Golden West Biologicals Earns ISO Certifications for Medical Device Manufacturing

Golden West Biologicals Inc. (GWB) has achieved dual ISO 9001:2008 and ISO 13485:2003 certification for its quality management system.

GWB President and CEO Brian Golie said attaining the certifications demonstrates his company’s unwavering commitment to quality.
“Considering the majority of our customer base manufactures and sells medical devices, adding ISO 13485 to our existing ISO 9001 certification promotes their confidence in our quality management system and positions GWB to remain a vendor of choice,” he said.
ISO 13485 is the quality management system standard for medical device manufacturers as well as their sub-tier suppliers and subcontractors.

Based on the ISO 9001 standard, ISO 13485 includes additional requirements for medical device manufacturers to demonstrate their intent to comply with applicable regulatory and statutory requirements. ISO 13485 is recognized as an aid in supporting compliance with the European Union’s Medical Device Directive.

GWB Chief Operating Officer Tammy Guenthner noted surpassing these milestones enables the Temecula, Calif., company to continue developing and marketing new products to meet customer needs.

“Additionally, this furthers our product development strategy and lays the foundation for obtaining CE marks and expansion in the European Union,” Guenthner said in a news release.

Golden West Biologicals is a privately held company that supplies customers with biological products for the development and manufacture of immunoassays. Products include processed human sera matrices, highly purified protein fractions, disease state plasmas, antigens and antibodies. GWB also has developed the Mass Spect Gold and Seratrol product lines to address customer need for ultra-low human sera for ultrasensitive testing and matrix-effect free base material for calibrators and controls.