§ 287.2 - Definitions.

§ 287.2 Definitions.^[1]

Accreditation means a procedure used to provide formal notice that a body or person is competent to carry out specific tasks. These tasks include: sampling and testing; inspection; certification; and registration.^[2]

For the purposes of this part:

Agency means any Executive Branch Department, independent commission, board, bureau, office, agency, government-owned or controlled corporation, or other establishment of the Federal governmentGovernment. It also includes any regulatory commission or board, except for independent regulatory commission commissions insofar as they are subject to separate statutory requirements regarding policy setting, management, operation, and use of conformity assessment activities. It does not include the legislative or judicial branches of the Federal governmentGovernment.

Agency Standards Executive means an official designated by an agency as its representative on the Interagency Committee for Standards Policy (ICSP) and delegated the responsibility for agency implementation of Office of Management and Budget (OMB) Circular A-119 and the guidance in this part.

Certification means a procedure used to provide written assurance that

Conformity assessment is a demonstration, whether directly or indirectly, that specified requirements relating to a product, process,

service

system,

or person's qualifications conforms to specified requirements.

Conformity assessment means any activity concerned with determining directly or indirectly that requirements person, or body are fulfilled. Requirements for products, services, systems, persons, and organizations are those defined by law or regulation or , by an agency in a procurement action. Conformity assessment includes: sampling and testing; inspection; supplier's declaration of conformity; certification; and quality and environmental management system assessment and registration. It also includes accreditation and recognition. Conformity assessment regulatory or procurement actions, or an agency programmatic policy. Conformity assessment does not include mandatory administrative procedures (such as registration notification) for granting permission for a good or service to be produced, marketed, or used for a stated purpose or under stated conditions. Conformity assessment activities may be conducted by the supplier (first party) or by the buyer (second party) either directly or by another party on the supplier's or buyer's behalf, or by a body not under the control or influence of either the buyer or the seller (third party).

Inspection is defines ad the evaluation by observation and judgment accompanied as appropriate by measurement, testing or gauging of the conformity of a product, process or service to specified requirements.

NIST means the National Institute of Standards and Technology, an agency within the United States Department of Commerce.

Recognition means a procedure used to provide formal notice that an accreditation body is competent to carry out specific tasks. These tasks include: the accreditation of testing laboratories and inspection, certification, and registration bodies. A governmental recognition system is a set of one or more procedures used by a Federal agency to provide recognition.

Registration means a procedure used to give written assurance that a system conforms to specified requirements. Such systems include those established for the management of product, process or service quality and environmental performance.

Sampling means the selection of one or more specimens of a product, process, or service for the purpose of evaluating the conformity of the product, process or service to specified requirements.

Supplier's declaration of conformity means a procedure by which a supplier gives written assurance that a product, process, service or organization conforms to specified requirements.

Testing means the action of carrying out one or more technical operations (tests) that determine one or more characteristics or performance of a given product, material, equipment, organism, person's qualifications, physical phenomenon, process, or service according to a specified technical procedure (test method).

Footnotes - 287.2

^[1] Definitions of accreditation, certification, conformity assessment, inspection, supplier's declaration of conformity, registration and testing are based on the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC), Guide 2 (1996). In certain industrial sectors, it is recognized that organizations other than ISO or IEC may issue definitions relevant to conformity assessment, such as the Codex Alimentarius Commission with respect to the food industry sector.

^[2] For some agencies, accreditation may mean that a body or person meets requirements defined in a specific section(s) of the CFR. The referenced section(s) may include only limited requirements for demonstration of technical competency

related terminology and concepts, including a discussion of the value and benefits of conformity assessment, are contained in NIST Special Publication 2000-01, ABCs of Conformity Assessment (2018) found free of charge at: https://doi.org/10.6028/NIST.SP.2000-01 and NIST Special Publication 2000-02, Conformity Assessment Considerations for Federal Agencies, found at: https://doi.org/10.6028/NIST.SP.2000-02. The definitions of conformity assessment related terminology included in these documents are based on voluntary consensus standards. See OMB Circular A-119 for a description of voluntary consensus standards and recommendations for their development and use by Federal agencies.