ISO/IEC 17025 is the main standard used by testing and calibration laboratories. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 adds in the concept of competence to the equation. And it applies directly to those organizations that produce testing and calibration results. Since its initial release, a second release was made in 2005 after it was agreed that it needed to have its quality system words more closely aligned with the 2000 version of ISO 9001.
The standard was first published in 2001 and on 12 May 2005 the alignment work of the ISO committee responsible for it was completed with the issuance of the revised standard. The most significant changes introduced greater emphasis on the responsibilities of senior management, and explicit requirements for continual improvement of the management system itself, and particularly, communication with the customer .
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 and test/calibration equipment.
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results . It is also the basis for accreditation from an Accreditation Body. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence.
A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.