National Voluntary Conformity Assessment System Evaluation (NVCASE) Program

DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

[Docket No. 970620147-7147-01]

National Voluntary Conformity Assessment System Evaluation

(NVCASE) Program

AGENCY: National Institute of Standards and Technology, Commerce.

ACTION: Notice: Proposal To Establish Recognition Program.

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SUMMARY: NIST hereby proposes to establish a recognition program under

NVCASE that will recognize accreditors of Quality System Registrars.

NIST recognized accreditors may then accredit companies (Registrars)

which in turn may register organizations that operate under applicable

quality system standards that satisfy specific foreign regulatory

requirements. The resulting recognition program will allow NIST to

designate qualified U.S. conformity assessment bodies and assure their

competence to other governments.

The action being taken under this notice only addresses development

of generic program requirements. Once a generic program is established,

applicants will be required to specify the specific mandated foreign

regulation(s) covered by the application. In cases where a Mutual

Recognition Agreement (MRA) covering the mutual recognition of

conformity assessment has been negotiated between the United States and

another country, the sectors which may be included in an application

may be limited to those covered by the MRA.

NIST proposes to apply the requirements contained in the *ISO/IEC

Guide 61--``General requirements for assessment and accreditation of

certification/registration bodies'' to all applicant accreditation

bodies. If further proposes that registrars applying for accreditation

be assessed against the requirements of *ISO/IEC Guide 62--``General

requirements for bodies operating assessment and certification/

registration of quality systems''. These generic requirements will be

supplemented with specific sectoral requirements as necessary. Such

specific sectoral requirements will be developed through consultation

with appropriate experts in the affected sector. Organizations needing

to be registered shall be registered to a quality management system

standard appropriate for the regulation/sector involved.

*ISO documents available from: International Organization for

Standardization, Casa postale 56, CH-1211, Geneve 20, Switzerland.

DATES: Comments on this notice must be received by September 29, 1997.

ADDRESSES: Comments should be submitted in writing to Robert L.

Gladhill, NVCASE Program Manager, NIST, Bldg. 820, Room 282,

Gaithersburg, MD 20899, by fax 301-963-2871 or E-mail at

[email protected].

FOR FURTHER INFORMATION CONTACT:

Robert L. Gladhill, NVCASE Program Manager, at NIST, Bldg. 820, Room

282, Gaithersburg, MD 20899, by telephone at 301-975-4273 or by telefax

at 301-963-2871.

[[Page 45628]]

SUPPLEMENTARY INFORMATION: The National Institute of Standards and

Technology received letters dated May 10, 1994, and October 31, 1994,

from the American National Standards Institute requesting to have the

ANSI-RAB American National Accreditation Program for Registrars of

Quality Systems recognized under NVCASE. The request seeks U.S.

Government assurance of the competency of the ANSI-RAB program to

accredit registrars so that they can in turn register organizations in

satisfaction of foreign mandatory regulatory requirements.

The NVCASE procedures at 15 CFR Part 286 require NIST to seek

public consultation when it receives requests for evaluation. The

original request was published in the Federal Register at Vol. 60, No.

20/Tuesday, January 31, 1995, page 5901. A 30-day public comment period

ended on March 2, 1995. The comments received are discussed below.

No action was taken on the request until now, pending conclusion of

U.S.-EU MRA negotiations. The MRA was initiated on June 20, 1997. NIST

is now proceeding with establishment of criteria and initiation of the

application process.

NIST received responses from 15 different organizations during the

public comment period on the original ANSI request and also considered

an additional letter received after the official period closed.

Of the 16 letters considered, nine indicated general support, five

opposed specific sectoral areas included in the request, one indicated

general non-support and one provided only a general comment. The

specific sectors to which the five commenters voiced opposition are not

planned for inclusion under the proposed NVCASE program. The pressure

vessel sector is not presently part of the U.S.-EU negotiations (three

opponents), and the medical device sector is under the jurisdiction of

the Food and Drug Administration (FDA); NIST will not take action in

that sector without full agreement from FDA (two opponents). Further,

NIST will not accept any application for recognition in these two

sectors without notifying the opposing entities and other members of

the sectoral community.

Notwithstanding any other provision of law, no person is required

to respond nor shall a person be subject to a penalty for failure to

comply with a collection of information subject to the requirements of

the Paperwork Reduction Act unless that collection of information

displays a currently valid OMB Control Number.

Dated: August 22, 1997.

Elaine Bunten-Mines,

Director, Program Office.

[FR Doc. 97-22928 Filed 8-27-97; 8:45 am]

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