When a healthcare institution has a medical device calibrated, how can it know the results are truly reliable? The answer lies in the TS EN ISO/IEC 17025 standard.
What is ISO/IEC 17025?
ISO/IEC 17025 is an international standard that defines the general requirements for the competence of testing and calibration laboratories. It demonstrates not only that a laboratory measures accurately, but that it can do so in a technically competent, impartial and consistent manner. The standard rests on two pillars:
- Management requirements: Quality management system, record management, document control and continual improvement.
- Technical requirements: Personnel competence, equipment traceability, validity of measurement methods, and calculation of measurement uncertainty.
Traceability and measurement uncertainty
Two concepts sit at the heart of the standard:
Measurement traceability means the reference devices used can be linked to national/international standards through an unbroken chain. In other words, the device in the laboratory is calibrated against a higher-level reference, which in turn is calibrated against another. This chain proves what the measurement is "accurate against."
Measurement uncertainty is the numerically expressed confidence interval inherent in every measurement. Every certificate issued under ISO/IEC 17025 reports this uncertainty, making it transparent how confidently the result can be used.
Why is it important in biomedical metrology?
Every quantity a medical device measures — pressure, flow, energy, temperature, weight, volume — directly affects the patient. A certificate from an accredited laboratory guarantees that:
- The measurement is traceable to international standards,
- The results are audited by an independent accreditation body (TÜRKAK in Türkiye),
- The uncertainty and decision rule are clearly reported.
Accreditation vs. certification
Certificates such as ISO 9001 attest to an organization's quality system; ISO/IEC 17025 accreditation, on the other hand, proves technical competence in specific tests and calibrations. The two complement each other but are not interchangeable.
The DTS approach
Dijital Teknoloji Servisi carries out its calibration and testing activities under TS EN ISO/IEC 17025, and its inspection activities under TS EN ISO/IEC 17020 (TÜRKAK AB-0769) accreditation. Our certified engineers and specialists preserve the traceability of reference devices to produce reliable, transparent results in the field.