ISO/IEC 17025 Alignment with Customer Quality Requirements
How Field Calibrations, Inc.'s ISO/IEC 17025:2017 accreditation maps to the quality-management and regulatory standards our customers operate under — across manufacturing, medical, pharmaceutical, aerospace/defense, automotive, and life-sciences sectors.
Field Calibrations, Inc. is an ISO/IEC 17025:2017 accredited calibration laboratory providing high-precision instrument calibration services with measurements traceable to the National Institute of Standards and Technology (NIST).
Our quality management system aligns with the principles of ISO 9001 while fully complying with the specific requirements of ISO/IEC 17025.
What we hold and align to
Accredited testing & calibration laboratory (IAS CL-112) — primary
Effective Mar 10, 2026 · Expires Mar 1, 2027
Special-process supplier quality — supported via the AS9100 / aerospace pathway
Calibration system requirements — compliant
Measurement management systems — aligned
Pyrometry / thermal processing — aligned
QMS aligned with the principles of ISO 9001
Standards traceable to national references
Industry & regulatory alignment
| Industry / Sector | Applicable Standards | How FCI's ISO/IEC 17025 Accreditation Supports Compliance |
|---|---|---|
| General / Manufacturing | ISO 9001 | Requires documented control of monitoring and measuring equipment with measurements traceable to recognized standards. FCI's accredited calibrations provide the traceable evidence this control relies on. |
| Medical Devices | ISO 13485; FDA 21 CFR Part 820 | Mandates strict control of monitoring and measuring equipment, with calibration that is traceable, documented, and retained for quality records and audits. FCI certificates supply the documented, traceable basis for these records. |
| Pharmaceuticals | ISO/IEC 17025; cGMP (21 CFR 210/211); ICH | Equipment used in manufacturing, testing, QC, and release activities must be calibrated and traceable. FCI's accredited calibration records support FDA audit evidence and cGMP expectations. |
| Aerospace / Defense | AS9100; NADCAP | AS9100 extends ISO 9001 with stricter calibration and traceability expectations. NADCAP special-process environments commonly require accredited calibration and traceable evidence, typically on an ISO/IEC 17025 basis — which FCI provides. |
| Automotive | IATF 16949 | Extends ISO 9001 with strong emphasis on calibrated equipment, measurement-system control, and measurement systems analysis (MSA). FCI's accredited calibrations and uncertainty data support these measurement-system requirements. |
| Life Sciences (broad) | ISO/IEC 17025; FDA regulations | Supports pharmaceutical, biotech, medical-device, and laboratory QA expectations where traceable, documented calibration of measuring equipment is required. |
Our processes, equipment, personnel competency, and traceability to national standards (NIST) are subject to regular internal assessments and external accreditation audits, providing the necessary assurance of quality and competence.
Need this mapped into your supplier file?
Request our Supplier Quality Survey Compliance Package — it includes a one-page alignment summary you can drop into your audit records.