ISO 9001:2015 Clause 1

What is the ISO 9001:2015 Clause 1 About?

Clause 1, Scope of the Operation of the ISO 9001 Standard defines the applicability and boundaries of ISO 9001, which is an international standard for quality management systems. It outlines the purpose and general framework of the standard, including its scope and exclusions.

The scope defines the range of activities, processes, products, and services to which the organization intends to apply the standard. It specifies the specific requirements and criteria that organizations need to meet to achieve ISO 9001 certification.

The Specific Objectives of Clause 1 are as follows:

Scope Definition:

The section defines the scope of the ISO 9001:2015 standard by specifying the range of activities, products, and services to which it is applicable. It clarifies that the standard is relevant to any organization, regardless of its size or sector, that wishes to establish, implement, and maintain a quality management system (QMS) to enhance customer satisfaction and meet applicable requirements.

Exclusions (if any):

Section 1 also addresses the topic of exclusions, where an organization may determine that specific ISO 9001 requirements are not applicable or cannot be met due to the nature of its operations. If any exclusions are identified, the section requires organizations to provide justification and ensure that such exclusions do not affect the organization’s ability to provide products and services that meet customer and regulatory requirements.

Alignment with Other Standards:

The section highlights that ISO 9001:2015 is designed to be compatible with other management system standards, particularly those that follow the Annex SL framework. This promotes harmonization and facilitates the integration of multiple management systems within an organization, allowing for more streamlined and cohesive processes.

Clarification for Users:

Section 1 provides essential information for users of the standard, including auditors, organizations seeking certification, and other interested parties. It establishes a common understanding of the standard’s scope and applicability, helping users determine if ISO 9001 is relevant to their specific circumstances.

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.

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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.

“Core Business Solutions was started by my brother, Mike Dawson, and myself, true entrepreneurs at heart looking for a better way to make a living and help small businesses improve the quality of the products and services they provide.

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.