Quality Tech Services, Inc. (QTS) announces its continued certification to ISO 13485 (3 yr.). In meeting the demands of this standard, the company demonstrated that it continues to have the appropriate quality systems in place and that these systems are consistently executed in daily operations. In addition to being ISO 13485 certified the QTS facility is registered with the FDA.
“Maintaining a world-class quality management system is a key goal for QTS,” states John Klapperich, Director of Quality.” Our employees are fully trained in the quality requirements for their positions and understand the important role each plays in providing safe and effective medical device assembly and packaging.”
The quality assurance standards under ISO 13485 cover QTS’ medical device contract services, including cleanroom assembly, engineering validations, label support and printing, cleaning and passivation, sterile and non-sterile packaging, tray and pouch sealing, material sourcing, inventory management and sterilization coordination.
QTS achieved its original certification to ISO 13488 in 2002, followed by ISO 13485 in 2005. Today, ISO 13485 is the ISO quality management system standard for medical device manufacturers. The standard aims to facilitate compliance to corresponding medical device regulatory requirements for quality management systems. QTS’ Quality Management System is certified to ISO 13485 through TÜV SÜD America, which is an accredited Management Systems Registrar in the U.S., Europe and Asia.
QTS has designed and maintained its quality system to ensure efficient assembly and packaging of medical devices for the last 10 years. As a contract manufacturer of devices used in hospitals and healthcare facilities worldwide, the company feels it is critical to maintain certification to international quality standards. Customers can feel confident that the company’s services meet rigorous quality standards as well as have the flexibility to offer custom medical device assembly and packaging solutions.
Read the full press release here.