Integrated Quality Management System

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, Nihon Kohden conducted two product recalls, causing inconvenience to those in clinical practice. We are making company-wide efforts to prevent any reoccurrence and are pursuing the world’s highest quality levels throughout the entire value chain.
In FY2023, we will take actions to achieve the following quality targets.

In FY2023, we will take actions to achieve the following quality targets.

1) We will build a global quality management system to strengthen regulatory compliance and postmarketing monitoring in each country.
In response to the increasing demand for high-quality medical devices at the global level, Nihon Kohden has strengthened its regulatory compliance in each country where its products are sold, improved its global post-marketing monitoring, and enhanced its QMS in April 2023. Under the new structure, we will thoroughly collect and deploy information on medical device-related laws and regulations in each country to shorten the time required for global product registration and ensure the timely supply of products. We will also continue to improve our post-marketing monitoring system and use the information obtained to improve internal processes and provide feedback to design teams to improve the quality of our products and services more rapidly.
Cyber-attacks on medical institutions have been increasing in recent years and are posing a growing threat. In addition to cyber-risk mitigation measures and the early detection of security incidents, we have established a PSIRT (Product Security Incident Response Team) to provide appropriate support for early recovery in the event of a security incident. We will continue to strengthen our cyber security response.

2) We will improve customer service as well as software and manufacturing quality to pursue customer value.
To enhance services for our customers, we will work to improve daily operations, increase efficiency and speed, and respond to customer feedback in an appropriate and timely manner. In addition to thirdparty evaluations of software design, we will work to reduce product failures after shipment by analyzing problems in the product manufacturing process and taking measures to prevent their recurrence.

Nihon Kohden has obtained ISO 9001:2015 certification for its quality management system and ISO 13485:2016 certification for its medical devices and in vitro diagnostics. The Company has also obtained numerous certifications and accreditations including the Medical Device Single Audit Program (MDSAP)~{*} certification. Our Reliability Center has obtained laboratory accreditation in accordance with ISO 17025:2017. In addition, the Company has responded to the Medical Device Regulation (MDR) effective in May 2021 and the In Vitro Diagnostic Medical Device Regulation (IVDR) effective in May 2022 in Europe.

3) We will work to shorten downtime and reduce failure rates to achieve high product availability.
To increase the utilization rates of products used by our customers, we will work to reduce the failure and re-repair rates. We will also promote the prompt provision of replacement devices in the event of malfunctions and the reduction of delivery times of repair parts and repair times.

4) We will work on human resource development to achieve quality targets and pursue customer value.
To achieve the above quality targets and pursue customer value, we will develop human resources by providing practical training across all Nihon Kohden departments.

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.