3796:4-2-02 Testing laboratory proficiency testing and certification.

(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.

Cite as Ohio Admin. Code 3796:4-2-02

Effective: 9/8/2017
Five Year Review (FYR) Dates: 09/08/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 3796.03
Rule Amplifies: R.C. 3796.03