ISO 17025 Accreditation
What Is ISO/IEC 17025 Accreditation?
ISO/IEC 17025 accreditation is an internationally recognized verification that a laboratory has demonstrated the technical competence, quality systems, and measurement capabilities required to perform accurate and reliable calibrations and testing.
Transcat Pipettes is an accredited laboratory, certified by the ANSI National Accreditation Board (ANAB). Pipettes.com calibration competency is verified by our accreditation to all the industry standards, including:
ISO/IEC 17025:2017
ISO/IEC 17025 is the global standard for testing and calibration laboratory competence. It establishes requirements for technical competency, quality management, equipment control, measurement traceability, uncertainty analysis, and continuous improvement. Accreditation to ISO/IEC 17025 helps ensure that calibration results are accurate, reliable, and recognized worldwide.
ISO 8655:2022
ISO 8655 is the international standard that specifically defines the requirements and test methods used for calibrating piston-operated pipettes and related liquid handling instruments. The standard establishes procedures for verifying pipette performance, environmental controls, testing conditions, maximum permissible errors, and measurement uncertainty requirements. Compliance with ISO 8655 helps ensure accurate and repeatable liquid handling measurements.
ANSI/NCSL Z540.3
ANSI/NCSL Z540.3 is a measurement assurance standard that establishes requirements for calibration systems used throughout industry. The standard emphasizes measurement risk management, traceability, uncertainty analysis, and decision rules for determining compliance. Organizations operating in regulated industries often use ANSI/NCSL Z540.3 to strengthen confidence in measurement processes and calibration results.
USP Chapter <41> Balances
USP Chapter <41> establishes requirements for the use and performance verification of balances within pharmaceutical and laboratory environments. Because gravimetric analysis is the primary method used for pipette calibration, balance performance is a critical component of calibration accuracy. Compliance with USP requirements helps support reliable mass measurements used during calibration activities.
What does ISO/IEC 17025 measure?
- Individual competence of staff to perform.
- Use of proper equipment and its maintenance and calibration.
- Having in place sufficient quality assurance and quality control processes.
- Sampling in place to the appropriate degree.
- Procedures in place for their inspection/testing/calibration.
- Validated methods for obtaining data.
- The ability to report and record accurate data.
- Traceability to national standards whenever appropriate.
- Proper environmental conditions to perform testing/calibration/inspection


What evidence does an accredited laboratory have to prove its accreditation status?
Accredited laboratories have both a Certificate of Accreditation (stating ISO/IEC 17025 accreditation has been granted) and they have a “Scope of Accreditation”, this scope is determined by the laboratory, and assessment activities will be focused on those processes that affect this scope.
ISO/IEC 17025 vs. ISO 9001
ISO 9001 is applicable to many businesses and industries, while ISO 17025 is specifically valuable for testing and calibration.
Even though labs can be certified and audited (or registered) to internal management systems such as ISO 9001 (the standard typically used in manufacturing and service type organizations for managing the quality of their product or services) – ISO 9001 DOES NOT evaluate technical competence – this means that evaluation of ISO 9001 won’t ensure that the testing/calibration/inspection data provided is accurate, competent, or reliable. ISO/IEC 17025 Accreditations fill the “gap” of technical competence not addressed by ISO 9001.
Where ISO 9001 covers the facility, ISO/IEC 17025 specifically covers methods or functions detailed in each laboratory’s “Scope of Accreditation”.
