Janco
Electronics, Inc. (JEI) is now certified for ISO 13485:2003. ISO
13485:2003 is a quality-management standard for medical device
manufacturing developed by the International Organization for
Standardization. ISO 13485 certification will ensure that JEI has the
required level of Quality Management systems in place to properly
service the medical electronics services industry. It covers fundamental
GMP (Good Manufacturing Practice) principles, which apply during the
manufacture of medical devices.
In a 2008 Quality Magazine article titled “Understanding
ISO 13485”, Steve Wichelecki wrote that ISO 13485 centers on
fulfilling regulatory as well as customer specifications. “The
certification aligns an organization’s management system to the
requirements of the FDA’s Quality System Regulation (QSR) requirements
as well as many other regulatory requirements found throughout the
world,” Wichelecki wrote.
President and CEO of JEI Rollins Janetos said, “Janco Electronics’
management team has worked extremely hard to upgrade and implement its
Quality Management systems to meet the ISO 13485 standard. We are very
proud of our accomplishment and we are excited to further develop our
medical electronics business sector.”
Customers of JEI will benefit from the company's experience and
expertise because of achieved certifications of ISO 9001, ISO 13485, IPC
RoHS, IPC-A-610, J-STD-001, and many more.
About Janco-Electronics, Inc.
JEI,
a veteran and family owned business operating for over 50 years, is a
full service contract manufacturer and test facility specializing in
military, medical, microwave communications, industrial, and commercial
markets. The company's business model is to exceed customer expectations
by delivering high-quality manufacturing and high-reliability
electro-mechanical systems. For more information visit our website: www.janco-electronics.com
or email us at: sales@janco-electronics.com.
Source(s) : Janco Electronics, Inc.