Quality Accreditations ATCC is an ISO 9001:2015 certified, ISO 13485:2016 certified, ISO 17025:2005 and ISO Guide 34:2009 accredited organization. ISO 9001:2015 March 2007 Quality management system; reaffirms commitment to quality products, customer service and continued improvement. Certifies a company's Quality Management System. The company must demonstrate that products and/or services are developed, produced and distributed in accordance with the Quality Management System. Assures customers that ATCC provides services and manufactures products in accordance with a sound Quality Management System. The Quality Management System involves official written procedures and training documentation. It also requires all complaints to be documented and corrective and/or preventative actions to be established. ISO 13485:2016 July 2014 Certifies a company’s Quality Management System to provide medical devices and related services that consistently meet customer and regulatory requirements. Facilitates harmonized medical device regulatory requirements for Quality Management Systems. ATCC ISO 13485 medical device products can be used as controls in molecular diagnostic research, including assay development and validation; the diagnosis, evaluation, and research of disease status; and the surveillance of infectious agents affecting public health. ISO/IEC 17025:2017 March 2009 General requirements for the competence of testing and calibration laboratories. ISO 17025 assures customers that the characterization and purity testing (QC testing) protocols used in the manufacture of ATCC products are precise, accurate and have repeatability. Customers use ISO 17025 to confirm or recognize the competence of ATCC to produce products that will provide them consistent, reliable results. ISO 17025 allows customers to have confidence in the performance of ATCC products and can eliminate the need for time consuming, expensive supply audits. Scope includes specific tests or properties measured for Microbial and Cell Cultures. ISO 17034:2016 May 2008 Specifies general requirements for the competence and consistent operation of reference material producers, including the production of certified reference materials. Certificate of analysis for each CRM includes certified values and uncertainty measurements, as appropriate. ATCC is accredited to ISO 17034 as a reference material producer through ANAB.