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The risk-based approach, introduced in the 2015 version, is retained and strengthened. It is complemented in the 2026 version by its counterpart: the opportunity-based approach. The negative (risk) and the positive (opportunity) are treated equally (or nearly so) in ISO 9001:2026. This fact sheet explains in detail the requirements related to both throughout the standard. We will cover the new requirements, the importance of defining the scope of the QMS, the scope of risks, the scope of opportunities, and finally the associated documentation requirements.
A brief look back at the development of this 2026 version: In May 2021, on the deadline for the revision decision, an international vote concluded, by a narrow majority, to retain the 2015 version against the recommendation of the ISO TC 176 Working Group, which was responsible for drafting the standard. In 2023, following intense lobbying, a new vote reversed the result, with a narrow majority. TC 176 was then mandated to prepare a limited revision of ISO 9001. This background to the revision largely explains the final outcome and the limited number of new elements in the standard. Let’s acknowledge, however, that the introduction of “quality culture” is a promising development!
Although the conformity assessment and management system standards offer a large flexibility to reference materials users regarding management and control of reference materials, numerous questions stay still open to users preparing a first assessment of their skills. This article aims has to answer has some of enter they to facilitate the dialogue between users and auditors. It presents different approaches recommended to assure traceability demonstration in audit situation, to verify the truthfulness of the Reference materials accompanying certificates and finally an approach of control of the processes of measure.
In 2015, the ISO 9001 standard incorporated requirements regarding the management of knowledge specific to each organization, grouped under a section titled, somewhat ambiguously, “Organizational Knowledge.” In the English version, the section title is in the singular: “Organizational knowledge,” which is less confusing. It must be acknowledged that, in the absence of precise and auditable requirements, companies and auditors have tended to overlook these requirements—for example, by conflating them with the individual competencies typically outlined in job descriptions as knowledge, know-how, and interpersonal skills.
The 2015 version had given the impression of prioritizing the process approach at the expense of the more complex system dimension. So much so that the management principles of the “process approach” and the “system approach” were then merged into a single principle, which was and remains known as the “process approach.” The new version restores the logical order of these concepts and reestablishes the importance and preeminence of the principle and reality associated with the concept of “system.” The definition of QMS itself is clarified, as are the auditable characteristics related to its planning and evaluation.
The ISO/IEC 17025 standard ‘General requirements for the competence of testing and calibration laboratories’ requires measurement methods to be validated when they are not standardised or when they are used outside the scope of application provided for by the standard, and to associate an uncertainty with the measurement value. Chemical analysis laboratories generally know how to validate their measurement methods, but they sometimes encounter difficulties in assessing measurement uncertainty. This document outlines the various ways, covered by the ‘Guide to the expression of uncertainty in measurement’ (GUM), of assessing it, using data from within or outside the laboratory.
Since the 2000 version of ISO 9001, the process-based approach has been at the heart of QMS structures. Despite its long history, however, the subject remains open to debate on several fronts, sparking controversies within the quality community that rival those of the Capulets and Montagues. This controversy centers on how to define processes: either by replicating the company’s hierarchical silos (sales/purchasing/engineering/production, etc.) or by defining cross-functional processes that align with end-to-end workflows, creating value for customers and other stakeholders. The drafters of ISO 9001 have refrained from taking sides in this ongoing controversy, likely fearing that there is more to lose than to gain from an initiative that could lead to a schism.
With each new version of ISO 9001, quality managers and their leadership teams have two questions on their minds: What’s new? What needs to be done, added, or changed in our organization’s QMS (quality management system)? This new version is somewhat paradoxical, as it includes several differences or changes from the current version without the text of ISO/DIS 9001 itself, at this stage, providing a clear explanation of the overall significance of these differences and changes. Building on its undeniable success and the experience gained over decades, the new version of ISO 9001 boldly reaffirms its core principles.
The new versions of ISO 9000 and ISO 9001 continue to be a major event for the community of users of these standards, even nearly forty years after the first version was released. This new version is, however, somewhat paradoxical, as it includes a large number of (minor) differences or changes compared to the current version, without really introducing any significant new requirements. Just as with the release of a new version of an iconic car model, we appreciate entering the new ISO 9000 and ISO 9001 standards on familiar ground, reassured to find our main points of reference, though sometimes with a touch of disappointment at the lack of boldness.
The risk of explosive atmospheres (ATEX) is frequent in laboratories due to the use of inflammable products(gases or liquids). A regulation has been drafted in order to improve the health and safety of workers exposed to the ATEX risk. This article is dedicated to the implementation of this regulation within laboratories. The regulation, its principles and main requirements as well as the definition of ATEX zones are firstly listed. The implementation of this regulation in laboratories is then presented on the basis of general information and illustrated with a few cases of common situations.
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