Quality Accreditations

ATCC is an ISO 9001:2015 certified, ISO 13485:2016 certified, ISO 17025:2017 and ISO 17034:2016 accredited organization.
 BSI FM 516121

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.
 BSI ISO 13485 Logo

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.

ilac-mra ACLASS Accredited Testing AT-1383
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.

ANAB Reference Material Producer 17034
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.