality and Vigilance Control System

Product Recall and Repair Information Posted on Our Website

Sysmex posts information about product recalls and repairs on its website under “Important Product Notices.”

Working Aggressively to Stamp Out Counterfeit Reagents

To assure accurate testing results, Sysmex asks its customers to use Sysmex-branded instruments and reagents together. In recent years, however, counterfeit Sysmex reagents have been found in circulation in some areas. The use of such reagents endangers the reliability of testing results and, in some cases, can be harmful to patients’ health. For this reason, Sysmex continuously monitors markets for counterfeit reagents. When they are discovered, we work with local government institutions and judicial bodies to ensure the swift and thorough enforcement of our intellectual property rights.

Enhancing Customer Satisfaction

Conducting Customer Satisfaction Surveys in Japan and Overseas

Sysmex conducts customer satisfaction surveys in various countries and regions, including China and Japan as well as major countries in the Americas, EMEA,* and the Asia Pacific region. These surveys use indices customized for each country and region in accordance with the products and services offered in them.
Sysmex America has received the Best Customer Satisfaction award for 16 consecutive years, as well as the Best System Performance and the Best Service awards in the hematology system manufacturer category, among the IMV ServiceTrak Awards organized by IMV, a specialist provider of market research to the medical imaging processing and the laboratory diagnostic industries. In addition, it has received a Supplier Legacy Award from its business partner Premier Inc. for its long-term contribution to the provision of products and services that help improve operational efficiencies in clinical settings at low cost.
Sysmex Shanghai won several awards for excellence at the Chinese Medical Device Industry Conference in recognition of superior product quality and after-sales service.

  • Europe, the Middle East, and Africa
  • Customer satisfaction rating in the United States
  • IMV ServiceTrak

Efforts to Incorporate Customer Feedback in Our Products and Services

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 to utilize them in new product development and operational improvements. In fiscal 2022, we gathered feedback from some 13,600 customers in the Japanese market, and from many customers in 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.

Providing Highly Satisfying User Training

Online Training
Online Training
Sysmex provides training on instrument operation and maintenance for customers in each region as part of customer support. In response to the “new normal”, we have provided an online training system in various parts of the world in recent years, by which training can be live-streamed or attended on demand.
In addition, we have globally integrated, and begun providing, user training programs offered by Sysmex America and Sysmex Europe in a single training program under the brand name “Caresphere™ Academy”.

Project for Promoting Digitalization 

Product Quality Improvement Activities Based on Reforming Services and Support

Sysmex supplies its products to over 190 countries and regions around the world. However, in the past, it has been difficult to obtain accurate information on instrument failures and service status. To address this issue, in 2019, people involved in services and support at different regional headquarters came together and started a project for restructuring these business areas.
In this project, we began accumulating global data on instrument failures and service status through common global codes created for service- and support-related information in each region. At the same time, we formed a team of experts to monitor data, speed up the quality and service improvement process, and proactively detect defects, reducing instrument failure rates.

Project for Promoting Digitalization

Activities to Improve the Quality of Technical Services and Scientific Support Based on Training Reforms

As part of its training reform, Sysmex introduced a virtual training space to train its technical service engineers and scientific support personnel across the world. This virtual training space enables them to participate in training and to experience and learn, through their avatars, about new software products from anywhere in the world. As they can share the operation of the software in a virtual space, all the participants can learn how to operate the software irrespective of where they are, even without physical terminals. We will continuously offer training in which the participants can effectively learn to provide high-quality technical services and scientific support across the world.

Activities to Improve the Quality of Technical Services and Scientific Support Based on Training Reforms

Disseminating Useful Information

Support Information website (Japan)
Support Information website (Japan)

Sysmex disseminates valuable information to its customers in the Support Information section of its website in Japan. Sysmex continually expands the functionalities of the website to ensure that customers can use the website to a greater extent, such as by adding an email magazine distribution service, which communicates the latest information, and “My Page” functionality, which enables users to manage content and their browsing history.

Responding to Inquiries Rapidly and Responsibly

The Sysmex Group has established regional customer support centers to reply quickly and carefully to inquiries, as well as to 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 agreement required for use). By creating a database containing maintenance histories and the details of past inquiries from customers for quick reference, the center responds to inquiries and requests rapidly and carefully.

Scientific Activities

Sysmex holds scientific seminars to impart the latest information about clinical testing in various countries and regions across the world. In Asia, we work with government agencies, including national health ministries and major academic societies, to conduct scientific activities designed to help improve the quality of clinical testing.

Holding Scientific Seminars for Medical Professionals

Sysmex Scientific Seminar 2022
Sysmex Scientific Seminar 2022

Sysmex has held annual Scientific Seminars since 1978 to discuss topics selected from a range of medical research areas and to provide opportunities to share the latest information and knowledge. In 2022, a seminar on the theme of hematologic diseases was held in hybrid form, with both online and onsite participation, and around 3,500 people from all over the world attended. We globally distributed videos of the lectures after the seminar. We also conduct participant surveys in each country in order to determine medical issues and interests specific to countries and regions. This information is utilized to determine themes for future seminars or Group initiatives.
In addition, we have held many other seminars globally, in which a wide range of people participated. Through these initiatives, we aim to build trust-based relationships with medical professionals and help improve the quality of healthcare.

Activities for Patients and the General Public

Scientific Information Website: “Medicine meets Technology”
Scientific Information Website: “Medicine meets Technology”

Sysmex set up the online scientific information website “Medical meets Technology” to provide information on the varied roles of technology in healthcare from a scientific viewpoint in an easy-to-understand format.
In addition, from the viewpoint of informed consent, product information for the NCC Oncopanel™, a testing system for cancer genome profiling, has been newly developed with easy-to-understand explanations for patients and their families. Such information was previously only available to medical professionals. In response to issues related to antimicrobial resistance (AMR), we are conducting a variety of initiatives, which include the global implementation of “#AMRfighter”, an awareness-raising activity, and widely distribute a scientific booklet titled “Proper Use of Antibiotics” directed at patients and the general public.