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ISO 17025 Revision Proposed!

During the 2013 ILAC General Assembly, the ILAC Laboratory Committee (LC) requested that ILAC submit a New Work Item Proposal to ISO/CASCO to revise ISO/IEC 17025:2005 as soon as practicable.

The rationale being that ISO/IEC 17025 is scheduled for systematic review in 2015 which means that after the ISO formal processes have concluded it will most likely be 2016 before the actual revision of the document will be able to commence. The ILAC Laboratory Committee, which is a committee made up of ILAC Stakeholder members with a laboratory focus as opposed to accreditation body members felt the need to encourage some further action as the standard was 8 years old at that time and it is likely to take several years to finalise a revision.

As a result of the General Assembly discussion on the LC proposal, the draft resolution was amended to take into account the request from members, to consult with their accredited laboratories before being asked to vote on whether or not to proceed with submitting a proposal for the revision of ISO/IEC 17025 to ISO/CASCO. The resolution was subsequently amended to reflect this request.

The current standard is nine years old and contains references to documents that no longer exist under the designation shown in the current standard, e. g. ISO/IEC Guide 43-1 and Guide 43-2; ISO/IEC Guide 58:1993 and ISO/IEC Guide 65, while other references are not to the most recent versions, eg ISO 9001:2000.

In the wider market place it has been noted that there are examples of regulators and specifiers hesitating to adopt a system that relies on such an out of date standard.

The ILAC Executive Committee subsequently agreed that the information below was to be used in support of the NWIP for the revision of ISO/IEC 17025.

Clauses of ISO/IEC 17025 that require revision:

The clauses of ISO/IEC 17025 where there is consensus amongst the IILAC AIC that revision is needed include:

  • 5.4 Calibration, Measurement Uncertainty & Validation/Verification
  • 5.5 Equipment (possibly)
  • 5.6 Traceability*
  • 5.7 Sampling
  • 5.9 Quality Assurance including Proficiency Testing
  • 5.10 Reporting Results (opinions/interpretation)

Other areas that should be considered in the revision include, not listed in order of importance:

  • The terminology used in the current standard is outdated and causes confusion in today’s world, e.g. changes to VIM terminology and the fact that hard copy is now rarely used for manuals, records and reports;
  • The scope requires revision and updating to cover new areas;
  • ISO/IEC 17025 takes a prescriptive approach and is out of step with the modern standards approaches which are performance-based or process-based. The formatting should also be matched to newer standards such as ISO 9001, ISO 15189, ISO/IEC 17020, ISO/IEC 17043, ISO/IEC 17021, ISO/IEC 17065;
  • Bio-security and bio-safety considerations associated with laboratory work should be added;
  • Impartiality needs to be addressed in a more informed way;
  • Subcontracting circumstances need to be clarified (reference to how this is handled in ISO/IEC 17043 would be helpful);
  • Traceability requirements should be expanded/clarified along more informed lines;
  • Sampling and sub-sampling needs to be considered with more recognition that reliable test results are directly related to sampling;
  • Consider pre- and post- analysis requirements;
  • Reconsider the handling of testing and calibration as separate parts of the standard. The reasons for any different approaches in the standard between these areas should be clarified;
  • Review ISO/IEC 17000 and its relevance to ISO/IEC 17025;
  • Incorporate and recognise the use of computer systems, electronic records and report issue, as well as remote issue, of results/reports;
  • Address software validation to allow for its relevance to testing and result generation, as well as records management;
  • Clarify further the possible conflict that may exist between ISO/IEC 17025 and national regulations and the need to establish precedence;
  • Consider the relevance of the product certification standard (ISO/IEC 17065) to ISO/IEC 17025;
  • Ensure that notes are avoided in the future standard version. There are too many notes included in the current version which make it difficult to use;
  • Update the Bibliography.

The proposal states that ISO 17025 is not a management system standard (MSS) so it will not have to follow the mandatory clause structure and common text that is now required for all new or revised MSS’s.

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