[Federal Register Volume 60, Number 23 (Friday, February 3, 1995)]
[Notices]
[Pages 6700-6701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2718]



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DEPARTMENT OF COMMERCE

Workshop on National Voluntary Conformity Assessment Systems 
Evaluation (NVCASE) Program

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Meeting notice.

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SUMMARY: This is to advise the public that the National Institute of 
Standards and Technology (NIST) will conduct a workshop to brief 
interested parties on the NVCASE program and to review documents that 
will be used as the generic basis for requirements of the operational 
program. The workshop will be in two parts:
    (1) A briefing on the purpose and operation of the NVCASE program: 
the presentation will proceed step-by-step through the procedures set 
forth in the April 22, 1994 Federal Register Notice (15 CFR part 286); 
and
    (2) A review of present and proposed international documents that 
will be used as the generic basis for program requirements.
    The public is encouraged to call to NIST's attention documents 
useful for this purpose.

DATES: The workshop will be held Thursday, March 9, 1995, from 10:00 
a.m. to 6:00 p.m. Registration will start at 9:30 am.

ADDRESSES: The workshop will be held in the Green Auditorium at the 
National Institute of Standards and Technology, Gaithersburg, Maryland.

FOR FURTHER INFORMATION CONTACT: (1) For administrative and logistic 
information, contact Ms. Marilyn Stream, National Institute of 
Standards and Technology, Building 417, Room 107, Gaithersburg, 
Maryland 20899; Phone: (301) 975-4029. Fax: (301) 963-2871. (2) For 
information concerning the NVCASE program contact Mr. Robert Gladhill, 
Program Manager, National Institute of Standards and Technology, 
Building 417, Room 107, Gaithersburg, Maryland 20899; Phone: (301) 975-
4273. Fax: (301) 963-2871. (3) For information on how to obtain copies 
of the documents, contact the American National Standards Institute 
(ANSI), 11 West 42nd Street, 13th Floor, New York, New York 10036, USA; 
Phone: (212) 642-4900. Fax: (212) 398-0023.

SUPPLEMENTARY INFORMATION: The National Institute of Standards and 
Technology (NIST) offers a voluntary program on a fee-for-service basis 
to evaluate the competence of conformity assessment activities.
    The National Voluntary Conformity Assessment Systems Evaluation 
(NVCASE) Program may be applied to activities related to laboratory 
testing, product certification, and quality system registration. NVCASE 
evaluates and provides official recognition to qualifying bodies in the 
United States that effectively demonstrate that they satisfy 
established criteria and applicable regulatory requirements of other 
countries.
    NVCASE recognition (1) provides other governments with a basis for 
having confidence that qualifying U.S. conformity assessment bodies are 
competent, and (2) promotes the acceptance of U.S. products in 
regulated foreign markets based on U.S. conformity assessment results.
    NVCASE offers evaluation services to support U.S. trade in 
regulated foreign markets, but not for domestic applications. NVCASE 
does not unilaterally establish program areas. All requests to 
establish evaluation services in a specific product sector are first 
published for public advice and comment. If another U.S. Government 
[[Page 6701]] agency has domestic regulatory responsibility for that 
sector, the cognizant agency is consulted prior to any program action 
by NIST.
    A U.S. regulatory agency may, at its discretion, defer evaluation 
and recognition of conformity assessment activities related to foreign 
trade to NVCASE, or may itself perform required evaluation activities. 
In the event of deferral to NVCASE, the regulatory agency fully retains 
its domestic authority and responsibility for the product sector.
    NVCASE recognition may be obtained for different levels of 
activity. For example, a body may be recognized to accredit other 
bodies, (e.g., an accreditor of laboratories, or of certifiers, or of 
registrars). If accreditation is not available elsewhere, a body may be 
accredited directly by NVCASE to perform some specific function (e.g., 
to certify specific products, or as a quality system registrar).
    The NVCASE evaluation process requires that a body provide 
sufficient information to allow thorough evaluation of its management 
system and operations. The criteria used are based on internationally 
accepted requirements.
    Prior to obtaining recognition, each participant must undergo an 
initial on-site assessment by qualified assessors. Any elements of non-
conformance must be resolved prior to the granting of recognition. Once 
recognition has been granted, follow-up assessments are conducted on a 
regular basis, along with periodic surveillance visits, both announced 
and unannounced. NVCASE recognition is effective until either voluntary 
or involuntary termination.
    NVCASE listings of all recognized bodies include the name, address, 
pertinent contacts, and the scope of recognition. NVCASE also maintains 
listings of qualified bodies that have been accredited or otherwise 
approved by a NVCASE-recognized accreditor (but only within the scope 
and period of recognition of the accreditor), indicating they are 
traceable to NIST via the NVCASE-recognized body. All listings are 
freely disseminated and available to the public through various media.
    In the event that a recognized body is found not to conform with 
the established criteria, NVCASE will terminate the recognition and 
delist the body. NIST will no longer assure that body's conformity 
assessment activities are competent.
    If the body is of a type which accredits or otherwise approves 
other groups (e.g., an accreditation body that accredits laboratories), 
these accredited groups (e.g., laboratories) may be delisted and lost 
their traceability to NIST.
    However, if the accredited groups were not involved in the 
circumstances that led to the termination of recognition of the 
accreditation body, NVCASE will consider granting a grace period during 
which accreditation can be obtained from another NVCASE-recognized 
accreditation body prior to being delisted. To the extent that one or 
more accredited bodies were affected by the circumstances which lead to 
the termination of recognition of the accrediting body, all those 
involved will be immediately delisted.
    Bodies that have had their NVCASE recognition terminated may regain 
recognition if and when they can demonstrate conformance with all 
requirements.
    As indicated, the NVCASE Program intends to rely on and utilize 
international conformity assessment documents such as those developed 
by the International Organization for Standardization (ISO) Committee 
on Conformity Assessment. These documents adopted jointly by ISO and 
the International Electrotechnical Commission (IEC) are as follows:

ISO/IEC Guide 25, ``General Requirements for the Competence of 
Calibration and Testing Laboratories,'' Third edition; 1990;
ISO/IEC Guide 58, ``Calibration and Testing Laboratory Accreditation 
Systems--General Requirements for Operation and Recognition,'' First 
edition, 1993;

    In addition, under consideration for adoption are:

ISO/CASCO 226 (rev. 2), ``General requirements for certification or 
registration body assessment and accreditation systems'';
ISO/CASCO 227 (rev. 2), ``General requirements for bodies operating 
assessment and certification/registration of quality systems'';
ISO/CASCO 228 (rev. 2), ``General requirements for bodies operating 
product certification systems'' (or currently available equivalent).

    ISO/IEC guides are used as a basis for many conformity assessment 
activities at international, regional and national levels and have been 
approved by the American National Standards Institute (ANSI), the U.S. 
member body to ISO.

    Dated: January 31, 1995.
Samuel Kramer,
Associate Director.
[FR Doc. 95-2718 Filed 2-2-95; 8:45 am]
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