ISO 17025

Customer pressure for Testing and Calibration Laboratories 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.

ISO 17025 was last revised in 2005 and 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 be all too familar to experienced laboratories. The challenges 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.

MOCG’s consulting approach to ISO 17025 ensures 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.

Purchase the ISO 17025 Standard (ANSI/ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories)