The ISO 17025 accreditation by the American Association for Laboratory Accreditation (A2LA) demonstrates that Alkemist Labs meets managerial and technical quality benchmarks as required by the International Organization for Standardization ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories for the tests performed within Alkemist’s scope, explained the company.
Elan Sudberg, CEO of Alkemist Labs, told NutraIngredients-USA that only a handful of the lab’s clients required they achieve ISO 17025 accreditation, and were hesitant to work with Alkemist Labs until they achieved it.
“The remaining and largest group of clients simply requested it but just performed rigorous in-house audits in the meantime.”
Accreditation was achieved after a thorough assessment and review of the lab’s quality management system and competence to perform Dietary Supplement Identification and Qualitative Analysis HPTLC testing and Botanical Identification and Qualitative Analysis by Microscopy.
Sudberg told us that the dietary supplement industry is not well versed on what all the accreditations mean. For example, can labs be GMP certified? What does ISO 17025 mean?
“Many think having an FDA registration number means being audited by the FDA when in fact it is only an identification number and not an indication that they pass any FDA standards,” he said. “This is why it's important to educate the industry, which we're doing in a variety of ways, to know what our broad scope ISO 17025 accreditations means in comparison to the many test method specific ISO accreditations out there.”
Flexible Scope
The ISO 17025 accreditation is said to meet the A2LA P112 Flexible Scope Policy, which states: “There are circumstances in which a laboratory performs testing activities for which it cannot identify either standard test methods prepared by national, international, or professional standards writing bodies or in-house developed non-standard methods on their fixed scope of accreditation.
“These situations usually arise when the laboratory requires flexibility in allowing for changes in the matrices within a product area (flexibility concerning object/matrix/sample) or with respect to parameters (flexibility concerning parameters/components/analytes)” which allows the lab discretion to adapt method parameters to a wide variety of preparations and products to best meet customer needs.
“Often times ISO 17025 is marketed as an overall blanket symbol of quality for all methods, however it’s important to understand the scope of the accreditation and not assume it is for something relevant to the tests you might be needing,” said Sudberg. “It’s important to ask what an accreditation is for and not make assumptions.”
Holly Johnson PhD, Alkemist’s Laboratory Director, added that Alkemist’s Quality Management system is, “first-rate and I had no doubt A2LA would find us compliant with the ISO 17025 standard, but I am delighted they granted us a flexible scope, which indicates confidence in our expertise to apply appropriate valid methods in a complex and fluctuating product market.”
The lab also announced it met the more specific requirements of AOAC Analytical Laboratory Accreditation Criteria Committee (ALACC) Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals. Accreditation to this guidance demonstrates that Alkemist Labs has technical expertise and quality systems specific to the dietary supplement, food and pharmaceutical industries which go above and beyond those of ISO/IEC 17025.