NIST Criteria for Conformity Assessment Body (CAB)
Qualification U.S./EU MRA –Telecom Annex

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Role

NIST designated Conformity Assessment Bodies (CABs) operating under the European Union (EU) Radio and Telecommunications Terminal Equipment (R&TTE) Directive (1999/5/EC) will be considered equivalent to a European Notified Body (NB).

The R&TTE Directive significantly changes the conformity assessment procedures that covered products must meet in order to be imported into the European Union. The Directive allows all covered products to be placed on the EU market based on a Supplier's Declaration of Conformity (SDOC). However, there is still a role for a NB under Annexes III, IV, and V of the Directive.

Annex III (Internal production control plus specific apparatus tests) requires that a NB be consulted when the radio test suites considered to be essential are different from those defined in the harmonized standards. The sole function of the NB is to review, evaluate and advise the manufacturer of the proper tests that should be performed in order to meet the essential requirements of the Directive. This will require evaluating such items as details of the product for its usage and general parameters and determining any specific requirements of the territory of intended usage, e.g., spectrum allocation, frequency band requirements.

Annex IV (Technical Construction File) requires that a NB be able to evaluate technical documentation and issue an opinion as to whether or not it forms a technical construction file (TCF). The NB must also review the tests performed and issue an opinion as to whether or not the correct testing was performed. (See Annex III above).

Annex V (Full quality assurance) requires that a manufacturer have its quality system audited by a NB. The NB must be competent to perform a thorough evaluation of a manufacturers quality system per the requirements noted in Annex V.

To qualify under The MRA and Directive 1999/5/EC - Annex III an organization must be located in the U.S. and be 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 technical understanding of radio 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 radio technology. It is not necessary to cover all test methods or technology included in the bodies work.
   
   
3. Information identifying specific technically competent individuals utilized by the body and describing their background and experience in performing the type of engineering judgements needed to analyze a specific proposal for a product and recommend a proper test suite.
   
   
4. A documented procedure to follow when analyzing a product to determine the proper test suite to recommend.

To qualify under Annex IV an organization must be able to fulfill the conditions noted for Annex III plus:

1. Detailed documented procedures as to how to perform TCF evaluations;
   
   
2. Documented procedures for training staff to perform TCF evaluations;
   
   
3. Information identifying specific technically competent individuals by describing their background and experience in performing the type of engineering judgements needed to evaluate TCFs under the R&TTE Directive including their knowledge of associated requirements e.g., EMC and/or LVD/safety;
   
   
4. 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. (Note R&TTE Directive Annex VI point 1)

To qualify under Annex V, an organization must be located in the U.S. and be 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 technical understanding. This can be demonstrated by supplying a current valid certificate of accreditation to ISO/IEC Guide 62, with a scope covering a representative set of appropriate technology;
   
   
3. Detailed documented procedures as to how the body performs quality system reviews under the R&TTE Directive;
   
   
4. Documented procedures for training staff to perform evaluations of quality management systems under the R&TTE Directive;
   
   
5. Information identifying specific technically competent individuals and describing their background and experience in performing the type of judgements needed to perform the functions described above.

Common Criteria for All Annexes

An organization must be able to comply with the following:

Annex VI of the Directive requires that a body must have sufficient liability insurance coverage to protect itself from lawsuits arising from its activities. An applicant must be able to provide evidence that it has such insurance and the coverage limits.

Annex VI of the Directive requires that a body must observe professional secrecy. An applicant 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.

Each CAB must keep NIST informed of all changes which may affect its status, e.g., change in key personnel, change in accreditation status, change in location, legal status, insurance coverage or other factor 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 is 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 is 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

Please note that R&TTE Directive, Annex VI, point 1, includes restrictions for designers, manufacturers, suppliers or installers, network operators or service providers. (See enclosure III)

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

• Checklist for R&TTE CAB Request
• CAB Declaration U.S./EU MRA RTTE Annex