(1) A marijuana testing laboratory must meet all applicable requirements under the Montana Medical Marijuana Act (Title 50, chapter 46, part 3, MCA) and this subchapter in order to qualify for licensure or licensure renewal.

(2) An applicant for a testing laboratory license must provide, to the department's state laboratory, documentation to support fulfillment of these requirements, which includes but is not limited to the following:

(a) certificates of insurance and bonding;

(b) business license;

(c) laboratory licensure fee payment;

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

(e) laboratory employee fingerprint/background check clearance;

(f) laboratory security/storage plan;

(g) quality assurance plan;

(h) standard operating procedures;

(i) validation studies/data and results;

(j) proficiency data/results;

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

(l) director references; and

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

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

(4) A laboratory audit will be scheduled with the applicant following receipt of all required documentation.

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

(6) An applicant, that meets all of the requirements of this subchapter and 50-46-311, MCA, but is not ISO/IEC 17025:2017 accredited, may be qualified for a provisional license pending ISO/IEC 17025:2017 accreditation approval, if written evidence of pending ISO accreditation and the results of an audit by the state laboratory indicate that accreditation will be achieved within 12 months from the date of licensure.

(7) A provisional laboratory license may not be extended or reissued beyond the date of the initial 12-month term.

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

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

(10) For the purpose of this subchapter, the department 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.

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