Society
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.
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.
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.
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.
In addition to Quality Policy training, Sysmex provides regular quality management training to the relevant departments, as well as specialized training on laws and regulations for employees in specific departments or job categories. In fiscal 2023, we provided training on the topic of quality 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 training regarding quality at all production facilities for final products and ISO-certified business offices managed by our Group companies overseas.
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.
Sysmex posts information about product recalls and repairs on its website under “Important Product Notices.”
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 to be in circulation in some instances. The use of such counterfeit reagents endangers the reliability of testing results, and in some cases, they can be harmful to patients’ health. For this reason, Sysmex continuously monitors markets for counterfeit reagents. When they are discovered, we exercise our intellectual property rights and work with local government institutions and judicial bodies to ensure swift and thorough responses.
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. These accolades are among the IMV ServiceTrak™ Awards organized by IMV, a specialist provider of market research to the medical imaging processing and the laboratory diagnostic fields. 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 received the highest excellence award in the 2024 China Medical Device Industrial Data Survey. The company received top honors in all five categories evaluated by the survey: market share, overall customer satisfaction, retention, NPS (a customer loyalty index), and training satisfaction. The company has received recognition as a result of this survey for three consecutive years.
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.
Sysmex provides training for instrument operation and maintenance for customers in each region as part of our customer support. In recent years, to respond to a sustainable society, we have provided an online training system in different parts of the world by which training can be live-streamed or attended on demand.
We established a training center for technical services and application support in Brazil and Turkey to serve as a new base. In addition, the user training program provided is a globally integrated program under the name “Caresphere™ Academy.”
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, people involved in technical services and application support at different regional headquarters came together and initiated a restructuring project.
In addition to accumulating global data on instrument failures and service status through common global codes created for service-related information in each region, this project reformed the market support escalation system and promoted the digitalization of data. A global team of experts periodically monitors this data to speed up the quality and service improvement process while also proactively detecting defects and reducing instrument failure rates.
As part of its training reform, Sysmex introduced a virtual training space to train its technical service engineers and application support personnel around 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 are able to operate the software together in a virtual space, all participants can learn how to use the software, irrespective of where they are—and even if they are without physical terminals. We will continuously offer training that enables the participants to effectively learn to provide high-quality technical services and application support around the world.
Sysmex Corporation disseminates valuable information to its customers in Japan through the Support Information section of its website. Sysmex continually expands the functionalities of the website to ensure that customers have the ability to use the website to a greater extent. Examples include adding an email magazine distribution service, which communicates the latest information, and "My Page" functionality, which allows users to manage content and their browsing histories.
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.
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.
Sysmex has held annual Scientific Seminars since 1978 to discuss topics selected from a wide range of medical research areas and to provide opportunities to share knowledge from the latest information and research. The topic in 2023 was clonal hematopoiesis, and the seminar was held in an onsite and an online hybrid format. The lectures in Kobe and Tokyo were streamed not only domestically but also internationally. The seminar was conducted primarily in English, with simultaneous interpretation offered in Chinese, Indonesian, Thai, and Vietnamese. We were pleased to be able to welcome participants from 21 countries worldwide. After the seminar, videos of the lectures were distributed globally. We also conducted country-specific participant surveys to identify medical issues and interests that differed depending on country and region. We utilize such information for future seminar theme setting and the Group’s initiatives.
In addition, we have held many other seminars globally with a wide range of attendees. Through these initiatives, we aim to build trust-based relationships with medical professionals and help improve healthcare quality globally.
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.