DDL has expanded the scope of its ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA) to include ISO 80369 testing for small-bore connectors, the ISTA test series for distribution simulation, and numerous standards for environmental conditioning.
The ISO 80369 series of small-bore connector standards are a replacement for the ISO 594-1 and ISO 594-2 standards, though the FDA will still accept submissions citing ISO 594 through the end of 2019. DDL’s ISO/IEC 17025 accreditation will continue to include the ISO 594 standards.
The ISTA series of distribution tests simulate the shocks and stresses normally encountered during handling and transportation. The following ISTA tests have been added to DDL’s scope of accreditation: ISTA 1A, ISTA 1B, ISTA 1C, ISTA 1D, ISTA 1E, ISTA 1G, ISTA 1H, ISTA 2A, ISTA 2B, ISTA 2C, ISTA 3A, ISTA 3B, ISTA 3E, ISTA 3F, ISTA 3H, ISTA 4AB, 6-Sam’s Club, 6-Amazon.com-B, ISTA 6-FEDEX-A, and ISTA-FEDEX-B.
Environmental conditioning is the practice of reproducing the various temperature and humidity extremes that a package or product is expected to be exposed to in its transportation, storage and/or in-use life. The following standards for environmental conditioning are included in DDL’s updated accreditation: ASTM D4332, ASTM F2825, ASTM F1980, ASTM D618, Tappi T402, ISO 2233, IEC 60601, ISTA 7D, and ISTA 2A.
“This expansion of our ISO 17025 accreditation demonstrates our commitment to continually improve our Quality System in order to provide our customers with superior service,” says Corey Hensel, General Manager, DDL, Inc. “This accreditation also demonstrates our technical competency and capability to consistently produce precise and accurate test data our customers can trust in order to meet their regulatory requirements.”
ISO/IEC 17025:2005 is the international standard by which a laboratory’s commitment to quality and technical competence are evaluated. DDL achieved ISO/IEC 17025:2005 accreditation by demonstrating its laboratories are in compliance with the standard and A2LA accreditation requirements.
Please visit www.testedandproven.com/about-ddl/certifications/ to download a copy of DDL’s updated ISO/IEC 17025:2005 accreditation.