Factory Calibration vs. traceable calibration according to ISO 17025

Factory Calibration: It is the calibration carried out by the manufacturer during the manufacturing process of the instrument, whosepurpose is to ensure that the instrument meets the specifications and tolerances established by the manufacturer.

Documentation:

  • A calibration certificate is provided detailing the results and the conditions under which the calibration was performed. The certificate is limited to the deviation of the instrument to be calibrated with respect to the standard.

Benefits:

  • It is cheaper and faster.
  • Suitable for non-critical uses where traceability is not a requirement.

Limitations:

  • Does not always meet international standards.
  • May not be sufficient for specific audits or regulations.

Traceable Calibration according to ISO 17025: It is the calibration performed by an accredited laboratory that meets the requirements of the ISO/IEC 17025 standard. Its purpose is to ensure that the instrument complies with the specifications and tolerances established by the manufacturer.

Documentation:

  • A traceable calibration certificate is issued that includes the uncertainty of the measurement, methods used, and traceability to recognized standards.

Benefits:

  • Internationally recognized for its rigor and accuracy.
  • It is essential to meet quality standards and strict regulations.
  • Required for most audits and certifications.

Limitations:

  • May be more expensive and time-consuming.
  • May require more frequent periodic calibration.

To determine the type of calibration needed, the need must first be assessed based on three key aspects: The use of the instrument, the regulatory requirements and audits. If the instrument is used in critical processes where precision is essential, such as in the production of high-precision components or research laboratories, and is subject to strict regulations requiring traceability, then calibration according to ISO 17025 is the best option. This is especially important if your company must present evidence of calibration during external audits, as it ensures that measurements are accurate and verifiable.

On the other hand, if the instrument is used in non-critical applications, such as routine maintenance tasks or in educational environments, and is not subject to strict regulations or demanding audits, factory calibration may be sufficient. This option is more cost-effective and offers the precision necessary for less critical uses, avoiding unnecessary expenses without compromising the basic functionality of the instrument.

In summary, if your instruments are critical for accuracy, regulated by strict regulations, or subject to audits, you need traceable calibration to ISO 17025. If these conditions do not apply and the use of the instrument is not critical, factory calibration will be enough.