What does accreditation to an ISO standard actually mean?
By Holly E. Johnson, Ph.D.
Big news this month is that Alkemist has been accredited to the ISO 17025 standard. We all hear the term ISO thrown around and know accreditation is prestigious and denotes a special level of competence, but what does it really mean? And how do you know if it applies to what you are expecting an accredited laboratory to do for you?
ISO is the International Organization for Standardization, an independent non-governmental organization formed in 1946 when 25 countries sent representatives to the Institute of Civil Engineers in London to establish a new coalition ‘to facilitate the international coordination and unification of industrial standards’. ISO now has members from 162 countries and has issued over 20,000 International Standards pertinent to a wide variety of industries including technology, manufacturing, agriculture, healthcare and food safety (www.iso.org). The standards are intended to facilitate international trade and ensure the quality, safety, and efficiency of products and services.
Such standards provide guidelines or requirements that, when adhered to, ensure products and services are fit for purpose as identified and agreed to by a pool of experts competent to make those determinations. Some popular standards include ISO 3166 for Country codes, ISO 14000 for Environmental management, and of course ISO 17025 which is titled: General requirements for the competence of testing and calibration laboratories.
Within the 17025 standard, organizations must identify a specific scope including the exact methods, techniques, technology, and equipment. Generally this scope is fixed and quite restricted, not allowing for even the slightest method deviation, and may only apply to a small part of the procedures followed in a particular laboratory. For instance, a lab could be accredited to the ISO 17025 standard for evaluation of silymarin content in milk thistle by HPLC using the USP method, but not for evaluation of those same compounds in the same material using another method or technology. Or alternately, a lab may be accredited to determine botanical identity of a specific plant by microscopy, but not by HPTLC. So, when you see or hear of a testing lab claiming ISO accreditation, it’s important to check the scope of the accreditation to determine what it actually covers.
Alkemist was granted a rare flexible scope under A2LA’s P112 Flexible Scope Policy, which allows the lab discretion to adapt method parameters to a wide variety of preparations and products to best meet an array of changing customer needs, as long as they are scientifically valid per cGMP. This indicates enormous confidence in our quality management system and expertise to appropriately apply valid method parameters and optimize analyses for a wide variety of materials. This is especially relevant with botanical identity testing in today’s complex and fluctuating product market, where the nature of botanical crude raw material and extracts is so variable in content that there is simply no one method that applies to all the many variations of botanical materials both in nature and the marketplace.
In order to achieve this accreditation, years of preparation were necessary. It required many months in implementing systems of analysis as well as building an impeccable quality system. With this perspective in mind, we are very proud of this accreditation, because it is further validation that we have the knowledge, equipment, and experience to competently provide the most accurate lab tests for our clients, even with very complicated analyses.
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