Quality and Safety of Products and Services
Nihon Kohden Quality Policy
Quality Targets
Integrated Quality Management System
Japan as well as countries in Europe and North America each has rigorous standards and legislation regulating entry into the medical devices market. For example, the United States has QSR (conventionally GMP) established by the Food & Drug Administration (FDA) for the design and manufacturing processes of medical devices. In Europe there is the Medical Devices Directive (93/42/EEC), while Canada has medical device regulations and quality standards developed by the Canadian Standards Association (CSA).
Nihon Kohden not only complies with these regulations, it was among the first in the industry to ensure that its systems and practices conform to global standards to develop and manufacture medical engineering devices that have high degrees of quality and safety. To demonstrate its compliance with these standards, Nihon Kohden has received a number of certifications and accreditations by third-party institutions.
Nihon Kohden has also received Medical Device Single Audit Program (MDSAP)* certification ahead of other manufacturers in Japan.
*MDSAP is a third party Auditing Organization's program to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements.

ISO 9001/ISO 13485 certificate
- Obtained ISO 9001 certification in January 1995 from the Japan Quality Assurance Organization (JQA). In February 2003, this certification was upgraded to the year 2000 version. In August 2008, the certification body was switched to the British Standards Institute (BSI). This certification was upgraded to the 2008 version in February 2010, and the 2015 version in December 2016.
- Obtained certification in accordance with the EU Medical Devices Directive in July 1996 from BSI.
- Obtained ISO 13485 certification (including certification under Canada’s medical device regulations) in February 2003 from BSI. ISO 13485 certification was obtained from BSI in August 2008 and upgraded to the 2016 version in December 2016.
- Obtained MDSAP certification (Medical Device Single Audit Program) in October 2018 from BSI.
Certification based on ISO/IEC 17025 accreditation
Nihon Kohden focuses a great deal on product evaluations in order to develop medical devices that have high degrees of quality and safety. Independent from development, manufacturing and sales departments, our Reliability Center serves as an organization that carries out appropriate product evaluations and consists of iNARTE (The International Association for Radio, Telecommunications and Electromagnetics) - EMC (Electromagnetic Compatibility) and PS (Product Safety) engineers. The Reliability Center is accredited as a third party laboratory that complies with ISO/IEC 17025.
- Obtained laboratory accreditation in the field of electromedical apparatuses in accordance with ISO/IEC 17025 (JISQ 17025) from the Japan Accreditation Board (JAB) in October 2007.
- Obtained laboratory accreditation in field of EMC in accordance with ISO/IEC 17025 from the NVLAP* in March 2009 (which terminated at the end of March 2019) and JAB in March 2019.
*NVLAP: National Voluntary Laboratory Accreditation Program run by the National Institute of Standards and Technology (NIST)

Testing Laboratory
Accreditation Certificate
No. RTL02430

iNARTE Certificate

Kawamoto Office
10m Anechoic Chamber

Advanced Technology Center
10m Anechoic Chamber

Advanced Technology Center
Rooms for tests of vibration resistance

Advanced Technology Center
Rooms for tests of water resistance
Customer Satisfaction Survey
Ensuring Product Safety Post Release
From Collecting Safety Information to Product Recalls/Modifications
Whenever new information on safety is obtained, the Chief Marketing Officer, Quality Assurance Officer and Safety Management Officer immediately convene a meeting to examine ways to address products that have already been shipped and to determine if a product recall or modification is necessary.
If a recall or modification is required, the health threat is categorized either as Class I, Class II or Class III following Japan’s Pharmaceuticals and Medical Devices Act, and Nihon Kohden as well as the Pharmaceuticals and Medical Devices Agency publish pertinent information on their websites. Immediately thereafter the Nihon Kohden Group’s sales and service staff contact customers directly.
Support System for Safety
Nationwide Deployment of Safety Managers
To improve the quality and safety and ensure correct usage of medical devices, the MDIC certification program is run by the JSMI and accredits and develops personnel who can contribute to patient safety and the improvement of healthcare quality, by collecting and providing information on medical incidents and defects and sharing knowledge and technical information necessary for correct usage and maintenance of medical devices between medical safety managers, medical equipment safety managers, medical device users (physicians, nurses, and clinical engineers, etc.) and medical device marketing companies, including manufacturers, marketers and licensors, and repair outlets. To become a Medical Device Information Communicator, a person must take the MDIC seminar organized by the JSMI and pass the certification exam.
Providing the AED Linkage - AED Remote Monitoring System

Committed to helping customers with daily maintenance to ensure their AED can be used at any time
Given this commitment, Nihon Kohden developed the AED Linkage AED remote monitoring system. This system helps support daily maintenance by notifying customers of issues with the AED, or the expiration date of the AED’s electrode pads and batteries, using an email generated based on information gathered from a self-test performed by the AED unit and sent to a server via a remote monitoring terminal. Nihon Kohden is dedicated to providing an environment where all of its customers can be able to readily use an AED with peace of mind.
Call Center Services

Holding Seminars Nationwide in Japan
In July 2004, Automated External Defibrillators (AED) were approved for uses by the general public in Japan and since then many public facilities have installed AED units onsite.
Nihon Kohden organizes classes on CPR and AED to ensure that more of the general public are able to use an AED if need be.
Ensuring Fair Business Practices
We constantly strive to educate stakeholders about this policy to ensure that it is made known to and practiced by all across the value chain, including not only executives and employees, but also customers and business partners.
Heightening Transparency of Relationships with Medical Institutions
In recent years, a number of scandals involving inappropriate relationships between pharmaceuticals and medical device manufactures and healthcare professional have come to light in countries around the world. As a result, society now demands that such vested interests be made known widely to secure the safety and best interests of persons receiving medical care. In the U.S., the Sunshine Act, part of the country’s healthcare reform, took effect in August 2013, while in Japan similar guidelines on transparency, although voluntary in nature, have been applied to pharmaceuticals companies starting in 2012 and medical devices manufacturers in 2013.
Nihon Kohden carefully follows these laws and guidelines and discloses its relationships with healthcare professionals using appropriate means. By doing so, we are seeking to foster greater trust in the Nihon Kohden Group and the healthcare industry.
In-house Training on Sound and Fair Business Practices
Furthermore, Fair Competition Code Instructors are deployed to each of our sales subsidiaries and departments to support employees with engaging in sound and fair business practices, which ensures Nihon Kohden has system in place to empower its employees to take the right actions.