Omega Laboratories Awarded ISO / IEC 17025 Accreditation

Omega 11/10/2009 Press Release

MOGADORE, Ohio, November 10, 2009 /PRNewswire/ -- Omega Laboratories, Inc. today announced that it has received International Organization for Standardization / International Electrotechnical Commission (ISO/IEC) 17025 accreditation for its analysis of drugs and drug metabolites in hair. ISO accreditation recognizes technical expertise within a defined scope, as well as the operation of a comprehensive laboratory quality management system. Omega Laboratories is one of a select group of laboratories worldwide to receive this prestigious accreditation and is the only hair testing laboratory to do so in the United States.

“At Omega we are focused on providing the highest-quality and most reliable testing procedure available,” said Dr. John Vitullo, CEO of Omega Laboratories. “This internationally recognized accreditation means that we offer our clients an unsurpassed level of expertise and proficiency in our hair testing for drugs of abuse process. This accreditation is one more way Omega maintains its position as an industry leader in quality and service.”

ISO/IEC 17025 accreditation requirements cover competency of laboratory-developed testing methods, laboratory operations, staff training and experience, safety, documentation and quality control procedures. Accreditation to the ISO/IEC 17025 standard provides both proof of proficiency and expertise to regulatory authorities worldwide. The management system requirements in ISO/IEC 17025:2005 meet the principles of ISO 9001:2008 Quality Management Systems. Omega’s ISO/IEC 17025 accreditation was granted by ANSI-ASQ National Accreditation Board/ACLASS.

“We had our clients in mind when deciding to obtain ISO/IEC 17025 accreditation, since it provides them with a greater confidence level in choosing a laboratory,” said Dr. Vitullo. “Several respected accrediting agencies have referred to ISO/IEC 17025 as the gold standard of laboratory accreditation, and we strongly feel that it is the most comprehensive quality process available to our industry.”

According to the January 2009 FDA guidance document entitled Submission of Laboratory Packages by Accredited Laboratories, “ISO/IEC 17025 is the most widely used laboratory standard for federal testing laboratories, including FDA’s own laboratories, and ISO/IEC 17025 is internationally recognized and accepted world-wide."

About ACLASS - The ANSI-ASQ National Accreditation Board under the ACLASS brand, is internationally recognized by ILAC, APLAC, and IAAC as a signatory of multilateral recognition arrangements (MRAs) that facilitate acceptance of test and calibration data between ACLASS-accredited laboratories and the international community.