Certification opens way for business growth, development of additional products and markets.
TEMECULA, Calif., March 20, 2014 -
Golden West Biologicals, Inc. (GWB) announced today that it has achieved dual ISO 9001:2008 and ISO 13485:2003 certification for its quality management system. National Quality Assurance, USA, one of the world’s largest and most respected ISO registrants completed the review.
“Attaining these certifications demonstrates GWB’s unwavering commitment to quality,” said President and CEO Brian Golie. “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.
“Surpassing these milestones enables us to continue developing and marketing new products to meet the needs of our customers,” said Tammy Guenthner, Chief Operating Officer at GWB. “Additionally, this furthers our product development strategy and lays the foundation for obtaining CE marks and expansion in the European Union.”
About Golden West Biologicals, Inc.
Golden West Biologicals, Inc. (GWB) is a privately held company headquartered in Temecula, California. The company was formed in 1989 to directly address the need for cost effective and technically superior biological raw materials for in vitro diagnostic applications. GWB provides manufacturers and laboratories with over 80 human and animal biological products including vitamin D free human serum, human serum for ultra-sensitive testing, human serum albumin/gamma globulin, and rabbit gamma globulin. Additional information, including the complete line of products, can be found at the company website www.goldenwestbio.com.
Golden West Biologicals, Inc.