Laboratory errors have a reported frequency of 0.012–0.6 % of all test results. This is why proficiency testing (PT), a formal type of interlaboratory comparisons, is an essential component in the laboratory accreditation process. By adhering to the PT requirements specified in ISO/IEC 17043, PT providers can competently monitor the quality of a laboratory’s performance, ensuring accurate and safe performance of a product.
ISO/IEC 17043 was revised in 2023. The current, second edition is ISO/IEC 17043:2023 – Conformity Assessment – General Requirements For The Competence Of Proficiency Testing Providers.
What Is The Point of Proficiency Testing (PT)?
By making interlaboratory comparisons, proficiency testing (PT) enables a laboratory to assess if its analysis results against pre-established criteria is satisfactory. Here is what PT can provide:
- Evaluation of the effectiveness of specific measurements, calibrations, and tests
- Evidence of competence
- Indication of an underlying or emerging problem
- Education of participating laboratories
- Provision of additional confidence
Before PT occurs, it is essential that PT testing providers operate competently, generating valid evaluations of participant performance. These critical requirements for PT providers are provided in ISO/IEC 17043.
What Is the Scope of ISO/IEC 17043?
ISO/IEC 17043 specifies general requirements for the development, operation, and competence of providers of proficiency testing schemes. These requirements are intended to be general for all types of proficiency testing schemes and can be used as a basis for specific technical requirements for certain fields.
This international standard is used by and applicable to the following participants:
- Testing and calibration laboratories
- Legal regulation by governments and regional agreements
- Industrial and professional standards
What Are the Changes to the New ISO/IEC 17043?
ISO/IEC 17043:2023 – Conformity Assessment – General Requirements For The Competence Of Proficiency Testing Providers revises and supersedes ISO 17043:2010. This revision to ISO/IEC 17043 was approved by 100% of ISO/CASCO P- Members (77 out of 77 voting) and 100% of IEC P-Members (32 out of 32 voting).
Rationale for Revising ISO/IEC 17043:
- Insert new CASCO common elements
- Implement editorial changes to informative Annexes
- Make clarifications in technical requirements to clarify PT for inspection and sampling
- Align with other CASCO standards (e.g., ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories and ISO 17034, General Requirements for the Competence of Reference Material Producers) and ISO 13528, Statistical Methods
- Revise the outdated structure, bibliography, and requirements for management system
- Update the use of symbols for statistical calculations
Key Changes to ISO/IEC 17043:
- Inclusion of other types of conformity assessment activities (inspection and sampling) beyond test and calibration as currently stated and clarification of PT for inspection and sampling
- Harmonization with the revision of ISO/IEC 17025, including technical requirements and structure
- Harmonization with the statistical symbols, terms, and definitions in ISO 13528:2016
- Incorporation of requirements from ISO/CASCO PROC 33
- Inclusion of the requirement that testing activities, calibration activities and PT item production conform to the relevant requirements of appropriate ISO conformity assessment standards
- Introduction of the risk-based thinking in the revised standard
- Deletion of Annex C and revision of Annexes A and B (Informative)
ISO/IEC FDIS 17043:2023 Conformity Assessment – General Requirements For The Competence Of Proficiency Testing Providers is available on the ANSI Webstore.
ANAB Accreditation for Proficiency Test Providers
ANAB accredits proficiency test providers to ISO/IEC 17043 and/or domestic standards, such as TNI Standard EL-V3-2016 and the relevant elements of ISO/IEC 17025. PT providers that attain ANAB accreditation gain increased confidence from their customers that their services are operating in accordance with the specified technical and management system requirements.