#### § 188.3 Definitions.

Unless otherwise noted, these terms and their definitions are for the purposes of this part.

*Accreditation.* Third-party attestation conveying formal demonstration of a laboratory's competence to carry out specific tasks.

*Accreditation body (AB).* Authoritative organization that performs accreditation.

*Assessment.* Process undertaken by an AB to evaluate the competence of a laboratory, based on requirements contained in the DoD Quality Systems Manual for Environmental Laboratories (QSM), for a defined scope of accreditation.

*Change.* A reissuance of the DoD QSM containing minor changes to requirements or clarifications of existing requirements necessary to ensure consistent implementation.

*Complaint.* Defined in International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories” (available for purchase at *http://www.iso.org/iso/store.htm*).

*Contractor project chemist.* Defined in Under Secretary of Defense for Acquisition, Technology, and Logistics Memorandum, “Acquisitions Involving Environmental Sampling or Testing Services” (available at *http://www.acq.osd.mil/dpap/dars/dfars/changenotice/2008/20080303/223.7.pdf*).

*Corrective action response.* Description, prepared by the laboratory, of specific actions to be taken to correct a deficiency and prevent its reoccurrence.

*Deficiency.* An unauthorized deviation from requirements.

*Definitive data.* Defined in DoD Instruction 4715.15, “Environmental Quality Systems” (available at *http://www.dtic.mil/whs/directives/corres/pdf/471515p.pdf*).

*Environmental Data Quality Workgroup (EDQW) component principal.* A voting member of the DoD EDQW.

*Errata sheet.* A document prepared by the EDQW and issued by the EDQW chair, defining minor “pen and ink” changes that apply to the most recently issued version of the DoD QSM. Errata will be corrected in the next change or revision of the DoD QSM.

*Government chemist.* Defined in USD(AT&L) Memorandum, “Acquisitions Involving Environmental Sampling or Testing Services.”

*Government oversight.* The set of activities performed by or on behalf of the DoD EDQW to provide assurance that ABs and assessors are providing thorough, consistent, objective, and impartial assessments within the specified scopes of accreditation and to identify opportunities for continual improvement of the DoD QSM and DoD ELAP.

*International Laboratory Accreditation Cooperation (ILAC) mutual recognition arrangement (MRA).* An arrangement through which ABs are evaluated and accepted by their peers for conformance to ILAC rules and procedures. To be accepted into the ILAC MRA, the AB must become a signatory to its requirements; specifically, it must commit to maintain conformance with the current version of Deputy Secretary of Defense Memorandum, “Ensuring Quality of Information Disseminated to the Public by the Department of Defense”) and ensure that the laboratories it accredits comply with ISO/IEC 17025:2005.

*ILAC MRA peer evaluation.* The process through which ABs are assessed by other ABs and receive or maintain acceptance into the ILAC MRA.

*Project-specific laboratory approval.* The set of activities undertaken by the DoD EDQW to assess whether a laboratory is competent to perform specific tests, in the case where no DoD-ELAP accredited laboratory is able to perform the required tests.

*Quality system.* Defined in ISO/IEC 17025:2005.

*Recognition.* The acceptance of an AB by the EDQW based on its demonstrated commitment to maintain signatory status in the ILAC MRA and accept the DoD ELAP conditions and criteria for recognition.

*Revision.* A reissuance of the DoD QSM containing significant changes in requirements or scope. A significant change is one that could reasonably be expected to affect a laboratory's ability to comply with the requirement (*i.e.,* the laboratory is likely to have to make a change in its quality system or technical procedures in order to maintain compliance).

*Scope of accreditation.* Specific laboratory services, stated in terms of test method, matrix, and analyte, for which accreditation is sought or has been granted.