NIST Criteria for Conformity Assessment
Qualification U.S./EU MRA –Telecom Annex
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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).
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).
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.
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:
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,
- 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.
- 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
- 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
- Detailed documented procedures as to how to perform TCF
- Documented procedures for training staff to perform
- 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;
- 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)
qualify under Annex V, an organization must be located in the U.S. and be
able to demonstrate:
- 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,
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
- Detailed documented procedures as to how the body performs
quality system reviews under the R&TTE Directive;
- Documented procedures
for training staff to perform evaluations of quality management systems under
the R&TTE Directive;
- 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
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.
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.
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
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.
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.