ATCC is an ISO 9001:2008 certified, ISO 13485:2003 certified, ISO 17025:2005 and ISO Guide 34:2009 accredited organization.
- 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.
- 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 13485:2003 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.
- General requirements for the competence of testing and calibration laboratories.
- ISO 17025:2005 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 17025:2005 to confirm or recognize the competence of ATCC to produce products that will provide them consistent, reliable results.
- ISO 17025:2005 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.
- Certifies the competence of a manufacturer as a reference material producer.
- Methods used to produce certified reference material are evaluated and validated to be proven acceptable.
- Certificate of Analysis for each CRM includes additional data.
ISO Guide 34:2009 provides the highest level of quality assurance; providing objective third-party recognition that ATCC is a qualified reference material producer. To achieve ISO Guide 34:2009, ATCC was audited by (ACLASS), a private non-profit that provides accrediting services.
ACLASS evaluated methods used to test the identity, viability and purity of the microbial reference cultures produced by ATCC. After successfully completing the evaluation process, ATCC is a recognized Reference Material Producer.