To achieve this quality policy, Nihon Kohden sets group-wide targets and continually strives to ensure quality and enhance customer satisfaction in all processes, from development to production, sales and after-sales services. Our goal is to be a company that is continually viewed and supported by customers as a trusted partner.

Our long-term vision for 2020 includes the goal of “achieving the highest level of quality in the world.” In pursuit of product and service quality, we set three targets for daily quality improvement activities.

1. "Risk Zero" design and  production
2. Achieve a high utilization rate by users
3. Achieve excellent usability

Medical devices supporting the frontlines of medicine require extremely advanced degrees of quality and safety.

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 obtained ISO9001 certification for its quality management system and ISO13485 certification for its medical devices, and was the first medical devices manufacturer in Japan to receive certification in the CSA’s medical devices category.

• Obtained ISO9001 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). In February, 2010 this certification was upgraded to the 2008 version.
• Obtained certification in accordance with the EU Medical Devices Directive in July 1996 from BSI.
• Obtained ISO13485 certification (including certification under Canada’s medical device regulations) in February 2003 from BSI. In August 2008, ISO13485 certification was obtained from BSI.

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. The Reliability Center has received laboratory accreditation in accordance with ISO17025 from a third-party institution.

• Obtained laboratory accreditation in the field of electromedical apparatuses in accordance with ISO/IEC17025 (JIS Q 17025) from the Japan Accreditation Board (JBA) in October 2007.
• Obtained calibration institution accreditation in accordance with ISO/IEC17025 from JAB in July 2012.
• Obtained laboratory accreditation in field of EMC in accordance with ISO/IEC17025 from the NVLAP* in March 2009.
• EMC testing facilities are registered with the VCCI and FCC.

・3 employees are iNARTE accredited safety testing engineers.
・3 employees are iNARTE accredited EMC testing engineers.

*NVLAP: National Voluntary Laboratory Accreditation Program run by the National Institute of Standards and Technology (NIST)

1) Achieve design and production intended to eliminate risk
Given today’s social conditions, a company claiming to have zero risk in its products is doing just that – claiming. Nevertheless, Nihon Kohden recognizes that vital importance of continually pursuing improvement activities to take steps toward achieving as little risk as possible to ensure customer safety and peace of mind. With this in mind, our development, service and manufacturing departments work closely together to carry out design and production work intended to eliminate risk.

2) Achieve a high utilization rate by users
The key behind ensuring the highest level of quality and customer satisfaction far into the future is designing and manufacturing devices that breakdown less often as well as returning products in a short period of time even if they do breakdown. We use utilization rate as a metric to quantify and measure our improvement activities. We continue our efforts to achieve an even higher utilization rate so that products purchased by customers can be used at anytime without fail.

3) Achieve excellent usability
In addition to mitigating risk and achieving a high utilization, developing products that are easy to use and closely in tune with customer needs is of the utmost importance. To accomplish this we constantly strive to improve operability (ease of handling), visibility (ease of understanding), and comfort (ease of use).

Nihon Kohden regularly conducts customer satisfaction surveys to continually improve the quality of its products and services. Feedback and opinions from these surveys are shared with development, production, sales and service departments.

Nihon Kohden is highly cognizant of the fact that medical devices directly involve human lives. To ensure that its products being used by customers and patients are safe and secure, Nihon Kohden makes daily efforts to improve the quality of its products. However, in the unlikely event a defect is found in one of our products after shipment that poses even a slight risk to the health of users, we have systems in place that enables us to carry out an immediate response and guarantee the safety and security of our customers and patients.

Nihon Kohden compiles a host of information on safety, including defects discovered in the design and production process, safety information obtained from sources overseas, and customer complaints, among other sources. In this way, we are constantly monitoring for possible health risks posed to customers and patients.
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.

Nihon Kohden not only strives to improve the quality and safety of its products, but also supports customers manage safety and helps spread medical technologies, which directly links with safety after a product has been delivered.

Nihon Kohden deploys specialized safety managers nationwide who have received accreditation as Medical Device Information Communicator (MDIC*). To ensure customers use our products correctly, we organize safety workshops in every corner of Japan. Nearly 1,500 of these safety workshops were held in 2013 alone.
Nihon Kohden also promotes preventive activities for safety purposes, such as offering advice on maintenance inspections and providing information for safety management.

Nihon Kohden organizes a vital signs seminar and seminars co-sponsored with academic societies and for all physicians and other healthcare professionals as part of its efforts to ensure the latest, most advanced medical devices are used and understood correctly on frontlines of medicine.

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.

Nihon Kohden recognizes that carrying out sound, fair, transparent, open, positive and competitive business activities in accordance with the Nihon Kohden Charter of Conduct will foster greater trust from society and is absolutely essential for the continuity of its business.
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.

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.

Nihon Kohden regularly conducts compliance training for all of its employees in Japan to ensure they continually maintain the correct understanding and mindset toward sound and fair business practices. Departments related to sales and procurement have established legal affairs training tailored to the needs of their organization, which includes Fair Competition Code and the Act against Delay in Payment of Subcontract Proceeds, Etc. to Subcontractors, to foster greater understanding toward 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.