Tech Library

ISO 9001 Revised for the First Time in About 11 Years

ISO 9001, the international standard for Quality Management Systems (QMS), is scheduled to have a revised edition (ISO 9001:2026) published in September 2026, approximately 11 years after the release of the 2015 edition.

This revision does not fundamentally change the basic approaches to quality management (such as the PDCA cycle or the process approach).
However, taking into account changes in the business environment—such as the rapid advancement of digitalization, climate change, and the increasing complexity of supply chains—the requirements are expected to be clarified and strengthened to align with current business conditions.
Based on information available as of July 2026, this article provides a detailed overview of the background of the revision, its key points, and the steps companies should take to prepare now.

Why is it being revised?

ISO standards are periodically revised to adapt to changes in the social and technological environment. Since the publication of the 2015 edition, the environment surrounding businesses has changed significantly.

• Advances in DX (digital transformation) and the expanding use of digital technologies such as AI and IoT
• Increasing complexity and vulnerability of supply chains due to geopolitical risks
• Climate change mitigation and a focus on sustainability
• A severe human resource shortage and the crisis of knowledge transfer

The purpose of this revision is to appropriately integrate these contemporary challenges into the QMS, prevent it from becoming a mere formality, and further enhance its effectiveness.

Key Points in the Revision

1．Consideration of Climate Change (Reflection of the Harmonized Structure)
Due to the revision of the Harmonized Structure common to ISO management system standards, organizations are now required to account for the impacts of climate change when considering the “Organization and its Context” (ISO 9001:2026, Section4.1) and the “Needs and Expectations of Interested Parties” (ISO 9001:2026, Section4.2).
In ISO 9001:2026, the operation of a QMS based on this approach is expected to become even more important.

2．Digitalization, the Use of Advanced Technologies (such as AI), and Data Integrity
Document management is expected to shift from the traditional paper-based approach to one based on the use of digital technologies such as the Cloud, IoT, and AI.
Ensuring the reliability of digital data (including protection against tampering) and methods for quality assurance in business automation processes are becoming increasingly important topics.

3．Advanced Risk Management
The “risk-based approach” traditionally required is expected to be further strengthened. It is anticipated that it will become increasingly important to broaden the scope of risks to be considered—such as physical risks associated with climate change, cybersecurity risks, and supply chain risks stemming from the diversification of outsourced partners and suppliers—and to evaluate and mitigate them accordingly.

4．Developing a Quality Culture and Ethical Standards
In recent years, focus on quality culture and ethics within organizations has grown.
Under the leadership of top management, it is important to develop a quality-focused culture throughout the company and establish a compliance system that ensures adherence to rules.

5．Organizational Knowledge Transfer and Human Resource Development
To supplement the human resource shortage, a more practical approach to managing the “Organizational Knowledge (ISO 9001:2026, Section 7.1.6)” is required.
Rather than simply creating manuals, it is necessary to establish a system that transforms informal knowledge into formal knowledge and utilizes digital tools to efficiently and reliably pass on technical skills and knowledges to the next generation.

Prepare Now: Key Actions for Companies (Especially in the Manufacturer Industry)

Rather than waiting for the official release of the revised edition to take action, it is effective to move forward with the following initiatives now in order to improve the existing QMS.

✔　Expansion of Risk Assessments (Climate Change, BCP(*), Security)
Implementing quality risk management in conjunction with BCP (Business Continuity Plan), including the development of alternative processes in anticipation of disasters and system failures

✔　Improving the Reliability of Digital Documents and Electronic Records
Establishing operational rules for digital data, including approval workflows, access permissions, and backup systems

✔　Standardization and Documentation of Skills and Knowledge (Knowledge Management)
Conducting an inventory of tasks that rely on field technicians, and establishing systems for training and competency management using video manuals and digital tools

✔　Strengthening Supplier Management and Collaboration
Conduct regular risk assessments of outsourced partners and suppliers, establishing alternative supply routes and a system for real-time information sharing with suppliers

✔　Self-Assessment of Compliance and Quality Culture
Review whether there are any “ambiguous operational practices arising from difficulties in adhering to rules” on work sites, and whether an open and communicative workplace environment is being maintained

(※)　BCP : Business Continuity Plan
A plan to ensure that critical business operations are not interrupted in the case of emergencies such as disasters, accidents, infectious diseases, or cyberattacks, or to restore operations as quickly as possible in the case of an interruption

Summary

ISO 9001:2026 is a revision intended to “further enhance the effectiveness of quality management systems while taking into account changes in the current business environment,” while maintaining the basic framework of quality management.
The most important thing for companies is not to treat the “maintenance and renewal” of certification as an end in itself, but rather to use this revision as an opportunity to leverage their QMS as a management system for solving business challenges and improving workplace operations (such as digital transformation and skills transfer).
Although a transition period is expected to be provided after the publication of ISO 9001:2026, it is important not to view this simply as a matter of complying with the revision, but rather to proactively use it as a valuable opportunity to review the company’s QMS and enhance its competitiveness.