Bio/Data Corporation voluntarily adopted the ISO Quality Management System Standards in 2004 and continues to comply with those Standards. In 2005, the Company's Quality System was registered compliant with the ISO 9001:2000 Standard. Shortly after registration to ISO 9001:2000 the Company added ISO's medical device-specific Standard as an objective for its Quality Management System and attained 13485:2003 registration in 2006. This Standard requires that a company demonstrate its ability to consistently produce medical devices that meet both customer and regulatory requirements.
BSI Management Systems, the Company's accredited ISO registrar, audits our quality systems. product performance, regulatory status and customer satisfaction periodically to verify compliance to the current versions of each Standard.
Bio/Data Corporation's Quality Management Systems are compliant with ISO Standard 13485. Effective quality management systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. ISO 13485 provides a focus for the quality management system requirements for medical device manufacturers.