Medical

Pursuing Quality and Establishing Sustainable Supply Chains

The Eiken Group operates a quality management system, guided by its Quality Policy. From research and development through manufacturing and sales to after-production/after-sales follow-up, the Group strictly complies with related laws and ordinances, public guidelines and in-house regulations, ensuring customers of a steady supply of high-quality, effective and safe products and services. If an abnormality or defect is found in a product, the Group takes prompt corrective action.

Based on a supply-chain sustainability policy, the Group works with the partner companies in its supply chains to conduct responsible procurement, making every effort to ensure that each company fulfills its social responsibilities.

Quality Policy

EIKEN CHEMICAL 's management philosophy is to "protect the health of the public through health care services”. On the basis of this philosophy of management, all of the employees of EIKEN CHEMICAL actively promote the following principles of our quality policy, aiming to maintain the company that is always trusted for its unwavering quality.

  1. Satisfy the demands of our customers and the requirements of the related laws and regulations, steadily providing the products, the technology, and the information that gives top priority to quality and safety.
  2. In order to ensure implementation of the quality policy, establish quality objectives in each department and ensure that these objectives are accomplished. Moreover, EIKEN CHEMICAL periodically revises and upgrades these quality objectives.
  3. Create and employ a quality management system, continuously improve the efficiency of the system by management reviews, becoming a company that is competitively strong.

Quality Management System

Eiken Chemical operates a quality management system, centered on the Reliability Assurance Division and under the supervision of the president and CEO. The president drafts the Company’s quality policy and the various Divisions set quality targets based on their respective management and quality policies. Management reviews are held each month to support and improve quality systems.

The Company is certified under the ISO 9001 and ISO 13485 international quality standards. In accordance with ISO 9001 and ISO 13485, as well as the requirements of the laws and regulations of Japan and countries to which the Company exports, Eiken Chemical supports quality systems, including their required processes and interactions. Moreover, the Company continuously improves the efficacy of its quality management system.

Proactive Activities on Quality

Guided by the motto “Trusted for quality, growing through technology,” the Eiken Group conducts its business activities in accordance with its quality policy. To establish Eiken Quality and build customer satisfaction into products and services through the efforts of all employees, the Eiken Group conducts “proactive activities” on quality assurance, regularly conducting initiatives and campaigns to raise awareness of quality matters in-house. Through these activities, we are building a culture that places top priority on quality and fostering that culture Company-wide.

Various Certification Acquisitions

ISO9001:2015

Eiken Chemical has acquired an ISO9001 certification for all of its business locations by meeting the international standards for quality management systems for the provision of products and services.

Applied Standard ISO9001:2015
Scope of Certificate Design and Development, Production and Distribution of IVD Reagents for Microbiological testing, Clinical chemical testing, Urine testing, Immunochemical testing, Serological testing and Nucleic acid testing, Media and Reagents for Microbiological testing, Specimen receptacles and apparatus for clinical, Food and Environmental testing and Reagents for Food and Environmental Analysis and Animal and Plant Diagnosis.
Design, Distribution, Installation and Servicing of IVD Analyzers and related devices for specimen collection.
Certification Body TÜV SÜD Management Service GmbH
Certification No. 12 100 26393 TMS
Valid until 2024-07-30
Facilities Head Office, Nogi Plant, Nasu Plant, Europe Office

ISO13485:2016

Eiken Chemical has acquired an ISO13485 certification for all of its business locations by meeting the international standards for quality management systems for medical devices and related products.

Applied Standard ISO13485:2016
Scope of Certificate Design and Development, Production and Distribution of IVD reagents for Microbiological testing, Clinical chemical testing, Urine testing, Immunochemical testing, Serological testing and Nucleic acid testing.
Production and Distribution of Swabs and Specimen containers for Microbiological testing.
Design, Distribution, Installation and Servicing of IVD Analyzers and related devices for specimen collection.
Certification Body TÜV SÜD Product Service GmbH
Certification No. Q5 056540 0024 Rev.02
Valid until 2024-06-24
Facilities Head Office, Nogi Plant, Nasu Plant, Europe Office

MDSAP Certification

Eiken Chemical has acquired a certification for the MDSAP (Medical Device Single Audit Program) international standard for medical devices quality management systems adopted in MDSAP member nations (Japan, the United States, Canada, Australia, and Brazil).

Quality Support on the Medical Front Lines

EQCS-Net: Comprehensive System for External Precision Management Services

At Eiken Chemical, the Eiken Quality Control Service (EQCS), an external precision management service for fecal immunochemical test, was launched in 1995. This system is now being used in numerous facilities and has expanded to additional fields such as urinalysis tests and immunological tests as well. EQCS-Net is a comprehensive system for these multiple external precision management services.

'Eiken' Food Microbiological Testing Precision Management Survey

In order to test microbiological content of foods and the production environment and scientifically manage food quality, objective evaluation of the ability (competency) of the testing room is essential. Eiken Chemical implements food microbiological testing precision management surveys as part of its external precision management services to provide these evaluations to all of our clients.

Supplier Sustainability Policy

Based on the management philosophy that the Eiken Group will “protects the health of the public through health care services,” the Eiken Group has established the “Eiken Group Global Code of Conduct," which indicates the actions that all employees and others should take to contribute to society by providing products and services that protect the health and life of people around the world. In order to contribute to attaining a truly worthwhile meaningful society through our business activities, the Eiken Group will works promotes with our suppliers to promote fulfill the fulfillment of social responsibility compliance and implements eco-friendly initiatives with its partners that give consideration to environment environmentally friendly efforts with our suppliers throughout the supply chain based on this policy. As a result in so doing, together with your cooperation, we will strives to achieve a sustainable society. We greatly anticipate our suppliers' eagerly look forward to your understanding and joining us in practicing this policy. We also look forward to your cooperation in applying it to your entire supply chain.

Compliance with laws and regulations and development of a system

(1) Compliance with laws and regulations
We will ensure that our company complies with laws and regulations in the countries and regions where we do business, and we will respect the International Code of Conduct and conduct our business in a fair and equitable manner.

(2) Development of a system Establishment of systems
In addition to training and enlightening our employees and others, we will establish effective mechanisms such as an organization and system for early detection of problems.

Human rights and labor

(1)Prohibition of forced labor
We do not use forced, slave labor or trafficked labor in any form.

(2) Prohibition of child labor
We do not allow children under the minimum working age to work.

(3) Elimination of discrimination
We do not discriminate on the basis of race, religion, gender, age, nationality, region of origin, language, disability, gender identity, sexual orientation or the like.

(4) Wages based on laws and regulations
We comply with all relevant laws and regulations, including minimum wages and overtime allowances, and pay fair wages that meet or exceed the statutory minimum standards in the country or region in which our employees and others work.

(5) Management of working hours
We comply with statutory limits for overtime work and vacations, and properly manage working hours, leave and holidays for employees and others.

(6) Freedom of association and right to collective bargaining
We comply with laws and regulations relating to freedom of association and collective bargaining and respect the rights of employees and others to join trade unions and to form trade unions and the right to collective bargaining.

Consideration of safety and health

(1) Safety and health
We strive to prevent industrial accidents and ensure the safety of our employees and others. For that purpose, we prepare business manuals and the like and provide appropriate education and training.

(2) Health management
We strive to create a comfortable working environment and strive to maintain and promote the physical and mental health of our employees and others.

Ethics

(1) Anti-corruption
We maintain fair relationships with customers, our suppliers and business partners , and government and other public agencies, and do not provide or accept improper benefits, such as corruption, bribery, or fraud.

(2) Ethical behavior
We ensure compliance with laws and regulations to engage in fair and free competition, protect intellectual property rights, conduct responsible marketing, provide disclosure, respect confidentiality, protect privacy including personal information, and refrain from association with antisocial forces.

(3) Proper accounting and tax processing
We conduct proper accounting and tax processing in accordance with accounting and tax-related laws and regulations.

(4) Whistleblower system
We establish and operate systems through which individuals can report acts in our company that constitute or may constitute violations by organizations or individuals of laws, regulations, or internal regulations such as work rules. Those systems protect the confidentiality of our employees and others, so that they can report violations without the risk of retaliation.

Consideration of the global environment

(1) Building environmental management systems
We regularly inspect and continuously audit the status of implementation to make improvements, and review environmental actions to reduce our environmental impact.

(2) Action on climate change
We strive to reduce greenhouse gases by setting quantitative voluntary targets through energy conservation and the use of low-carbon and decarbonized energy.

(3) Pollution prevention
We comply with relevant laws and regulations to prevent soil, air and water pollution, and thoroughly manage substances that may cause environmental pollution or safety violations.

(4) Water use and resource recycling
We reduce the use and emissions of limited global resources such as water and raw materials and promote sustainable and efficient use.

(5) Reduction and proper disposal of waste
We set quantitative voluntary targets and strive to reduce waste by promoting recycled use and implement proper disposal.

(6) Conservation of biodiversity
We grasp the impact of our business activities on biodiversity and strive to conserve natural ecosystems.

Ensuring safety, security and quality

(1) Construction of mechanisms to uphold quality
We establish and operate a mechanism to uphold the quality standards agreed to with the Eiken Group to maintain the quality of our products and services.

(2) Ensuring safety
We comply with laws and regulations related to our products and services and their manufacture, and strive to provide reliable products and services while ensuring safety.

Definition of terms

(1) Suppliers
Suppliers, manufacturing contractors, business contractors (those who provide any service to the Eiken Group), and others

(2) Employees and others
All persons including executives, full-time employees, seconded employees, dispatched employees, part-time employees, and others

Formulated: April 1, 2022
President and CEO
Eiken Chemical Co., Ltd.