ISO 13485:2016 Certification Complete
Ashaway, Rhode Island, USA, December 10, 2018
High Performance Medical Solutions (HPMS), a division of Hitachi Cable America Inc., is pleased to announce that the Hitachi Metals Suzhou, China cable assembly factory is now operating to the latest ISO 13485:2016 standard. This achievement brings both the U.S. Rhode Island facility and the Suzhou, China facility up to the latest standard and ahead of the March 21st, 2019 deadline for completion.
The latest 13485:2016 standard supports the more stringent regulatory demands required of the industry and puts new procedures in place that will significantly improve our global quality.
Eileen Archambault, VP of Quality Assurance and Compliance at High Performance Medical Solutions commented, “The transition to the new standard has been very beneficial to our organization. The recertification process was an excellent opportunity to increase the emphasis we place on risk management within our quality management system. Those improvements, along with ongoing risk reduction activities, pave the way for delivering high quality products that will be safer for end users”.
About Hitachi’s medical components in America:
To learn more about Hitachi Cable America, Inc. and the High Performance Medical Solutions division, please visit our website at www.hca.hitachi-cable.com.
About Hitachi Metals, Ltd.
Hitachi Metals, Ltd., headquartered in Tokyo, Japan, with consolidated revenue totaling 910 billion yen in fiscal 2016 (ended March 31, 2017) is one of the major members of the Hitachi Group companies. The company manufactures and markets a diverse portfolio of high-grade metal products and materials, magnetic materials and applications, high-grade functional components and equipment, wires, cables and related products, please visit the company's website at www.hitachi-metals.co.jp/e/.
About Hitachi, Ltd.
Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, delivers innovations that answer society’s challenges. The company’s consolidated revenues for fiscal 2016 (ended March 31, 2017) totaled 10,034.3 billion yen ($85.8 billion). The Hitachi Group is a global leader in the Social Innovation Business, and it has approximately 335,000 employees worldwide. Through collaborative creation, Hitachi is providing solutions to customers in a broad range of sectors, including Power / Energy, Industry / Distribution / Water, Urban Development, and Finance / Government & Public / Healthcare. For more information on Hitachi, please visit the company's website at http://www.hitachi.com.
Steven Kenney
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Richard Roth
Dir., Business Development, Medical
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