ISO/IEC 17025 takes into consideration the new ways of working of laboratories today. The most substantive changes are as follows:
- The scope has been revised to cover all laboratory activities, including testing, calibration and the sampling associated with subsequent calibration and testing.
- A new structure has been adopted to align the standard with the other existing ISO/IEC conformity assessment standards such as the ISO/IEC 17000 series on conformity assessment.
- The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and the ISO/IEC 17000 series (standards for conformity assessment activities), putting the emphasis on the results of a process instead of the detailed description of its tasks and steps.
- The standard has a stronger focus on information technologies. In recognition of the fact that hard-copy manuals, records and reports are slowly being phased out in favour of electronic versions, it incorporates the use of computer systems, electronic records and the production of electronic results and reports.
- A new section has been added introducing the concept of risk-based thinking and describes the commonalities with the new version of ISO 9001:2015, Quality management systems – Requirements.
- The terminology has been updated. Examples include changes to the International Vocabulary of Metrology (VIM) and alignment with ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment.
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