How Cannabis Testing Labs Can Navigate ISO 17025 Accreditation

A 10-step approach for cannabis testing laboratories to achieve ISO 17025 accreditation

by Arun Apte, CEO, CloudLIMS.com

Even though some states in the U.S. have made cannabis legal, it's still against federal law. This means that the rules and regulations for cannabis-related businesses are different from state to state. For instance, in some states, testing facilities for cannabis must get ISO/IEC 17025 accreditation as part of their licensing process, and they need to be inspected by a qualified auditor. On the other hand, in other states, many labs are choosing to get audited voluntarily to become accredited.

An introduction to ISO/IEC 17025

ISO/IEC 17025 is a global standard that outlines the fundamental requirements for labs to operate competently, impartially, and consistently. The standard outlines the necessary activities for lab operations to establish trust in their ability to produce valid and reliable calibration, testing, and sampling results.

The current version of this standard is ISO/IEC 17025:2017, which was developed through collaboration between the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

Accreditation is an official declaration by an accreditation body that a lab is capable of fulfilling the requirements of ISO 17025 to conduct tests in accordance with its accredited scope.

ISO/IEC 17025 requirements

The ISO/IEC 17025 standard delineates precise criteria that cannabis testing labs must fulfill to showcase their competence. The standard incorporates five major sections: general requirements (section 4), structural requirements (section 5), resource requirements (section 6), process requirements (section 7), and management system requirements (section 8).

• Section 4 - General Requirements:  In this section, there are two essential requisites, namely impartiality and confidentiality, that are crucial for upholding the integrity of laboratories. Impartiality mandates that the lab does not allow any external pressures, including financial or commercial incentives, to compromise the quality of results. Any conflicts of interest, whether they are personal or internal, are identified and dealt with to guarantee neutrality. Confidentiality necessitates that the lab maintains the privacy of all information and results.
• Section 5 - Structural Requirements: This section outlines the fundamental organizational elements of a lab, its spectrum of operations, and its dedication to an efficient management system. The requirement is that a lab aiming for the accreditation must either be a legal entity itself or be part of a legal entity that is responsible for ensuring that its testing and calibration duties are performed with accountability. This section elucidates the obligations of management in an accredited lab and their obligations towards customers and regulatory bodies. Moreover, it outlines the basic prerequisites for personnel, their given authority, and the resources necessary for accomplishing their obligations.
• Section 6 - Resource Requirements: For conducting its testing tasks, the lab must possess the appropriate resources, such as facilities, equipment, personnel, and financial resources.
• Section 7 - Process Requirements: This section of the standard details 11 sub-clauses that aim to enhance efficiency. It commences with the evaluation of requests, tenders, and contracts. The most technical and crucial aspect of the standard is the selection, verification, and validation of methods, which encompasses sampling, handling of test items, and technical record-keeping. The standard also provides explicit requirements for the reporting of test results, managing complaints, and non-conforming work. Additionally, it focuses on controlling data and information management, which is particularly relevant in today's digital age.
• Section 8 - Management Systems Requirements:  This section of the standard includes eight sub-clauses, such as management system documentation, which includes controlling records and documents, addressing potential risks and opportunities, implementing improvements, and taking corrective actions. The section concludes with the requirements for internal audits and management review processes.

A step-by-step approach

The path to achieving ISO 17025 accreditation can be broken down into a series of steps. We recommend adopting the following step-by-step approach to cannabis testing labs aiming to achieve the accreditation:

1. Create a quality policy: It should articulate the lab's commitment to quality and its general quality goals. Communicate this policy to all lab personnel and relevant parties.
2. Specify the lab's scope: It should encompass the testing techniques and services it offers, and record it in a scope statement.
3. Create a quality manual: To conform to the ISO/IEC 17025 standard, create a quality manual that clearly describes the lab's quality management system, including its policies, procedures, and work instructions.
4. Establish a document control system: The system should be able to manage all lab documents such as work instructions, standard operating procedures (SOPs), and records. This system should guarantee that documents are controlled, updated, accessible, and maintained in accordance with the standard.
5. Implement quality management procedures: This step requires implementing procedures to manage operational quality, such as managing equipment calibration and maintenance, initiating corrective and preventive actions for work that do not meet the required standards, and conducting internal audits.
6. Train Personnel: Make sure that lab staff are trained and have the necessary skills to perform their job functions effectively. Create a training plan and keep records of training. Ensure that analytical tasks are only assigned to competent and trained personnel.
7. Participate in proficiency testing programs: To demonstrate the technical competence of the lab, enroll in programs for proficiency testing.
8. Perform internal audits: To evaluate the effectiveness of the lab's quality management system and identify areas of improvement, perform internal audits. Internal audits provide an opportunity to review and verify that all necessary preparations for an external audit are acceptable.
9. Prepare for external assessments: In preparation for external assessments, review the lab's quality management system to ensure compliance with the standard's requirements and address any deficiencies identified in internal audits.
10. Apply for accreditation: To obtain accreditation, choose an accreditation body and then apply for accreditation. An external auditor will then assess your lab to ensure that it complies with the various requirements of the standard.

Cannabis testing lab software

Cannabis testing lab software, also known as Laboratory Information Management System (LIMS), helps automate and manage essential laboratory processes, including:

• Document management: Proper management of documents is crucial for ensuring compliance with ISO 17025. It guarantees that lab personnel have access to the latest procedures, instructions, and other crucial documents needed to carry out their work accurately and efficiently. It also ensures that the lab is following established procedures and that all documentation is precise and consistent. A cannabis testing lab software can support document management by allowing labs to manage, authorize, and distribute documents such as SOPs. Additionally, this system can enforce version control and grant role-based document access rights to ensure that only authorized personnel can access accurate and up-to-date documents.
• Personnel training and competency management: For cannabis testing labs to comply with ISO 17025, it is crucial to guarantee that lab personnel are well-trained and competent to carry out their assigned tasks and duties. A cannabis testing lab software enables managing training of lab personnel and their professional competency, notifies staff about upcoming training(s), and generates custom training and competency reports.
• Instrument calibration and maintenance management: Proper calibration and maintenance of equipment is essential to ensure accurate and reliable test results. Labs must identify equipment that requires calibration and maintenance, establish a calibration and maintenance program, set up schedules, conduct calibration and maintenance activities, and document calibration and maintenance data. A cannabis testing lab software can assist with automating calibration and maintenance schedules for equipment according to the manufacturer's recommendations. The system can also provide reminders for upcoming calibration and maintenance activities, track equipment maintenance history, and store calibration and maintenance data at a centralized location. This makes it easy for lab personnel and auditors to access the information they need.

ISO/IEC 17025 outlines specific criteria that labs must fulfill to demonstrate their technical competence. While some states may not require this accreditation, it is still important for cannabis testing labs to adhere to thefundamental requirements of ISO/IEC 17025 to establish trust and confidence in their test results.

Leading and competitive cannabis laboratories face significant pressure to enhance their adherence to ISO 17025 standards. This is crucial in order to prove to regulators, consumers, and industry stakeholders that their findings are both precise and dependable. A cannabis testing lab software can prove to be more than a useful ally in this endeavor of theirs.

About the author: Arun Apte is a serial entrepreneur and laboratory research scientist specializing in bioinformatics. He founded CloudLIMS in 2014, bringing the benefits of a SaaS LIMS to the cannabis testing laboratory market. This has enabled hundreds of cannabis testing and extraction laboratories to manage data, automate testing workflows, and follow regulatory compliance, such as ISO/IEC 17025:2017. Arun is an invited speaker at cannabis conferences all over the world. Prior to founding CloudLIMS, he founded PREMIER Biosoft forging strategic partnerships with Thermo, Agilent, SCIEX, and other mass spectrometry instrument companies. Arun Apte holds a B.A. in molecular and cell biology and biophysics from the University of California at Berkeley. He has published extensively on bioinformatics.