STANDARDS
A STANDARD is an agreed, repeatable way of doing something. It is a published document that contains a technical specification or other precise criteria designed to be used consistently as a rule, guideline, or definition. Standards help make life simpler and increases reliability and effectiveness of many goods and services. They are intended to be inspirational - a summary of good and best practice rather than general practice. Standards are created by bringing together the experience and expertise of all interested parties such as the procedures, sellers, buyers, users, and regulators of a particular material, product, process, or service.
Bio/Data Corporation adheres to the requirements of the current good manufacturing practices (GMP) of the U.S. Food and Drug Administration (FDA). These requirements relate directly to the methods used in the quality control of designing, manufacturing, testing, packaging, labeling, storing, installing, and servicing of the in-vitro medical devices offered by the company.
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.
The ANSI National Accreditation Board (ANAB) is a non-governmental organization that provides accreditation services and training to public- and private-sector organizations, serving the global marketplace. ANAB is the largest accreditation body in North America and provides services in more than 75 countries. Our business depends on focusing on customers so all users will continue to value our service and have confidence in the ANAB accreditation symbol.
The CE Mark certifies that a product has met the European Union's (EU) health, safety, and environmental requirements.
The Underwriters Laboratories is a nonprofit organization dedicated to advancing the UL Mission through the discovery and application of scientific knowledge.
Bio/Data Corporation has received a Certificate of GMP from the South Korea Ministry of Food and Drug Safety. This certifies that Bio/Data complies with South Korea Good Manufacturing Practices of Medical Devices for its product range of in-vitro diagnostic instruments and reagents.
The Standards Council of Canada (SCC) is a federal Crown corporation responsible for promoting standardization in Canada. Located in Ottawa, SCC has a 13-member Governing Council and a staff of approximately 112. It reports to Parliament through the Minister of Innovation, Science and Economic Development Canada.
Bio/Data Corporation's Quality Management Systems are compliant with ISO Standard 13485:2016. 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.