Sypris Achieves ISO 13485 Re-certification


Reading time ( words)

Sypris Electronics LLC, a subsidiary of Sypris Solutions Inc., 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.”

About Sypris Electronics

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.

About  NSF International Strategic Registrations (NSF-ISR)

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.

Share




Suggested Items

Four Silver Linings in the Stormy Clouds of Pandemic, Supply Chain, and Inflation

09/14/2022 | Dr. Ronald C. Lasky, Indium Corp.
It may be difficult to see any bright spots in the current and recent economic situation. We have all experienced the devastation of the pandemic, supply chain issues, and most recently, inflation. However, as a senior technologist for an international materials supplier (Indium Corporation) and a professor of engineering at an Ivy League research university (Dartmouth College), I offer these four silver linings for those of us in the electronics industry.

Thriving Through Greater EMS Collaboration

08/23/2022 | Chris Peters, USPAE
Events of the past two years have clearly demonstrated the value of strong trading relationships. When materials become constrained, as in the recent microchip shortage or any of the pandemic-driven supply chain snafus, the companies that have those materials have a choice to make. Which customers will be put at the front of the line, and which will be placed at the rear? Too often, company executives assume that since they are a large buyer, they automatically will be prioritized when supplies are constrained. Research has shown that this is not always the case, and that assumption can leave a company in a weakened position.

New Book from I-Connect007 Examines Evolution of Electronics Industry NPI

08/01/2022 | I-Connect007
The Electronics Industry’s Guide to… The Evolving PCB NPI Process is the first book in I-Connect007’s new The Electronics Industry’s Guide to… technical series. This valuable resource is for all segments of the electronics interconnect industry.



Copyright © 2022 I-Connect007. All rights reserved.