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Trustworthy Products and Services with Quality Ensured

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.

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 2021-07-30
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.00
Valid until 2021-06-24
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).

Provision of Precision Management Services

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.