ISO 9001

ISO 9001:2026 — What’s Changing and What It Means for Your QMS

ISO 9001 is under revision, with the next version expected to reflect significant changes in how organisations manage quality, risk and performance.

This article outlines the key proposed changes and what organisations should start preparing today.

What is ISO 9001:2026?

ISO 9001:2026 is the upcoming revision of ISO 9001:2015, expected to reflect changes in digitalisation, stakeholder expectations and organisational resilience.

The revision is expected to strengthen risk-based thinking, improve alignment with modern business environments and place greater emphasis on data-driven quality management.

1. Digitalisation and Cybersecurity

The revised standard is expected to place stronger emphasis on digital environments and risks associated with technology-enabled operations.

Expected Focus:

  • Data integrity and protection
  • Cybersecurity risks affecting quality processes
  • Digital process control and automation

What It Means:

  • Digital systems supporting the QMS should be controlled
  • IT and data-related risks should be identified and managed
  • Dependencies on software and digital platforms should be addressed

2. Enhanced Risk-Based Thinking

Risk-based thinking is expected to expand beyond operational issues into broader business and external risk areas.

Expected Focus:

  • Supply chain risks
  • IT and cybersecurity risks
  • External disruptions and resilience

What It Means:

  • Risk registers may need broader coverage
  • Risk evaluation may need to become more dynamic
  • Alignment with continuity planning may become more important

3. Stronger Stakeholder and ESG Focus

The new version is expected to strengthen the role of interested parties and broader governance-related expectations.

Expected Focus:

  • Broader stakeholder expectations
  • Sustainability-related considerations
  • Ethical and governance-related impacts

What It Means:

  • Stakeholder analysis may need to be more robust
  • Organisations may need to consider wider expectations beyond customers
  • QMS planning may become more closely linked to governance and ESG priorities

4. Improved Performance Evaluation

Performance evaluation is expected to become more evidence-based and data-driven.

Expected Focus:

  • Meaningful KPIs
  • Better analysis of performance data
  • More effective monitoring and review

What It Means:

  • KPIs should be measurable and relevant
  • Management review should rely on stronger evidence
  • Organisations should monitor quality performance more effectively

5. Innovation and Continual Improvement Culture

Continual improvement is expected to move beyond corrective action and place more emphasis on innovation and proactive change.

Expected Focus:

  • Innovation within the QMS
  • Proactive improvement initiatives
  • Culture of adaptability and learning

What It Means:

  • Improvement systems should not be limited to closing nonconformities
  • Organisations may need to demonstrate structured improvement efforts
  • Culture may become a more visible element during audits

ISO 9001:2015 vs ISO 9001:2026 (Proposed)

Area ISO 9001:2015 ISO 9001:2026 (Proposed)
Risk Operational focus Broader view including IT, supply chain and external risks
Digitalisation Limited emphasis Stronger integration of digital systems and risks
Stakeholders Basic identification Expanded expectations and wider business context
Performance KPI and monitoring focus More data-driven and evidence-based evaluation
Improvement Corrective action driven More proactive and innovation-oriented

What Organisations Should Do Now

Immediate Actions:

  • Review the risk management framework to include IT and supply chain risks
  • Strengthen controls over digital systems supporting the QMS
  • Improve KPI structure and performance monitoring
  • Reassess stakeholder analysis and expectations

Medium-Term Actions:

  • Align QMS planning more closely with broader business and governance priorities
  • Expand internal audit scope to cover digital and outsourced controls
  • Train teams on broader risk-based thinking and emerging expectations

Impact on Existing ISO 9001 Certified Organisations

Organisations already certified to ISO 9001:2015 should expect a future transition period once the revised standard is published.

Get Your Free ISO 9001 Starter Pack

Includes clause-based checklist, documented information list and basic audit checklist.

Download Free Starter Pack

Need a System Ready for Future ISO Updates?

Access a practical Level 1–4 ISO 9001 document kit designed for implementation and future refinement.

View ISO 9001 Document Kit

Frequently Asked Questions (FAQ)

No. Organisations should monitor the official revision process and prepare based on emerging themes rather than assuming final wording.

Once the revised standard is published, a transition period is generally expected before the previous version is withdrawn.

Not immediately, but early preparation can reduce future transition effort and implementation risk.