ISO 9001:2015 Clause 4.3
What is ISO 9001:2015 Clause 4.3?
Clause 4.3 of ISO 9001:2015, titled “Scope of the Quality Management System and Its Processes,” establishes the requirement for organizations to determine the scope of their quality management system (QMS) and identify and manage its processes.
What are the Objectives of Clause 4.3?
Determining the Scope of the QMS
Organizations need to define and document the boundaries and applicability of their quality management system. This includes specifying the products, services, and locations covered by the QMS. The scope should consider the organization’s activities, functions, and interactions with external parties, ensuring clarity on what is and isn’t covered by the QMS.
Identifying and Managing Processes
Organizations are required to identify the processes needed for the QMS and their interactions. This involves determining the sequence and interaction of these processes and their ability to achieve the intended outcomes, including the effective operation and control of these processes.
Documenting the QMS
The organization needs to establish and maintain documented information necessary for the effectiveness of the QMS. This documentation may include process descriptions, procedures, policies, and records required by ISO 9001 and deemed necessary for the organization’s operations and conformity to customer and regulatory requirements.
What is the Purpose of Clause 4.3?
The purpose of Clause 4.3 is to provide a framework for organizations to clearly define the scope of their QMS, ensuring that it covers all relevant processes and activities required to meet quality objectives and deliver products or services that meet customer expectations.
Documenting the QMS Process
This clause also underscores the importance of documenting the QMS processes, which aids in understanding, implementing, and maintaining the system while providing evidence of conformity to ISO 9001 requirements.
Establish the Boundaries of the QMS
Clause 4.3 ensures that organizations establish the boundaries of their quality management system, define and manage its processes effectively, and maintain the necessary documentation to support the QMS’s successful operation.
Other ISO 9001:2015 Clauses:
What is the History of Clause 4.3?
Clause 4.3 in ISO 9001:2015, focusing on the “Scope of the Quality Management System and Its Processes,” represents a shift in the standard’s structure and approach compared to earlier versions.
ISO 9001:2008
Before ISO 9001:2015, the structure of the standard was different, and the specific breakdown of clauses varied. The previous version, ISO 9001:2008, didn’t have a dedicated clause numbered as 4.3 with the same focus and depth on the scope of the QMS and its processes.
In ISO 9001:2008, the concepts related to the scope of the quality management system and its processes were dispersed across different clauses, such as Clause 4 (Quality Management System), Clause 5 (Management Responsibility), and Clause 7 (Product Realization).
ISO 9001:2015
The revision to ISO 9001:2015 aimed to enhance clarity, alignment with other management system standards, and a more structured approach to the QMS. The inclusion of Clause 4.3 as a distinct section was part of this restructuring process.
This addition reflected a more explicit emphasis on defining the scope of the QMS and managing its processes as fundamental elements of effective quality management. It aimed to encourage organizations to establish a more systematic and structured approach to identifying and managing the processes that contribute to achieving quality objectives and meeting customer requirements.
Therefore, the inclusion of Clause 4.3 in ISO 9001:2015 was part of a broader effort to improve the clarity and effectiveness of the standard, ensuring that organizations clearly define the boundaries and processes of their quality management systems.
Helpful Resources: Planning your 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
Consulting Support for ISO 9001
Every year, we help hundreds of small businesses achieve ISO 9001 certification. Support for ISO 9001 is available through any of our Consulting Programs
As an American business with a story like yours, we know that time is valuable. Our expert consultants are here to take on the difficult, technical aspects of certification so you can focus on your business. They’ll work with you every step of the way until you’re successfully certified.
Interested? Get a Free Quote.
In many industries, ISO 9001 has become a supply-chain requirement. When landing a big contract, ISO 9001 certification could make all the difference.
About Core Business Solutions, Inc.
The bottom line: we are real people that have developed a team to come along side you to help you grow and succeed.”
— Scott Dawson, President and Co-Founder
Related Standards
We provide consulting support for various other standards, as well as support for companies seeking multiple certifications through an Integrated Management System.
AS9100
Aerospace Manufacturers
AS9120
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
AS9100
AS9120
ISO 14001
ISO
20000-1
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.