ISO 9001:2026 Quality Management Systems

Transition from ISO 9001:2015

Organizations certified to ISO 9001:2015 have three years to move to ISO 9001:2026. Customer focus, the process approach, risk-based thinking and continual improvement remain at the heart of the standard, and ISO 9001:2026 continues to follow the Harmonized Structure that ISO uses for all of its management system standards.

Key dates: after 18 months (March 2028), no new ISO 9001:2015 certificates will be issued, and all ISO 9001:2015 certificates expire 36 months after publication (September 2029).

Omnex offers a one-day Transitioning to ISO 9001:2026 course, in person, or virtually.

For leadership teams, the ISO 9001:2026 Executive Overview: The Role of Top Management covers the role of top management in a successful transition.

The Evolution of ISO 9001

From manufacturing conformance to a process-based business management system

The 1987 edition focused strongly on manufacturing and conformance, with 20 stand-alone requirements, and the 1994 revision was largely incremental. The 2000 revision shifted toward customer focus, process focus, customer satisfaction and continual improvement, and the 2008 revision primarily clarified it. The 2015 revision added organizational context, interested party expectations, risk-based thinking and aligned ISO 9001 with the Harmonized Structure that ISO developed for its management system standards, with leadership central to the PDCA model.

The QMS in Context

Context and expectations feed the quality policy, objectives, risks, opportunities and process planning

A QMS includes the quality policy, quality objectives and the processes needed to satisfy relevant quality-related needs and expectations. It applies across the organization within its defined scope and can be understood as part of the broader business management system. Context and interested party expectations feed the quality policy, objectives, risks, opportunities and process planning.

The QMS and the PDCA Cycle

Leadership supports the full cycle; improvement feeds the next cycle

• Plan: customer requirements, organizational context, interested party expectations, process approach, risks and opportunities, and quality objectives.
• Do: resources, support and operational processes.
• Check: customer satisfaction, internal audit, monitoring, measurement, analysis and management review.
• Act: correction, corrective action and continual improvement.

The Process Approach

Elements of a Single Process

Process maps should show not only workflow, but how intended QMS results are achieved (4.4.1)

Each process should identify its inputs, outputs, sequence, interfaces, criteria, methods, measurements, performance indicators, resources and responsibilities. Clause 4.4.1 connects the process approach with risks and opportunities, performance measurement, accountability and continual improvement. Process maps should demonstrate not only workflow, but how intended QMS results are achieved. The sequence and interaction of processes are at the heart of the QMS.

Risks and Opportunities

Planning begins with context, interested party needs and expectations, and intended QMS results. Risks address uncertainty that could adversely affect results, conformity, customer satisfaction or process performance.

ISO 9001:2026 treats opportunities more explicitly and separately from risks. Opportunities should be identified, evaluated and acted on when they can improve products, services, processes, customer satisfaction, resilience or QMS performance. Actions for risks and opportunities are integrated into QMS processes, and their effectiveness is evaluated.

The Harmonized Structure

A consistent clause framework, core text and terminology shared across ISO management system standards

The Harmonized Structure is ISO’s common framework for all of its management system standards, including ISO 9001 and ISO 14001. It provides a consistent clause framework, harmonized core text and shared terminology, supporting integrated management systems with standards such as ISO 14001. Organizations do not need to structure their procedures by clause sequence; documentation should follow how the organization actually operates.

Seven Quality Management Principles

• Customer focus
• Leadership
• Engagement of people
• Process approach
• Improvement
• Evidence-based decision-making
• Relationship management

Why Implement ISO 9001?

ISO 9001 gives organizations an international management systems framework that supports the delivery of high-quality products and services. Implementation can improve business performance, boost employee morale, enforce standardized operating procedures and enhance clarity for staff.

Certification

Once you have implemented the standard, you can invite an authorized certification body to audit your ISO 9001 QMS. Upon successfully completing the audit, the certification body grants your organization an ISO 9001 certificate. ISO 9001 certification can be issued only to organizations, not to individuals.

How Omnex Helps

Omnex has been a pioneer in providing Quality Management System services to thousands of organizations worldwide, along with support for occupational health and safety (ISO 45001), environmental management (ISO 14001), Business Operating System frameworks, disciplined problem solving and value-based auditing techniques. Omnex has a strong track record of achieving zero nonconformities during certification audits.

• Consulting, Implementation & Coaching
• Training and Competency Development
• Quality Outsourcing
• Digital Collaboration Software Platform

ISO 9001:2026 Training

All courses are offered in person in Ann Arbor, MI, or virtually. The Executive Overview is scheduled on demand and can be delivered onsite.

Integrated Management Systems courses and E-Learning modules are also available.