As more and more Cannabis products on the market fail to conform to quality and safety specifications, we have witnessed an increase in awareness from medical cannabis companies. That also includes patients and consumers who require the necessary testing, both analytical and microbiology laboratories.
ISO 17025 is an international standard that defines the requirements for product testing and calibration laboratories.
The ISO 17025 standard is suitable for all laboratories regardless of the number of employees or the scope of their operations. The laboratory can also adopt the ISO 17025 partially, only for specific activities and gradually expand the scope of accreditation. Laboratory ISO 17025 certification provides formal international recognition of the laboratory’s technical and operational capabilities and quality of work and therefore serves as a means for customers and organizations to ensure accurate, qualitative, reliable, comparable and qualified results.
What is the ISO 17025 standard?
ISO 17025 is an international standard published by the International Organization for Standardization, which defines the general requirements for testing and calibration laboratories. Similar to ISO 9001, this standard emphasizes continuous improvement, senior management’s responsibility for quality issues, risks and customer services.
The main sections of the ISO 17025 standard
ISO 17025 consists of five main elements:
The two main sections of ISO 17025 are management requirements and technical requirements. Management requirements are primarily related to the operation and efficiency of the quality management system in the laboratory. Technical requirements relate to staff skills, work methodologies, integrity and the reliability of test results and calibrations performed in the laboratory.
The main management requirements in ISO 17025
Tests and calibrations performed in the laboratory are required to comply with the requirements of ISO 17025. It is also under laboratory responsibility to provide services according to the customer’s requirements while maintaining all information as confidential.
The quality management system must be managed effectively and should include documentation of all tests performed. All activities performed are based on working procedures.
ISO 17025 certified laboratories will manage and handle customer complaints based on appropriate procedures and will record all complaints and deviations, and investigate and implement corrective actions and effectiveness verification accordingly.
The laboratory should make all necessary efforts to continually improve the effectiveness of the quality of their management system, including management surveys, quality policy, quality goals, internal audits, data review, corrective and preventive actions, etc.
The main technical requirements of ISO 17025
Cannabis products are tested for analysis such as microbial bio-burden, cannabinoids, and terpenes concentration, pesticides and solvents residuals, toxins and others. There are various factors that may affect analysis integrity, accuracy, and reliability such as human factors, environmental factors, test methods, instrumentation calibration, laboratory equipment validation, and analysis test methods validation. Certified laboratories should follow Good Laboratories Practices (GLP) and must document activities such as test methods development, calibrations, staff training, and laboratory equipment status.
The certified laboratory should use validated analysis methods in order to specificity, linearity, repetition, accuracy, and robustness of the test methods. Laboratory staff should document the validation results according to an approved validation protocol.
ISO 17025 also ensure that the working environment “supports” working procedures to be performed in a proper and convenient manner in order to minimize the effect on test results. Environmental conditions in the laboratory should be controlled in terms of temperature, humidity, sterilization, ventilation, noise levels, radiation levels, lighting, and air cleanliness.
In order to achieve the required testing accuracy, laboratory equipment used for testing, calibration, and sampling should be calibrated periodically and before usage according to laboratory requirements and ISO 17025 requirements. Laboratory staff should follow Good Documentation Practices (GDP) in order to report test results accurately and in an objective manner. All products analysis certificates will be approved by the Quality Assurance Manager at the laboratory.
About Cannabis GxP consultancy
Cannabis GXP is proud to stand at the forefront of the Cannabis industry in Israel and worldwide thanks to many years of experience in these areas.
Our team is compelled to spread the message of the importance of cannabis science, regulation and standardization as the world enters a new era of cannabis legislation.
We aim to position our clients with their best foot forward when it comes to anything and everything cannabis related.
Our vast expertise allows us to assist companies in a wide range of services and needs: Anything from Cannabis R&D, growing and manufacturing, new products development, facility design, technology, Quality Assurance, Good Practices (GAP/GMP/GLP/GDP/GCP), staff training, local and global regulations.
Cannabis GxP is a subsidiary company of Bio-Chem Ltd. (2007), a consultancy firm for the Pharmaceutical field, medical devices, Cosmetics and food supplements industry based in Israel.
Our cannabis consultancy services include:
If you need one or several of our services, we will be more than happy to assist.
Please do not hesitate to contact us for further information.