Society
Pursuit of Quality and Trust
Quality Management
Group Quality Management System
At Sysmex, under the supervision and management of the CEO, the Quality Assurance Department leads our quality management effort.
More specifically, we hold a quality meeting each month at which the managers of our Development, Production, and Marketing and Service Departments explore what we can do to monitor the quality, effectiveness, and safety of products and services, along with improvement measures. We also hold Quality System Committee meetings regularly to review responses to inspections by regulatory bodies, quality targets, and 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. Out of the 77 companies in the Sysmex Group, 35 have been ISO 9001 certified and 22 have been ISO 13485 certified.
In fiscal 2020, 11 cases of nonconformity were identified during an internal quality audit. These issues are being addressed. No cases of nonconformity were found during an external quality audit.
Starting from fiscal 2021, we set the number of recalls and the number of FDA warning letters as indicators for the monitoring of progress toward sustainability targets, thereby improving quality.
More specifically, we hold a quality meeting each month at which the managers of our Development, Production, and Marketing and Service Departments explore what we can do to monitor the quality, effectiveness, and safety of products and services, along with improvement measures. We also hold Quality System Committee meetings regularly to review responses to inspections by regulatory bodies, quality targets, and 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. Out of the 77 companies in the Sysmex Group, 35 have been ISO 9001 certified and 22 have been ISO 13485 certified.
In fiscal 2020, 11 cases of nonconformity were identified during an internal quality audit. These issues are being addressed. No cases of nonconformity were found during an external quality audit.
Starting from fiscal 2021, we set the number of recalls and the number of FDA warning letters as indicators for the monitoring of progress toward sustainability targets, thereby improving quality.
- Wholly owned subsidiaries
Sustainable Improvement Programs
Reinforcing Structures for Maintaining and Enhancing Quality
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.
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.
Providing High Quality Products and Services through Third-Party Certification
To enhance credibility, we are strengthening our quality assurance system regarding product inspection results.
Sysmex International Reagents received ISO Guide 34 certification (now ISO 17034). This international standard relates to the competence of reference material producers. This was the first ISO Guide 34 certification granted in the hematology field in Japan. It certifies a manufacturer’s competence to provide reference materials of proper quality. This certification will strengthen 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.
Sysmex International Reagents received ISO Guide 34 certification (now ISO 17034). This international standard relates to the competence of reference material producers. This was the first ISO Guide 34 certification granted in the hematology field in Japan. It certifies a manufacturer’s competence to provide reference materials of proper quality. This certification will strengthen 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
Sysmex provides regular quality management training for relevant departments and specialized training in legal restrictions for employees in certain departments or job categories, in addition to training in our Quality Policy. In fiscal 2020, we provided quality training for a total of about 3,000 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.
As a company that provides products and services in more than 190 countries and regions around the world, we conduct training on the regulatory systems of individual countries for engineers in development departments, ensuring that we develop products in accordance with applicable laws and regulations.
Quality and Safety Information
Sharing Customer Feedback within the Group
Sysmex established the Post-marketing Quality Assurance Department, which controls information regarding the quality and safety of our products. Its function is to field the various 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 put in place a structure for incorporating this information in the next generation of products.
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, reagents whose names and container shapes have been disguised to look like Sysmex reagents have been found in circulation in some areas. The use of such counterfeit reagents cannot guarantee 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. We also caution medical institutions against the use of counterfeit reagents by placing advertisements in newspapers.
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 each market.
Sysmex America has ranked number one for 14 consecutive years among manufacturers of hematology analyzers in an IMV ServiceTrak survey of customer satisfaction. Sysmex America was also one of the recipients of the 2020 GHXcellence Awards, which are given to healthcare providers that go above and beyond to support patients and communities, as a top performer in the North American market. We also conduct regular customer satisfaction surveys in EMEA and the Asia Pacific region, which have reported high levels of customer satisfaction.
Sysmex America has ranked number one for 14 consecutive years among manufacturers of hematology analyzers in an IMV ServiceTrak survey of customer satisfaction. Sysmex America was also one of the recipients of the 2020 GHXcellence Awards, which are given to healthcare providers that go above and beyond to support patients and communities, as a top performer in the North American market. We also conduct regular customer satisfaction surveys in EMEA and the Asia Pacific region, which have reported high levels of customer satisfaction.
- EMEA: Europe, the Middle East, and Africa
Efforts to Incorporate Customer Feedback into Our Products and Services
Requests and comments from customers are gathered by the Voice of the Customer (VOC) Group. After analyzing this information from various perspectives, the results are provided as feedback to related divisions so they can be utilized in new product development and operational improvements. In fiscal 2020, we gathered some 18,000 customer’s feedback in the Japanese market. 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
Sysmex conducts instrument and maintenance training in each region as part of its customer support.
In the United States, Canada, and Latin America, where medical institutions are scattered over a large area, Sysmex America offers “Center for Learning” online training so that customers do not have to travel to a Sysmex training facility. During fiscal 2020, we made improvements to the training system we had offered based on customer comments. These improvements included customization and better accessibility. Consequently, more than 90% of approximately 3,000 users in a user survey replied that they were satisfied or very satisfied with the improved system. For this effort, we worked with the online program development team of Sysmex Europe. This cooperation allowed us to incorporate the merits of Sysmex Academy Online run by Sysmex Europe and to share the content of their website.
The success of this project led the Center for Learning and its development team to win the Gold Awards for Best Customer Training Program and Best Learning Team categories from the Brandon Hall Group, and the Annual LTEN Excellence Awards from the Life Sciences Trainers & Educators Network.
In the United States, Canada, and Latin America, where medical institutions are scattered over a large area, Sysmex America offers “Center for Learning” online training so that customers do not have to travel to a Sysmex training facility. During fiscal 2020, we made improvements to the training system we had offered based on customer comments. These improvements included customization and better accessibility. Consequently, more than 90% of approximately 3,000 users in a user survey replied that they were satisfied or very satisfied with the improved system. For this effort, we worked with the online program development team of Sysmex Europe. This cooperation allowed us to incorporate the merits of Sysmex Academy Online run by Sysmex Europe and to share the content of their website.
The success of this project led the Center for Learning and its development team to win the Gold Awards for Best Customer Training Program and Best Learning Team categories from the Brandon Hall Group, and the Annual LTEN Excellence Awards from the Life Sciences Trainers & Educators Network.
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Virtual training via the Center for Learning -
Disseminating Useful Information
Sysmex disseminates information that is useful for its customers in the “Support Information” section of its website.
Up-to-date information is distributed using an email magazine service. We also offer a “Personal Page” function for managing content and viewing history. In these ways, we are continuously enhancing functionality to facilitate customer use.
Up-to-date information is distributed using an email magazine service. We also offer a “Personal Page” function for managing content and viewing history. In these ways, we are continuously enhancing functionality to facilitate customer use.
Enhancing Service and Support
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, Sysmex Corporation maintains a Customer Support Center, where experienced staff members with expert knowledge cater to customers 24 hours a day, 365 days a year (separate agreement required). 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 quickly and carefully.
In Japan, Sysmex Corporation maintains a Customer Support Center, where experienced staff members with expert knowledge cater to customers 24 hours a day, 365 days a year (separate agreement required). 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 quickly and carefully.
Offering Solutions Utilizing IT
Sysmex offers Caresphere, a network solution designed to provide a wide range of online support options and services. Caresphere supports stable operation of test instruments at hospitals through such functions as instrument quality control*, automated monitoring, and failure prediction based on real-time analysis. We also offer application services to assist with the efficiency and quality management of testing.
Utilizing ISO to Increase the Quality of Clinical Testing
Recently, the field of clinical testing has met with a strong demand for improved test result quality, and awareness of international standards is increasing around the world. One such standard is ISO 15189 (Medical laboratories–requirements for quality and competence). The number of clinical laboratories that have obtained certification based on this standard is increasing, with the certification having become obligatory in some countries.
Sysmex Corporation has received certification under the ISO/IEC 17025 international standard for clinical testing calibration institutions and the ISO 15195 standard. This certifies that we meet the international standards for the quality of the calibration service we provide with our automated hematology analyzers. We were the first company in Japan to receive such accreditation in this field.
The calibration certificate we issue is accepted as a globally recognized document that ISO 15189 requires to ensure traceability and calibration. As of March 31, 2021, we had issued calibration certificates for more than 7,200 instruments. Furthermore, Caresphere XQC, an external quality assessment service provided by Sysmex, was the first in Japan in any industry to receive certification under ISO/IEC 17043 (Conformity assessment–General requirements for proficiency testing).
Sysmex Corporation has received certification under the ISO/IEC 17025 international standard for clinical testing calibration institutions and the ISO 15195 standard. This certifies that we meet the international standards for the quality of the calibration service we provide with our automated hematology analyzers. We were the first company in Japan to receive such accreditation in this field.
The calibration certificate we issue is accepted as a globally recognized document that ISO 15189 requires to ensure traceability and calibration. As of March 31, 2021, we had issued calibration certificates for more than 7,200 instruments. Furthermore, Caresphere XQC, an external quality assessment service provided by Sysmex, was the first in Japan in any industry to receive certification under ISO/IEC 17043 (Conformity assessment–General requirements for proficiency testing).
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 (e.g., countries’ health ministries) and major academic societies in order to run scientific activities designed to help improve the quality of clinical testing.
Holding Scientific Seminars for Clinical Professionals
Sysmex has held a Sysmex Scientific Seminar annually since 1978. This seminar discusses subjects selected from a range of medical research areas in order to serve as an opportunity to provide the latest information and share knowledge acquired from research. The 43rd Seminar scheduled in fiscal 2020 was postponed due to the COVID-19 pandemic.
Under these circumstances, we held the Sysmex Global Webinar for COVID-19 to provide the latest on-the-ground clinical information around the world, with the aim of developing testing systems that work amid the pandemic. At the Webinar, distinguished doctors from different countries, including Japan, gave lectures on what the COVID-19 pandemic looked like in their regions, and they offered new knowledge and insight. The Webinar was also held in EMEA, the United States, and Asia. A total of around 1,800 healthcare professionals attended.
Under these circumstances, we held the Sysmex Global Webinar for COVID-19 to provide the latest on-the-ground clinical information around the world, with the aim of developing testing systems that work amid the pandemic. At the Webinar, distinguished doctors from different countries, including Japan, gave lectures on what the COVID-19 pandemic looked like in their regions, and they offered new knowledge and insight. The Webinar was also held in EMEA, the United States, and Asia. A total of around 1,800 healthcare professionals attended.
We also hosted online seminars on other subjects, which were attended by approximately 2,000 healthcare professionals in total.
Through these initiatives, we aim to build trust-based relationships with healthcare professionals and help improve the quality of healthcare.
Through these initiatives, we aim to build trust-based relationships with healthcare professionals and help improve the quality of healthcare.
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Sysmex Global Webinar for COVID-19 -
EMEA Sysmex Virtual Expo 3D booth