ISO 9001:2026

ISO 9001:2026 & Operational Excellence

From Quality Management to Sustainable Process Performance: what the new edition of ISO 9001 brings and how to use it as an opportunity to improve.

From Quality Management to Sustainable Process Performance

ISO 9001 is entering a new chapter.

The sixth edition of the world’s most widely used quality management standard was published on 16 September 2026, replacing ISO 9001:2015.

For organisations, however, the significance of ISO 9001:2026 extends beyond updating documentation or preparing for a transition audit.

It provides an opportunity to reconsider a more fundamental question:

Does our Quality Management System simply demonstrate conformity, or does it actively help our organisation perform better?

At Greece Lean Six Sigma, we approach quality management through the complementary perspectives of management systems, Operational Excellence and continuous improvement.

Through our PECB ISO 9001 training pathways and our Lean Six Sigma and Operational Excellence programmes, professionals and organisations can develop the capabilities required not only to understand and manage a Quality Management System, but also to improve the processes operating within it.


ISO 9001:2026, What Is Changing?

ISO 9001:2026 is the sixth edition of ISO 9001, the international standard defining requirements for Quality Management Systems.

The revised edition retains the established management-system framework while responding to the evolving environment in which organisations operate.

The revision places increased attention on areas including:

  • leadership and organisational responsibility;
  • quality culture;
  • risks and opportunities;
  • organisational context;
  • customer and stakeholder expectations;
  • process effectiveness;
  • performance evaluation;
  • continual improvement.

The objective is not to replace the principles of ISO 9001, but to ensure that the standard continues to support organisations operating in increasingly complex, technology-enabled and rapidly changing environments.

For organisations already certified against ISO 9001:2015, publication of the new edition will initiate a transition process.

The appropriate response should therefore go beyond asking:

“What clauses have changed?”

Organisations should also ask:

“What do these changes mean for the way our processes are managed, measured and improved?”


Why ISO 9001:2026 Matters for Organisations

A Quality Management System should not operate as a parallel administrative structure.

It should form part of the way the organisation manages its operations.

An effective QMS connects:

Customer Requirements
↓
Processes
↓
Responsibilities & Controls
↓
Performance Measures
↓
Risks & Opportunities
↓
Corrective Action
↓
Continual Improvement

When these elements operate together, quality management becomes an organisational capability rather than simply a certification requirement.

ISO itself associates ISO 9001 with improved performance, stronger customer confidence, process improvement, reduced inefficiencies and ongoing optimisation.

For senior leaders, Quality Managers and Process Owners, ISO 9001:2026 therefore presents an opportunity to examine whether the management system is genuinely contributing to business performance.


From ISO Compliance to Operational Excellence

Certification and Operational Excellence are related, but they are not identical.

A process may be documented.

It may have an owner.

It may contain defined controls.

It may comply with an approved procedure.

And yet that same process may still be:

  • unnecessarily slow;
  • costly;
  • dependent on manual intervention;
  • affected by excessive variation;
  • producing rework;
  • creating customer complaints;
  • generating duplicated activities;
  • difficult to measure;
  • poorly integrated with other processes.

This is where Operational Excellence complements Quality Management.

ISO 9001 provides the management-system framework.

Operational Excellence asks how effectively the processes within that framework actually perform.

The goal should therefore not simply be:

Document → Audit → Certify

but increasingly:

Understand → Control → Measure → Improve → Sustain


ISO 9001 and Lean Six Sigma

Lean Six Sigma and ISO 9001 serve different purposes, but they can reinforce one another considerably.

ISO 9001 establishes requirements for an effective Quality Management System.

Lean Six Sigma provides a structured approach for analysing and improving process performance.

Together, they can help organisations move from management-system conformity toward measurable operational improvement.

Where do they connect?

Customer Focus

ISO 9001 places the customer at the centre of quality management.

Lean Six Sigma translates customer expectations into measurable requirements through concepts such as:

  • Voice of the Customer;
  • Critical-to-Quality requirements;
  • process outputs;
  • customer-value analysis.

Process Approach

ISO 9001 requires organisations to understand and manage interconnected processes.

Lean Six Sigma strengthens this perspective through:

  • process mapping;
  • SIPOC;
  • value-stream analysis;
  • process measurement;
  • identification of waste and constraints.

Evidence-Based Decision Making

Management systems require monitoring, measurement and evaluation.

Lean Six Sigma provides analytical methods for understanding process behaviour, variation and performance.

Risks and Opportunities

Quality management requires organisations to identify and respond to relevant risks and opportunities.

Operational Excellence complements this by examining how process weaknesses, variation, waste and failure modes affect organisational performance.

Nonconformity and Root Cause

Correcting a problem is not necessarily the same as eliminating its cause.

Structured problem-solving and root-cause analysis help organisations move beyond symptom correction toward sustainable improvement.

Continual Improvement

ISO 9001 establishes continual improvement as a fundamental element of quality management.

Lean Six Sigma provides structured improvement methodologies, including DMAIC, that enable organisations to convert improvement objectives into disciplined projects with measurable outcomes.


Quality Management System vs Operational Excellence

Quality Management SystemOperational Excellence
Defines and controls processesImproves process performance
Establishes responsibilitiesStrengthens process ownership
Addresses risks and opportunitiesAnalyses causes of poor performance
Requires monitoring and measurementBuilds meaningful process metrics
Manages nonconformitiesReduces recurrence through root-cause analysis
Supports continual improvementProvides structured improvement methodologies
Demonstrates conformityPursues sustainable performance

The objective is not to choose one or the other.

For mature organisations, the stronger question is:

How can the Quality Management System become an engine for Operational Excellence?


What Should Organisations Consider Ahead of ISO 9001:2026?

Organisations should avoid treating the transition solely as a documentation exercise.

The publication of a revised standard provides an opportunity to review the effectiveness of the existing management system more broadly.

Areas worth examining include:

1. Organisational Context

Have significant changes in the organisation, market, technology, customers, workforce or operating environment been adequately reflected in the QMS?

2. Leadership

Is quality actively governed by leadership, or primarily delegated to the Quality Department?

3. Quality Culture

Do employees understand how their work influences quality, customer value and organisational performance?

4. Process Ownership

Does each significant process have clear ownership, responsibilities, interfaces and performance expectations?

5. Risks and Opportunities

Are risks and opportunities actively connected to operational decisions and process performance?

6. Performance Measurement

Are existing KPIs genuinely useful for managing processes, or are they primarily collected for reporting purposes?

7. Nonconformities and Corrective Actions

Does the organisation systematically distinguish between immediate correction and effective root-cause elimination?

8. Continual Improvement

Can the organisation demonstrate a structured system for identifying, prioritising, implementing and sustaining improvements?

These questions do not constitute a certification checklist.

They are strategic questions that help organisations assess whether their management system is delivering operational value.


PECB ISO 9001 Training

Develop internationally recognised competence in Quality Management Systems

Greece Lean Six Sigma offers PECB ISO 9001 training pathways for professionals seeking to develop competence in understanding, implementing and auditing Quality Management Systems.

PECB ISO 9001 Foundation

Designed for professionals who want to develop a fundamental understanding of ISO 9001 requirements and Quality Management System principles.

Suitable for:

  • professionals entering quality management;
  • members of QMS teams;
  • process participants;
  • managers seeking an understanding of ISO 9001;
  • professionals considering further ISO 9001 certification.

PECB ISO 9001 Lead Implementer

Develop the competence required to support the establishment, implementation, operation, maintenance and continual improvement of a Quality Management System.

The programme is particularly relevant for professionals involved in:

  • QMS implementation;
  • quality management;
  • process management;
  • organisational improvement;
  • preparation for certification;
  • QMS maintenance and continual improvement.

PECB ISO 9001 Lead Auditor

Develop the competencies required to plan, conduct and lead Quality Management System audits using internationally recognised auditing principles and practices.

The programme is particularly relevant for:

  • internal and external auditors;
  • Quality Managers;
  • consultants;
  • professionals responsible for QMS conformity;
  • audit programme managers;
  • professionals pursuing a career in management-system auditing.

Which Development Path Is Right for You?

Your appropriate pathway depends on your role and professional objective.

I need to understand ISO 9001

PECB ISO 9001 Foundation

↓

I need to implement or manage a Quality Management System

PECB ISO 9001 Lead Implementer

↓

I need to audit Quality Management Systems

PECB ISO 9001 Lead Auditor

↓

I need to improve process performance

Lean Six Sigma Yellow Belt / Green Belt

↓

I lead improvement or transformation across the organisation

Lean Six Sigma Green Belt / Black Belt + Operational Excellence capability

Quality Management and Operational Excellence should therefore be viewed as complementary professional capabilities, rather than competing disciplines.


ISO 9001 + Lean Six Sigma: A Broader Capability Pathway

For organisations seeking performance beyond basic conformity, professional development can combine management-system knowledge with process-improvement capability.

MANAGEMENT SYSTEM

PECB ISO 9001

Understand → Implement → Audit → Improve

PROCESS EXCELLENCE

Lean Six Sigma

Define → Measure → Analyse → Improve → Control

=

ORGANISATIONAL CAPABILITY

Quality + Process Performance + Continuous Improvement

This combination is particularly valuable for professionals responsible for Quality, Operations, Continuous Improvement, Process Excellence, Transformation and internal governance.


Who Can Benefit?

The ISO 9001:2026 and Operational Excellence perspective is particularly relevant for:

  • CEOs and senior management;
  • Quality Managers;
  • Operational Excellence leaders;
  • Continuous Improvement professionals;
  • Process Owners;
  • Operations Managers;
  • Internal Auditors;
  • Management System Managers;
  • Compliance professionals;
  • Lean Six Sigma practitioners;
  • consultants;
  • project and transformation leaders.

It is applicable across manufacturing and service environments, including healthcare, hospitality, logistics, financial services, technology, professional services and the public sector.


Corporate Training & Organisational Capability Development

Turn management-system requirements into organisational capability

Greece Lean Six Sigma supports organisations seeking to strengthen the relationship between Quality Management, process performance and continuous improvement.

Corporate learning solutions may combine relevant areas such as:

  • ISO 9001 management-system competence;
  • PECB professional training;
  • Lean Six Sigma;
  • process management;
  • Operational Excellence;
  • performance measurement;
  • structured problem solving;
  • continuous improvement capability.

Programmes can be designed for different organisational audiences and levels of responsibility, from awareness and process-owner development to specialist and leadership capability.

Our objective is not simply to deliver training content.

It is to help organisations build the knowledge required to manage and improve processes more effectively.


Coming Soon

ISO 9001:2026 & Operational Excellence Executive Masterclass

From Standard Requirements to Process Performance

A focused executive learning programme exploring the implications of ISO 9001:2026 from the perspective of Quality Management, process performance and Operational Excellence.

Indicative themes will include:

  • understanding the revised ISO 9001 environment;
  • implications for Quality Management Systems;
  • leadership and quality culture;
  • process ownership;
  • risks and opportunities;
  • performance measurement;
  • continual improvement;
  • the relationship between ISO 9001 and Lean Six Sigma;
  • preparing organisational capability for the transition.

Why Greece Lean Six Sigma?

Greece Lean Six Sigma provides professional development across complementary disciplines including:

Lean Six Sigma
Operational Excellence
Process Improvement
Transformation
PECB Management-System Training
Governance, Risk & Compliance

Our approach recognises that contemporary organisations rarely face isolated improvement challenges.

Quality, process performance, risk, technology, people and transformation increasingly interact.

Developing professionals who can understand those connections is therefore becoming as important as developing expertise within individual disciplines.


Frequently Asked Questions

What is ISO 9001:2026?

ISO 9001:2026 is the sixth edition of the international Quality Management System standard ISO 9001. It is intended to replace ISO 9001:2015 and reflects the evolution of organisational and stakeholder expectations while maintaining the established Quality Management System framework.


When was ISO 9001:2026 published?

The sixth edition of ISO 9001 was published on 16 September 2026.

Until formal publication occurs, organisations should rely on official ISO information for the definitive status and requirements of the standard.


Will ISO 9001:2026 replace ISO 9001:2015?

Yes. ISO has confirmed that the sixth edition will replace ISO 9001:2015.

Organisations currently certified against ISO 9001:2015 will have a transition period to adapt their Quality Management Systems. Transition requirements and timing should be confirmed through applicable accreditation and certification arrangements following publication.


Does my organisation need to start changing its QMS immediately?

Organisations should avoid making uncontrolled changes based solely on commentary about draft requirements.

However, this is an appropriate time to review the effectiveness of the existing Quality Management System, identify capability gaps and follow official publication and transition guidance.


Is ISO 9001 certification the same as Operational Excellence?

No.

ISO 9001 establishes requirements for an effective Quality Management System.

Operational Excellence focuses more broadly on how an organisation continuously improves processes, performance, customer value and organisational capability.

The two approaches can strongly reinforce one another.


How does Lean Six Sigma support ISO 9001?

Lean Six Sigma provides structured methods and tools that can support areas relevant to an effective QMS, including:

  • customer requirements;
  • process understanding;
  • measurement;
  • root-cause analysis;
  • variation reduction;
  • waste reduction;
  • problem solving;
  • continual improvement.

Lean Six Sigma does not replace ISO 9001. It strengthens an organisation’s ability to improve the performance of processes operating within its management system.


Which PECB ISO 9001 course should I choose?

Professionals seeking an introduction to ISO 9001 may consider PECB ISO 9001 Foundation.

Professionals responsible for implementing, managing or continually improving a QMS may consider PECB ISO 9001 Lead Implementer.

Professionals responsible for conducting or leading QMS audits may consider PECB ISO 9001 Lead Auditor.

Greece Lean Six Sigma can assist you in identifying the pathway most appropriate to your role and professional objectives.


Can ISO 9001 training be delivered for organisations?

Yes.

Corporate training can be structured according to organisational needs, participant roles and intended capability outcomes.

Contact Greece Lean Six Sigma to discuss PECB training, Lean Six Sigma programmes or broader Operational Excellence capability development.


Is your organisation ready for the next generation of Quality Management?

ISO 9001:2026 represents more than a standards transition.

It is an opportunity to examine how quality, process performance and continual improvement work together across the organisation.

Whether your objective is to:

  • understand ISO 9001;
  • develop implementation competence;
  • strengthen auditing capability;
  • improve operational processes;
  • develop Lean Six Sigma practitioners; or
  • build a broader culture of Operational Excellence,

Greece Lean Six Sigma can support the appropriate professional-development pathway.

PECB ISO 9001 Training

Foundation | Lead Implementer | Lead Auditor

Lean Six Sigma

Yellow Belt | Green Belt | Black Belt

Corporate Capability Development

Quality | Process Excellence | Operational Excellence | Transformation


PAGE DISCLAIMER / UPDATE NOTE

Information update: October 2026

ISO 9001:2026 was published on 16 September 2026. Information on this page will be reviewed following formal publication of the sixth edition and subsequent official transition guidance.

Greece Lean Six Sigma recommends referring to official ISO, accreditation and certification sources for definitive requirements and transition arrangements.

Get ready for ISO 9001:2026

Turn the transition into an opportunity: a simpler system, KPIs that matter and audits that improve.

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