New edition of ISO/IEC 17025

New edition of the international standard ISO/IEC 17025 is expected to be published by the end of November 2017, that will replace version from 2005 which was jointly prepared by the International Organization for Standardization - ISO and the International Electrotechnical Commission - IEC. It is a standard that specifies the general requirements for competence to conduct testing and/or calibration, including sampling.

 

 

Since the standard was published, market conditions have changed significantly, so it was necessary to revise this standard. The audit process was initiated in February 2015 as a result of a joint proposal by the International Laboratory Accreditation Cooperation - ILAC and the South African Bureau of Standards - SABS.

 

 

 

The new edition of the standard takes into account the activities and new ways of working of laboratories today. The main changes, according to the International Organization for Standardization - ISO, are as follow:

  • 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. Modern-day laboratories work increasingly with information and communication technologies, and the working group felt it was necessary to develop a chapter on this topic.

 

  • 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, Quality Management Systems - Requirements.
  • 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. Examples include changes to the International Vocabulary of Metrology (VIM) and alignment with the ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment.

 

  • A new structure has been adopted to align the standard with other existing ISO/IEC ​​conformity assessment standards, such as the ISO/IEC 17000 series on conformity assessment.
  • The scope has been revised to cover all laboratory activities, including testing, calibration and the sampling associated with subsequent calibration and testing.

 

 

Technical Committee BAS TC 3, Quality Management and Quality Assurance, will work on the translation of the new edition of the ISO/IEC 17025 and is scheduled for publication is expected at the next year.

 

 

The transition period required for the implementation of this standard will last for three years.

 

Taken over and revised from www.iso.org.