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INDEPENDENT LABORATORY ACCEPTANCE INFORMATION

GUIDANCE FOR ACCEPTANCE OR RECOGNITION:

CFR SECTION LABORATORY
TYPE
159.010 ACCEPTED
159.010-7 RECOGNIZED

Independent Laboratories conduct initial (approval) and follow-up (production) testing of equipment and materials that require Coast Guard Approval.  Accepted and recognized independent laboratories act on behalf of the Coast Guard during the approval process for selected equipment approval categories ensuring that the equipment meets appropriate standards.  For certain cases a Recognized Independent Laboratory can issue approvals on behalf of the Coast Guard.  CG-5214 can only accept and recognize laboratories that are engaged in the testing of lifesaving and fire protection equipment and materials.

ISO 17025 accreditation from an accreditation body who is a full member of the International Laboratory Accreditation Cooperation (ILAC) or a recognized accreditation body by the National Cooperation for Laboratory Accreditation (NACLA) is required for acceptance for testing under the IMO FTP Code, which requires an audited quality control system.

Once a laboratory has been accepted, we can accept test reports (with regards to scope of the acceptance) from the laboratory in an application for Coast Guard type approvals.  The laboratory does not issue the approvals and this office does not accept certificates in lieu of test reports.  When the client identifies that the testing is for Coast Guard, then it is the laboratory's responsibility to ensure that the testing is carried out in such a manner acceptable to the Coast Guard.  Should the laboratory have a question, they are encouraged to contact us prior to testing.  Where a recognized (U.S. accepted) laboratory is required by the relevant equipment or material regulations, the laboratory must meet the requirements for recognition in addition to the requirements for acceptance.

INDEPENDENT LABORATORY ACCEPTANCE


ACCEPTANCE GUIDANCE & INFORMATION

(a) To be accepted by the Coast Guard as an independent laboratory, a laboratory must—

(1)  Be engaged, as a regular part of its business, in performing inspections and tests that are the same as or similar to the inspections and tests required in the applicable subpart;

(2)  Possess or have access to the apparatus, facilities, personnel, and calibrated instruments that are necessary to inspect and test the equipment or material under the applicable subpart;  In addition, for testing under the FTP Code, have ISO 17025 accreditation from accreditation body who is a full member of the International Laboratory Accreditation Cooperation (ILAC) or a recognized accreditation body by the National Cooperation for Laboratory Accreditation (NACLA).

(3)  Not be owned or controlled by—
(i)     The manufacturer of the equipment or material to be inspected or tested under this subchapter or any manufacturer of similar equipment or material;
(ii)   A vendor of the equipment or material to be inspected or tested under this subchapter or a vendor of similar equipment or material; or
(iii)  A supplier of materials to the manufacturer;

(4)  Not be dependent on Coast Guard acceptance under this subchapter to remain in business; and

(5)  Not advertise or promote the manufacturer’s equipment or material that the laboratory inspects and tests under this subchapter.

APPLICATION FOR ACCEPTANCE.

(a) Each application for acceptance of an organization as an independent laboratory must contain the following:

(1)  The name and address of the organization.

(2)  A list of the equipment or material that the organization would inspect, or test, or both, under this subchapter.

(3)  A description of the organization’s experience and its qualifications for conducting the inspections and tests required in the applicable subpart.  Often, laboratories send in resumes while the application is aimed at the ability of the laboratory to meet the requirements for the positions.  The information should reflect what the lab would require when filling the position, not the current occupant. However, the current occupant is expected to at least meet or exceed the requirements given in the application.
(4)  A description of the apparatus and facilities available to the organization for conducting those inspections and tests.

(5)  If instruments are used in the required tests and inspections, a description of the instrument calibration program applying to those instruments

(6)  The position titles of personnel who are to perform, supervise, or witness those inspections or tests, along with the training and experience required for personnel in those positions.
(Position titles and qualifications for these positions should be identified rather than identifying individuals.)

(7)  A statement signed by the chief officer of the organization or the chief officer’s representative, that an official representative of the Coast Guard is allowed access upon request to the place where tests and inspections take place, to verify the information submitted in the application, or to witness tests and inspections.

(b) Each application for acceptance as an independent laboratory that is not submitted by an agency of a state or another national government, or by a classification society, must also contain the following:

(1)  The name and address of each subsidiary and division of the organization, or a statement that none are involved in the testing or manufacturing of equipment approved under this subchapter.

(2)  The name, title, address, and principal business activity of each of the organization’s officers and directors, and the name, address, and principal business activity of each person, company, or corporation that owns at least three percent interest in the organization or in a company or corporation that controls the organization.

Please send the Submittal Package and other related information to the following address:

Commandant (CG-5214)
U.S. Coast Guard
2100 Second Street, S.W.
Washington, DC 20593-0001

After we have completed a review of the submittal package, we will contact the laboratory to arrange on site inspection of the testing facility.  For laboratories located outside the United States, the laboratory is required to pay travel expenses for the facility inspection.

Once the laboratory has been accepted, it will be issued an acceptance letter, and its name will be listed under the U. S. Coast Guard Accepted Independent Laboratory Database.

INDEPENDENT LABORATORY RECOGNITION


RECOGNITION GUIDANCE & INFORMATION

For a laboratory to become a Recognized Independent Laboratory, it must meet all the requirements for acceptance, and enter into a Memorandum of Understanding (MOU) with the Coast Guard in accordance with 46 CFR 159.010-7.

Please send the request to become a Recognized Independent Laboratory to the following address:

Commandant (CG-5214)
U.S. Coast Guard
2100 Second Street, S.W.
Washington, DC 20593-0001

Please ensure that the Approval Category(s) the laboratory wishes to conduct is included within the request.

Once the laboratory has been recognized, it will execute a Memorandum of Understanding with the Coast Guard, and its name will be listed under the U. S. Coast Guard Accepted Independent Laboratory Database as recognized for the appropriate subpart(s).

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Last Modified 7/31/2008