The process of achieving ISO accreditation includes passing a comprehensive assessment and review of the lab’s quality management system and competence to perform specific tests. It’s a task-based approach, and not a review of overall operations, as a GMP audit might be.
NOW announced today that it has received ISO/IEC 17025:2017 accreditation from the American Association for Laboratory Accreditation (A2LA) for its analytical and microbial laboratories for several ‘scopes,’ of operation, including arsenic speciation in raw materials and finished products by HPLC-ICP-MS; determination of acid value by titration; determination of peroxide value by FoodLabFat; metal and mineral testing by ICP-MS (arsenic, cadmium, iodine, lead and mercury); and multi-pesticide residue analysis by GC-MS/MS for 195 pesticides.
What do the ISO ‘scopes’ imply?
Aaron Secrist, Executive Vice President of Quality, R&D and Operations, NOW Health Group, said his company chose those scopes because they represent some of the most complicated tests the company routinely performs. Other scopes are planned to be added in the future, but starting at the top, so to speak, could serve as an indicator of an overall high level of overall competence, he said.
Sadly, some other labs seem to go about it the other wary around, certifying a more simple test or two and then holding that up as a statement of operational quality.
“I can’t speak to the intentions of every lab out there but there are enough labs advertising themselves as ISO 17025 labs with a very simple and narrow scope of accreditation that I have to think it is calculated. Many companies that are looking for contract labs will ask the question, ‘Are you ISO/IEC 17025 certified?’ without asking the right follow up question which should be, ‘What is the scope of your accreditation?’ I think that contract labs have been getting asked the first question for a long time without being asked the second so a lack of robust contract lab qualification process has likely contributed to this issue,” Secrist told NutraIngredients-USA.
“ NOW has spent a lot of time and resources over the last decade building up our in-house lab capabilities and expertise to ensure that the data coming out of our labs has integrity, which is crucial because we make regulatory and business decisions everyday based on this data,” Secrist said.
“We have built our in-house labs into a very strong competitive advantage, not only because of the increased ability for us to test the incoming ingredients and finished products much faster than a contract lab ever could, but we are also able to validate our test methods against each of our thousand or so specific finished product matrices, something contract labs could never do for each company they service in an economical way,” he added.
Some brand holders seem content to not ask too many questions
Secrist said if other labs are misrepresenting what their ISO certifications might imply, it’s up to brand holders to see through that. And it’s not hard to do, assuming a brand holder has invested in the right personnel with the right expertise and training.
“I have never asked ISO about this but I think they would tell you that the scope of ISO 17025 accreditation is always clear so it is easy to look it up and find out for those that are willing to put in the effort,” Secrist said.
“Unfortunately, many companies in the industry do not have a robust qualification process which would solve this issue very quickly. A lot of companies just want to get the answer they are looking for quickly and cheaply and don’t want to “look under the hood” so to speak. This is one of the great advantages of in-house labs and is very similar to the advantages of in-house manufacturing as opposed to using contract manufacturers. We control the quality,” he added.
Founded in 1968, NOW has grown into a diverse supplement manufacturer with more than 1,400 products. The company’s labs are located at its headquarters and in house manufacturing facility in Bloomingdale, IL.