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DDL’s Edison NJ Laboratory Receives ISO/IEC 17025 Accreditation

DDL announced that its Edison, NJ laboratory has received ISO/IEC 17025:2017 accreditation from the American Association for Laboratory Accreditation (A2LA). ISO/IEC 17025:2017 is the international standard by which a laboratory’s commitment to quality and technical competence are evaluated. DDL achieved ISO/IEC 17025:2017 accreditation by demonstrating its Edison laboratory is in compliance with the standard and A2LA accreditation requirements.

DDL ISO 17025 Accreditation

DDL also recently added 3,500 cubic feet of storage area to its ambient real time storage capabilities (i.e. 23C & 50% RH), added an additional 1,200 cubic feet of environmental storage capacity, and installed a new Vaisala Continuous Monitoring System. DDL offers a full suite of package testing including environmental conditioning, distribution simulation, integrity and strength testing, thermal performance, and shelf life testing at its Edison facility.

“Receiving ISO/IEC 17025: 2017 accreditation for our Edison laboratory further demonstrates our commitment to meeting the highest level of quality assurance for our customers,” says Tamera Presler, General Manager, DDL, Inc. “This accreditation combined with the recent upgrades and added capacity to our Edison facility, further reaffirms our technical competency and capability to produce precise and accurate test data that our customers can rely upon to meet their regulatory requirements.”

Please visit https://www.ddltesting.com/about-ddl/quality-and-certifications/ to download a copy of DDL’s ISO/IEC 17025:2017 accreditation.

DDL’s MN and CA Testing Laboratories Transition to ISO 17025:2017

DDL is pleased to announce its Minnesota and California testing laboratories have completed the transition to ISO 17025:2017.

“This transition reflects a tremendous amount of work on the part of DDL personnel to demonstrate compliance to the current standard, to embrace best practices, and to continuously improve how we conduct business,” said Christine Velarde, Quality Assurance Manager, DDL, Inc. “This success is due to the collaboration mindset of our employees and determination to function as a team. We are proud to have achieved this significant milestone.”

Accreditation to ISO 17025 requires that a laboratory can demonstrate implementation of a Quality Management System compliant to the requirements within the standard in addition to providing objective evidence of technical capability and competence. DDL’s Minnesota and California testing laboratories have both been ISO 17025 accredited since 2015. DDL’s Edison, New Jersey testing laboratory is in the process of becoming an ISO 17025:2017 accredited laboratory.

To download a copy of the updated certifications, please visit
https://www.ddltesting.com/about-ddl/quality-and-certifications/ or call 800-229-4235 if you would like to speak with one of our testing experts.

DDL Expands Scope of its ISO/IEC 17025 Accreditation

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.

DDL Expands Scope of its ISO/IEC 17025 Accreditation

DDL has expanded the scope of its ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA) to include ISO 594-1 and ISO 594-2 testing for conical (Luer) fittings.

A conical Luer fitting is the most common means of achieving a leak-free connection between two medical devices (e.g. a syringe and hypodermic needle) that carry small volumes of fluids. There are two varieties of Luer taper connections known as Luer-lock and Luer-slip. ISO 594-1 defines the dimensions and validation test specifications of Luer-slip fittings. ISO 594-2 defines the dimensions and validation test specifications of Luer-lock fittings. DDL tests both standalone Luer adapters and Luers which are components of various devices, and has large collection of reference connectors which allows for dramatically reduced timelines to complete testing.

ISO/IEC 17025:2005 is the international standard by which a laboratory’s commitment to quality and technical competence are evaluated. DDL previously achieved ISO/IEC 17025:2005 accreditation for its distribution testing, and strength and integrity testing by demonstrating its laboratories are in compliance with the standard and A2LA accreditation requirements.

“This expansion of our ISO 17025 accreditation to include ISO 594-1 and ISO 594-2 testing further demonstrates our commitment to continuously improve our Quality system and offer superior service within our industry,” says Corey Hensel, General Manager, DDL, Inc. “This accreditation also further demonstrates our technical competency and capability to produce precise and accurate test data our customers can rely upon to meet their regulatory requirements.”

Please visit www.testedandproven.com/about-ddl/certifications/ to download a copy of DDL’s ISO/IEC 17025:2005 accreditation.

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