State accreditation guides

Every state’s lab accreditation guide, A to Z.

Fifty states, the District of Columbia and Puerto Rico. Find your state, see who accredits or certifies environmental labs there and under which standard, and open the guide. Each guide covers the agency, the rules, reciprocity for out-of-state labs and what auditors check in your initial calibrations.

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NELAP accreditation bodyState program (non-NELAP)Drinking water lab certificationEPA region certifies

Beyond the state programs

Accreditation does not stop at the state line.

Most regulated labs answer to more than one program. These are the federal, national and industry bodies that set calibration expectations alongside the state programs above, and the WLTR page that covers each one.

Environmental

TNI and NELAP

The NELAC Institute publishes the TNI Standard, the quality system most environmental programs assess against. NELAP accreditation bodies are the state agencies TNI recognizes to accredit labs to it; the directory above marks each one.

Initial calibration, calibration verification and the acceptance limits sit in Volume 1 of the standard, by method.

Defense and energy

DoD and DOE ELAP

Labs supporting Department of Defense and Department of Energy environmental work are accredited to the DoD and DOE Quality Systems Manual (QSM) by the accreditation bodies DoD ELAP recognizes: A2LA, ANAB and PJLA. QSM version 6.0 is the current edition.

QSM carries its own calibration acceptance criteria on top of the TNI Standard, method by method.

Federal

EPA

EPA sets the method and quality control rules behind the state programs: the drinking water laboratory certification manual that state certification programs adopt, direct certification where EPA keeps primacy (the District of Columbia and Wyoming), and the wastewater methods in 40 CFR Part 136.

40 CFR 136.7 lists the quality control elements, calibration included, that apply wherever a method lacks its own.

Pharma and bioanalytical

FDA

FDA does not accredit labs; it regulates them. Bioanalytical, pharmaceutical QC and food labs work under 21 CFR Part 58 (GLP), Part 211 (cGMP), Part 11 (electronic records and signatures), ICH M10 and ICH Q2(R2). FDA auditors read the calibration record, not the summary.

Every excluded standard, every refit and every model change needs an attributable reason in the record.

Accreditation bodies

ISO/IEC 17025

A2LA, ANAB, PJLA and IAS accredit testing labs to ISO/IEC 17025, the baseline for cannabis, food, forensic and many state programs. Several state environmental programs accept it with TNI supplements.

Clause 7 requires validated methods and traceable calibration; the acceptance limits come from the method or the regulator.

Forensic

Forensic toxicology

Forensic labs are accredited to ISO/IEC 17025 by ANAB or A2LA with forensic supplemental requirements. ANSI/ASB Standard 036 sets the calibration requirements for quantitative toxicology.

Standard 036 expects a documented calibration model choice and acceptance at every level, with the result defensible in court.

Food and supplements

FDA LAAF and 21 CFR Part 111

FDA’s Laboratory Accreditation for Analyses of Foods program requires LAAF-accredited labs for certain food testing, on the basis of ISO/IEC 17025 accreditation by an FDA-recognized body. Dietary supplement labs work under 21 CFR Part 111.

Pesticide, mycotoxin and contaminant calibrations are judged at the maximum residue limit, so the low end of the curve decides the result.

Before your next audit

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Bring a recent initial calibration. We will walk you through every analyte and candidate model in the Calibration Intelligence dashboard, the best fit, and the record your QA manager would sign.

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