A certificate of analysis lands in your inbox. The numbers look right. The format looks official. You file it, check the box, and move on.

Many food, supplement, and consumer goods brands do exactly this. Few ask the question that matters: who ran this test, and how do we know they did it right?

ISO/IEC 17025 accreditation is one answer to that question. Many brands never ask it, which makes it one of the most common blind spots in food safety.

What ISO 17025 accreditation is

ISO/IEC 17025 is the international standard for testing and calibration laboratories. It sets requirements for a lab’s competence, impartiality, and consistent operation. When a lab is accredited, an independent accreditation body has assessed it against that standard. The assessment looks at areas such as:

• Test methods that are validated and fit for purpose
• Equipment that is calibrated and maintained
• Staff who are qualified and authorized for the work they do
• A quality management system that supports consistent results
• Controls for data and information management and for reporting results

A lab cannot simply claim accreditation. It is a decision by a third party, such as A2LA, ANAB, or IAS in the United States, and it is reassessed over time. Accreditation is generally conferred for two years. A lab that says it “follows” or “complies with” ISO 17025 has not necessarily been accredited. Ask to see the certificate.

Scope: accreditation covers specific methods

Accreditation applies to the methods on a lab’s scope of accreditation. A lab can be accredited for one test and not another. A result carries the weight of accreditation only if the method used sits inside that scope.

That makes the scope document the most useful page to ask for.

When FDA requires an accredited lab

FDA’s Laboratory Accreditation for Analyses of Foods (LAAF) program shows how the agency treats accredited labs. In defined cases of heightened food safety concern, testing must be done by a LAAF-accredited lab, and the lab sends the results directly to FDA. Those cases include testing to support release of imported food that FDA has detained, follow-up testing for sprouts, shell eggs, and bottled water, testing ordered by FDA in a directed food laboratory order, and testing offered as evidence in a mandatory recall hearing.

ISO/IEC 17025 accreditation is the foundation of LAAF accreditation. LAAF labs must also pass a proficiency test within the last 12 months for each method, and they must run reference materials or quality control samples with each batch.

Most food testing falls outside those cases. Routine product and environmental testing under a food safety plan does not have to be done by a LAAF-accredited lab, and FDA applies the program one category at a time, with six months’ notice. For most routine testing, accreditation is a quality choice. It is a choice that shows up in retailer reviews and in how defensible your record is.

The problem with non-accredited testing

Not every lab that tests food is accredited. Some are in-house supplier labs. Some are competent third-party labs that have never been assessed. Some have never gone through the process.

The results from these labs may be accurate. Without accreditation, no independent body has verified that. The gap matters most in three situations:

• A retailer qualification. Some retail buyers ask for results from an accredited laboratory, depending on their program and product. A documentation request is easier to answer when the lab’s accreditation and scope are already on file.
• A regulatory review. Where the LAAF rule applies, FDA requires an accredited lab. In other reviews, FDA expects valid methods and reliable results, and accreditation is one way to show both.
• A recall or legal proceeding. If your product is tied to an illness or a regulatory action, the strength of your testing record can depend on how the results were generated. Recall costs build quickly, and so does the pressure to show how you tested.

Where brands get caught

A common scenario is a brand that has relied on results from a lab it never examined. It might be a contract manufacturer’s in-house lab or a low-cost regional lab. Results come back clean. Nobody asks questions.

Then a retail buyer asks for accredited documentation, or an auditor asks for the lab’s scope of accreditation. At that point the brand has to re-test products and rebuild documentation, sometimes while an account is waiting.

For the supplier version of this story, see Your Supplier Says It’s Safe. But Who’s Checking?.

Closing the gap before one of those moments is usually easier than closing it after.

Five questions to ask your testing lab

If you are not sure whether your testing program rests on accredited results, start here. Ask your lab:

1. Are you ISO/IEC 17025 accredited? By which accreditation body, and can you share your scope of accreditation?

2. Is the method for my product inside your scope? Accreditation covers specific methods. FDA’s draft guidance recommends a method shown to give reliable results in the food being tested. Confirm that the tests run on your products are within the accredited scope.

3. Can you provide chain of custody from sample intake to result delivery? This record is essential for defensibility.

4. What proficiency testing or comparison programs do you take part in? LAAF labs must pass a proficiency test for each method within the last 12 months. It is a fair question for any lab.

5. How are results generated and reported? Ask whether the data system is validated and whether manual steps remain. Manual transcription adds a chance for error.

If your lab cannot answer these clearly, that is useful information.

What accreditation looks like in practice

At Genista, ISO/IEC 17025 accreditation is the foundation of how we operate. We are accredited by the International Accreditation Service (IAS), and our accredited scope covers more than 100 methods across microbiology (including real-time PCR pathogen detection), GMO testing, allergens, and chemistry (organic, pesticide, and inorganic, including metals and water activity). You can check it on IAS’s public listing. IAS is a signatory to the ILAC Mutual Recognition Arrangement, and our certificate carries the ILAC-MRA mark.

Tests run within that scope are documented in a validated system and delivered with a chain of custody record from sample receipt to result.

We combine that scope with high-throughput robotics, real-time PCR, and connected software to deliver next-day results on most tests. We built the system so speed and accuracy work together, and the accredited scope sets the limits of what we report.

The bottom line

Test results do not all come with the same evidence behind them. The number on a COA is only as strong as the process behind it: independently assessed, validated for your product, and documented.

If you are not sure whether your current testing program meets that standard, find out before an audit, a retailer request, or a recall makes the question urgent.