NVCASE Program in the Code of Federal Regulations (15CFR, PART 286)

Table of Contents

286.1 Purpose

286.2 Scope

286.3 Objective

286.4 Implementation

286.5 Program requirements

286.6 Public consultation

286.7 Evaluation process

286.8 Confidentiality of information

286.9 Maintaining recognized status

286.10 Appeal

286.11 Listings

286.12 Terminations

Sec. 286.1 Purpose.

The purpose of this program is to enable U.S. industry to satisfy mandated foreign technical 

requirements using the results of U.S.-based conformity assessment programs that perform 

technical evaluations comparable in their rigor to practices in the receiving country. Under this 

program, the Department of Commerce, acting through the National 

Institute of Standards and Technology, evaluates U.S.-based conformity assessment bodies in 

order to be able to give assurances to a foreign government that qualifying bodies meet that 

government's requirements and can provide results that are acceptable to that government. The 

program is intended to provide a technically-based U.S. approval process for U.S. industry to 

gain foreign market access; the acceptability of conformity assessment results to the relevant 

foreign government will be a matter for agreement between the two governments.

Sec. 286.2 Scope.

(a) For purposes of this program, conformity assessment consists of product sample 

testing, product certification, and quality system registration. Associated activities can be 

classified by level:

(1) Conformity level: This level encompasses comparing a product, process, 

service, or system with a standard or specification. As appropriate, the evaluating 

body can be a testing laboratory, product certifier or certification body, or quality 

system registrar.
(2) Accreditation level: This level encompasses the evaluation of a testing 

laboratory, a certification body, or a quality system registrar by an independent 

body--an accreditation body--based on requirements for the acceptance of these 

bodies, and the granting of accreditation to those which meet the established 

requirements.

(3) Recognition level: This level encompasses the evaluation of an accreditation 

body based on requirements for its acceptance, and the recognition by the 

evaluating body of the accreditation body which satisfies the established 

requirements.

(b) NIST operates the NVCASE program as follows:

(1) Conformity level: Under this program NIST accepts requests for evaluations 

of U.S. bodies involved in activities related to conformity assessment. NIST does 

not perform conformity assessments as part of the program and therefore does not 

accept requests for such evaluations. 

(2) Accreditation level: NIST accepts requests for accreditation of conformity 

assessment bodies only when (i) directed by U.S. law; (ii) requested by another 

U.S. government agency; or (iii) requested to respond to a specific U.S. industrial 

or technical need, relative to a mandatory foreign technical requirement, if it has 

been determined after public consultation that (A) there is no satisfactory 

accreditation alternative available and the private sector has declined to make 

acceptable accreditation available, and (B) there is evidence that significant public 

disadvantage would result from the absence of any alternative.

(3) Recognition level: NIST accepts requests for recognition of bodies that 

accredit testing laboratories, certification bodies, and quality system registrars 

when (i) directed by U.S. law; (ii) requested by another U.S. government agency; 

or (iii) requested to respond to a specific U.S. industrial or technical need relative 

to a mandatory foreign technical requirement if it has been determined after 

public consultation that (A) there is no suitable alternative available and (B) there 

is evidence that significant public disadvantage would result from the absence of 

any alternative.

Sec. 286.3 Objective.

The objective of the program is to identify the activities of requesting U.S.-based conformity 

assessment bodies that have been evaluated as meeting requirements established for their 

acceptance by foreign governments. The evaluations may be provided by NIST or by bodies 

recognized by NIST for this purpose under the scope of this program.

Sec. 286.4 Implementation.
The program is operated on a cost reimbursable basis. It is open for voluntary participation by 

any U.S.-based body that conducts activities related to conformity assessment falling within the 

program's scope. A common procedural approach is followed in responding to a request to 

participate. (See Sec. 286.7 Evaluation process.) All evaluation activities rely on the use of 

generic program requirements based on standards and guides for the operation and acceptance of 

activities related to conformity assessment. Specific criteria for use in each evaluation are 

derived from the program requirements, as appropriate, for the mandated foreign technical 

requirements specified in the request to participate. A request involving a foreign technical 

requirement not previously addressed by NVCASE will result in an announcement of NIST's 

intent to develop evaluation criteria specific to the relevant requirements. NIST will contact all 

cognizant and interested federal agencies to coordinate appropriate actions and procedures.

Sec. 286.5 Program requirements.

NIST provides and maintains documented generic requirements to be applied in evaluations 

related to accreditation and recognition within the scope of the program. Available 

documentation is provided on request to prospective program participants and other interested 

parties. Generic requirements are developed with public input and are based on guides for the 

acceptance of conformity assessment activities issued by such international organizations as the 

International Organization for Standardization and the International Electrotechnical 

Commission. NIST also provides and maintains documented criteria provided in response to 

requests for evaluations specific to mandated foreign technical requirements. Criteria are 

developed with public input derived from the application and interpretation of generic program 

requirements in relation to specified mandated requirements. Both documented generic 

requirements and specific criteria are developed and maintained with input from the public.

Sec. 286.6 Public consultation.

NIST relies on substantial advice and technical assistance from all parties interested in program 

requirements and related specific criteria. Interested U.S. government agencies are routinely to 

be informed of prospective NVCASE actions, and advice is sought from those agencies on any 

actions of mutual interest. In preparing program documentation, input is also sought from 

workshops announced in the Federal Register and open tothe general public and other public 

means to identify appropriate standards and guides and to develop and maintain generic 

requirements, based on the identified standards and guides. 

Where relevant Federal advisory committees are available, their advice may also be sought. 

Similar procedures will be followed with respect to each request for evaluation which 

necessitates the development of criteria, derived from the generic requirements, specific to 

mandated foreign technical requirements.

Sec. 286.7 Evaluation process.

(a) Each applicant requesting to be evaluated under NVCASE is expected to initiate the 

process and assume designated responsibilities as NIST proceeds with its evaluation:
(1) Application. The applicant completes and submit a request to be evaluated.

(2) Fee. The applicant submits a partial payment with the application and agrees 

to submit the remaining balance based on evaluation costs as a condition for 

satisfactory completion of the process.

(3) Documentation. The applicant operates a system and procedures that meet the 

applicable generic requirements and specific criteria. Relevant documentation 

submitted with the application is reviewed by NIST.

(4) On-site assessment. The applicant and NIST cooperate in the scheduling and 

conduct of all necessary on-site evaluations, including the resolution of any 

deficiencies cited.

(5) Final review. The applicant provides any supplementary materials requested 

by NIST, then NIST completes the review and decides on appropriate action. 

(b) NIST may take one of the following actions with regard to an applicant:

(1) Certificate. If an applicant fully demonstrates conformity with all program 

requirements and specific criteria, NIST issues a certificate documenting this 

finding. Each certificate is accompanied by a document describing the specific 

scope of the accreditation or recognition.

(2) Denial. If an applicant cannot demonstrate conformity with all program 

requirements and specific criteria, NIST may deny award of the certificate. An 

applicant who has failed to complete the evaluation satisfactorily may reapply 

when prepared to demonstrate full conformance with program requirements.

Sec. 286.8 Confidentiality of information.

All information collected relative to an applicant during an evaluation is maintained as 

confidential. Information is released only as required under the terms of the Freedom of 

Information Act or other legal requirement, subject to the rules of the Department of Commerce 

for such disclosure as found in 15 CFR part 4.

Sec. 286.9 Maintaining recognized status.

Each program participant remaining in the program shall continuously meet all program 

requirements and cooperate with NIST in the conduct of all surveillance and reassessment 

activities. Participants shall reimburse NIST for expenses incurred for these purposes.

Sec. 286.10 Appeal.
Any applicant or other affected party may appeal to the NIST Director any action taken under the 

program. When appropriate, the Director may seek an independent review by the Deputy Chief 

Counsel.

Sec. 286.11 Listings.

(a) NIST maintains lists of all bodies holding current NIST program certificates, together 

with the assessment areas for which they are issued.

(b) NIST also maintains lists of those qualified conformity assessment bodies that are 

currently accredited by bodies recognized by NIST, along with the activities of the 

assessment bodies within the scope of the NIST recognition program.

(c) The lists are made available to the public through various media, e.g., printed 

directories, electronic bulletin boards, or other means to ensure accessibility by all 

potential users.

(d) With respect to the lists specified in paragraph (a) and (b) of this section, NIST may 

delist any body if it determines the action to be in the public interest.

Sec. 286.12 Terminations.

(a) Voluntary termination. Any participant may voluntarily terminate participation at any 

time by written notification to NIST.

(b) Involuntary termination. If a participant does not continue to meet all program 

requirements, or if NIST determines it to be necessary in the public interest, NIST may 

withdraw that participant's certificate. A body that has had its status as a certificate holder 

terminated may reapply when prepared to demonstrate full conformance with program 

requirements.