Demystifying ISO 17025 Requirements for Cannabis Testing Labs: A Step-by-Step Guide
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Although many states in the United States have legalized or decriminalized cannabis, it remains illegal at the federal level. As a result, regulations surrounding cannabis businesses vary significantly from state to state. In certain states, cannabis testing facilities must achieve ISO/IEC 17025 accreditation as part of the licensing process, which involves an inspection by a qualified auditor. In other states, many laboratories are opting to undergo audits willingly to achieve accreditation.
ISO/IEC 17025 is an internationally recognized standard for the competence of testing and calibration labs. It provides a framework for labs to demonstrate that they are technically competent and can produce accurate and reliable results. In the context of cannabis testing, ISO 17025 accreditation is particularly relevant as it provides a standardized approach to lab operations and quality management. Accreditation to this standard ensures that cannabis testing labs follow consistent and rigorous procedures, have appropriately trained staff, use validated methods, and have proper quality control measures in place. By following ISO 17025 standards, cannabis testing labs can demonstrate to regulators, consumers, and industry stakeholders that their results are accurate, reliable, and trustworthy. Obtaining this accreditation is a means for labs to showcase their quality and distinguish themselves from competitors who have not undergone external verification of their methods and operation.
Understanding ISO 17025
ISO 17025 accreditation provides several benefits to cannabis testing labs, including improved accuracy and reliability of results through consistent procedures, validated methods, and quality control measures. The accreditation ensures compliance with regulations and creates better business opportunities by demonstrating a commitment to quality and professionalism.
This standard is divided into five sections, which cover general requirements (clause 4), structural requirements (clause 5), resource requirements (clause 6), process requirements (clause 7), and management system requirements (clause 8). Here’s a quick rundown of the key requirements of ISO 17025:
- General requirements: The lab must ensure that testing activities are conducted impartially. It must also securely manage data to prevent unauthorized data access and take measures for continuous improvement.
- Structural requirements: The lab must have a defined organizational structure, including clear roles and responsibilities for all personnel.
- Resource requirements: It must have the necessary resources, including facilities, equipment, personnel, and financial resources, to carry out its testing activities.
- Process requirements: It must have documented procedures for all testing activities, including sampling, preparation, analysis, validation, and reporting of test results.
- Management system requirements: It must have a management system that includes processes for corrective and preventive actions, control of records and management system documents, actions to address risks and opportunities, and internal audits.
By meeting these requirements, labs can demonstrate their technical competence, provide reliable and accurate results, and build trust and confidence with their customers and stakeholders.
Achieving ISO 17025 accreditation - A 10-step approach
Meeting ISO 17025 requirements for cannabis testing labs involves following a series of steps to establish and maintain a quality management system. These steps can include:
- Establish a quality policy: Develop a quality policy that outlines the lab’s commitment to quality and its overall quality objectives. This policy should be communicated to all lab personnel and stakeholders.
- Define laboratory scope: Define the lab scope, including the testing methods and services provided, and document it in a scope statement.
- Develop a quality manual: Develop a quality manual that outlines the lab’s quality management system and its implementation. This manual should describe the lab’s policies, procedures, and work instructions.
- Establish document control: Implement a document control system to manage all lab documents, including procedures, work instructions, and records. This system should ensure that documents are controlled, updated, and maintained as required by the standard.
- Implement quality management procedures: Implement quality management procedures, including procedures for calibration and maintenance of equipment, control of non-conforming work, corrective and preventive actions, and internal audits.
- Train laboratory personnel: Ensure that laboratory personnel are trained and competent in their respective areas of work. Develop a training plan and maintain training records. Ensure that analytical tasks are assigned only to trained and competent personnel.
- Participate in proficiency testing: Participate in proficiency testing programs to demonstrate the lab’s technical competence.
- Conduct internal audits: Conduct internal audits to evaluate the effectiveness of the lab’s quality management system and identify opportunities for improvement. The internal audit provides a chance to review and ensure that all necessary preparations for the audit are acceptable before an external audit.
- Prepare for external assessments: Prepare for external assessments by reviewing the lab’s quality management system and ensuring that all requirements of the standard are met and all lacunae identified in internal audits are addressed.
- Apply for accreditation: Apply for accreditation from an accreditation body. As part of the audit or accreditation process, the lab is assessed by an external auditor to ensure compliance with the various requirements of the standard.
By following these steps, cannabis testing labs can meet the requirements of ISO 17025 and demonstrate their technical competence in cannabis testing.
Image 1: A 10-step approach for cannabis testing laboratories to achieve ISO 17025 accreditation (Figure courtesy CloudLIMS).
Document management, personnel competency, and equipment calibration and maintenance: how a SaaS LIMS for CBD/THC testing can help
Document management is an essential part of ISO 17025 compliance. Proper document control ensures that lab personnel have access to up-to-date procedures, instructions, and other important documents needed to perform their work correctly and efficiently. It also helps ensure that the lab is following established procedures and that all documentation is accurate and consistent. A software as a service laboratory information management system (SaaS-LIMS) for CBD and THC testing can support document management by enabling labs to manage, approve, and distribute documents, such as standard operating procedures (SOPs). Furthermore, an SaaS-LIMS for CBD and THC testing can enforce version controls and assign role-based document access rights to ensure that documents are accurate, up-to-date, and accessible to authorized personnel.
Personnel competency and training are also crucial components of ISO 17025 compliance for cannabis testing labs. It is essential to ensure that lab personnel are adequately trained and competent to perform their assigned tasks and responsibilities. To implement personnel training, labs should identify training needs, develop a training program, implement the program, evaluate personnel competency, and maintain training records.
In cannabis testing labs, equipment calibration is crucial for ensuring reliable test results. Labs should identify equipment requiring calibration and maintenance, develop a calibration and maintenance program, establish calibration and maintenance schedules, conduct calibration and maintenance, and document all calibration and maintenance activities. A SaaS-LIMS can automate calibration and maintenance schedules for equipment based on manufacturer recommendations. The system can provide reminders for upcoming calibration and maintenance activities and track equipment maintenance history. A LIMS can also provide a centralized location for storing calibration and maintenance data, allowing lab personnel and auditors to quickly and easily access the information they need.
Image 2: A SaaS LIMS for CBD and THC testing to manage staff training and competency.
ISO 17025 ensures that labs follow consistent and rigorous procedures, have appropriately trained staff, use validated methods, and have proper quality control measures in place. Through this accreditation, labs can demonstrate their quality, build trust and credibility with regulators, consumers, and industry stakeholders, and create better business opportunities. Meeting ISO 17025 requirements for cannabis testing labs involves following a series of steps including implementing quality management procedures, training lab personnel, conducting internal audits, preparing for external assessments, and more. Document management and control, personnel competency, and equipment calibration and maintenance are essential components of the process, and a SaaS-LIMS for CBD and THC testing can help with these seemingly daunting tasks. Overall, following ISO 17025 standards provides cannabis testing labs with the means to showcase their quality and distinguish themselves from competitors who are not ISO 17025 accredited.