ISO 13528:2022/Amd 1:2026
(Amendment)Statistical methods for use in proficiency testing by interlaboratory comparison — Amendment 1
General Information
- Abstract
- Status
- Published
- Publication Date
- 27-Jul-2026
- Technical Committee
- ISO/TC 69/SC 6 - Measurement methods and results
- Drafting Committee
- ISO/TC 69/SC 6 - Measurement methods and results
- Current Stage
- 6060 - International Standard published
- Start Date
- 28-Jul-2026
- Due Date
- 12-Jul-2026
- Completion Date
- 28-Jul-2026
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ISO 13528:2022/Amd 1:2026 - Statistical methods for use in proficiency testing by interlaboratory comparison — Amendment 1
ISO 13528:2022/Amd 1:2026 - Méthodes statistiques utilisées dans les essais d'aptitude par comparaison interlaboratoires — Amendement 1
Overview
ISO 13528:2022/Amd 1:2026 is an amendment to the widely recognized ISO 13528 standard, which provides statistical methods for proficiency testing by interlaboratory comparison. Developed by the International Organization for Standardization (ISO), this amendment updates technical content and references to ensure full alignment with the latest practices and supporting standards, particularly ISO/IEC 17043:2023.
Proficiency testing is essential for evaluating the performance of laboratories, enhancing measurement quality, and ensuring data reliability. This standard plays a critical role in supporting these objectives by offering rigorous statistical frameworks for data interpretation and assessment in interlaboratory comparisons.
Key Topics
Updated References to ISO/IEC 17043:2023
The amendment systematically replaces previous references to ISO/IEC 17043:2010 with ISO/IEC 17043:2023, ensuring alignment with the current requirements for proficiency testing providers and participants.Clarification of Statistical Definitions and Formulae
Changes include corrected formula references and updated terminology, such as clarifying the meaning of "standard deviation for proficiency assessment." These refinements support improved accuracy and understanding in statistical application.Amended Reporting and Documentation Requirements
Updates require proficiency testing providers to document the reasons for statistical assumptions and demonstrate that these assumptions are reasonable, as aligned with the latest ISO/IEC 17043:2023 clauses.Data Handling Procedures
Providers must have documented criteria and procedures for managing inappropriate results and identifying statistical outliers. The amendment refers to established best practices, including early removal of obvious data blunders recommended by IUPAC.Precision in Assigned Values and Scoring
Several numerical amendments-such as in Annex E’s assigned value rounding-ensure standardized data reporting and enhance the validity of performance scores.
Applications
ISO 13528:2022/Amd 1:2026 is valuable for a wide range of organizations involved in proficiency testing and interlaboratory comparisons, including:
- Testing and Calibration Laboratories
To demonstrate measurement competence and comply with accreditation requirements. - Proficiency Testing Providers
For designing, conducting, and evaluating proficiency tests in a consistent, statistically robust manner. - Accreditation Bodies
Assessing technical compliance of laboratories and proficiency testing schemes with current international standards. - Quality Managers and Technical Assessors
Ensuring continuous improvement in measurement quality and laboratory performance. - Industry Sectors
Such as food safety, environmental analysis, clinical diagnostics, and materials testing, all of which rely on reliable interlaboratory comparisons for regulatory compliance and market access.
Utilizing this amendment helps enhance trust in laboratory results, supports quality assurance programs, and sustains international recognition of testing capabilities.
Related Standards
For comprehensive implementation and best practices in proficiency testing and statistical methods, consider the following related standards:
- ISO 13528:2022 - Statistical methods for use in proficiency testing by interlaboratory comparison (core standard).
- ISO/IEC 17043:2023 - Conformity assessment - General requirements for proficiency testing.
- ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories.
- IUPAC Harmonized Protocol - Guidelines for proficiency testing and data outlier assessment used as reference in the amendment.
ISO 13528:2022/Amd 1:2026 represents a crucial step in keeping proficiency testing statistical methods current, reliable, and harmonized with evolving international best practices. Adopting this amendment supports laboratory quality systems, risk management, and regulatory compliance across diverse scientific and industrial domains.
Relations
- Amends
ISO 13528:2022 - Statistical methods for use in proficiency testing by interlaboratory comparison - Effective Date
- 13-Jul-2024
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ISO 13528:2022/Amd 1:2026 - Statistical methods for use in proficiency testing by interlaboratory comparison — Amendment 1
ISO 13528:2022/Amd 1:2026 - Méthodes statistiques utilisées dans les essais d'aptitude par comparaison interlaboratoires — Amendement 1
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Frequently Asked Questions
ISO 13528:2022/Amd 1:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Statistical methods for use in proficiency testing by interlaboratory comparison — Amendment 1". This standard covers: Statistical methods for use in proficiency testing by interlaboratory comparison — Amendment 1
Statistical methods for use in proficiency testing by interlaboratory comparison — Amendment 1
ISO 13528:2022/Amd 1:2026 is classified under the following ICS (International Classification for Standards) categories: 03.120.30 - Application of statistical methods. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 13528:2022/Amd 1:2026 has the following relationships with other standards: It is inter standard links to ISO 13528:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 13528:2022/Amd 1:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
International
Standard
ISO 13528
Third edition
Statistical methods for use
2022-08
in proficiency testing by
interlaboratory comparison
AMENDMENT 1
2026-07
AMENDMENT 1
Méthodes statistiques utilisées dans les essais d'aptitude par
comparaison interlaboratoires
AMENDEMENT 1
Reference number
ISO 13528:2022/Amd.1:2026(en) © ISO 2026
ISO 13528:2022/Amd.1:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 13528:2022/Amd.1:2026(en)
Foreword
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This document was prepared by Technical Committee ISO/TC 69, Applications of statistical methods,
Subcommittee SC 6, Measurement methods and results.
Any feedback or questions on this document should be directed to the user’s national standards body. A
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...
Norme
internationale
ISO 13528
Troisième édition
Méthodes statistiques utilisées
2022-08
dans les essais d'aptitude par
comparaison interlaboratoires
AMENDEMENT 1
2026-07
AMENDEMENT 1
Statistical methods for use in proficiency testing by
interlaboratory comparison
AMENDMENT 1
Numéro de référence
ISO 13528:2022/Amd.1:2026(fr) © ISO 2026
ISO 13528:2022/Amd.1:2026(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2026
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
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Tél.: +41 22 749 01 11
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Publié en Suisse
ii
ISO 13528:2022/Amd.1:2026(fr)
Avant-propos
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Le présent document été élaboré par le comité technique ISO/TC 69, Application des méthodes statistiques,
sous-comité SC 6, Méthodes et résultats de mesure.
Il convient que l'utilisateur adresse tout retour d'information ou toute question concernant le présent
document à l'organisme national de normalisation de son pays. Une liste exhaustiv
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