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37.107.301    TESTING LABORATORY ENDORSEMENT REQUIREMENTS

(1) A testing laboratory applicant must meet all applicable requirements under the Montana Marijuana Regulation and Taxation Act (Title 16, chapter 12, MCA) and this subchapter in order to qualify for endorsement of either licensure or renewal.

(2) An applicant must provide, to the department's state laboratory, documentation to support fulfillment of these requirements, which includes the following:

(a) certificates of insurance and bonding in accordance with ARM 42.39.417;

(b) business license;

(c) property owner permission form for laboratories, if applicable;

(d) department-issued employee badge;

(e) laboratory security/storage plan;

(f) quality manual;

(g) standard operating procedures;

(h) validation studies/data and results;

(i) proficiency data/results;

(j) scientific director professional resume, college transcripts/degrees from an accredited college or university;

(k) scientific director references; and

(l) Certificate of ISO/IEC 17025:2017 accreditation and associated audit reports by an approved accreditation or credentialing body.

(3) An application for endorsement for a testing laboratory license or renewal of license will not be considered complete, and an on-site inspection will not be scheduled, until all of the required documentation is provided.

(4) An inspection of the testing laboratory will be scheduled with the applicant following receipt of all required documentation.

(5) An applicant must implement processes that are ISO/IEC 17025:2017 compliant.

(6)  An applicant that meets all of the requirements under the Montana Marijuana Regulation and Taxation Act (Title 16, chapter 12, MCA) and this subchapter and that is actively seeking ISO/IEC 17025:2017 accreditation may be approved for endorsement if written evidence of pending ISO accreditation and an inspection from the state laboratory indicate that accreditation will be achieved within 12 months from the date of endorsement.

(7) A testing laboratory must maintain ISO accreditation for all methods/analytes in ARM 37.107.316, at all times.

(8) If a testing laboratory's method/analyte ISO accreditation lapses or is revoked, the testing laboratory must not perform those methods until it is reinstated.

(9) For the purpose of this subchapter, the state laboratory adopts and incorporates by reference ISO/IEC 17025:2017, which sets forth general requirements for the competence of testing and calibration laboratories. A copy of the publication may be obtained from the American National Standards Institute (ANSI), 1899 L St. NW, 11th Floor, Washington, DC 20036; https://webstore.ansi.org/SDO/ISO.

 

History: 16-12-202, 16-12-209, MCA; IMP, 16-12-202, 16-12-209, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19; AMD, 2022 MAR p. 58, Eff. 1/15/22.

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