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.