Update on revision of ISO/IEC 17025

The revision of ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is now complete and the new version of the standard was published by ISO on 29 November 2017.

As previously advised, NATA is planning to conduct combined Member and Technical Assessor fora in each of the states early in 2018. These fora will cover information on NATA’s transition policy for the new standard together with an overview of the standard and a gap analysis between the new and previous versions.

It is intended at this stage that assessments against the new standard will be conducted from 1 July 2018. Confirmation will be provided once the transition policy is released in early 2018.

Accredited and applicant facilities will need to obtain a copy of the new standard directly from a supplier of standards. Standards Australia has prepared a work item to adopt in full the ISO version as an Australian standard. It is anticipated that this version will become available in early 2018 however no confirmation date has been advised.

Further information on the fora will be made available in due course.

In brief, the main changes to the standard include:

  • the new standard is clearer and more direct, without necessarily changing the essence of the previous version
  • adoption of the mandatory ISO/CASCO structure
    • as per the current ISO/IEC 17020 and recently published ISO/IEC 17034
  • the scope of the standard now covers ‘laboratory activities’ which includes testing, calibration and sampling (as a standalone activity)
  • there is greater emphasis on impartiality, risks and opportunities
  • emphasis is now placed on the result of a process instead of a detailed description of tasks and steps
  • there is a reduction in the amount of documentation necessary
  • purchasing and subcontracting have been combined
  • requirements covering information technology and the validation of such systems (as per ISO 15189) have been included
  • metrological traceability has been made clearer with simplified text
  • the term ‘decision rules’ has been introduced in relation to pass/fail results for statements of conformity
    • how MU is to be taken into account when making such statements
  • two management system options
    • Option A = comply with the management system requirements as covered
    • Option B = adoption of an ISO 9001 system

Members who may be interested in what NATA’s transition policy will be in relation to the adoption of a new standard for accreditation can refer to the current Policy Circular 49 Implementation of ISO 17034:2016 in NATA’s Reference Material Producers accreditation program available on the NATA website. The Reference Material Producers ISO 17034 Standard Application Document, also available from the website, additionally outlines NATA’s assessment approach in relation to the two management system options.