ISO 9001:2015 Clause 4.4

What is ISO 9001:2015 Clause 4.4?

In ISO 9001:2015, Clause 4.4 is titled “Quality Management System and its Processes.” This clause is integral to defining and establishing the framework for the Quality Management System (QMS) within an organization.

What are the Specific Objectives of Clause 4.4?

Establishing the Quality Management System (QMS)

This clause addresses the requirement for an organization to establish, implement, maintain, and continually improve its QMS. It emphasizes the importance of aligning the QMS with the organization’s strategic direction and objectives.

Processes in the QMS

It involves identifying, implementing, and managing the processes necessary for the QMS to function effectively. This includes determining the sequence and interaction of these processes to ensure they achieve the desired outcomes and meet customer requirements.

Documentation Requirements

Clause 4.4 emphasizes the importance of maintaining documented information necessary for the effectiveness of the QMS. This documentation might include process descriptions, procedures, policies, and records required by ISO 9001 and essential for the organization’s operations and conformity to customer and regulatory requirements.

Process Integration

This clause also emphasizes the integration of the QMS processes into the organization’s overall business processes. It encourages organizations to consider how these quality-related processes align with other functions and activities.

Overall, Clause 4.4 serves as a cornerstone for establishing a structured QMS. It emphasizes the need for clear documentation, well-defined processes, alignment with organizational objectives, and continual improvement as fundamental elements for ensuring the QMS’s effectiveness in meeting quality objectives and customer satisfaction.

ISO 9001 Clause 4 Sub-Clauses Chart

What is the History of Clause 4.4?

The structure and content of ISO 9001:2015, including Clause 4.4, reflect a significant revision from earlier versions of the standard. Before ISO 9001:2015, the structure of the standard was different, and the specific breakdown of clauses varied.

Previous Versions of Clause 4.4

In previous versions, such as ISO 9001:2008, the requirements related to the quality management system were distributed across different clauses. There wasn’t a dedicated clause numbered as 4.4 with the same focus and depth on the QMS and its processes.

ISO 9001:2015 Revision

The 2015 revision aimed to enhance the standard by aligning it with a more common structure known as the High-Level Structure (HLS), shared among various ISO management system standards. This revision aimed to:

Enhance Consistency

Align ISO 9001 with other ISO management system standards to facilitate easier integration for organizations implementing multiple systems (e.g., quality, environment, health, and safety).

Emphasize Key Principles

Focus on core concepts such as risk-based thinking, the context of the organization, leadership commitment, and continuous improvement.

Improve Clarity and Usability

Make the standard more accessible and user-friendly for organizations of varying sizes and industries.

The introduction of Clause 4.4 in ISO 9001:2015 was part of this restructuring process. This clause, focusing specifically on the Quality Management System and its Processes, aimed to bring together requirements related to establishing, implementing, maintaining, and improving the QMS into a distinct section.

Streamline and Consolidate QMS Related Requirements

The evolution of Clause 4.4 reflected a concerted effort to streamline and consolidate QMS-related requirements, emphasizing the importance of a well-defined and documented system that aligns with organizational goals, ensures compliance, and drives continual improvement.

This restructuring aimed to provide organizations with a more coherent and structured framework for developing and managing their quality management systems, making it easier to comprehend and implement the standard’s requirements.

Helpful Resources:  Planning your QMS Podcast

Planning you QMS Podcast

In this week’s podcast, Suzanne Weber-Smatko, Manager of Consulting Services here at Core Business Solutions, will guide us on how to start planning your QMS. Suzanne discusses the creation of a quality manual, the importance of using the PDCA cycle when beginning the process of planning, and the importance of maintaining documentation. Learn More

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Related Standards

We provide consulting support for various other standards, as well as support for companies seeking multiple certifications through an Integrated Management System.



Aerospace Manufacturers


Aerospace Distributors

ISO 14001

Environmental Management Systems

ISO 27001

Information Security Management Systems

ISO 20000-1

Service Management Systems

ISO 45001

OH&S Management Systems

ISO 13485

Medical Device Manufacturers



ISO 14001


ISO 27001

ISO 45001

ISO 13485

Equip Your Business to Meet ISO 9001 With CORE

At Core Business Solutions, we’re here to equip your company for success in meeting ISO 9001 requirements. We’ve helped hundreds of small businesses grow and deliver the best solutions to their clients. We provide ISO training services, consulting help, and compliance software and to help you get certified and stay certified. We focus on optimizing your processes and helping you implement an ISO-compliant QMS. When you partner with us, you’ll get the tools and help you need for success.

For more information on the ISO 9001:2015 standard, please visit our articles page. You can also call our consulting office at 866-354-0300 or contact us online.

Do you want to update your existing ISO 9001 QMS System or refresh it?

We provide consulting services to assist you in your ISO 9001 Quality Management System refresh. We listen, conduct a gap analysis, update your Quality Policy and any necessary documentation or procedures, find areas of waste or improvement, simplify and automate. And we do it fast. Core offers firm, fixed pricing. Download our information sheet today to learn more or call us at 866-354-0300 Extension 2.