Femto Scientific provides ISO/IEC 17025 accredited autoclave calibration and steam sterilizer validation that keeps clinical and hospital laboratories CAP- and CLIA-ready — NIST-traceable certificates with as-found and as-left data and documented uncertainty for the sterilizers in your microbiology, media preparation, pathology, and central sterile processing areas.
- NIST-traceable temperature, pressure & timer calibration
- Survey- and inspection-ready documentation
- As-found & as-left data on every certificate
- Documented measurement uncertainty (k=2)
- Calibrated to satisfy CAP checklists & CLIA
- Onsite service for benchtop & floor-standing units
- Preventative maintenance & safety-system inspection
- Automatic recertification scheduling
Sterilizer calibration records your CAP inspector can check off without a second question.
Autoclave Calibration Requirements for CAP and CLIA Laboratories
Clinical laboratories accredited by the College of American Pathologists (CAP) or operating under CLIA must calibrate sterilization equipment with NIST-traceable standards and keep the records available for survey. ISO/IEC 17025 accredited calibration is the cleanest way to demonstrate that competency for every autoclave used in specimen processing, media preparation, and central sterile reprocessing.
CAP Survey Readiness
CAP checklists require documented, NIST-traceable calibration of sterilization equipment with evidence of corrective action for out-of-tolerance findings. Our certificates document NIST-traceable calibration, the calibration date, as-found/as-left results, and reported uncertainty — exactly what surveyors expect for autoclave equipment qualification.
CLIA Quality Control
CLIA requires documented quality-control and maintenance programs for equipment used in patient-care testing, including autoclaves used in specimen processing, with calibration records maintained and available for inspection. Our accredited certificates meet those requirements and integrate directly with your LIMS.
Hospital & Central Sterile Processing
An out-of-tolerance sensor or a failed air-removal system can compromise instrument sterility and specimen integrity. Accredited calibration with documented uncertainty — plus Bowie-Dick and vacuum leak testing for pre-vacuum sterilizers — gives you the evidence to demonstrate sterilization validity and scope any impact if equipment is found out of tolerance.
A Full Calibration, Not Just a Cycle Printout Check
A cycle printout confirms the autoclave ran; it does not confirm the sensors are accurate. Accredited calibration verifies the chamber, drain, and jacket temperature sensors, the pressure gauge, and the timer against NIST-traceable references and documents it for CAP and CLIA compliance.
- NIST-traceable temperature, pressure & timer calibration
- Benchtop, tabletop & floor-standing sterilizers
- As-found & as-left data with adjustment
- Documented expanded uncertainty (k=2)
- Barcode calibration stickers for asset tracking
- Electronic certificates for paperless QMS
Most CAP and CLIA laboratories calibrate sterilization equipment at least annually. Compare service levels and turnaround on the autoclave calibration & validation service page, or see our guide for pharmaceutical & GMP autoclave validation.
CAP & CLIA Autoclave Validation FAQs
CAP (College of American Pathologists) requires documented, NIST-traceable calibration of sterilization equipment on a defined schedule as part of its laboratory accreditation requirements. CAP inspection checklists include verification that autoclave calibration records are current, include traceability documentation, and that corrective action was taken for out-of-tolerance findings. CLIA (Clinical Laboratory Improvement Amendments) requires laboratories to have documented quality control programs for all equipment used in patient care testing, including autoclave equipment used in specimen processing. CLIA regulations require calibration records to be maintained and available for review during inspections. Femto Scientific’s ISO 17025 accredited certificates satisfy both CAP and CLIA documentation requirements.
Yes. Femto Scientific calibrates autoclaves and steam sterilizers used in hospital laboratories, clinical microbiology labs, pathology departments, central sterile departments, and specimen processing areas. Hospital and clinical laboratory autoclave calibration services include NIST-traceable temperature sensor and pressure gauge calibration, timer verification, preventative maintenance inspection, and calibration certificates formatted to satisfy CAP inspection checklists and CLIA quality system requirements. Our ISO/IEC 17025 accredited certificates are accepted by CAP surveyors and CLIA compliance officers as evidence of sterilization equipment performance and documentation compliance.
Yes. All Femto Scientific autoclave calibration certificates are based on NIST-traceable reference standards. Our reference thermometers, RTD probes, and pressure standards are calibrated against NIST-traceable primary standards and recertified on a documented schedule. Traceability documentation for all reference standards used in your autoclave calibration is included in the calibration certificate, providing the unbroken chain of comparison to NIST national measurement standards required by FDA, CAP, CLIA, and ISO programs.
Yes. Femto Scientific’s validation reports are formatted for regulatory review and are designed to be inspection-ready for FDA investigators, CAP surveyors, ISO 13485 auditors, and facility quality auditors. Reports include a cover page with equipment identification, protocol approval signatures, all raw data, calibration certificates for all reference instruments used, calculations, summary tables, conclusion statements, and deviation documentation. Electronic delivery in PDF format allows immediate integration into your electronic QMS. We can also prepare reports to your organization’s specific document format and numbering requirements upon request.
Yes. Femto Scientific calibrates and validates benchtop and tabletop autoclaves from all major manufacturers including Tuttnauer, Fisherbrand, Benchmark Scientific BioClave, Heidolph, Systec, Thermo Scientific/Napco, and others. Benchtop autoclave validation follows the same IQ/OQ/PQ framework as larger floor-standing models, with thermal distribution studies scaled to the smaller chamber volume. Benchtop autoclaves used in GMP, GLP, clinical laboratory, or medical device manufacturing environments require the same level of qualification documentation as production autoclaves. Contact us to discuss validation scope and documentation requirements for your specific benchtop autoclave model.
Keep Every Clinical Autoclave Survey-Ready
Send us your sterilizer count and types — we’ll return a quote with turnaround options and a recommended calibration interval that keeps your laboratory inside CAP and CLIA requirements year-round.