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Responsible Provision of Products and Services

Securing of Product Quality and Safety

Product Quality and Safety Policies

Sysmex has constructed a system to ensure compliance with laws and regulations around the world based on the Quality Policy, the Core Behavior and the Sysmex Corporation Quality Compliance Policy, and we act accordingly.

Quality Policy

By shaping the advancement of healthcare, our global business activities
contribute to the creation of a fulfilling and healthy society.

Core behavior
  1. We understand our customer's needs, and provide products and solutions that meet or exceed their expectations.
  2. We act based on our customer's viewpoints by realizing that "Quality is customer satisfaction".
  3. 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.
  4. We continually create innovative value for our stakeholders by developing and applying new and unique technologies and knowledge.
  5. We comply with all relevant national or regional regulations and standards to provide safe products.
  6. We maintain and continually improve the effectiveness of our quality management system.
  7. We establish quality objectives consistent with this quality policy, and measure our performance against them.

Revised in May 2007

Quality Management

Building a Global Quality Management System

写真: グローバルRAQA会議でのセッションGlobal RAQA Meeting

With regard to our quality management system, at Group companies all production sites and nearly all development sites have put in place management systems following either the ISO 9001 or ISO 13485* international standards. Of our 65 Group companies, 32 have obtained ISO 9001 certification and 19 have received ISO 13485 certification in the aim of reinforcing their quality management systems. Sysmex also conducts management reviews and audits of quality activities at its principal Group companies to confirm that the management system is operating properly.

To share quality-related information throughout the Group, we regularly hold the Global RAQA (regulatory affairs/quality assurance) Meeting, at which Quality Assurance Department managers from Group companies in Japan and overseas gather.

Quality management system for the design and manufacture of medical devices

Sustainable Improvement Programs

Reinforcing Structures for Maintaining and Enhancing Product Quality

Used in laboratory 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 at 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. Also, 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. As well as these efforts, in the unlikely event of a defective product we have systems in place to quickly identify and respond to the problem.

On factory floors, we introduced clean rooms into our flow cell parts manufacturing process in fiscal 2016. Increasing the cleanliness of the working environment led to higher quality and yields. To reinforce quality at suppliers, efforts to improve process change management and factory audits led to a reduction of around half in the rate of nonconforming parts year on year.

In addition, our global quality complaint processing system allows us to gather quality information in a timely way from markets around the world. When we receive information about a bug or malfunction, we immediately look into the cause and cease distribution of the product. Sharing information globally about bugs and malfunctions, as well as corrective and preventive actions, helps us maintain and enhance product quality.

Employee Training

Focusing on Specialized Quality Training

Group training

Group training

In addition to quality policy training for all employees, we conduct specialized quality education targeting specific departments and job types. Being a company that provides products and services in more than 190 countries and regions around the world, we conduct education on individual countries’ regulatory systems for engineers in development divisions, making a thorough effort to develop products in accordance with laws and regulations.

In fiscal 2016, we conducted training related to quality system regulations on requirements for ensuring the quality and safety of medical instruments in the United States. We also conducted training on regulations requiring unique device identification for medical instruments (UDI). At our Ono Factory, we held workshop-style quality training for people responsible for Good Manufacturing Practice (GMP), increasing quality awareness through an exchange of opinions based on case studies.

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