The contract research organization (CRO) has been recertified to the new ISO9001:2015 standard – the international standard that specifies requirements for a quality management system (QMS).
The company’s Teklad Diets site produces and distributes Envigo Teklad Laboratory Animal diets globally.
“The diets fed to laboratory animals should reduce, not introduce variation,” Kurt Schafer, quality assurance specialist at Envigo told Outsourcing-Pharma.com.
“Managing key components such as protein, fat, vitamins and minerals as well as non-nutrients such as isoflavones will help researchers minimize variation that diets can cause, depending on the research objectives.”
The inspection, verification, testing and certification company, SGS North America Inc., conducted the four-day audit at Envigo’s Madison, WI site.
According to the company, the audit revealed Envigo had established and maintained its QMS in line with requirements of the new standard, which companies were required to recertify to by September 2017.
"This certification is an important demonstration of Envigo Teklad’s commitment to following or in many cases exceeding industry standards for manufacturing processes that ensure our customer get the highest quality product possible," said Schafer.
“This certification covers all of our Quality Management System, verifying the increased role of Top Management that is detailed in the ISO9001:2015 Standard ensuring an action driven process for continuous improvement.”