Golden West Biologicals has announced that it has achieved dual ISO 9001:2008 and ISO 13485:2003 certification for its quality management system.
National Quality Assurance, USA has completed the review.
Golden West Biologicals president and CEO Brian Golie said attaining these certifications demonstrates GWB’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,"
ISO 13485 is the quality management system standard for medical device manufacturers and 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 Medical Device Directive.
Golden West Biologicals COO Tammy Guenthner noted surpassing these milestones enables the company to continue developing and marketing new products to meet the needs of its customers.
"Additionally, this furthers our product development strategy and lays the foundation for obtaining CE marks and expansion in the European Union," Guenthner added.