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Supplement Perspectives

ISO 17025 Accreditation: Commonly Misunderstood and Underappreciated

Joint health Supplements
<p>You need to know the whole story behind your certification, says contract lab guru Elan Sudberg. </p>

Much has been written on seals of approval in our industry, usually when a company announces getting one of them. There are many to choose from, and only a few that really mean anything. Certification claims bombard the consumer and since there are so many, they sometimes raise confusion instead of confidence.

Newest to the natural products industry, and sure to shake thing up, is UL. While a few consumers might think they know what GMP certified means or the NSF seal of approval stands for, everybody knows what UL stands for. They have been on every electrical device we use since nearly the beginning of electrical devices. If a seal of approval ends up being part of this education-based alliance with NPA, it could be monumentally helpful to the dietary supplement industry.

For now, we wait and hope that this potential (or some other) B-to-C certification resolves some of the confusion. In the meantime, here’s an important question we need to ask: what about B-to-B certification?

Behind all these B-to-C seals of approval should live an important B-to-B of seal of approval, a quiet giant named International Organization for Standardization (ISO) accreditation. 9001 is the certification most people seem to know about; it spans into many industries, and just about every large manufacturer of just about any product is ISO 9001 (or some variation thereof) certified. The accreditation most meaningful to our industry is ISO 17025, which is about how you manage a quality system and confirms compliance with the AOAC Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals.

I think when we don’t know much about certification we just accept it as being relevant and somehow good. Ask questions. Do not simply accept an ISO as such.

Ask, “What is the scope of the accreditation?”  For example, it is possible for a lab to be ISO 17025 and not say for what, leaving assumptions to be made. Without inquiring you may not find out that it’s for a narrow, possibly irrelevant, scope such as pH testing only. While the accreditation process ensures a solid quality system, and that’s really, really important, if you aren’t in need of pH testing, then this ISO accreditation is not helpful. So ask, specifically, what a company’s ISO 17025 testing covers.

Who certifies the certifiers? Any good accreditation body will be frequently under review by the International Laboratory Accreditation Cooperation (ILAC), Mutual Recognition Arrangement (MRA), and the International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MLA). If not, global acceptance of your ISO accreditation may be in question.

Buyer beware. Not all accrediting bodies are created the same. There are many to choose from. Here are some of the best: A2LA, Laboratory Accreditation Bureau, ACLASS, and Perry Johnson Laboratory Accreditation Inc. These firms offer the strictest of audits and requirements. Those that “make it through” are like a well-decorated marine, ready for business.

Remember, quality costs money and doing things right can take time. You want your certification to mean something, right?
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