ISO 17025 Testing & Calibration Labs

What is ISO 17025? How Did it Start?

The ISO 17025 standard helps maintain the quality of laboratory services by governing laboratory operations and procedures, as well as the technical quality of data provided by the laboratories.

The origins of ISO 17025 can be traced back to EN 45001 and ISO/IEC Guide 25. The first revision of ISO 17025 was released in 1999, with the most current revision being released in 2005.
The sections of the ISO 17025 standard:

  • Scope
  • Normative References
  • Terms & Definitions
  • Management Requirements
  • Technical Requirements

What Type of Businesses are Accredited?:

The most common type of businesses adhering to ISO 17025 are:

  • Calibration laboratories
  • Analytical or testing laboratories
  • In-house laboratories

The ISO 17025 standard offers key advantages for both users and providers. Users of ISO 17025 laboratory services benefit from enhanced data reporting that makes it possible to compare measurements from different laboratories — even those from multiple countries. The enhancement and standardization of laboratory data provides companies an increased level of confidence in their test instrument accuracy.

What are the Auditing Requirements?:

Becoming and maintaining accreditation to the ISO 17025 standard requires two types of auditing:

  1. Internal Audits – Audits by internal or contracted staff that are specifically trained to the ISO 17025 standard and internal procedures/requirements.
  2. External Audits – Auditing by an external accreditation body.

Internal Auditing is key to understanding compliance of the company to the requirements of the ISO 17025 standard. It requires review and assessment to verify that the current quality system is effective – and if not, to correct and prevent any identified issues. ISO 17025 has very clear requirements regarding the internal audit process, as evidenced by the excerpt below from Section 4.14:

“The laboratory shall periodically, and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the management system and this International Standard.”

“The internal audit program shall address all elements of the management system, including the testing and/or calibration activities.”

“It is the responsibility of the quality manager to plan and organize audits as required by the schedule and requested by management. Such audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited. The cycle for internal auditing should normally be completed in one year.”