SUMIDA: Company News

Notice of obtainment of “ISO13485:2012” by Sumida Power Technology

September 9th 2015 Press Release

SUMIDA CORPORATION announced today that one of its consolidated subsidiary companies, *Sumida Power Technology Co., Ltd.(hereinafter called “SPT Company”) has obtained from a third-party certifier, Bureau Veritas, a certification of ISO13485:2012 on August 19, 2015 which is the International Standard for quality management system for medical equipments.

*Sumida Power Technology Co., Ltd. is headed by a representative director Tomoharu Suseki, and is based on Ueda City, Nagano Prefecture, Japan with lines of business including development, design, manufacture and distribution of electronic components such as transformers, reactor coils and etc. for use in medical equipments

The ISO13485:2012 that SPT Company got certified for is the International Standard that includes additional requirements especially for medical equipments, using the requirements of ISO9001:2008 as a basis. Its concept has been incorporated into the framework of the laws and regulations in many countries including *Japan’s QMS ministerial ordinance, and it is an effective quality management system aiming to continuously design, manufacture and distribute high-quality as well as safe and useful electronic components for medical equipments.

*Japan’s QMS ministerial ordinance: Manufacturers of medical devices designated by Health, Labor and Welfare Ministry in Japan are required to exercise production and quality management according to this QMS ministerial ordinance.

By obtaining this certification of ISO13485:2012, SPT Company can demonstrate their quality responsibilities to the customers and the authorities for the electronic components to be developed, designed, manufactured and distributed by them and has a great advantage in expanding their businesses in the medical sector, not only in Japanese market but also in the global market.

As health-care market is positioned as one of the most essential strategic markets for Sumida group’s Mid-Term Business Plan (2015-2017), we take this opportunity to further strengthen and expand our business in development, design, manufacture and distribution of high-quality as well as safe and useful electronic components for the medical equipments market by utilizing cutting-edge technologies.

At this stage, no direct impacts are expected on our consolidated business forecasts for FY2015 due to obtainment of this ISO certification.

【Details of the certification】
(1) Applicable standards ISO13485:2012
(2) Business operator Sumida Power Technology Co., Ltd.
(3) Date obtained August 19, 2015
(4) Scope of certification Design and manufacture of electronic components intended to be used in medical electrical equipments
(5) Review/Certification organization Bureau Veritas Japan Co., Ltd

 

ISO Certificate Image


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