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:
- 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,
- 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,
- Detailed documented procedures regarding
how the evaluation of a TCF is performed,
- 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;
- 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.
- 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,
- 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.
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