After a long wait, the ISO 9001 revision is now becoming a reality

A first experts’ meeting took place in London from 4-8 December 2023, and the first balloting is now open to comment internally on the CD (committee draft) that has been established.

Here a quick screening of the main proposed changes compared to the 2015 version:

• The title is now “Quality management systems — Requirements with guidance for use”
• Lot of definitions have been added – replacing the reference to 9000
• New subclauses have been added:

1.       4.2 c) which of these requirements will be addressed through the quality management system
2.       6.3 e) how the effectiveness of the change will be monitored;
3.       6.3 f) how to review of the results of the change.
4.       10.1 b) addressing future needs and expectations;
5.       improving products and services to meet requirements as well as to address future needs and expectations;
6.       correcting, preventing or reducing undesired effects;
7.       improving the performance and effectiveness of the quality management system.

• Total rewording of 10.3, requiring identifying opportunities and taking actions to:

• New title for Annex A, which is now “Guidance on the use of this international standard” and incorporating (40 pages) the full ISO TS 9002 implementation guidelines.

This means that ISO 9001 is intended to become a stand-alone document, including the applicable definitions and implementation guidelines.

The next major step will be to move from CD to DIS (draft international standard), with an open consultation that will last until Q1/Q2 2025.

Source: from Didier BLANC, ViaSyst Director.