Transition to ISO/IEC 17043:2023
Action required
All accredited proficiency testing (PT) providers shall review their quality management system against the requirements of the new standard and prepare for their assessment against this standard based on the schedule outlined below.
Assessors for the Proficiency Testing Provider Accreditation Program (PTPAP) shall be formally qualified for the new standard.
All accredited proficiency testing providers shall be transitioned to ISO/IEC 17043:2023 before May 8, 2026
Affected customers
SCC and BNQ Proficiency Testing Accreditation Program customers and applicants.
Background
ISO/IEC 17043:2023 Conformity assessment — General requirements for the competence of proficiency testing providers was published on May 9, 2023.
The International Laboratory Accreditation Cooperation (ILAC) has agreed that there shall be a three-year transition period, by the end of which providers accredited to ISO/IEC 17043:2010 worldwide must have been assessed and accredited to ISO/IEC 17043:2023. SCC and its partner, Bureau de normalization de Quebec (BNQ), are implementing a transition plan with the following key dates.
January 2024
- SCC and its partner BNQ will be ready to assess PT providers to ISO 17043:2023 by January 2, 2024.
- New applications for accreditation to ISO 17043:2023 will be accepted starting on January 2, 2024.
January 2024 to April 2024
- PT providers that have their annual surveillance/assessment/reassessment between January 2 to April 30, 2024 can choose to be assessed against the 2023 version or the 2010 version.
May 2024
- All initial assessments will be conducted against ISO 17043:2023 as of May 1, 2024.
- All annual surveillance/reassessments will be conducted against ISO 17043:2023 as of May 1, 2024.
May 2026
Accreditations to ISO 17043:2010 are no longer valid as of May 5, 2026, and PT providers that have not transitioned to ISO 17043:2010 can no longer claim accreditation for their activities.
New requirements
Main changes to the standard include but may not be limited to:
- Aligning the management system requirements throughout the standard with the management system requirements in ISO/IEC 17025:2017 and ISO 15189:2022.
- Testing or measurement requirements under the responsibility of the PT provider align with the relevant ISO/IEC 17025 and ISO 15189 requirements related to the validity of testing or measurement results.
- Aligning with ISO/IEC 17025:2017 requirements for topics under control of data and information management, and shared elements such as:
- organizational structure
- impartiality and confidentiality
- resources
- process control
- management system
- considerations to risks and opportunities
- Producing a PT item as a reference material shall meet the relevant ISO 17034 requirements when applicable.
- Increased responsibility for the PT provider to notify all the participants in writing regarding the work of external services and products providers that can affect the validity of PT activities. Subcontractors/purchasing services and supplies terminology is replaced by external service providers in the new standard.
- New requirements around internal and external personnel regarding specific activities within operation of PT schemes.
- New section about surveillance of the processes to ensure the validity of PT schemes.
- Handling of complaints and appeals is divided in two sections, with more emphasis on the requirements description for how to handle appeals.
- Addition of a new requirement for the PT provider – when issuing an amended report to a subset of participants – to make an analysis of the potential impact of the other participants for that PT schemes and/or PT round to ensure there is no influence on the general performance of the other participants.
- Additions to definitions to enhance better understanding of some concepts such as: consensus value, proficiency testing, PT scheme and standard deviation.
- Removal of the following definitions: robust statistical method, subcontractor, metrological traceability and coordinator.
Deadline
All PT providers have until May 8, 2026 to transition to the new standard. Accreditation certificates issued against ISO 17043:2010 requirements will no longer be valid after this date.
Questions?
For more information, please contact Vivekananthan Kulasingham, Manager Compliance and Assessment Services at vivekananthan.kulasingham@scc-ccn.ca or +1-613-238-3222.