Qalitex Laboratories Achieves ISO 17025 Accreditation for Analytical Testing

A2LA-accredited Irvine lab explains why accredited vs. self-declared compliance determines COA acceptance by Amazon, retailers, and FDA.

IRVINE, CA, UNITED STATES, March 17, 2026 /EINPresswire.com/ — Qalitex Laboratories, an ISO 17025-accredited third-party testing laboratory with facilities in Irvine and San Diego, California, today shared expert insights on what ISO/IEC 17025:2017 accreditation requires and why the distinction between accredited and non-accredited testing matters for dietary supplement brands, cosmetic companies, and Amazon FBA sellers navigating FDA compliance and retailer qualification requirements.

ISO/IEC 17025:2017 is the international standard for testing and calibration laboratory competence, published by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Accreditation to this standard is granted only after an independent body — in the U.S., typically A2LA (American Association for Laboratory Accreditation) or ANAB (ANSI National Accreditation Board) — conducts a rigorous on-site technical assessment of personnel qualifications, equipment calibration records, test method validation, quality management systems, and proficiency testing participation. Accreditation is not a self-declaration; it is independently verified and publicly searchable.

For supplement and cosmetic brands, ISO 17025 accreditation has practical significance: Amazon compliance programs, major retailers such as Whole Foods Market and Target, and FDA import alert requirements all reference ISO 17025 accreditation as the benchmark for acceptable third-party testing documentation. Certificates of Analysis (COAs) from non-accredited labs may not meet these standards, regardless of internal quality claims.

“The question we get most often from new clients is whether their current lab is truly ISO 17025 accredited or simply claims compliance,” said Nour Abochama, Vice President of Operations at Qalitex Laboratories. “Compliance means the lab says it follows the standard. Accreditation means an independent body verified it does. Anyone can check our A2LA accreditation number in about 30 seconds, and we encourage every brand to do the same for any lab they work with — including ours.”

ISO 17025:2017 requirements are divided into management requirements — covering quality management systems, document control, and corrective actions — and technical requirements, which address personnel competence, equipment calibration, measurement traceability, test method validation, and proper handling of test items. Accreditation scope matters as much as status: a lab may be accredited for water testing but not for heavy metals, microbiology, or other critical methods. Brands should confirm that a laboratory’s accreditation explicitly covers the methods required for their products.

Qalitex’s A2LA accreditation covers analytical chemistry, including HPLC identity and potency testing, ICP-MS heavy metal analysis per USP , GC-MS and LC-MS/MS pesticide residue testing, microbiology per USP and , preservative efficacy per USP and ISO 11930, and ICH Q1A(R2)-compliant stability testing. The laboratory serves brands from raw material inspection through finished product release, with 48-hour turnaround on standard analytical panels.

Recent regulatory developments have made accreditation increasingly critical. FDA enforcement of 21 CFR Part 111 cGMP regulations requires identity verification of all incoming raw materials. For cosmetics, the Modernization of Cosmetics Regulation Act (MoCRA), effective 2024, mandates safety substantiation from qualified, accredited laboratories.

“The brands we see after an Amazon compliance hold or retailer audit often already have testing documentation — but from labs whose accreditation does not cover the specific methods used,” said Abochama. “It’s not that they weren’t trying to comply; the difference between an accredited and a non-accredited method isn’t always obvious from a COA. Part of our onboarding process is reviewing existing documentation and identifying gaps before they become regulatory issues.”

Brands can verify laboratory accreditation at a2la.org
and anab.org
, both of which allow searches by laboratory name, location, and accreditation scope. Qalitex’s A2LA accreditation details, including scope and certificate, are publicly available in the A2LA directory.

Resources:
Full article: https://qalitex.com/iso-17025-accredited-laboratory/

About Qalitex Laboratories
Qalitex Laboratories is an ISO 17025-accredited third-party analytical testing laboratory with facilities in Irvine and San Diego, California. The laboratory provides certificate of analysis (COA) testing, heavy metal analysis by ICP-MS, microbiology testing per USP and , preservative efficacy testing, stability studies under ICH guidelines, and regulatory compliance support for dietary supplement brands, cosmetic companies, and consumer goods manufacturers. Turnaround times start at 48 hours for standard panels. Testing programs meet 21 CFR Part 111, California Proposition 65, Amazon supplement compliance requirements, and Health Canada NHP Directorate standards.

Nour Abochama
Qalitex Laboratories
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