Safety, Quality, and Reliability
Focus on Safety
Nihon Kohden designs and manufactures medical equipment in conformity with the standards of IEC601-1 (Medical Electrical Equipment: General Requirements for Safety).
Nihon Kohden also incorporates accident prevention measures such as our touch-proof DIN connectors which cannot be inserted the wrong way or accidentally inserted into power connectors. Patient and operator safety is our #1 priority.
Focus on Quality and Reliability
Nihon Kohden products have earned a reputation for quality and long life.
One reason is that all export products and major components are manufactured in our own ISO-9001, EN 46001 certified factories.
All factories and all European products have ISO 9001 and EN46001 certification. In addition, many of our products have CE marking for the European market.
Nihon Kohden's Quality System
In 1984, Nihon Kohden implemented a comprehensive company wide quality system, IQC - Integrated Quality Control. Under this system, quality begins at the earliest stage of every product's life. Our IQC applies to the entire manufacturing process, from the planning stage through product development, design, parts procurement, production, inspection, storage, sales, distribution and after-sales support. IQC also involves nearly every employee.
Our rigid test procedures are structured to exceed the provisions of the GMP, Good Manufacturing Practice, codes enforced by the US Food and Drug Administration. Nihon Kohden also has 130 in-house quality control inspection staff to ensure that standards are implemented and maintained in every department of the Company.
IQC extends beyond production and into sales and support at each subsidiary. These staff are responsible for ongoing contact with customers to determine their needs and making sure that these changing requirements are reflected in new products. Service engineers are responsible for communicating any problem that may arise in the use of Nihon Kohden products, and assuring the customers of Nihon Kohden's commitment to their satisfaction.
In 1995, Nihon Kohden received ISO 9001 certification, the international standard for quality systems. In addition, Nihon Kohden's four manufacturing facilities in Japan are the first factories in the medical equipment industry to be certified by the CSA, Canadian Standards Association, under their category certification system. Most products sent to North America carry the CSA label.
Quality improvement is and always has been an ongoing process for Nihon Kohden.
ISO 9001 Quality Management System