The Gold Standard in Calibration — ISO/IEC 17025:2017 Accredited
Femto Scientific holds ISO/IEC 17025:2017 accreditation for the calibration of laboratory instruments. Every calibration certificate we issue is backed by independently audited technical competence, NIST-traceable measurement standards, and documented quality management.
Request ISO 17025 CertificateWhat Is ISO/IEC 17025:2017?
ISO/IEC 17025:2017 is the international standard that defines the requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It is published by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) and is recognized in over 100 countries.
Unlike ISO 9001, which governs quality management systems, ISO/IEC 17025 specifically addresses the technical competence required to produce valid measurement results. Accreditation to this standard is granted only after a laboratory demonstrates — through a rigorous third-party assessment — that it has the people, equipment, processes, and quality systems necessary to produce traceable, reliable calibration data.
Accreditation is maintained through periodic on-site assessments and ongoing proficiency testing, ensuring that the laboratory's competence is continuously verified — not just declared.
- Internationally recognized standard
- Independently third-party assessed
- Covers technical competence and impartiality
- NIST-traceable measurement results
- Maintained by ongoing audits
- Accepted by FDA, CAP, CLIA, and more
What Does NIST Traceability Mean?
NIST traceability means that every measurement made during a calibration can be linked — through an unbroken chain of comparisons — to the primary standards maintained by the National Institute of Standards and Technology (NIST), the official metrology authority of the United States.
At each step in the chain, a calibration is performed with known uncertainty. By maintaining this unbroken chain, the final result on your instrument can be mathematically related to the national standard. This is what gives a calibration certificate its legal and regulatory weight.
- Unbroken measurement chain to NIST
- Documented uncertainty at each step
- Certified reference materials used
- Defensible in FDA inspections and audits
- Accepted by accreditation bodies worldwide
- Required for GMP and GLP compliance
Femto Scientific's Accreditation Scope
Femto Scientific's ISO/IEC 17025:2017 accreditation covers the calibration of multiple instrument categories used in pharmaceutical, biotech, clinical, and research laboratories. Our accreditation scope includes:
- Pipettes and Liquid Handling Single-channel, multi-channel, repeat dispense, and electronic pipettes from all major manufacturers including Gilson, Eppendorf, Thermo Fisher, Rainin, and Hamilton.
- Balances and Scales Analytical balances, precision balances, top-loading balances, moisture analyzers, and platform scales including brands such as Mettler Toledo, Sartorius, Ohaus, and A&D.
- Temperature Measuring Instruments Thermometers, temperature probes, RTDs, and data loggers calibrated against NIST-traceable reference standards.
- Environmental Monitoring Sensors Temperature and humidity sensors used in storage monitoring, including the ARTEMIS remote monitoring platform.
What You Receive With an ISO 17025 Accredited Certificate
When you choose our ISO 17025 service level, your calibration certificate includes the following — all required to satisfy audit inquiries from FDA, CAP, CLIA, and accreditation bodies:
- ISO/IEC 17025:2017 accredited certificate header
- As-found and as-left measurement data
- Measurement uncertainty for each test point
- Reference standard identification and traceability
- Environmental conditions at time of calibration
- Instrument identification and serial number
- Technician signature and calibration date
- Calibration due date and barcoded ID tag
Who Requires ISO 17025 Calibration?
ISO/IEC 17025 accredited calibration is required or strongly recommended under the following regulatory frameworks and standards:
FDA 21 CFR Part 211 (GMP)
Pharmaceutical manufacturers must calibrate all instruments used in production and quality control at defined intervals using standards traceable to NIST. ISO 17025 certificates provide the documentation required during FDA inspections.
FDA 21 CFR Part 58 (GLP)
Nonclinical laboratory studies must maintain calibrated instruments with documented records. ISO 17025 accredited calibration supports GLP compliance for preclinical and toxicology laboratories.
CAP Laboratory Accreditation
The College of American Pathologists requires clinical laboratories to use calibrated, verified instrumentation. ISO 17025 certificates satisfy CAP's instrument verification documentation requirements.
CLIA (42 CFR Part 493)
Clinical Laboratory Improvement Amendments require calibration verification for all quantitative test systems. ISO 17025 documentation supports CLIA compliance for hospital and reference laboratories.
ICH Q10 / Pharmaceutical QMS
The ICH Q10 pharmaceutical quality system guideline requires measurement systems to be qualified and calibrated. ISO 17025 accreditation is the accepted standard for calibration suppliers in pharma supply chains.
ISO 15189 (Medical Laboratories)
Medical laboratories accredited to ISO 15189 must use equipment that is calibrated by competent providers. ISO 17025 accreditation of the calibration laboratory satisfies this supplier qualification requirement.
Request an ISO 17025 Accredited Calibration
Contact our team to discuss your calibration requirements, review our accreditation scope, or schedule service for your laboratory instruments.