The Final Draft International Standard of ISO / IEC 17025 has been approved. Here are a few points for your attention.

Important changes relate to the structure of the standard, the so-called high level structure. Unfortunatelly the 17000 series of standards are not really classified in compliance with the overall classification. When writing this standard, more attention was paid to the other accreditation standards that have been written or adapted since the establishment of the high level structure. Just like ISO 9001, this standard requires that a laboratory must identify and manage risks. This concerns risks relating to independence (4.1), but also risks resulting from deviations/non-conformities during the technical execution of work (7.10). Risks must be identified that may affect the validity of results.

The standard is somewhat updated to present-day use of computers and software by adding a clause on laboratory information systems (LIMS). Other requirements on this subject in the new standard are not much different from the current version.

The requirement for traceability is condensed in one clause (6.5) but explained more elaborate in appendix A to the standard.

For calibration and testing laboratories, that have analysed their uncertainties the change in approach to verification and reporting conformity to specifications is major (7.8.6). The new standard defines a decision rule that must be agreed with the customer prior to the calibration (read clause 7.1.3) and that must be used to test specifications. For testing laboratories such a decision rule may follow a written standard that prescribes the method to be used as well as the way to evaluate conformity to specification.  If there is no such reference, the new standard allows several possibilities to verify specifications, but the method used must be agreed with the customer; must be recorded and the laboratory must have considered (and understand) the risk of a false conclusion.

For more information see this article in CALLAB magazine. RvA has published a cross-reference table in its introduction document RvA T049 of the ISO/IEC 17025:2017. The table also discusses the differences between the old and new ISO/IEC 17025. 

 Our course on metrology, traceability and uncertainty already deals with the new standard and its changes for calibration and test laboratories.

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