What You Need to Know About ISO/IEC 17025:2017 Accreditation
Accreditation is a process where an authoritative body formally recognizes an organization’s ability to successfully perform a specific set of tasks based on conformance to international standard(s). Developed by an independent group of experts, the standards exist to support uniformity across organizations worldwide. Organizations accredited to international standards are recognized for both quality and competency.
Here, we'll explore what you need to know about ISO/IEC 17025:2017 accreditation and why it is important for the cannabis industry.
What is ISO & ISO/IEC 17025:2017?
The International Organization for Standardization (ISO) is an independent, non-governmental organization comprised of membership of 165 national standards bodies. As the world’s largest developer of voluntary international standards, ISO facilitates world trade by establishing more than twenty thousand standards from manufactured products and information technology to food safety and healthcare.
The standard used for testing laboratory accreditation is ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories. First released in 1999 and revised most recently in 2017, ISO 17025 includes requirements on staff competence, the validity and appropriateness of methods, and measurement traceability, among others. By obtaining accreditation and maintaining compliance with this comprehensive standard, a laboratory successfully demonstrates that they operate competently and generate valid results.
How to Get ISO/IEC 17025:2017 Accredited?
To become ISO/IEC 17025:2017 accredited, a laboratory must prove that it meets the requirements of the standard. The process of applying for accreditation includes an application to an Accrediting Organization (or AO, such as A2LA, PJLA, or ANAB), an assessment visit which may include peer review, an on-site audit, and potential corrective action before AO approval. However, it is worth noting that these procedures may vary between different AOs. Moreover, the application process will differ depending on the type of laboratory seeking consideration.
Why is ISO/IEC 17025:2017 Important to the Cannabis Industry?
The U.S. cannabis industry is growing at an unparalleled pace, with 2021 sales predicted to finish at $31 billion - a 41% increase over 2020's estimated revenue of $21 billion. As more states legalize marijuana for medicinal or recreational use, the need for accurate cannabis testing becomes more important and ISO/IEC 17025 will be an instrumental standard for this industry.
While testing requirements are different in each state, most states require laboratories testing legal cannabis to maintain ISO 17025 accreditation. By requiring compliance to the ISO 17025, regulatory officials can craft laboratory regulations around the requirements of the standard. Additionally, requiring adherence to ISO 17025 also allows state regulators to use the findings of regular internal/external ISO audits and proficiency testing for laboratory monitoring.
Maintaining ISO 17025 accreditation has benefits beyond the laboratory. Let’s use food testing as an example; these labs verify that food products are labeled accurately and free of contaminants, a step vital to public health. Accreditation ensures that food testing laboratories are competent and able to produce reliable results, thereby consumers can rest assured that the products they use were tested in accordance with international standards.
Similarly, accreditation allows the cannabis industry to have confidence not only in the labs that perform the testing but also in the results. When cannabis becomes federally legal, having ISO 17025 accreditation will allow labs to be prepared should federal agencies like the FDA enact regulation.
Where Do I Start?
Success in business requires a solid foundation and a proven reputation. For labs, selecting right staff, equipment, policies, and technical procedures is crucial. Implementing ISO 17025 provides labs with the technical and quality management system needed for continuous improvement of laboratory practices.
Implementing and maintaining ISO 17025 accreditation requires challenging work and a commitment by all lab employees. However, the benefits of ISO accreditation greatly outweigh any growing pains faced during implementation.
Want to learn more about ISO 17025, or to discuss audit preparation and accreditation strategies, contact us.