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ISO/IEC 17043:2023 publication and transition

ISO/IEC 17043:2023 Conformity assessment – General requirements for proficiency testing has now been published (9th May 2023). The International Laboratory Accreditation Cooperation (ILAC) has agreed that there shall be a three-year transition period; by the end of this period providers accredited to ISO/IEC 17043:2010 worldwide must have been assessed and accredited to ISO/IEC 17043:2023.

Some key updates to the standard include (this list is not exhaustive):

  • Any testing requirements ‘shall be conducted in accordance with the relevant requirements of ISO/IEC 17025’ for measurement/testing of PT items, inc. homogeneity and stability testing.
  • More detail on methods/equipment being ‘appropriately validated and maintained’.
  • A requirement for reference material producers (RMPs) to meet ISO 17034 relevant requirements.
  • Subcontractors and purchasing services and supplies both replaced by external service providers.
  • Expanded the requirement to validate changes to information management systems as well as initial validation.
  • Changes to the requirements for PT reports, e.g., to include MU.
  • Additional requirements for ‘legally enforceable arrangements’ for management of information and informing clients in advance of information placed in the public domain.
  • Much more description on requirements for impartiality.
  • Requirements for a Quality Manager and deputies removed.
  • Changes to management system requirements in line with ISO 15189:2022 / ISO/IEC 17025:2017. Much less prescriptive.
  • Complaints and appeals separated, different definitions. More description of requirements for handling appeals.
  • Changes to management review requirements in line with other recent Standard republications.
  • No requirement for Quality Policy/Manual.
  • Option for ISO 9001 certified management system.

 

More information will follow, in the next few weeks, of detailed UKAS guidance for transition of customers currently accredited under ISO/IEC 17043:2010 and the impact of the new standard on applicant customers.

 

Download a pdf of this bulletin here.