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The ISO/IEC 17043 Edition 2023: Key Changes and Expectations

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accreditationconsultancy
The ISO/IEC 17043 Edition 2023: Key Changes and Expectations

The conformity assessment standard ISO/IEC 17043, General Requirements for Competence of Proficiency Testing (PT) Providers, was released on May 8, 2023. With the final voting starting in January 2023, the standard's review process got underway in 2020. The first edition, ISO/IEC 17043:2010, is replaced by this revision, which is the standard second edition.


What Key Changes Will ISO/IEC 17043:2023 Make?

Harmonization with ISO/IEC 17025:2017 and ISO 13528:2022, as well as the addition of the requirement that testing and calibration activities and proficiency testing item production conform to pertinent requirements of appropriate ISO conformity assessment standards, are the main changes to the 2023 edition of ISO/IEC 17043. New standards regarding impartiality, risk, and information management were added to the standard in addition to updating and harmonizing the existing requirements.


A few significant revisions to the standard include (this list is not complete):

  • Modifications to the management review requirements in keeping with recent revisions of the Standard.
  • No need for a quality policy or manual.
  • Option for a management system with ISO 9001 certification.
  • All testing requirements for PT products, including homogeneity and stability testing, "shall be conducted by the relevant requirements of ISO/IEC 17025."
  • Additional obligations for managing information and notifying clients before it is made public, as well as for "legally enforceable arrangements."
  • Much more details on the criteria for impartiality.
  • Removing the need for a quality manager and deputies.
  • More information on the "appropriately validated and maintained" procedures and equipment.
  • A prerequisite is that applicable ISO 17034 standards be met by reference material manufacturers (RMPs).
  • External service providers replaced both subcontractors and the acquisition of goods and services.
  • Expanded the obligation to validate both initial validation and updates to information management systems.
  • Modifications to the requirements for PT reports, such as adding MU.
  • Alterations to management system specifications to comply with ISO 15189:2022 and ISO/IEC 17025:2017. a lot less restrictive.
  • Appeals and complaints have separate definitions. Additional details regarding the conditions for handling appeals.


What Does ISO/IEC 17043 Purpose?

The general standards for the creation, management, and expertise of proficiency testing scheme providers are outlined in ISO/IEC 17043. These specifications, which can be used as the foundation for more specific technical specifications for certain domains, are intended to be general for all varieties of proficiency testing plans. The following parties can utilize and comply with this international standard:

  • Laboratories for calibration and testing
  • Governmental legal restrictions and regional agreements
  • Professional and industrial standards


About Accreditationconsultancy.com

Accreditationconsultancy.com is a one-stop consulting resource for ISO/IEC 17025 accreditation and other global market accreditation standards. With more than 2700 clients across more than 30 nations, we are the leading ISO/IEC Accreditation Consultancy. Since 2000, we have operated a calibration laboratory that is accredited by ISO/IEC 17025. For suppliers of proficiency tests (PT), Accreditationconsultancy.com offers ISO 17043:2023 accreditation and documentation consulting. The majority of the ISO 17043 accrediting documentation needs to be composed of the ISO 17043 manual, ISO 17043 procedures, SOPs, formats for different activities, audit checklists, etc.


For ISO 17043 Training

Punyam Academy has created a dedicated online ISO/IEC 17043 Auditor Training course for individuals looking to become certified Exemplar Global ISO/IEC 17043 Auditor for the conformity evaluation of proficiency testing providers.


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