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Advisory Committees

May 12, 2011: Allergenic Products Advisory Committee Meeting Background Document: ISO 17025 Accreditation of the Laboratory of Immunobiochemistry

ISO 17025 Accreditation of the Laboratory of Immunobiochemistry

In 1972, it was ruled in Frye v. Unites States, that expert opinion based on a scientific technique is admissible only if that technique is “generally accepted” to be reliable by the relevant scientific community. In 1993, in, Daubert v. Merrill Dow Pharmaeuticals, Inc., the court reaffirmed that testimony from expert witnesses must be based on “scientific” evidence that is grounded in scientific methods and procedures, and relevant to the task at hand. This case, in which the parents of two minor children alleged their serious birth defects were caused by the mother’s prenatal ingestion of the prescription drug Bendectin, further defined the role of testimony from expert witnesses. Rather than Frye, Daubert used the Federal Rules of Evidence, as the standard for admitting expert scientific testimony in a federal trial. The Federal Rules of Evidence place appropriate limits on the admissibility of purportedly scientific evidence by assigning to the trial judge the task of ensuring that an expert’s testimony both rests on a reliable foundation and is relevant to the task at hand.

The importance of laboratory procedure in legal testimony is underscored by the testimony of Frederic Whithurst, Ph.D., an FBI expert witness who testified in 1989 that FBI laboratories “cut corners in their work, skipped various tests required or ‘suggested’ by the FDA lab protocols, and that they often phrased reports in terms of favoring the prosecution.” Then in 1995, as a whistleblower for the FBI, Dr. Whithurst was interviewed by ABC-TV’s Prime Time Live and reported on questionable results provided in the O.J. Simpson Murder Trial and the World Trade Center Bombing ( Newton). Two years later, the Office of the Inspector General reported on an evaluation of 51 cases identified by Dr. Whithurst and identified instances of improper report preparation, insufficient documentation of results, scientifically flawed reports, inadequate records, and unqualified examiners. Dr. Whithurst’s testimonies lead the FBI crime lab to agree to forty major reforms, including undergoing an accreditation process.

Following these media awareness events, the FDA Senior Science Council recommended in 1998 that FDA develop quality systems compliant to ISO 17025 (then known as ISO Guide 25) for all official testing activities. ISO 17025 is also known as “General Requirements for the Competence of Testing and Calibration Laboratories,” and merges the requirements for technical competence in testing and calibration with requirements for quality systems. ISO 17025 is the main standard used by testing laboratories and is broken into two main sections: management and technical requirements. The management section is primarily related to operation and effectiveness of the quality management system within the laboratory, and the technical requirements section includes factors that determine the correctness and reliability of tests performed in the laboratory.

In response to the Senior Science Council’s recommendations, the Center for Biologics Evaluation and Review (CBER) evaluated existing gaps in CBER testing and lot release activities, purchased and implemented quality system software, developed the quality system policy manual, and provided basic ISO 17025 training for select laboratory personnel. To facilitate the goal of ISO 17025 accreditation, CBER created the Division of Product Quality in 2006, and then decided that official testing be transferred to DPQ, thus satisfying the goal that the testing would be performed in an accredited laboratory according the standards of ISO 17025.

The Laboratory of Immunobiochemistry (LIB), however, was concerned that because of the uniqueness of allergenic extracts, transfer of testing knowledge and skills to DPQ would hamper CBER’s ability to regulate allergenic products. The LIB therefore chose in 2009 to not transfer testing of allergenic products to DPQ, but instead to pursue ISO 17025 accreditation for tests that evaluate the potency of standardized allergenic extracts including competition ELISAs that evaluate potency of grass pollens and mite allergenic extracts; and radial immunodiffusion assays (RID) that evaluate potency of cat and ragweed allergenic extracts. Since then, the LIB has developed and implemented approximately 60% and 50% of its quality system, respectively.

At the May, 2011 APAC meeting, LIB intends to provide background on FDA’s decision to seek accreditation for official testing activities, the requirements of ISO 17025, and the status of LIB’s quality system development.

The reference is included with the briefing documents to provide to committee members an example of the benefits of obtaining ISO 17025 accreditation.


Honsa JD, McIntyre DA, ISO 17025: Practical Benefits of Impelenting a Quality System, Journal of AOAC International, 2003, 86(5), 1038. (Attached)

Newton M, “The encyclopedia of American law enforcement”, Infobase Publishing, 2007, ISBN 0816062900, 9780816062904, page 361-362.

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