Latest Developments in ISO 9001 Revision

The ISO 9001 Quality Management System international standard is organized and developed by the ISO Technical Committee on Quality Management and Quality Assurance (ISO/TC 176). It is the most widely applied management system standard globally, suitable for organizations of any industry and size to establish and improve quality management systems. The standard was first published in 1987, and the current version ISO 9001:2015 is the 5th edition. As of May 2024, China has issued 932,000 quality management system certification certificates and has 871,000 certified organizations, ranking first in the world for several consecutive years in both certificates issued and certified organizations, playing a crucial role in improving the quality management level of Chinese enterprises.

1. Overview of ISO 9001 Revision Work

In November 2023, ISO/TC 176/SC 2 (Management Systems Sub-Technical Committee) established Working Group 29 (WG 29) "ISO 9001 Revision" to officially start the revision of the ISO 9001 international standard. In December of the same year, WG29 held its first meeting in London, UK, and formed a Working Draft (WD). From February to April 2024, WG29 reviewed collected comments and formed a Committee Draft (CD). The plan is to form a Draft International Standard (DIS) between September and November 2024, a Final Draft International Standard (FDIS) between July and August 2025, and officially publish in November 2025. Two registered experts from the China National Institute of Standardization participated in the ISO 9001 revision work representing China.

2. Main Changes in This Revision

The new version of ISO 9001 still bases its overall structural framework on the High-Level Structure (HLS) for management systems, maintaining the quality management principles, and adopting the PDCA cycle and risk-based thinking process approach. The new ISO 9001 mainly reflects the latest ISO trend directions in the following aspects.

(1) Strengthening Requirements on "Ethics and Integrity"

Ethics and integrity are important concepts long focused on by ISO/TC 176. The new ISO 9001 proposes to add requirements advocating ethics and integrity, with top management committing to and promoting adherence to ethics and integrity principles at all organizational levels.

(2) Adding Requirements on "Mission, Vision, Values, and Quality Culture"

Quality culture is a new quality management concept emphasized by ISO/TC 176. In August 2022, the international standard ISO 10010:2022 "Quality Management — Guidelines for Understanding, Evaluating, and Improving Organizational Quality Culture," proposed and led by China, was officially published by ISO. In this ISO 9001 revision, advocating a quality culture consistent with the organization's mission, vision, and values will also be included in the overall leadership requirements.

(3) Greater Focus on Climate Change Factors

At the ISO General Assembly in September 2021, ISO officially signed the "London Declaration," committing to ensure global standards support climate action by incorporating climate change factors into every newly developed international standard and adding climate change-related content in revisions of existing standards. In February 2024, ISO released revised versions of several management system standards related to climate change, explicitly adding in clause 4.1 that "the organization shall determine whether climate change is a relevant factor," and in clause 4.2 a note that "interested parties may raise climate change-related requirements." This revision will further strengthen attention to climate change.

(4) Updating the Concept of "Risks and Opportunities"

"Identifying and addressing risks" and "identifying and realizing improvement opportunities" will be two separate objectives for organizations when planning the quality management system in the new ISO 9001. Identifying risks to be addressed aims to ensure the quality management system achieves its intended results, prevents or reduces adverse effects, and achieves continual improvement. Identifying improvement opportunities aims to enhance beneficial effects. It should be noted that the new ISO 9001 does not separate all content involving "risks and opportunities" but decides based on specific circumstances whether to separate them.

(5) Emphasizing Attention to Emerging Technologies

The widespread application of emerging technologies brings new challenges and opportunities to organizational quality management. This revision adds guidance on the organization's application of emerging technologies, listing the use of artificial intelligence (AI), metaverse, virtual reality (VR), chatbots, and other emerging technologies.

(6) Focusing on the Accessibility of Documented Information

The new ISO 9001 no longer requires retention of documented information but emphasizes the accessibility of documented information. Documented information used as documents should ensure accessibility, and documented information used as records should ensure accessibility as evidence.

ISO/CD 9001 is currently in the research and voting stage, and the main technical content of the revision may still change. The technical content changes introduced in this article are for reference only; the content of the new ISO 9001 shall be subject to the official release.