MAR 28, 2018 06:00 AM PDT

The Accreditation Suite for a Cannabis Lab - Why 17025 is Not Enough

C.E. CREDITS: P.A.C.E. CE | Florida CE
  • BioSafety Program Manager, American Association for Laboratory Accreditation
      Roger Brauninger has worked at the American Association for Laboratory Accreditation (A2LA) since 1999. In his role as Biosafety Program manager, his focus is on developing and maintaining accreditation programs in the Life Sciences with emphasis on microbial and chemical risks to people, animals and the environment. He is A2LA's point person for interacting with organizations working with food and drug safety, human and animal anti-doping, cannabis and biological and chemical threat agents. Mr. Brauninger has conducted numerous management system assessments to ISO/IEC 17025 and 17020 and also evaluates other assessors in this role. Roger also is an APLAC and IAAC peer evaluator and has performed multiple international peer evaluations of mutual recognition partners to the ISO/IEC 17011 standard for accreditation bodies.


    We will examine the positive relationship between the state governments who write and enforce cannabis regulations and the private sector working in this new industry. One area in particular is the testing laboratory, whose test results provide increased confidence on behalf of patients, consumers, regulators and the public that the cannabis product label accurately reflects what the product actually contains. Besides tests for potency, most states crafted regulations detailing the characteristics medical or recreational marijuana must meet in order to be sold commercially (e.g., no or minimal pesticides, heavy metals, microbial contaminants, residual processing solvents) and that the specified cannabinoid and terpene profiles adequately and competently characterized.

    Often due to government funding/capacity issues testing is performed by commercial laboratories. So what is the glue between government needs to ensure safety and process transparency and the consuming public? The glue is the third-party accreditation body who themselves are evaluated by their peers to ensure that they meet ISO 17011 who assess to the most appropriate QMS standard: ISO 17025 for laboratory testing, ISO 17034 for cannabis reference material production, ISO 17043 for cannabis proficiency testing providers in of late a greater interest in certification bodies in accreditation to ISO 17065. Collectively these interlocking independent auditing systems helps instill confidence in the entire process to all, however the ISO 17025 standard is where these other standards come together in providing the necessary support for the creditability of the testing results.   This presentation will detail common aspects of the ISO 17000-series standards and where they come together to help the laboratory’s accreditation to ISO 17025 in providing the critical assurance to customers and the public at large that the product testing performed in accredited laboratories has been to the highest standards.

    Learning Objectives:

    • In regulatory third-party programs, regulated entities generally contract with third parties to carry out product testing and other regulatory compliance assessment activities in the place of regulatory agencies
    • Accreditation is an accepted conformity assessment tool for ensuring laboratory competence and confidence in the accuracy and reliability test data whose infrastructure is well established through accreditation bodies (ABs) and the mutual recognition arrangements of the International Laboratory Accreditation Cooperation (ILAC)
    • Making use of the entire suite of  ISO/IEC 17000 standards helps to promote the needed confidence in the regulated product

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