International Standards

Assuring high quality acknowledged worldwide

International Standards

FSSC22000、ISO9001、ISO14001、ISO13485 promise you safety and security.

The Company acquired for its entire organization Certification under the ISO9001 standard, a world standard which relates to quality management systems and under the environmental management system related ISO14001 standard. Furthermore, Certification under the food safety management system related FSSC22000 standard has been acquired for the Company’s Gunma Fujioka and Saitama Miyoshi factories and under the medical instruments quality management system related ISO13485 standard for the Group member company Medix Showa. The Company engages in manufacture under the four aforesaid management systems. The Company is committed to maintaining and improving quality by complying, in the course of its day on day manufacturing activities, with the norms and standards laid down by these management systems and by complying with the conditions for products of favorable quality through giving instruction and training to its personnel entailing repeated performance of the procedures and rules laid down in the management systems. Its practice is to perform the inspections necessary in the manufacturing process and let pass into the next process only products having been found as being of favorable quality. Its standard practice is furthermore to not embark on manufacture until after the level of quality required and the tolerance limit have been determined based on the quality specifications the Company has exchanged with its customers and to thereupon ship out to customer only products which have been accepted as being conformant by inspection performed by the Quality Control Division being an entity independent of the Manufacturing Division.

ISO9001

Certification under the ISO9001 standard was acquired for the Gunma Fujioka plant in 1999 and for the entire Company in 2003.
ISO9001 is a quality management system standard the purport of which is the enhancing of the quality of “products and services.” Quality management system is defined as being “a system of controlling the entire process up to the supply of products and services to the customer.” ISO9001 giving as its purport “the attainment of customer satisfaction” considers it possible to achieve the continued supply of products and services of a more favorable quality through the operation of a system which continuously improves the process by which the products we manufacture and our services are supplied.

ISO14001

Certification under the ISO14001 standard was acquired for the entire Company in 2006.
ISO14001 is an international standard for Certification of environmental management systems. Its nature is akin to being a guideline for the configuration of a system whereby environmental risks attendant upon corporate activities are analyzed for the purpose of reducing such risks. It mandates a commitment towards achieving a sustainable environment through the establishment and operation of a system that expands those factors which are good for the environment and reduces by way of improvement those that are bad for the environment.

FSSC22000

Certification under the FSSC22000 standard was acquired for the Gunma Fujioka plant in 2014 and for the Saitama Miyoshi plant in the year following, 2015.
FSSC22000 is short for Food Safety System Certification 22000.
FSSC22000 denotes food safety system standards developed by the Foundation FSSC22000. Based on the view that food safety is realized through the food supply chain as whole on the basis of standards approved as one of the food safety certification schemes, FSSC22000 certification has in recent years come to be considered necessary not only for the food producing industry but also for the food packaging industry. While FSSC22000 and ISO22000 are apt to be easily confused it should be noted that FSSC22000 is a standard arrived at by the addition of certain additional requirement items  and of certain technical requirement items to ISO22000 and is consequently a standard more stringent than ISO22000.

ISO13485

Certification under the ISO13485 standard was acquired for the Development and Research Center, the Sales Division, the Quality Assurance Department, and for Medix Showa in 2009.
ISO13485 is an international standard for quality management systems special for the medical instruments industry. Its purport is considered to be its embedment in the national laws regulating the manufacturers of medical instruments in the respective countries and consequently the laws regulating medical instruments are established in almost all counties, notably European countries, Canada, and Australia, based on the requirements set forth in the ISO13485 standard. For the global export and sales of the medical instruments thus manufactured certification under this standard has been acquired on the recognition that it is a necessity that not only the domestic (Japanese) GMP standard but also the global standard be passed.

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