Sypris Achieves ISO 13485 Registration from NSF-ISR
May 25 2017 - 4:50PM
Business Wire
Quality Standards for Safe and Effective
Medical Devices
Sypris Electronics, LLC, a subsidiary of Sypris Solutions, Inc.
(Nasdaq/GM: SYPR), announced today that it has achieved ISO 13485
re-certification from NSF-ISR, a division of the global public
health organization NSF International.
ISO 13485 is the established quality standard for manufacturers
of medical devices and has been established by the International
Organization for Standardization (ISO), which is the largest
developer and publisher of international standards for the
implementation of Quality Management Systems.
The primary objective of ISO 13485 is to harmonize medical
device regulatory requirements for quality management systems. The
standard is specific to organizations providing medical devices or
services, regardless of the type or size of the organization. Based
on the ISO 9001 process approach to quality management, ISO 13485
focuses on what manufacturers must do to provide safe and effective
medical devices.
“By achieving ISO 13485 registration, Sypris Electronics is once
again demonstrating its commitment to quality and safety,” said
Andy Weinbach, Global Managing Director, NSF-ISR.
“The ISO 13485 registration allows us to leverage our operations
and engineering capabilities to further expand our presence in the
medical device industry,” commented Jim Long, Vice President &
General Manager of Sypris Electronics. “This re-certification
serves as the cornerstone for our ongoing commitment to service the
medical device industry.”
Sypris Electronics is a trusted provider of electronic
solutions, addressing customers’ needs for building complex,
mission-critical electronic and electro-mechanical devices and
integrated systems. Backed by 50 years of experience, Sypris’
engineering and manufacturing services span our customers’ product
life cycle all within a culture of continuous improvement and Six
Sigma/Lean thinking. Partners from multiple agencies and tier one
companies in Military (DoD), Space, Medical, Civil Avionics,
Telecom, and Industrial markets team with Sypris to deliver
high-reliability electronics built with strict adherence to
regulated requirements. For more information, please visit
www.sypriselectronics.com.
NSF International Strategic Registrations (NSF-ISR) offers
comprehensive management systems registrations to internationally
accepted standards for quality assurance and environmental
protection for the medical device, automotive, aerospace, chemical,
energy and manufacturing industries (e.g. ISO 9001, ISO 14001,
AS9100, TS16949, etc.). NSF International (nsf.org) is a global
independent organization that writes standards, and tests and
certifies products for the water, food, health sciences and
consumer goods industries to minimize adverse health effects and
protect the environment. Founded in 1944, NSF is committed to
protecting human health and safety worldwide.
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Sypris Electronics, LLCJim Long, 813-972-6747
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