Voluntary Conformity Assessment System Evaluation
To view documents which are , Adobe Acrobat's Reader is required. This software may be downloaded without charge. The software is identified in order to assist users of this information service. In no case does such identification imply recommendation or endorsement by the National Institute of Standards and Technology. If you are unable to use the Adobe Acrobat Reader Software and require a copy of a PDF document, please request a copy to be sent to you from email@example.com
The National Institute of Standards and Technology (NIST), through its Standards Services Division, 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 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, such as ISO 9000 series. The criteria for technical operation are based on internationally accepted criteria such as ISO/IEC Standard 17025 (or ISO/IEC Guide 25 until it is phased out) for laboratories and ISO/IEC Guide 58 for their accreditors, ISO/IEC Guide 61 for accreditors of registrars or product certifiers, ISO/IEC Guide 65 for product certifiers, and ISO/IEC Guide 62 for registrars.
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 28 6.
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.
National Institute of Standards and Technology
Standards Coordination and Conformity Group
Attention: NVCASE Program Manager
100 Bureau Drive, MS 2150
Gaithersburg, MD 20899-2150
Tel: (301) 975-5521