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

Print


Suggested Items

KYZEN’s Popular Cleaning Series Continues

11/25/2020 | I-Connect007 Editorial Team
Wondering what to look for in a PCB cleaning agent? In just 10 minutes, you will learn from Jack Reinke what impacts your waste stream as part of the latest installment of KYZEN’s Tech2Tech series. This special webinar is held live at two times: 7:18 a.m. and 5:33 p.m. PST December 3, 2020.

IPC Standards Development: Business Challenges and an Inside View

10/28/2020 | Graham Naisbitt, Gen3 Systems
With increasing frequency, standardising the standards, such as ISO 9201, imposes certain rules that must be met to ensure “fair play” amongst the supply chain. There will be those familiar with hearing about “false positives/negatives” and “never trust the salesman,” so mitigating these is no easy task. However, there is the chance for each 5-30 Task Group to review industry requirements and set out the work program for the ensuing period. With that in mind, much of what follows is based on comments we learn about from our industry around the world, many of whom are not yet IPC members. Yes, this is a membership recruitment drive, unashamedly, as well as a search for volunteers willing to help create the standards of tomorrow.

Real Time with… SMTAI 2020: Women’s Leadership Program Cruises Through Important Topics

10/09/2020 | Michelle Te, I-Connect007
The virtual environment didn’t stop a large gathering of women (and men) from learning, sharing, and enjoying the Women’s Leadership Program during SMTAI 2020. Michelle Te shares her experience.



Copyright © 2020 I-Connect007. All rights reserved.