ISO/IEC 17025 was developed specifically to give guidance to laboratory managers on both quality management and the technical requirements for the proper operation of a laboratory. There is a widespread misunderstanding that ISO 9001:2000 standard assures validity of test results at a level equivalent to accreditation to ISO/IEC 17025. In fact, ISO/IEC 17025 can be thought of as the technical compliment to ISO 9001:2000. In fact, any organisation that met the requirements of ISO/IEC 17025 was compliant to ISO 9000:1994 (but the converse is not true).

The ISO 9001 requirements are generic and can be used by any type of organisation, the ISO 17025 requirements are specific to laboratory functions. This standard addresses issues such as: the technical competence of personnel, ethical behaviour of staff, use of well-defined test & calibration procedures, participation in proficiency testing (i.e.: interlaboratory comparisons and/or reference materials), and provide guidance on the contents of test reports & certificates generated.

ISO/IEC 17025 is to provide a third-party demonstration to customers that the laboratory has the technical and managerial capabilities to perform specific tests, measurements, or calibrations, to stated standards or to customised procedures within their bounds of stated accuracies, chosen test methods & equipment.

There is currently a debate as to whether ISO/IEC 17025 will be updated to conform to ISO 9001:2000. Those in favour of the update argument that ISO 9001:2000 is really applicable to all types of organisations including the laboratory. Those against argument that the laboratory accreditation system should be written around the laboratory and that laboratories should not be forced into something else just to meet the new standard.

What Are The Benefits to Implementing ISO/IEC 17025?

• Provides valid test data that customers (internal or external) can trust;
• Effective quality control, qualified processes and demonstrated staff competence provide a greater degree of data defensibility;
• Third-party recognition to customers;
• Clear definition of roles, responsibilities, and authority, which provides for greater efficiency in operation of the laboratory;
• Audit and assessment activity by laboratory customers can be reduced through third party recognition;
• Increased efficiency should lead to a reduction in operating costs;
• Increased efficiency should result in less repeat sample analysis;
• Increased efficiency should decrease customer complaints, contribute to decreased sample turnaround times and free up capacity to increase throughput.