"Management system" refers to the organization's structure for managing its processes - or activities - that transform inputs of resources into a product or service which meet the organization's objectives, such as satisfying the customer's quality requirements, complying with regulations, or meeting environmental objectives.
ISO 9001 is a generic management standard that can be applied to any business enterprise, public administration, or government department.
Growth in the use of management systems generally has increased the need to ensure that laboratories can operate to a quality management system that is seen as compliant with ISO 9001 as well as demonstrate technical competency. Therefore, ISO 17025 was written to incorporate all the ISO 9001 requirements that are relevant to the scope of testing and calibration services as well as specifying the technical requirements for technical competence.
Testing and calibration laboratories that comply with ISO 17025 will also operate in accordance with ISO 9001.
ISO 17025 is an International Standard (published by the International Organization for Standardization) that specifies the general requirements for the competence to carry out tests and/or calibrations. There are 15 management requirements and 10 technical requirements. These requirements outline what a laboratory must do to become accredited.
ISO 17025 applies to all organizations performing tests and/or calibrations. It applies to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities covered by this International Standard.
ISO 17025 was first published in 1999 as a replacement to ISO Guide 25. ISO 17025 was revised and reissued in May 2005. ISO 17025:2005 is the most up to date version and all audits will be conducted against this version of the standard.
A laboratory must document a quality management system. A documented quality manual is a basic requirement on the road to laboratory accreditation. In addition, quality management procedures must be established for how the system is maintained. Once the system is documented it must be implemented in the laboratory. It will also accompany the laboratory’s application for accreditation. The implementation period will require several months to establish the records that an accreditation body will review at an accreditation audit. Finally, the laboratory undergoes the ISO17025 assessment by an accreditation body that is certified to perform laboratory accreditation.