Product Quality and Safety Policies
Sysmex has constructed a system to ensure compliance with laws and regulations around the world based on our Quality Policy, our Core Behaviors, Sysmex Corporation Quality Compliance Policy, and our Product Security Policy, and we act accordingly.
By shaping the advancement of healthcare, our global business activities contribute to the creation of a fulﬁlling and healthy society.
- We understand our customers’ needs, and provide products and solutions that meet or exceed their expectations.
- We act based on our customers’ 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.
Revised May 2007
Building a Global Quality Management System
All of Sysmexʼs production facilities* have obtained ISO 9001 or ISO 13485 certiﬁcation. Out of the 77 companies in the Sysmex Group, 33 have been ISO 9001 certified and 19 have been ISO 13485 certified. To ensure that these management systems are properly implemented, we conduct management reviews and quality audits of major Group companies. In fiscal 2018, 33 cases of nonconformity were identified in an internal quality audit, and one case was identified in an external quality audit. All of these issues have been resolved.
In addition, we regularly hold a Global RAQA (Regulatory Affairs Quality Assurance) Meeting, at which people in charge of quality assurance at Group companies in Japan and overseas gather. In this way, we are working to share quality information throughout the Group and reinforce our QA structure.
- Wholly owned subsidiaries
Sustainable Improvement Programs
Reinforcing Structures for Maintaining and Enhancing Quality
Used in laboratory testing, Sysmexʼs products play a vital role in protecting peopleʼs lives and health.
Being fully aware of this responsibility, Sysmex is making constant eﬀorts to maintain and improve product quality by building various 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 process leading up to market launch.
Also, when we market products that are manufactured by others, we verify their quality by conducting 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.
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 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 way from markets around the world. When we receive information about a problem or malfunction, we immediately look into the cause and cease distribution of the product.
Sharing information globally about problems and malfunctions, as well as corrective and preventive actions, helps us maintain and enhance product quality.
Providing High Quality Products and Services through Third-Party Certification
To enhance credibility, we are strengthening our quality assurance system regarding product inspection results.
Through these efforts, Sysmex International Reagents, which produces reference materials, received ISO Guide 34 certification in April 2018, an international standard concerning the competence of reference material producers. This was the first ISO Guide 34 certification granted in the hematology field in Japan, which certifies a manufacturer’s competence to provide reference materials of proper quality. This certification will strengthen our credibility concerning the quality of data in our products and services, enabling our customers in global clinical laboratories to verify their own competence to provide proper test data.
Sysmex has obtained the following additional certifications:
- ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
- ISO/IEC 17043 (Conformity assessment — general requirements for proficiency testing)
- ISO 15195 (Laboratory medicine — requirements for the competence of calibration laboratories using reference measurement procedures)
Focusing on Specialized Quality and Safety Training
In addition to quality policy education for all employees, Sysmex Corporation conducts basic and specialized quality education targeting speciﬁc departments and job types.
As a company that provides products and services in more than 190 countries and regions around the world, we conduct training on individual countries’ regulatory systems for engineers in development divisions, ensuring that we develop products in accordance with applicable laws and regulations.
Activities in FY2018 (Examples)
- Conducted training on Good Vigilance Practice (GVP) for safety management employees in charge of manufacturing, sales, and investigation of defects; this training was intended to ensure an accurate understanding of how to gather and use safety management information related to the causes of health hazards (784 employees)
- Conducted training on our Quality Policy, Sysmex Group’s quality objectives and regulations concerning QMS (i-Square and Kakogawa Factory, 389 employees)
|Sysmex International Reagents
- Conducted training on our Quality Policy and Sysmex Group’s quality objectives (Ono Factory and Seishin Factory, 265 employees)
- Conducted training on our Quality Policy and Sysmex Group’s quality objectives (145 employees)
- Conducted training on our Quality Policy and Sysmex Group’s quality objectives (195 employees)
- Conducted training on information management systems, including quality management, environment, and energy information
- Conducted technical training on a periodical basis for all employees subject to laws pertaining to medical device consultants (primarily those in charge of sales, marketing, and service)
- Responsible Provision of Products and Services
- Securing of Product Quality and Safety
- Appropriate Disclosure of Information Regarding Products and Services
- Assessment and Management of the Supply Chain
- Customer Relations