Not content with only providing high-quality products and services, Sysmex has committed itself to the creation of a system which allows us to ensure that customers can use our products safely, easily, and confidently. We also wish to offer satisfaction that more than meets their expectations by deepening our understanding of what customers really want through enhanced communications.
Quality Assurance
Quality Policy
By shaping the advancement of healthcare, our global business activities contribute to the creation of a fulfilling and healthy society.
Core behavior
- We understand our customer's needs, and provide products and solutions that meet or exceed their expectations.
- We act based on our customer's viewpoints by realizing that "Quality is customer satisfaction".
- We seek to reassure our customers by establishing the highest quality assurance standards and using them to enhance the quality of all aspects of our business.
- We continually create innovative value for our stakeholders by developing and applying new and unique technologies and knowledge.
- We comply with all relevant national or regional regulations and standards to provide safe products.
- We maintain and continually improve the effectiveness of our quality management system.
- We establish quality objectives consistent with this quality policy, and measure our performance against them.
ISO 9001 Certified Subsidiaries/Affiliates
The number of companies that have qualified for the ISO 9001 international standard on quality management among the 38 group companies, including Sysmex Corporation (as of March 31, 2009). All companies with development and/or production functions have been certified.
Forging a System for Ensuring Product Reliability
Used for clinical testing, Sysmex's products play a vital role in protecting the lives and health of people around the world. Throughout the product design and development stages, we are building and strengthening a system for maintaining product reliability, while at the same time ensuring compliance with the safety standards of countries around the world. We assess every kind of risk imaginable by repeatedly checking data accuracy and safety for users. Members from our Sales, Academic Support, and Services functions frequently meet to review the performance, usability, safety, etc. of prototypes from the user's point of view. In fiscal 2008, such reviews were conducted more than 160 times.
We place great emphasis on quality training for developers. A course for training "Risk Engineers," who assess potential risks when developing new products and changing the design of existing products, is taught by a team of experts including "Risk Advisors," who are in charge of product quality and safety control.
Meetings for Strengthening the Global Quality Assurance Structure
Global QA Meeting
In order to ensure accurate test results anytime, anywhere, Sysmex is working to maintain and improve the quality of our products and services throughout the world.
At a Global QA (Quality Assurance) Meeting of June 2008, representatives in charge of quality management systems from Sysmex Corporation and regional headquarters and subsidiaries from the Americas, Europe, China, and the Asia-Pacific region compared notes on the organizational structure, policy, and guidelines that are necessary to reinforce the global quality assurance structure, and shared issues with their counterparts from other regions.
Sharing Customer Feedback on Product Quality and Safety within the Company
At Sysmex Corporation, information on product quality and safety is centrally controlled at the Safety Information Division.
This Division investigates and analyzes such information from customers, and feeds their analysis results to relevant customers while also sharing them with Design, Manufacturing, and other related functions, so that these findings may be applied to quality improvement and product development.
Product Quality and Safety Information Control System
Creating valuable testing and diagnostic technologies
Sysmex System for Rapid Detection of Breast Cancer Lymph Node Metastasis Received Insurance Coverage in Japan
In June 2008, Sysmex Corporation was licensed by the Ministry of Health, Labour and Welfare of Japan for the manufacture and sale of a reagent for detecting breast cancer lymph node metastasis. In November of the same year, our rapid detection system for this indication was covered under Japan's national health insurance. These products have already been released in Europe. In the hopes of alleviating the burden on breast cancer patients, we will make continued efforts to market them globally as well.
Gene Amplification Detector RD-100i
Gene Amplification Reagent LINOAMP BC
Enhancing Usability
Taking an Engineering Approach to Basic Research Works on Testing Instrument Interfaces
Since fiscal 2007, Sysmex has been pursuing basic research in a bid to improve the usability of testing instruments. By taking an engineering approach to the study of usability, we make full use of "human-centered design" and other design techniques, in search of the ideal testing instrument interface.
In the previous fiscal year, we conducted behavioral analysis of users of testing instruments, i.e., how they perform tests, use PCs, etc., which yielded a standard model of testing operations. We will further advance our research work in this regard, so as to ensure that our products offer superior usability from the user's perspective.
Ensuring a Stable Supply of Products
Applying Recombinant DNA Technologies to Substitute Reagents Made from Materials of Biological Origin
Reagent R&D Lab
Currently, many kinds of reagents made from materials of biological origin are used for clinical testing. Such materials are difficult to source in a stable manner, but it is not easy to switch to a substitute without compromising their performance.
In 2009, Sysmex Corporation applied recombinant DNA technologies to become the first in the world to develop a substitute for reagents which use cow organs as a material. We will pursue R&D activities while consistently paying careful attention to stable supply, quality assurance, and the preservation of species.
After-sales Support
Responding to Inquiries both Rapidly and Responsibly to Support Accurate Testing
Sysmex Corporation maintains a Customer Support Center in Japan, where experienced staff members with expert knowledge cater to customers 24 hours a day, 365 days a year (separate contract necessary).
In order to respond to inquiries and requests from customers quickly and carefully, we have created a database of the details of past inquiries and maintenance history to ensure quick reference. Through close communications with technical support engineers at branch offices and sales offices around the country, the Center promptly sends them to the customer to perform maintenance services.
Sysmex also maintains customer service contacts at regional headquarters in the four regions where we operate (the Americas, Europe, China, and the Asia-Pacific region).
Inquiries to the Customer Support Center
Multifaceted Support for Customers’ Quality Control
At hospitals and other medical institutions, the accuracy of instruments is controlled to consistently maintain the reliability of testing data. The condition of their instruments is checked by comparing the measurement results of special reagents known as “control samples” with results from the previous day or with “standard values (measurements of “control samples” made by appropriately controlled instruments).”
Sysmex Corporation supports customers’ quality control by offering such control samples and standard values.
Customers’ testing instruments are connected to the Customer Support Center via our on-line Sysmex Network Communication Systems (SNCS). Measured values of controls sent via the SNCS from customers’ testing instruments are received by the Customer Support Center, which in turn sends its analysis results back to the customers. We support our customers in the quality control of their testing instruments by monitoring the condition of their instruments on a real-time basis, detecting any problems with them, and notifying customers of the same even before they have even become aware of it.
Many customers around the world also make use of the SNCS.
Testing Instruments Registered with On-line Quality Control Service (Global):Over10,000 units
Fiscal 2008 saw the shipment of the 10,000th testing instrument in the world which is capable of using SNCS and e-QAPi, our on-line quality control support services.
Supporting the Spread and Standardization of Automated Hematology Tests in Asia
Hematological testing with Sysmex XS-1000i at a Mongolian hospital
Healthcare infrastructures in some Asian countries are still in their infancy, and in some areas microscopes are still used to perform hematology analysis. Sysmex is working with local governments to promote the spread and standardization of automated hematology testing in many countries, including China, Mongolia, Thailand, and the Philippines.
We install instruments that set the standard for hematology testing in a country, and support their “remote quality control,” which is designed to improve the reliability of measurement data taken at hospitals across the country.
The Fight against Counterfeit Reagents
Eliminating Counterfeit Reagents to Assure Reliability of Patients’ Test Results
In order to assure accurate testing results, we ask our customers at medical institutions to use Sysmex-branded instruments and reagents together. In recent years, however, reagents disguised as Sysmex reagents have been found in circulation among such countries as China, the Philippines, and Indonesia. The use of such counterfeit reagents cannot guarantee the reliability of testing results and, in some cases, can be harmful to patients’ health.
While calling users’ attention to these illegal reagents by publishing announcement ads in local newspapers and by other means, we seek cooperation from local governments and, when necessary, we bring cases to court.
