The new version of the ISO 17043 standard, published in May 2023, represents a significant step forward in the standards governing proficiency testing and the competency requirements for their providers. This update replaces the original 2010 edition and reflects a more comprehensive approach that aligns with other conformity assessment standards, such as ISO 17025:2017 and ISO 13528:2022. Through a revised structure, changes to requirements, and greater attention to aspects like transparency and risk-based analysis, the standard establishes a more robust framework to ensure the quality and reliability of these types of services. Both providers and users of proficiency testing, including laboratories dedicated to testing, calibration, or sampling, will benefit from these changes, albeit in different ways.
Since their inception, proficiency tests have been a key resource for assessing technical competence and ensuring the quality of results obtained by laboratories and other entities involved in testing activities. However, technological developments, new regulatory expectations, and the experience accumulated over the past decade have made it necessary to review and update the principles governing this practice. The 2023 version of ISO 17043 addresses these needs and establishes a clearer standard aligned with the current realities of the sector.
Main Focus of the ISO 17043 Standard and Alignment with International Standards
The main conceptual difference in the new edition of the standard lies in its emphasis on the competence of proficiency testing providers rather than solely focusing on conformity assessment activities. This change reflects alignment with the direction taken by ISO 17025, which also prioritizes the evaluation of the competence of laboratories conducting testing, calibration, or sampling. Additionally, the scope of proficiency testing has been expanded, now recognized as applicable not only to testing and calibration activities but also to sampling and inspection processes.
One of the most significant innovations in this version is the harmonization of terminology with ISO 13528:2022. This integration allows for more consistent use of statistical concepts in proficiency testing, facilitating their practical application and improving understanding among involved parties. By incorporating common requirements from ISO/CASCO PROC 33, the standard also ensures greater uniformity in matters related to impartiality, confidentiality, complaint and appeal management, as well as management system design.
Changes in the Structure and Key Requirements of the ISO 17043 Standard
The structure of ISO 17043:2023 has been revised to align with contemporary conformity assessment standards. The sections dedicated to general, organizational, resource, process, and management system requirements are now clearly distinguished. This reorganization enhances the document’s readability and facilitates its implementation by providers.
In terms of impartiality, a specific chapter has been introduced detailing the importance of continuous monitoring of the activities and relationships of personnel involved in proficiency testing. This aims to identify potential conflicts of interest and ensure the integrity of the results is not compromised. Confidentiality is also reinforced by requiring legally enforceable agreements with clients and the proper management of information obtained from third parties.
Regarding resources, it is now mandatory to conduct tests and measurements to characterize items or assess their homogeneity and stability in accordance with the requirements of ISO 17025. This measure ensures that proficiency testing is based on metrologically sound procedures. Furthermore, when reference materials are used in testing, their compliance with applicable standards is emphasized.
In the area of processes, the standard introduces significant changes, such as the requirement to clearly communicate the objectives of the proficiency testing program, performance evaluation criteria, and any changes in the program’s design or operation. Specific provisions have also been added to prevent collusion between participants, strengthening the integrity of the results. A novel aspect is the inclusion of a section on data control and information management, considering the growing digitalization of processes.
The risk-based approach is another standout element in this update. This principle, applied throughout the standard, aims to identify and mitigate potential risks that could affect the validity of proficiency testing results. Providers must implement procedures to ensure continuous monitoring of their programs and consider the outcomes of these activities in their continuous improvement process.
Benefits for Proficiency Testing Users under the ISO 17043 Standard
Although the ISO 17043:2023 standard is primarily aimed at proficiency testing providers, users also benefit from the improvements introduced. One of the main advances is the greater transparency in communication between providers and participants. Providers are now required to clearly and explicitly communicate the program’s objectives, the methods for determining assigned values, and the performance evaluation criteria. This information enables participating laboratories to better understand the program’s foundations and how their results will be assessed.
Another important aspect is the strengthened management of confidentiality. Agreements between providers and participants must be legally enforceable, ensuring greater legal security for the parties involved. Additionally, procedures for complaint and appeal management have been clarified and reinforced, providing participants with a more robust mechanism for addressing potential disputes.
The new standard also addresses the use of measurement uncertainty in proficiency testing. Providers must consider whether it is necessary to include this aspect in the design of their programs and how to use it to evaluate participants’ performance. This measure can provide significant value to laboratories, enabling them to evaluate the relevance of their uncertainty statements and strengthen their internal practices.
Implementation and Transition Period
The international body ILAC has established a three-year transition period, until May 2026, to allow accredited providers and new applicants to adapt their policies and procedures to the requirements of ISO 17043:2023. During this time, laboratories using services from accredited providers will not need to make changes to their own work systems but will benefit from the improvements introduced in proficiency testing programs.
The main advantages include greater transparency in the information provided by providers, strengthened mechanisms for complaint and appeal management, and better integration of the risk-based approach in the organization of tests. These improvements not only increase confidence in proficiency testing results but also contribute to strengthening the overall quality of conformity assessment activities.
Why Choose SHAPYPRO
At SHAPYPRO, we are committed to excellence and continuous improvement, and we have adopted the principles of ISO 17043:2023 ACCREDITING to ensure that our proficiency testing services meet the highest international standards. Our programs are designed with a risk-based approach, ensuring that every stage of the process is carried out with maximum rigor and transparency. This includes implementing advanced measures to assess item homogeneity and stability, following the requirements of ISO 17025, and clearly communicating objectives and evaluation criteria to our participants.
Additionally, our services are characterized by a commitment to confidentiality and impartiality, backed by legally enforceable agreements and policies designed to ensure the integrity of the results. We also provide personalized support to our clients to help them identify opportunities for improvement and optimize their performance.
By choosing SHAPYPRO, you benefit from a team with proven experience and access to cutting-edge resources designed to deliver reliable, high-quality results. Contact us today to learn more about how our programs can help you achieve optimal levels of technical competence and validity in your testing and calibration activities.
We are the only accredited provider worldwide in this field of testing under ISO/IEC 17043. [Click here to download the accreditation]
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