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National Voluntary Conformity Assessment Systems Evaluation
NVCASE Overview
The National Institute of Standards and Technology (NIST) offers a voluntary program to evaluate and recognize organizations which support conformity assessment activities.
The National Voluntary Conformity Assessment Systems Evaluation (NVCASE) Program includes activities related to laboratory testing, product certification, and quality system registration. After NVCASE evaluation, NIST provides recognition to qualified U.S. organizations that effectively demonstrate conformance with established criteria. The ultimate goal is to help U.S. manufacturers satisfy applicable product requirements mandated by foreign or U.S. regulatory authorities through conformity assessment procedures.
NVCASE recognition (1) provides regulatory authorities with a basis for having confidence that qualifying U.S. conformity assessment bodies are competent, and (2) facilitates the acceptance of U.S. products in foreign regulated markets based on U.S. conformity assessment results.
NVCASE does not unilaterally establish program areas. Operational areas are established only after a formal request from a conformity assessment body (CAB) and concurrence of need from the affected industry sector. If another U.S. government agency has domestic regulatory responsibility for a sector, that agency will be consulted prior to any program action by NIST.
Conformity assessment activities may be conducted on three levels (1) the conformity level (e.g., product testing, product certification and quality system registration), (2) the accreditation level (e.g., the evaluation of testing laboratories, certification bodies, or a management system registrar by an independent body) and (3) the recognition of accreditors. NVCASE does not operate at the conformity or accreditation level, and operates only at the recognition level. NVCASE recognition may be sought by a body that accredits other bodies, (i.e., an accreditor of laboratories, certifiers or registrars). If acceptable accreditation is not available elsewhere, a body may be accredited directly by NVCASE to perform a function (i.e., to certify specific products).
In the NVCASE evaluation process, an applicant provides NIST with sufficient information to allow thorough assessment. The applicant's management system is thoroughly reviewed based on established internationally accepted criteria. The criteria for technical operation are based on internationally accepted Standards/Guides such as ISO/IEC Standard 17025 for testing laboratories; ISO/IEC Guide 65 for product certifiers; and ISO/IEC Standard 17011 for accreditors of testing laboratories or certification bodies.
Each participant must undergo an initial on-site assessment prior to obtaining recognition. All elements of non-conformance must be resolved before recognition will be granted. Once an organization is recognized, follow-up assessments are conducted on a regular two-year cycle, with periodic surveillance visits, both announced and unannounced. NVCASE recognition is effective until either voluntary or involuntary termination. The NVCASE program is described in Code of Federal Regulations, 15 CFR, Part 286.
NVCASE maintains listings of all recognized accreditors including criteria and their scope(s) of recognition. NIST also maintains listings of all designated conformity assessment bodies / certification bodies, including contact information and their scope(s) of designation.
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