一般財団法人日本品質保証機構 List of News Articles

The organization will send a lecturer to the "Seminar on Key Points of Medical Device Standards and Certification Systems - Based on JIS T 0601-1 and the Pharmaceutical and Medical Device Act" hosted by the Oita Prefectural Industrial Science and Technology Center on Tuesday, October 21, 2025, as part of the reskilling training for manufacturing technology personnel. In this seminar, we will clearly explain the overview of medical device certification based on the Pharmaceutical and Medical Device Act (hereinafter referred to as the PMD Act) and the evaluation standards JIS T 0601-1:2023 and JIS T 0601-1-2:2023, which are fundamental to the electrical safety tests and EMC tests required by the PMD Act.

On November 19, 2025 (Wednesday), our organization will hold a seminar titled "EMC Performance of In-Vehicle Equipment as Considered by Automobile Manufacturers," featuring speakers from Toyota Motor Corporation, Mazda Corporation, and Subaru Corporation. In recent years, the acceleration of autonomous driving and electrification technologies has been aimed at achieving carbon neutrality and advancing mobility. Within this context, it is expected that the demands for EMC (Electromagnetic Compatibility) regarding powertrains in electric vehicles (xEV) and fuel cell vehicles (FCV), as well as EV components, will become increasingly stringent. In this seminar, we will invite EMC experts from automobile manufacturers to provide insights to suppliers on the latest trends in standards regarding the "EMC performance required for in-vehicle equipment" in the future. We encourage you to take advantage of this opportunity.

The organization will be exhibiting at the "Automotive World Nagoya (8th Car Electronics Technology Exhibition)" to be held at Port Messe Nagoya from October 29 (Wednesday) to 31 (Friday), 2025. At our booth, we will introduce various testing, evaluation, certification, and calibration services required by the automotive industry. We look forward to your visit.

The organization will hold a free in-person seminar titled "Overview and Latest Information on the Electrical Appliance and Material Safety Law 2025 - Explanation of the Differences between J60335-1 and Appendix 8, J55014-1 and Appendix 10" on three dates: November 7, 2025 (Friday) in Osaka, November 21, 2025 (Friday) in Fukuoka, and December 4, 2025 (Thursday) in Tokyo. In this seminar, we will provide a clear explanation of the overview of the Electrical Appliance and Material Safety Law, the latest updates on technical standard interpretations, and the differences between Appendix 12 (J60335-1) and Appendix 8, as well as between Appendix 12 (J55014-1) and Chapter 10 of Appendix 10. We encourage you to participate. [Osaka] November 7, 2025 (Friday) 13:30–16:30 (Registration starts at 13:00) <Fully booked> [Fukuoka] November 21, 2025 (Friday) 13:30–16:30 (Registration starts at 13:00) [Tokyo] December 4, 2025 (Thursday) 13:30–16:30 (Registration starts at 13:00) <Fully booked>

Thank you very much for attending the seminar "Medical Device Standards Revision Seminar - Changes in JIS Standards" held on August 22, 2025, at Osaka ATC Green Eco Plaza, despite your busy schedule.

On September 19, 2025 (Friday), our organization will hold a seminar titled "EMC Performance of In-Vehicle Equipment as Considered by Automobile Manufacturers," featuring speakers from Toyota Motor Corporation, Mazda Corporation, and Subaru Corporation. In recent years, the acceleration of autonomous driving and electrification technologies has been aimed at achieving carbon neutrality and advancing mobility. Within this context, it is expected that the demands for EMC in electric vehicles (xEV) and fuel cell vehicles (FCV), particularly regarding the electrification of powertrains and EV components, will become increasingly stringent. In this seminar, we will invite EMC experts from automobile manufacturers to provide insights to suppliers on the latest trends in standards regarding the "EMC performance required for in-vehicle equipment" in the future. We encourage you to take advantage of this opportunity.

We are pleased to announce that our North Kansai Testing Center has introduced new equipment to conduct evaluations related to batteries (Annex B) and has started testing services in accordance with the latest general safety standard for household and similar electrical appliances, "JIS C 9335-1:2023." <Main Differences Between JIS C 9335-1:2014 and JIS C 9335-1:2023> Requirements for battery-operated devices Addressing hazards from misuse by children (electric shock, injury, etc.) Requirements for outlets for devices Evaluation of devices equipped with UV light sources Requirements for devices that can be remotely operated using public communication lines

The organization will exhibit at the "16th Healthcare and Medical Device Development Exhibition [Osaka]" to be held at Intex Osaka from October 1 (Wednesday) to October 3 (Friday), 2025, and will also hold a seminar at the exhibition. In recent years, there has been an increasing demand for safety/EMC testing, calibration of measuring instruments based on ISO/IEC 17025, medical device certification under the Pharmaceuticals and Medical Devices Act, and third-party certifications such as ISO 13485 in the fields of design, development, and manufacturing of medical devices. To meet our customers' needs, we provide these services in a one-stop manner. During the exhibition, we will introduce various testing services for medical devices, as well as conduct booth seminars and individual consultations. This is a great opportunity to gain the latest information, so please be sure to visit our exhibition booth.

The organization will exhibit at the "Automotive Technology Exhibition 2025 NAGOYA," which will be held from July 16 (Wednesday) to 18 (Friday), 2025, at Aichi Sky Expo (Aichi Prefectural International Exhibition Center). At our booth, we will introduce various testing, evaluation, certification, and calibration services required by the automotive industry. We look forward to your visit.

The organization will hold a free face-to-face seminar titled "Medical Device Standards Revision Seminar - Changes in JIS Standards" at the Osaka ATC Green Eco Plaza on Friday, August 22, 2025. In this seminar, we will clearly explain the main changes associated with the transition from JIS T 0601-1:2017 to JIS T 0601-1:2023 and from JIS T 0601-1-2:2018 to JIS T 0601-1-2:2023 regarding the basic standards for electrical safety tests and EMC tests required by the Pharmaceutical and Medical Device Act. Additionally, we plan to explain the main changes in JIS T 60601-1-8:2023 (General requirements, test methods, and application guidelines for alarm systems), which is a reference standard for JIS T 0601-1. We encourage you to take advantage of this opportunity.

The organization has received many requests from customers regarding the highly praised on-site testing service. Therefore, in addition to the Safety Electromagnetic Center, we are pleased to announce the launch of on-site testing and evaluation services related to the optical safety of large laser equipment at the North Kansai Testing Center. This service involves specialized engineers visiting the customer's specified location to conduct structural evaluations, label assessments, laser measurements, and more, based on standards such as JIS C 6802, IEC 60825-1, EN 60825-1, and 21 CFR 1040.10. This will resolve transportation issues related to the size and weight of products and enable evaluations in an environment equipped with the necessary peripheral devices for operational functions. We encourage you to take advantage of our on-site testing and evaluation services.

The organization has been registered in April 2025 as the first certification body (NCB) and testing laboratory (CBTL) in Japan under the IECEE CB scheme in the cybersecurity category, and we are pleased to announce the commencement of CB certificate issuance services. In the field of cybersecurity under the IECEE CB scheme, we will issue CB certificates that can be used as evidence to internationally demonstrate that security by design is being realized through our staff's provision of "Japanese-language conformity assessment services," which are completed within Japan. Typically, conformity assessments in the cybersecurity field include document verification and interviews regarding the customer's internal regulations and quality manuals. However, our "Japanese-language conformity assessment services" significantly reduce the burden on customers associated with language barriers. For more details, please refer to the news release below. https://www.jqa.jp/service_list/safety/topics/topics_safety_649.html

The organization will exhibit at "Medtec Japan," which will be held at Tokyo Big Sight from April 9 (Wednesday) to April 11 (Friday), 2025, and will also conduct a presentation at the seminar venue of the exhibition. At our exhibition booth, we will introduce services related to calibration, testing, and certification required in the medical device industry, and our sales representatives, who are well-versed in each service, will be available to assist you with your inquiries. Additionally, we will hold a "Basic Seminar on Testing and Certification" daily for companies considering entering the medical device industry. On April 11 (Friday), during the exhibitor presentation at Seminar-2M, we will discuss "Towards Further Improvement of Quality Management Systems - Key Changes from JIS T 0601-1:2017 to 2023 / Digital Transformation of Measurement Instrument Documentation," providing a clear explanation of the overview of the revision of JIS T 0601-1 and the mechanism and utilization of the "Digital Calibration Certificate." We sincerely look forward to your visit.

Our organization will be exhibiting at "Maritime 2025," which will be held in Imabari City, Ehime Prefecture, from May 22 (Thursday) to May 24 (Saturday), 2025. "Maritime" is one of the largest international maritime exhibitions in western Japan, held every two years in Imabari City, Ehime Prefecture. It is a valuable exhibition where you can obtain the latest information in various fields, including maritime regulations and technological development. At our exhibition booth, we will provide information on EMC testing and environmental testing based on IACS UR-E10 for businesses in the shipping industry, as well as cybersecurity assessments (IEC 62443 series). Our staff, who are well-versed in each service, will be available to assist you with any inquiries. We sincerely look forward to your visit.