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NIST Criteria for CAB Qualification
Under U.S./EU MRA - EMC Annex


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Role

U.S. designated Conformity Assessment Bodies (CABs) operating under the European Union (EU) EMC Directive 89/336/EEC Article 10.2 will be considered equivalent to an EU competent body. The CAB is responsible to evaluate and endorse a Technical Construction File (TCF), (regardless of who developed it), and issue a certificate or technical report that will be included in the TCF. The certificate or report need only state that the TCF has been judged to adequately substantiate that the procedures carried out for the conformity assessment of those parts not covered by the harmonized standards have been correctly performed. The certificate or report is not a declaration of conformity for the product and does not need to state such conformance. (See the E.U. Guide to the Application of Directive 89/336/EEC 1997 Edition, pages 25 - 26. - available from the European Commission, DG Enterprise)

To qualify under The MRA and Directive 89/336/EEC - Article 10.2 an organization must be located in the U.S. and able to demonstrate:

  1. Knowledge and understanding of, and relevant experience with, the technical requirements as well as interpretations and policies of the EU or member state in which it intends to provide services,

  2. General competence in quality management system operation, and basic understanding of EMC technology. This can be demonstrated by supplying a current valid certificate of accreditation against ISO/IEC Guide 25, Standard 17025, or Guide 65 with a scope covering a representative set of appropriate EMC technology. It is not necessary to cover all test methods or technology included in the body's work,

  3. Detailed documented procedures regarding how the evaluation of a TCF is performed,

  4. Information identifying specific technically competent individuals, describing their background and experience in performing the type of engineering judgements needed to evaluate TCFs under the EMC Directive;

  5. If a different part of the organization performs any testing or TCF development, the organization must be able to show how separation of the functions (supplying test data or developing a TCF vs. review and evaluation of a TCF) occurs such that the person(s) evaluating a TCF are not involved in producing the TCF or any test results being reviewed.

  6. Annex II of the Directive requires that a body must have sufficient liability insurance coverage to protect itself from lawsuits arising from its activities. A body must be able to demonstrate evidence that it has such insurance and the coverage limits,

  7. Annex II of the Directive requires that a body must observe professional secrecy. A body must be able to demonstrate that it has a policy and procedure to demonstrate that it is bound to observe professional secrecy with regard to all information gained in carrying out its tasks.

Once designated , each CAB must keep NIST informed of all changes which may affect its status, e.g., changes in key personnel, changes in accreditation status, changes in location, legal status, insurance coverage or other factors which may affect the organization's ability to perform the functions of a CAB under the referenced agreement.

Each organization nominated to become a CAB will be required to sign a statement declaring their commitment to the requirements and responsibilities of being a CAB. By signing this declaration the organization agrees to the terms of its nomination and its final designation.

All supporting information will be subject to expert technical review, both for evidence of general technical competence and claimed specific EMC competence. Additional documentation or supporting evidence may be necessary during the review process. In some cases a site visit may be necessary.

If appropriate information has been previously reviewed by NIST with regard to other CAB interests, it may not be necessary to review duplicate material. Only information sufficient to allow NIST to make a determination of competence for the additional CAB requirements is necessary.

All potential CABs are advised to have appropriate staff attend an EU MRA training course. Evidence that such training was completed will be very helpful in the evaluation for designation.


Contact:  maryjo.dibernardo@nist.gov



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Global Standards and Information Group, Standards Services Division, NIST, 100 Bureau Drive, MS 2100, Gaithersburg, MD 20899-2100
Phone: (301) 975-6094, Fax: (301) 975-4715, Email: gsig@nist.gov

Date created: October 11, 2000
Last updated: January 21, 2003

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