ISO 9001 Clause 1

ISO 9001:2015

Understanding ISO 9001:2015 Clause 1 – Scope of the Standard

At CertFast, we help small businesses become ISO 9001 certified. We make complex standards easy to understand and follow. One of the first—and most important—components of the ISO 9001:2015 standard is Clause 1: Scope.

What Is Clause 1 About?

Clause 1 of ISO 9001:2015 sets the stage for the quality management system (QMS). It explains who the standard is for, what it covers, and where it applies within an organization. In simple terms, it sets the limits of your QMS. It also helps make sure your business activities follow ISO requirements.

Your certification starts with Clause 1-Scope.  It covers your Quality Management System requirements. ISO 9001:2015 Clause 1 helps lay the foundation. To explore the other clauses of the standard, click on a link.

ISO 9001 Clauses

 

Key Elements of ISO 9001 Clause 1

 

1. Defining the Scope

This section identifies which parts of your business the standard will apply to. It covers relevant products, services, and processes that contribute to customer satisfaction and quality outcomes. This is especially valuable for small businesses trying to align limited resources with high-impact quality improvements.

2. Justifying Exclusions

Some parts of ISO 9001 may not apply to your operations. Clause 1 allows for exclusions, but you must justify them. For example, if your business does not do product design, you can leave out related clauses. Just make sure this does not affect your ability to meet customer or legal needs.

3. Integration-Friendly Framework

ISO 9001:2015 uses a structure called Annex SL. This design helps it work well with other standards, like ISO 14001 or ISO 45001. This is ideal for small businesses that want to grow into more comprehensive management systems over time.

4. Clear Guidance for All Users

Clause 1 clarifies things for your business. It also helps auditors, consultants, and others in your certification process. It helps everyone understand how the standard applies to your operations. This makes the audit and implementation process easier.

 

Why It Matters for Small Businesses

Getting certified can seem overwhelming, especially when you’re juggling day-to-day operations. That’s where CertFast can help.

At CertFast, we’re committed to helping small businesses across the U.S. successfully achieve ISO 9001 certification. Our consultants handle the technical heavy lifting so you can focus on running your business. From defining your scope to preparing for audits, we’re with you every step of the way.

ISO 9001 Certification