ISO/IEC 17025 was first issued in 1999 by the International Organization for Standardization (ISO) and the International Electro technical Commission (IEC). It is the single most important standard for calibration and testing laboratories around the world. Laboratories that are accredited to this international standard have demonstrated that they are technically competent and able to produce precise and accurate test and/or calibration data.
Accredited compliance with ISO 17025 ensures that a vendor has developed a framework and processes for high quality, device-independent calibration. Specifically, it addresses the structures and processes necessary in the areas of quality, administrative, procedure and documentation of technical services for a wide range of devices requiring calibration, including not just pipettes, but also medical devices, communication equipment, electronic devices, weight scales, pressure meters, calipers, and many more.
There are two main sections in ISO/IEC 17025 - Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements address the competence of staff, methodology, test/calibration equipment and the test methods. Full validation of test methods and proof of proficiency set this standard apart from ISO 9001 or 9002.
Laboratories that can demonstrate compliance with ISO/IEC 17025 at assessment have demonstrated they operate using sound management practices and are technically competent to perform specific tests, calibrations and/or measurements as well as at the same time are able to generate technically valid results for which they hold accreditation. To maintain this recognition, laboratories are re-evaluated periodically by the accreditation body to ensure their continued compliance with requirements, and to check that their standard of operation is being maintained. The laboratory may also be required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence.