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ISO 17025 facts

ISO 17025 was most recently revised in 2005, making the current revision ISO 17025:2005 is used by service providers and company laboratories. Companies who are registered to ISO 9001 will generally look to its testing and calibration service providers to be registered to ISO 17025. Companies may also opt to have their own internal laboratories obtain registration (or compliance) to ISO 17025 however this is typically only done by larger organizations with extensive internal testing and/or calibration activities. ISO 9001 does not require that a company’s internal laboratory or its external service providers be registered to ISO 17025.

 

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Testing and Calibration Laboratories

ISO 17025

ISO 17025 includes many of the requirements of ISO 9001 however it is structured differently and because it is focused on laboratories, it includes many requirements which ISO 9001 does not. ISO 17025 defines the requirements necessary for a laboratory to competently produce technically valid data and results. However, since laboratories can differ greatly from each other the requirements are still broad in nature and not specific to any equipment, specification, or testing model.

The requirements of ISO 17025 will likely be of little surprise to experienced laboratories. The challenges therefore arise not as much from understanding the requirements of the standard, but in implementing a management system that effectively and efficiently reinforces those requirements to ensure valid results.

Over-documenting, in light of these requirements and the presumed necessary documentation, specifications, and data, is a common pitfall for companies seeking registration to ISO 17025. To avoid this, an organization needs not only an understanding of the technical requirements of the standard, but also the requirements of an effective and efficient Management System. An effective Management System is one that establishes clear goals, closed loop information systems, and analysis mechanisms to ensure an organization continues to learn from actual results and therefore improve.

ExoLytic’s consulting services for ISO 17025 ensure that the documented laboratory system effectively manages the technical requirements by implementing a Management System that borrows, in principle, the requirements of Quality Management Systems such as that of ISO 9001 - without the unnecessary organizational overhead that a ISO 9001 may bring to an organization registering only to ISO 17025.