ISO 9001 Changes – Potential Changes in Quality Management

ISO 9001 Changes: What You May Need to Know

Quality Management is Evolving

Quality management is evolving to align with Industry 5.0. While Industry 4.0 emphasized automation and technological advancements, Industry 5.0 integrates human, environmental, and social considerations—fostering a more sustainable and balanced approach to business.

Sustainability and AI Governance

Sustainability is no longer optional—it’s a necessity. AI governance has become a priority, and the scope of quality management now extends to:

Environmental responsibility
Customer satisfaction
Controlled use of technology

ISO 9001 – Potential Changes on the Horizon

A significant change to ISO 9001 is expected in 2026, with subsequent alignments anticipated for related standards, including:

ISO 14001
ISO 45001
Industry-specific technical specifications

This article outlines potential upcoming changes and proactive steps your organization can take to prepare for the evolving global quality management system requirements.

The ISO Standards Update Cycle

The ISO standards maintenance process includes a review every five years to ensure ongoing relevance. Here’s a brief timeline:

2015: Major revision introduced risk-based thinking, leadership engagement, and customer-centric approaches.
2020: Review resulted in no changes to ISO 9001:2015.

Industry Trends Driving ISO 9001 Revisions

Over the past decade, industries have undergone significant transformation in areas such as:

Digital Transformation: Innovations in automation, business process optimization, enhanced customer interaction, and digital business models
Cybersecurity & Data Protection: Strengthening security protocols to safeguard sensitive information.
Sustainability: Increasing focus on eco-friendly practices and corporate responsibility.
Supply Chain Resilience: Addressing global supply chain disruptions and ensuring supplier performance and continuity.
Automation, Data Analytics & AI: Leveraging emerging technologies to improve operational efficiency and assist leadership with decision-making

To align with these developments, the ISO TC 179 subcommittee is working to update ISO 9001 to better reflect today’s evolving global business models.

ISO 9001 Update Timeline

CD1 (First Committee Draft): Released in December 2024, but rejected
CD2 (Second Draft): Currently in development
Final Publication: Expected in September 2026
Transition Period: Three years to implement the new standard

How to Prepare for ISO 9001 Changes

1. Monitor the Status of ISO 9001 Revisions

Periodically review updates from ISO and trusted industry sources to stay informed about changes to the standard. Understanding the scope, intent and timeline of these revisions will help your organization prepare your quality management system to address these changes effectively.

2. Conduct a Gap Analysis

After the standard has been published obtain a copy and perform a detailed gap analysis to compare the current state of your Quality Management System (QMS) with the updated requirements. Identify areas that need to be addressed to ensure compliance with ISO 9001:2026.

3. Revise Documentation and Processes

Review and where necessary update your policies, procedures, audit program and documentation to align with the revised standard. Ensure all changes are clearly identified, addressed and seamlessly integrated into your QMS and business processes where applicable.

4. Train and Educate Your Team

Provide thorough training for employees at all levels to ensure they understand the changes and their impact on daily operations. Train your internal auditors to ensure changes are included in the scope of your ongoing internal audits. Ensure the use of process approach and risk-based thinking auditing methods.

5. Prioritize Key Focus Areas

The 2026 revision is expected to emphasize several essential aspects:

– Digital Transformation & Technology

Leverage automation, AI, and data analytics to enhance operational efficiency and leadership decision-making.

– Risk & Opportunity Management

Take a proactive approach to identifying and addressing risks while capitalizing on opportunities to strengthen resilience.

– Sustainability & Ethical Practices

Align quality objectives with environmental sustainability and ethical business operations.

– Stakeholder Engagement

Broaden your organization’s focus beyond customers to include employees, suppliers, and relevant interested parties.

6. Develop a Transition Plan

Create a structured transition plan that outlines necessary steps, timelines, and resources for implementation. Regularly review and update this plan.

By proactively implementing these steps, your company can smoothly transition to ISO 9001:2026 while maintaining compliance and minimizing disruptions.

Equip Your Team with Skills to Last the Test of Time

Elcometer Education Institute is an Exemplar Global Recognized Training Provider, offering expert-led training on:

ISO 9001
ISO 14001
ISO 45001
ISO 17025
IATF 16949

Our dedicated development team closely monitors ISO revisions to ensure our training programs remain aligned with both current and future standards, equipping your organization with the essential skills to manage, maintain, and audit its management systems effectively.