Quality manager

The latest publications in this offer are:

• September 10, 2026

  R285

  Measurement uncertainty and conformity assessment - From uncertainty to risk

  This article explores the concept of measurement uncertainty and its evaluation as outlined in established standards. Measurement uncertainty is widely regarded as a measure of the quality and reliability of a measurement result, making it valuable for comparing results or assessing compliance with regulatory thresholds. Accounting for measurement uncertainty in conformity assessment leads to a risk-based interpretation, where risk is defined as the probability of exceeding a given threshold.The article serves as an introduction to the GUM suite of documents, Guide to the Expression of Uncertainty in Measurement, and the NF ISO 5725 standard, providing a comprehensive discussion of the conditions for applying these methods.

• September 10, 2026

  FIC1882

  Developments Regarding the Context, Risks, and Opportunities

  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.

• September 10, 2026

  FIC1879

  Developments in Management and Quality Culture

  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!

• July 10, 2026

  FIC1880

  Developments in human resources, skills, and knowledge

  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.

• July 10, 2026

  FIC1878

  Developments Regarding QMS Planning and Evaluation

  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.

• April 10, 2026

  R291

  Bayesian approach of measurement uncertainty evaluation

  Measurement uncertainty evaluation is essential to scientific and industrial activities, and to trade, where it enables, among other things, the comparison of measurement results with each other or with a specification. The "Guide to the Evaluation and Expression of Uncertainty" (GUM) aims to propose harmonized practices for this evaluation.This article presents the Bayesian approach and the main Bayesian techniques used in metrology. It illustrates how this statistical framework makes it possible to address more complex situations, such as the estimation of calibration curves with uncertainties on both axes, or the use of prior information on the measurand, thereby opening up new perspectives.

• April 10, 2026

  FIC1881

  Developments regarding the process-based approach

  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.

• April 10, 2026

  FIC1877

  Summary of Changes to ISO 9001

  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.

• April 10, 2026

  FIC1876

  Changes in terminology and definitions (ISO 9000 and ISO 9001)

  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.

• March 19, 2026

  G5120 Reviewed

  management system : manageent review

  Every benchmark of management systems introduces a logic of continuous improvement represented by the PDCA (Plan-Do-Check-Act) or Deming's wheel. Once the management system has been implemented, the management review is a privileged moment in the process of continuous improvement and the ideal occasion to conduct a critical review of the functioning of a body. Conducted on a regular basis and supported by a deeply involved management, this review defines actions in order to pursue, adapt, redirect a policy and objectives; it also allows for integrating improvements and modifications at the management system level. Therefore, by "closing the loop", it participates in the commitment and involvement of the management.

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