Current through all regulations passed and filed through September 16, 2024
(A)
Within two calendar years of the date of issuance of a
provisional license by the department, a testing laboratory shall become
accredited to the ISO/IEC 17025 "General Requirements for the Competence of
Testing and Calibration Laboratories" standard by a non-profit accreditation
body that is signatory to the "International Laboratory Accreditation
Cooperation (ILAC) Mutual Recognition Agreement (MRA)" and which operates in
accordance with ISO/IEC 17011 "General Requirements for accreditation Bodies
Accrediting Conformity Assessment Bodies," and shall consent to have all
inspections and reports pertaining to certification and accreditation made
available to the department.
(1)
If the director believes that a testing laboratory has
failed to meet the requirements of paragraph (A) of this rule, the director may
issue a notice of noncompliance to a licensed testing laboratory. The notice
shall include the factual basis for the director's belief, including any
appropriate supporting documentation.
(2)
Upon a notice
issued pursuant to paragraph (B) of this rule, a testing laboratory may respond
with any evidence sufficient to prove that the testing laboratory has met, and
continues to meet, the standards established by paragraph (A) of this
rule.
(3)
If a testing laboratory fails to respond to a notice
issued, or the director determines the evidence provided is insufficient to
establish that the conditions in paragraph (A) of this rule have been met, the
director shall move to fine, suspend, or revoke the testing laboratory
certificate of operation pursuant to rule
3796:5-6-01
of the Administrative Code.
(4)
At any time prior
to the issuance of a notice of noncompliance under this rule, a testing
laboratory may petition the director to toll computation of the time frames
provided in paragraph (A) of this rule. Such a petition shall provide the
following:
(a)
An explanation of the facts and circumstances that will not allow the testing
laboratory to become certified and accredited as required in paragraph (A) of
this rule; and
(b)
A plan for how and when the testing laboratory will be
able to meet the requirement of paragraph (A) of this rule, with specific
attention to how such a plan will allow the testing laboratory to meet the
standards established in paragraph (A).
(5)
Upon receipt of a
petition under paragraph (E) of this rule, the director may stay the
requirement of paragraph (A) of this rule for a testing laboratory. A
director's order staying the requirement of paragraph (A) of this rule shall
state the date upon which the stay is lifted using information provided by the
testing laboratory in accordance with paragraph (E)(2) of this
rule.
(B)
The department may require a testing laboratory to
participate in third party proficiency testing programs administered by
organizations accredited to ISO/IEC 17043 "Conformity Assessment - General
Requirements for Proficiency Testing," if such programs are
available.
