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.

In FY2022, we will take actions to achieve the following quality targets.

1) Build a global quality management system to strengthen regulatory compliance and post-marketing monitoring in each country.

Healthcare systems in every country are being overwhelmed as a result of the COVID-19 pandemic, and demand for high-quality medical devices is rising worldwide. Nihon Kohden is gathering information on medical device related laws and regulations in each country and comprehensively disseminating it within the Company, reducing global product registration times, and achieving timely launch of products to global markets. We are also improving post-marketing monitoring systems and using the acquired information to enhance internal processes and provide feedback that is useful for products, leading to higher product quality.

To have the customers feel continuous satisfaction with their purchase of Nihon Kohden products, we are continuing our efforts to design and manufacture products with low failure rates. To achieve this goal, we set quantitative targets for utilization rates, periodically review them, and provide feedback for use in design, production and service activities. In addition, we employ new technologies for remotely monitoring the status of product utilization rates, which lead to the prevention of failures. We are also working to reduce the time from receipt of products for repair to the provision of loaner devices as well as reducing repair times.

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 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.

Nihon Kohden has obtained ISO 9001 certification for its quality management system and ISO 13485 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 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 (MDD) 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.
• Obtained certification in accordance with the EU Medical Device Regulation (MDR) in April 2022 from BSI.
• Obtained certification in accordance with the EU In Vitro Diagnostic Medical Device Regulation (IVDR) in August 2022 from TÜV SÜD Product Service GmbH.

In addition, all overseas production sites of the Nihon Kohden Groups develop and manufacture products in accordance with their quality management systems that are commensurate with the risks of each product and comply with the law and regulatory requirements of each country. All overseas production sites of the Company Group have obtained ISO 13485 certification, and strive to maintain and improve the quality of their products and services through regular audits by a third-party organization.

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)

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 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.