It is commonly acknowledged that proficiency testing (PT) is a crucial instrument for proving the expertise of conformity assessment bodies. PT can indicate competence and serve as a warning indicator for hidden or growing difficulties. The goal of this paper is to increase trust in how PT providers conduct their business. It contains requirements for PT providers to demonstrate their expertise and capacity to make credible assessments of participant performance.
For the purpose of assessing laboratory performance, PT makes use of interlaboratory comparisons. The words "laboratories" and "measurements or tests" are both expanded in this text to encompass all varieties of conformity assessment organizations and their operations, respectively, by the definition of "interlaboratory comparison" (see 3.4). The term "method" as it is used in this publication and the definition of "measurement procedure" in ISO/IEC Guide 99 are interchangeable.
On May 8, 2023, the ISO/IEC 17043:2023 version, Conformity Assessment - General Requirements for the Competence of Proficiency Testing Providers, was released. The evaluation procedure for the standard started in 2020, and the voting for the final version started in January 2023. The ISO/IEC 17043:2010 first edition is replaced by this revision, which is the second edition of the standard.
The standard's technical requirements have undergone a few changes. There have been various modifications done for all conformity assessment documents to comply with the most recent ISO requirements. Additionally, a lot of the structural requirements of the new standard are more in line with ISO/IEC 17025:2017. The majority of these adjustments will be familiar to physical therapists (PT) who work in labs or who offer reference materials.
The new ISO 17043:2023 documents state that PT can be used in any area of conformity assessment, which is perhaps the most important way in which it recognises the applications of PT outside of testing and calibration. In terms of inspection, sample, result interpretation, and individual competency, there are currently accredited PT programs that provide challenges. The latest edition cancels and replaces the first edition (ISO/IEC 17043:2010), which has been technically revised.
- For measurement and testing of PT products, including homogeneity and stability testing, all testing requirements "shall be conducted by the relevant requirements of ISO/IEC 17025."
- More information on how techniques and equipment are appropriately validated and maintained.
- A requirement for reference material producers (RMPs) to meet ISO 17034 applicable standards.
- Subcontractors and purchasing services and supplies were both replaced by external service providers.
- External service providers took over as subcontractors and procured services and supplies.
- Changes to the necessities for PT reports, e.g., to contain MU.
- Other requirements for ‘legally enforceable measures for the management of information and informing clients in advance of information placed in the public domain.
- Much more explanation of requirements for impartiality.
- Requirements for a Quality Manager and deputies removed.
- Changes to management system necessities in line with ISO 15189:2022 / ISO/IEC 17025:2017.
- Complaints and demands are separated, with different definitions. More description of requirements for management appeals.
- Changes to management review requirements in line with other new Standard republications.
- No condition for Quality Policy/Manual.
- Choice for ISO 9001 certified quality management system.