Spectra Laboratories Achieves ISo 15189 Accreditation

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Spectra Laboatories becomes the first lab in North America to become ISO accredited and uses Paradigm software to help in it's venture

Spectra Laboratories has become the first U.S. laboratory to be accredited to ISO 15189 by A2LA. Spectra Laboratories is a division of Fresenius Medical Care of North America and is the leading provider of renal-specific laboratory testing services in the United States.

Obtaining A2LA accreditation was the result of the collective efforts undertaken by the staff and personnel of the laboratory during the past four years. Considerable energy and focus were devoted to labor and training that ultimately led to this accreditation. “This achievement represents Spectra Laboratories continued leadership in addressing the domestic and global needs of the clinical laboratory arena” stated Roxanne Robinson, A2LA vice president and chief operating officer.

In their successful attempt to become registered certified Spectra Laboratories chose Paradigm Document and Compliance Management Software tool assist them in meeting the stringent requirements of the standard. Betty Lim, Director of Quality Systems and Regulatory Affairs, states “Paradigm was central in assisting us in reaching this milestone for our organization.”

Gary Halford President of Interax Group (North American supplier for Paradigm Software) said that “all of us here would like to congratulate Spectra Labs on their great achievement.”

Paradigm is a full document and compliance management program used to manage quality programs such as ISO 15189. Paradigm’s modules helps meet requirements required by the standard such as document control, corrective action, calibration, training vendor status etc. Since 1995, Interax Group in association with Paradigm software has provided the structure to enable an extensive group of industries; organizations; hospitals and laboratories achieve registration to numerous ISO and other regulatory requirements.


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