As this article is being written, the (final draft) FDIS ISO 9001:2026 global vote has concluded, and we should soon see the new published requirements.

If published as drafted, which is widely expected, one of the most significant changes is an increased emphasis on demonstrating the effectiveness of the quality management system. This will be particularly true for solving issues or problems in your system. And at least in the management review, this effectiveness will need to be documented.

Here’s what to pay attention to in each section of the FDIS.

Introduction

The Terms and Definitions Clause 3.0 will now actually have some definitions. Clause 3.13—“Effectiveness” will be defined as “extent to which planned activities are realized and planned results are achieved.” The word effectiveness appears in the FDIS 32 times.

Based on the FDIS, process effectiveness appears to focus on an organization’s ability to demonstrate that its processes consistently:
• Achieve intended outputs
• Control variation
• Meet customer requirements
• Show continual improvement

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