While attending to constant improvement of the quality of our products and services, Sysmex is working hard to create a system that allows us to ensure that customers can confidently use such products with safety and ease. We sincerely wish to offer satisfaction that more than meets their expectations by deepening our understanding of “what customers truly want.”
By shaping the advancement of healthcare, our global business activities contribute to the creation of a fulfilling and healthy society.
- 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.
Creating a Global Quality Management System
Global QA Meeting in fiscal 2010
As of March 31, 2011, a total of 27 of the 44 Group companies were qualified for the ISO 9001 international standard for quality management systems, with all of the companies involved in development and production being certified.
In fiscal 2009, we newly established a “Sysmex Corporation Quality Compliance Policy”. In this Policy, we reaffirmed the laws, regulations, and in-house rules that we must comply with in order to maintain product quality and achieve customer satisfaction, and clearly defined systems and activities designed for conformance with them. At the same time, we developed procedures for global internal auditing, which is conducted to ensure the steady implementation of such systems and activities. In fiscal 2010, we conducted an audit of our factories in China and Singapore.
In addition, we hold a Global QA (Quality Assurance) Meeting each year where managers of quality management systems from Sysmex Corporation in Japan; the regional headquarters in the Americas, Europe, China, and the Asia-Pacific region; and affiliates gather to share information as a means of strengthening the global Sysmex quality assurance system.
Ensuring Product Quality
Used for clinical testing, Sysmex’s products play a vital role in protecting people’s lives and good health. Being fully aware of this responsibility, Sysmex is making constant efforts to maintain and improve product quality by building various systems, not to mention 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 process leading up to market launch.
When we market products that are manufactured by others, we verify their quality by conducting periodic audits of the manufacturers and meticulously inspecting the products.
Ensuring Product Safety
Absolutely Ensuring Product Safety
We care about the safety of clinical technologists and nurses, who are the users of our products. Accordingly, Sysmex products are designed and developed in compliance not only with the Pharmaceutical Affairs Act of Japan, but with even more stringent in-house standards.
For example, in order to prevent operators of clinical testing devices from contracting blood infection through wounds suffered while working, we have incorporated a number of ideas in our products to enhance their safety, e.g., designing all components used in devices to be free from any edges that might cause injury, and automatically housing the tips of piercing needles (for piercing blood collection tubes) when they are replaced.
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
For Responding to Inquiries both Rapidly and Responsibly
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 contract necessary).
By creating a database containing maintenance histories and the details of past inquiries from customers to ensure quick reference, the Center responds to inquiries and requests both quickly and carefully. We also maintain customer service contacts at our regional headquarters in the four regions outside of Japan (the Americas, Europe, China, and the Asia-Pacific region).
Inquiries to the Customer Support Center
Supporting Customers’Quality Control on a Daily Basis
At hospitals and other healthcare facilities, 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.
Sysmex Corporation supports customers’ quality control by offering such control samples. Customers’ instruments are connected to the Customer Support Center via our on-line Sysmex Network Communication Systems (SNCS). Measured values of control samples sent via the SNCS from customers’ instruments are received by the Customer Support Center, which checks to see if anything is wrong and then sends its analysis back to the customers. The SNCS also helps customers to prevent instrument failure, as it detects signs of problems even before customers have become aware of them. Going forward, we will further advance this “prediction” and “prevention” support service and strengthen our remote maintenance support by utilizing networks to cope with malfunctions.
Testing instruments registered with the on-line quality control service (worldwide)
Preparing Instruction Manuals That Are Easy to Understand
Instruction manuals that show users how to operate instruments in an easy-to-understand manner are essential for obtaining accurate test data. In fiscal 2010, as a means of making our manuals easier to understand, we revised the arrangement of their chapters to match the user's workflow, and made improvements to the font size and type to achieve easier-to-read print. For some instruments, we have also provided moving pictures on the display to provide users with viewable instruction manuals that make operating methods easier to understand.
Health Maintenance Support Service
Offering an Innovative Way to Help Employees Maintain and Improve Their Health
In December 2010, Sysmex launched the PROWELL Opti Health Guidance Optimization Service, a new SaaS*1 to help companies to manage employees' health. In Japan, companies provide consistent guidance on health improvement to employees whose routine health checkup results indicate the need for lifestyle improvements.
When a health adviser enters the results of an employee's routine health checkups and the employee answers questions pertaining to lifestyle habits, PROWELL Opti automatically analyzes the data and generates health guidance and suggestions for effective lifestyle changes. Recommended changes are shown in priority order, and the service describes the associated risks of disease, as well as visuals depicting an individual's physical condition. This service helps increase the degree of improvement by boosting motivation and providing consistent guidance procedures. Furthermore, by recording the results of each individual's lifestyle improvement efforts on a daily basis, the service helps individuals make their actions habitual.
*1 Software as a Service. SaaS refers to the provision of software services as needed, in the required amounts. Generally, such services are offered via the Internet.
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.
Holding Scientific Seminars for Healthcare Professionals
Sysmex keeps healthcare professionals updated on cutting-edge cientific information by sponsoring seminars and study sessions for doctors, nurses, and clinical technologists. In June 2010, venues in Kobe, Tokyo, Sendai, and Fukuoka were linked by satellite relay to hold the 33rd Sysmex Scientific Seminar under
the theme of “The Frontiers of Genetic Testing”.
The 13th Sysmex Scientific Seminar in China, which was held in October 2010, set a new record in participation with more than 800 people attending.
The 33rd Sysmex Scientific Seminar
Sysmex Scientific Seminar in China
Sysmex Journal International Available in More than 100 Countries
We distribute Sysmex Journal International to medical institutions and college libraries in more than 100 countries around the world, thus keeping many healthcare professionals updated on current clinical medicine and medical testing.
Publishing Picture Books to Explain Diseases and Testing
Sysmex compiles educational picture books on diseases and testing, which are distributed free of charge to clinics and other medical institutions to keep in their waiting rooms.
Introducing the characteristics of diseases and procedures of testing and treatment in a simple way, the picture books are narrated in the form of stories to keep children and readers unfamiliar with medicine interested as they read. We have received favorable feedback from the readers of these books.
Publishing an Picture Book on Von Willebrand Disease
In fiscal 2010, Sysmex published a new picture book, "A Story About Von Willebrand Disease." Von Willebrand disease is a hereditary abnormality that causes bleeding from the skin or mucous membranes. It is known to be caused by a deficiency or dysfunction of the blood coagulation factor called von Willebrand factor.
The book introduces basic knowledge of von Willebrand disease, such as causes, types and symptoms, as well as testing and treatment methods, for easy understanding. English and Chinese versions of the book have also been published.