ISO certification confirms implementation of quality systems in product design and development, manufacture, and distribution for Cylex's ImmuKnow(R) immune cell function assay.
Cylex has received of certification to ISO 13485:2003 and 9001:2000. The 13485:2003 certification includes compliance with the Canadian Medical Devices Conformity Assessment System (CMDCAS). These certifications signify compliance with internationally recognized standards in design, development, and manufacturing of medical products. The certifications were issued by TUV Rheinland of North America.
This is a major achievement for the Company," stated Brad L. Stewart, president of Cylex. "ISO certification confirms that quality systems have been implemented in product design and development, manufacture, operations, shipping, and service and will support CE marking of Cylex products that will be labeled for in vitro diagnostic use for sale within the European Community. In addition, the certification confirms that Cylex meets global quality design and manufacturing requirements for Canada."
ISO 13485:2003 provides Cylex's customers with a "Quality Pledge" in regard to the Company's ongoing dedication to quality manufacturing, as well as demonstrating our readiness to take on the demanding challenges of building medical devices that are robust and reliable.
"In addition to the ISO 13485:2003 certificate, Cylex voluntarily elected to obtain certification to ISO 9001:2000 as well," Stewart went on to say. "We did this to demonstrate our commitment to customer focus, customer satisfaction, and continuous quality improvement. And I want to take this opportunity to clearly recognize all Cylex's employees for the dedication, focus, and hard work that has made this certification possible."
Certification to ISO standards is a baseline quality system requirement in many key markets for approval to sell a medical device and therefore supports the Company's plans to market its ImmuKnow immune cell function assay to customers around the world.