The revision of ISO/IEC 17025 takes into account the activities and new ways of working of laboratories today. The main changes are:
The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies). The revised standard puts the emphasis on the results of a process instead of the detailed description of its tasks and steps.
With a stronger focus on information technologies, the standard now recognizes and incorporates the use of computer systems, electronic records and the production of electronic results and reports.
The new version of the standard includes a chapter on risk-based thinking and describes the commonalities with the new version of ISO 9001:2015.
The terminology has been updated to be more in step with today’s world and the fact that hard-copy manuals, records and reports are slowly being phased out in favour of electronic versions.
A new structure has been adopted to align the standard with the other existing ISO/IEC conformity assessment standards.
The scope has been revised to cover all laboratory activities including testing, calibration and the sampling associated with subsequent calibration and testing.
Using ISO/IEC 17025 facilitates cooperation between laboratories and other bodies. It assists in the exchange of information and experience and helps harmonize standards and procedures.Results also gain wider acceptance between countries when laboratories conform to the standard.
Currently European Lab Services is very busy making preparations for the transition of our quality system to the new version of ISO/IEC 17025.
For more information concerning IS0 17025, please contact our Quality Expert Anamary Van den Brande.
Please visit www.eurolabservices.eu for a full scope of our capabilities.