ATCC® Achieves Accreditation as a Reference Material Producer

ATCC (American Type Culture Collection) has renewed accreditation of its biological material production and testing processes for ISO Guide 34 - an international multi-industry standard specifically designed for producers of reference materials.

'The scope of ATCC's ISO Guide 34 accreditation, which extends across a wide range of the organization's processes for biomaterial production, is unprecedented in the biological sciences,' said Raymond Cypess, PhD/DVM, ATCC President and CEO. 'Objective, third-party accreditation for ATCC production of bacteria, viruses, cell lines, mycology products and nucleic acids reaffirms ATCC's commitment to quality products, customer service and continuous improvement.'

Authenticated biological materials from ATCC are widely used as reference strains for research and product testing. The availability of such biological standards enhances the validity, reliability and reproducibility of biotechnology research and development.

The inherent variability of biological materials brings unique challenges to establishing standards for in vitro model systems and to setting up ISO-compliant processes to produce them. Biological reference materials produced under an ISO Guide 34-accredited process have confirmed identity, well-defined characteristics and an established chain of custody - qualities essential to their effectiveness as biological standards in research and development.

ATCC Senior Director for Quality, Compliance and Biosafety Barry Waters, PhD, remarked, 'ISO 34 accreditation represents an objective measure of confidence in the consistency and quality of ATCC reference cultures. It expands ATCC's ability to produce internationally recognized standards for biological research and development, including certified reference materials (CRMs).'

The ISO Guide 34 standard for reference material producers is among those promulgated by the International Organization for Standardization (ISO), a network of national standards institutes from 157 countries. The organization operates a central secretariat located in Geneva, Switzerland to coordinate and administer the system. The ISO Guide 34 standard requires that the methods used to produce reference material are reproducible and controlled.

In late 2007, ATCC became certified in ISO 9001:2000, a widely known international standard for quality management systems.