Home > CSR > Certified according to ISO 13485

Certified according to ISO 13485 (Quality management systems on medical devices)

We are qualified as a manufacturer of clinical chemistry reagents,immunological reagents and related reagents in accordance with ISO 13485:2003.

In January 2005, the quality management systems for our products related to in-vitro diagnostics was certified according to ISO 13485, which is an international standard on quality management systems for medical devices. This standard was established based on ISO 9001 by adding up various specific requirements from the aspect of the influence and safety on clinical use.
In order to guarantee the demanding high quality for in-vitro diagnostics, we supply our own products under this internationally standardized quality management systems including the requirements of GMP (Good Manufacture Practice) requested by Ministry of Health, Labor and Welfare.

[ Outline of Certification ]

The name of the company

Kanto Chemical Co., Inc.
  Life Science Department
  Isehara Factory
Date of issue of Certification

January 5, 2005 : Primary audit
February 9, 2006 : Recent audit
Certification
body

Applicable standards

ISO 13485 : 2003
Scope of Certification

Design and Development, Production and Distribution of Clinical Chemistry Reagents, Immunological Reagents and related products.
Import, Production and Distribution of Microbiological Reagents.

 

 
ISO 13485