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The ISO9001 quality management system is about to undergo significant changes


Time:

2024-07-11

The ISO9001 quality management system standard is about to be updated, strengthening requirements for ethics and integrity, quality culture, climate change response, risk management, and paying attention to the application of emerging technologies. Enterprises should actively prepare to respond, improve their quality management level, and achieve higher quality development.

  

The ISO9001 Quality Management System International Standard, developed by the Technical Committee for Quality Management and Quality Assurance of the International Organization for Standardization (ISO/TC176), has been the most widely used management system standard globally since its first publication in 1987. It is applicable to any industry and organization of any size, helping them establish and improve quality management systems. The current version of ISO9001:2015 is the 5th edition. As of May 2024, China has issued a total of 932000 quality management system certification certificates and 871000 certified organizations, ranking first in the world for many consecutive years. It has played a crucial role in improving the quality management level of Chinese enterprises.

 

1、 Overview of ISO9001 Revision Work

In November 2023, the ISO/TC176/SC2 (Technical Committee for Management Systems) established the WG29 "ISO9001 Revision" working group, officially initiating the revision of the ISO9001 international standard. In December of the same year, the WG29 working group held its first meeting in London, UK, and formed a working draft (WD). From February to April 2024, the WG29 working group reviewed the collected opinions and formed a committee draft (CD). The draft international standard (DIS) is planned to be formed from September to November 2024, and the final draft international standard (FDIS) will be formed from July to August 2025, and officially released in November 2025. Two registered experts from the WG29 working group of the China Institute of Standardization represented China in the revision of ISO9001.


2、 The main changes in this revision

The new version of ISO9001 is still based on the higher-order structure of the management system (HLS) in the overall structural framework, maintaining the principles of quality management, and continuing to adopt the PDCA cycle and risk-based thinking process approach. The following are the main changes in this revision:

1. Strengthen the requirements for "morality and integrity"

Ethics and integrity are important concepts that ISO/TC176 has been focusing on for a long time. The new version of ISO9001 plans to add requirements for advocating ethics and integrity, with the top management committing to and promoting adherence to the principles of ethics and integrity at all levels of the organization.

2. Increase requirements for "mission, vision, values, and quality culture"

Quality culture is a new concept of quality management that ISO/TC176 focuses on. In August 2022, China proposed and led the development of the international standard ISO 10010:2022 "Guidelines for Understanding, Evaluating, and Improving the Quality Culture of Organizations in Quality Management", which was officially released by ISO. In this revision of ISO9001, advocating a quality culture that is consistent with the organization's mission, vision, and values will also be included as an overall requirement for leadership.

3. Pay more attention to climate change factors

At the International Organization for Standardization (ISO) conference in September 2021, ISO officially signed the London Declaration, committing to ensuring that global standards support climate action, incorporating climate change factors into every newly developed international standard, and adding climate change related content to the revision of existing international standards. In February 2024, ISO released a revised version of multiple management system standards on climate change, which clearly stated the addition of "organizations should determine whether climate change is a relevant factor" in clause 4.1 of the standard, and "note: relevant parties can propose climate change related requirements" in clause 4.2. This revision will further strengthen attention to climate change.

4. Update the concept of "risk and opportunity"

The new version of ISO9001 sets "identifying and responding to risks" and "identifying and implementing improvement opportunities" as two objectives for organizations when planning quality management systems. The purpose of identifying the risks to be addressed is to ensure that the quality management system can achieve its expected results, prevent or reduce adverse effects, and achieve continuous improvement. Identify improvement opportunities that need to be achieved with the aim of enhancing beneficial impact. It should be noted that the new version of ISO9001 does not separate all content related to "risks and opportunities", but rather determines whether to separate them based on specific circumstances.

5. Emphasize attention to emerging technologies

The widespread application of emerging technologies has brought new challenges and opportunities to the quality management of organizations. This revision has added guidance for organizations in the application of emerging technologies, listing the use of emerging technologies such as artificial intelligence (AI), metaverse, virtual reality (VR), and chatbots.

6. Emphasize the accessibility of written information

The new version of ISO9001 no longer requires the retention of written information, but emphasizes the accessibility of written information. The written information used as a document should ensure its accessibility, and the written information used as a record should ensure its accessibility as evidence.

ISO/CD9001 is currently in the research and voting stage, and the main technical content of the revision may still undergo changes. The technical changes introduced in this article are for reference only. The content of the new version of ISO9001 is subject to official release.

 

 

3、 How do enterprises respond to the new version of ISO9001

Faced with the upcoming new version of ISO9001, enterprises should actively prepare. The following suggestions can help enterprises smoothly transition and fully utilize the opportunities brought by the new standard:

1. Strengthening the construction of ethics and integrity: Enterprises should start from the top management, advocate and practice the principles of ethics and integrity, establish corresponding systems and culture, and ensure that every employee can understand and abide by these principles.

2. Building a consistent quality culture: Enterprises need to clarify their mission, vision, and values, and integrate them into the quality management system. This not only helps to enhance the overall quality culture of the enterprise, but also enhances the sense of identification and belonging of employees.

3. Pay attention to climate change factors: Enterprises should identify and evaluate the impact of climate change on their operations, develop corresponding response strategies and measures, and incorporate climate change factors into their quality management system.

4. Managing risks and opportunities: Enterprises should systematically identify and manage risks, while seizing opportunities for improvement, to ensure the effectiveness and continuous improvement of the quality management system.

5. Application of emerging technologies: Enterprises should actively explore and apply emerging technologies, such as artificial intelligence, virtual reality, etc., to improve their quality management level and competitiveness.

6. Ensure the accessibility of written information: Enterprises should ensure the accessibility of all written information, whether used as documents or as evidence for records, to ensure its integrity and traceability.

 

 

4、 The long-term impact of the new version of ISO9001

The revision of the new version of ISO9001 not only reflects the development trend of global quality management, but also provides new development directions and opportunities for enterprises. By implementing the new standards, enterprises can benefit from the following aspects:

1. Enhancing corporate image and reputation: By strengthening moral and integrity construction, enterprises can establish a good social image and enhance the trust of customers and partners.

2. Enhancing enterprise competitiveness: By building a consistent quality culture and applying emerging technologies, enterprises can enhance the quality of products and services, and enhance market competitiveness.

3. Promoting sustainable development: By focusing on climate change factors, enterprises can improve their environmental management level, promote sustainable development, and fulfill their social responsibilities.

4. Realize continuous improvement: By systematically managing risks and opportunities, enterprises can continuously enhance the effectiveness of their quality management system and achieve continuous improvement.

The revision of the ISO9001 quality management system is still ongoing, and enterprises should closely monitor the progress of the revision, actively prepare, and adjust and optimize the quality management system in a timely manner to meet future challenges and opportunities.

The revision of the ISO9001 quality management system is not only a refinement of current standards, but also a guide for global quality management practices. Enterprises should fully recognize the importance of this revision, actively respond, seize opportunities, improve their quality management level, and achieve higher quality development.

The official release of the new version of ISO9001 will bring new guidance and direction to global enterprises, allowing us to look forward to the arrival of this important standard and contribute to the improvement of global quality management level.

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