03. Aug 2023

Revision of the international quality standard approved

ISO 9001 is being revised!

In 2015, the last change of ISO 9001 was published. Now, eight years later in July 2023, the member states have once again decided to revise the international standard in quality management.

The proposal of the responsible committee ISO TC 176/SC2 for a limited revision was approved by a simple majority. For this purpose, a working group evaluated various inputs, such as interpretation requests, future studies on the subject of quality, audit practice and surveys of certified companies, in order to work out points that should be addressed in a revision. From this data, a specification for the project was prepared.

The goal of the revision is to leave well-established sections unchanged, it should not be a radical change. The working group recognizes that users are comfortable with the standard and demand continuity. No one is in the mood for a major revision. At the same time, however, topics resulting from the corona pandemic, supply bottlenecks, new technologies, etc. should be taken into account. Accordingly, soft adjustments are proposed in the areas of resilience, supply chain management, change management, sustainability, product quality and delivery reliability. Clarification could also take place in areas that may not have been regulated explicitly enough in the last revision: "Risks and opportunities", "Knowledge of the organization" or "Planning of changes" are sections where users would like more clarity. The revised "High Level Structure", which changes rarely used terms, e.g. in the area of documented information, and makes the standard more consistent, is also adopted.

Next steps

This specification done by the working group will  be sent out to all member states for comments and criticism in order to establish a solid basis and a clear mandate for the working group.

In the next step the working group will be put together, the first meeting could take place as early as the beginning of October 2023 at the scheduled meeting of the committee. Normally, standardization projects take two to three years. The schedule for the ISO 9001 revision will be precisely defined in the near future. As an authority for the Integrated Management System, Quality Austria will of course continue to keep you informed.

Only recently, our qualityaustria Expert, Mag. Dr. Anni Koubek, gave an outlook on the future of ISO 9001. Surprisingly, faster than expected and with a simple majority, the poll on whether the standard should be revised according to the prepared design specifications, was pronounced in favor of the revision.

Here you can find more news on the official website of International Organization for Standardization.

Author & contact person

Team

Ms. Dr. Anni Koubek

Executive Vice President Sector Management Medical Devices

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