Accreditations
The paperwork that makes your paperwork hold up.
When an FDA inspector, notified-body auditor, or AS9100 customer-quality reviewer examines your calibration records, what they're really checking is the accreditation your lab operates under. Here is ours, with the scope PDF one click away.

Accredited to ISO/IEC 17025:2017 by A2LA
- Accreditation body
- A2LA (American Association for Laboratory Accreditation)
- Certificate number
- 4296.01
- Standard
- ISO/IEC 17025:2017
- Scope
- Dimensional · Electrical · Mass · Mechanical · Pressure & Flow · Temperature & Humidity · Pipette
ISO/IEC 17025 is the international standard for the competence of calibration and testing laboratories. Accreditation means an independent body, in our case, A2LA, has verified that we operate a documented quality system, use traceable measurement standards, calculate measurement uncertainty correctly, and issue certificates that meet international expectations. For most regulated work (AS9100, ISO 13485, IATF 16949, FDA 21 CFR), ISO 17025 accreditation is the qualifying evidence your calibration supplier has to bring.
ANSI/NCSL Z540 Compliance
American Gage operates in compliance with both editions of the ANSI/NCSL Z540 series:
ANSI/NCSL Z540-1-1994
“Calibration Laboratories and Measuring and Test Equipment: General Requirements.”
ANSI/NCSL Z540.3-2006
“Requirements for the Calibration of Measuring and Test Equipment,” including the documented decision rule and test uncertainty ratio (TUR) that DoD primes, defense contractors, and most aerospace customers require on every certificate.
Every certificate we issue documents the TUR and the decision rule applied, supporting the false-accept risk analysis Z540.3-compliant customers run on incoming calibration evidence.
NIST Traceability
Every calibration we issue against a NIST-traceable reference connects, through an unbroken chain, to a U.S. national standard at the National Institute of Standards and Technology. The chain carries a stated uncertainty at each link, is documented on every certificate, and is what makes our calibration evidence acceptable to FDA, AS9100, ISO 13485, and Z540.3-driven audits worldwide.
What every certificate includes
- Instrument ID: manufacturer, model, serial, asset tag
- As-found readings before any adjustment
- As-left readings after calibration
- Measurement uncertainty (GUM; ISO 8655-7 for pipettes)
- Reference standards used + NIST traceability chain
- Environmental conditions during calibration
- Technician identity
- Calibration date + recommended due date
- Decision rule per Z540.3, with TUR documented
This format supports FDA inspection (21 CFR Parts 211 and 820), AS9100 customer-quality audits, ISO 13485 notified-body audits, Nadcap pyrometry reviews, and IATF 16949 supplier-qualification audits. Certificates are also accessible online through our customer portal.
Supplier-qualification packets
Qualifying us as a supplier should take you an afternoon, not a month. Our standard packet includes the current A2LA scope of accreditation, certificate of insurance (additional insureds added on request), an ISO 9001 customer letter on request, and quality-manual excerpts. Send the qualification template your procurement team uses. We fill it out and return it.
Need our scope for a supplier file?
Download the current A2LA scope PDF above, or request the full supplier-qualification packet. We return filled templates promptly.
