Calibration standard moves to final stage of revision


By LabOnline Staff
Thursday, 14 September, 2017


The International Organization for Standardization (ISO) is revising ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, 12 years after the publication of the previous version.

Over the years, ISO/IEC 17025 has become the international reference for testing and calibration laboratories wanting to demonstrate their capacity to deliver trusted results. The International Standard, published jointly by ISO and IEC (International Electrotechnical Commission), contains a set of requirements enabling laboratories to improve their ability to produce consistently valid results.

“ISO/IEC 17025 impacts the results delivered by laboratories in a number of ways,” said Warren Merkel, one of the convenors of the working group revising the standard. “The standard requires them to meet criteria for competence of their personnel, the calibration and maintenance of their equipment and the overall processes they use to generate the data. This requires laboratories to think and operate in a way that ensures their processes are under control and their data are reliable.”

However, the laboratory environment has changed dramatically since the standard was last published in 2005, leading to the decision to revise the standard and integrate significant changes. The review of the standard began in February 2015 as the result of a joint proposal by the International Laboratory Accreditation Cooperation (ILAC) and the South African Bureau of Standards (SABS).

“The revision was needed to cover all the technical changes, technical developments and developments in IT techniques that the industry has seen since the last version,” said Heribert Schorn, another convenor of the working group. “Additionally, the standard takes into consideration the new version of [Quality Management System standard] ISO 9001.”

The standard’s revision process has now reached the Final Draft International Standard (FDIS) stage — the last leg of development before publication. The main changes are as follows:

  • The process approach now matches that of newer standards such as ISO 9001, 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 recognises 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, 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.

Developed jointly by ISO and IEC via the Committee on conformity assessment (CASCO), the new version of ISO/IEC 17025 will replace the 2005 version and is scheduled for publication at the end of this year.

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