NIST Criteria for Conformity Assessment
Body (CAB) Qualifications
For
Recreational Craft Sectoral Annex of the
U.S./EU MRA
Role of U.S. CABs
NIST designated
Conformity Assessment Bodies (CABs) operating under the European Union (EU) Recreational
Craft Directive (94/25/EC) will be considered equivalent to a European Notified
Body (NB). Scopes for CAB Designation Annex I of the
Recreational Craft Directive defines the boat categories A through D. A CAB seeking
designation for boat design must specify its scope for the boat design category
defined in this Annex. The corresponding routes to conformity are described in
Article 8 of the Directive. Annex II of the Directive lists the boat components
covered by this directive. A CAB seeking designation for specific boat components
in this list must so specify in its scope. The corresponding routes to conformity
are described in Article 8 of the Directive. A CAB could apply for designation
for boat design category (Annex I) and/or boat components (Annex II). The
scope of the CAB must specify those relevant Annexes IV through XII of the Directive,
which require notified body intervention. The CAB must have qualified staff with
appropriate experience to perform these functions. Minimum CAB Qualifications The
CAB must be located in the United States. A CAB must be accredited to ISO/IEC
Guide 65 by an accreditor that operates in conformance with ISO/IEC Guide 61.
The accreditation certificate must indicate the specific scopes for which the
CAB has applied for designation. The CAB must adhere to the notified body
criteria in Annex XIV of the Directive. The CAB must document its experience
in carrying out the conformity assessment procedures for the scopes applied for
under this Directive. The CAB staff must have attended/received Recreational
Craft Directive training. Describe clearly the location, means, dates, and syllabus
of the training received. The laboratory, where the testing is accomplished,
must be accredited to ISO/IEC Guide 25 or its later version ISO/IEC Standard 17025,
accredited by an accreditor who operates in compliance with ISO/IEC Guide 58.
Other Requirements 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. 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 will
not be necessary to submit duplicate material for review. Only information sufficient
to allow NIST to make a determination of competence for the additional CAB requirements
is necessary 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, or other factors which may affect the organization's
ability to perform the functions of a CAB under the referenced agreement. Provide
the following checklist to ensure completeness of the application package, and
the CAB declaration:
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