AsureQuality receives ISO 13485:2012 certification

AsureQuality, a contract manufacturer of in vitro diagnostics, has announced it has achieved ISO 13485:2012 certification for the contract manufacture of in vitro diagnostic medical devices (IVDs).

AsureQuality is a provider of food safety and quality assurance services to the primary production and food manufacturing sectors in Australia, New Zealand, the Middle East and Asia. In 2007, the company established a purpose-built GMP facility in Melbourne, with core competencies in immunoassay kit production, automated microplate processing and production of associated biologicals.

The internationally recognised standards ISO 13485:2012 and ISO 9001:2008 for establishing quality management systems were awarded by TÜV Rheinland.

“This achievement is a significant milestone for AsureQuality and represents a major commitment to quality,” said Dr Michael Zalunardo, business manager - diagnostics. “Our local and international customer base is continuously expanding, including companies marketing highly regulated in vitro diagnostic medical devices. So it is important to us to ensure the quality systems of our GMP facility continue to meet, and exceed, our customers’ expectations.”