Determining the Scope of the Quality Management System according to ISO 9001:2015

Are you planning to define the scope of the quality management system (QMS) according to ISO 9001:2015 but aren’t sure where to start? Setting the right scope is essential for any organization aiming to meet ISO standards, as it sets the groundwork for your entire quality strategy. Without a clearly defined scope, your organization risks inefficient processes, ambiguous roles, and potential compliance failures that could jeopardize operations and damage your reputation.

But here’s the good news: once you’ve established a clear QMS scope, you’ll figure out streamlined operations, efficient workflows, and a foundation for continuous improvement. In this guide, you will find out what it means to define your QMS scope effectively, why it matters, and how you can set the path to smoother, more efficient processes. 

Let’s make ISO compliance simpler and more manageable, starting with your QMS scope.

What Does “Defining the Scope” Mean?

Defining the scope of the quality management system (QMS) is about establishing the boundaries and focus areas that your QMS will cover. In ISO 9001:2015, Clause 4.3 provides specific guidance on this, outlining how to determine the scope based on several internal and external factors.

Let’s look at the relevant clauses from 4.1 to 4.4, which frame how to approach this process:

• Clause 4.1: Understanding Context: Assess factors like market trends, legal requirements, and the competitive landscape that could impact your quality objectives.
• Clause 4.2: Interested Parties: Identify the needs of stakeholders, such as customers and regulators, whose requirements directly affect your QMS.
• Clause 4.3: Determining the Scope: Define the boundaries of your QMS by considering your organization’s products, services, and operational goals.
• Clause 4.4: Management System: Establish the processes needed to achieve consistent, high-quality outcomes in line with your defined scope.

So, why should you invest in defining the scope? According to the ASQ, companies prioritizing quality management practices can see a 40% drop in customer complaints. By reducing defects and errors, organizations enhance customer satisfaction and limit negative feedback. It showcases the impact of a well-defined QMS scope on overall quality. Let’s find out some important factors of the QMS scope.

Importance of Defining the Scope of the Quality Management System 

With a clear scope of the quality management system (QMS), you ensure that every aspect of quality management aligns with your business goals. Here’s why defining this scope is so important:

• Clear Focus
  A defined QMS scope provides a clear focus, helping your team understand what areas of the business are included and excluded. This direction ensures that quality efforts are targeted and effective.
• Improved Customer Satisfaction
  By establishing a QMS scope that addresses key quality areas, you can reduce defects and improve service, leading to fewer customer complaints and a more positive experience overall.
• Stronger Risk Management
  You ensure that all regulatory and customer requirements are addressed, reducing the risk of non-compliance and related issues.
• Continuous Improvement
  After defining a scope, you are automatically signing up for continuous improvement for your company. In this way, you can pave the way for the success of your organization. 

In short, by focusing on the scope of your quality management system, you create a structured, results-oriented approach that supports your organization's further growth. As we already understand the importance of the QMS scope, let’s explore what you should consider before implementing it in the next section. 

5 Key Considerations Before Defining Your QMS Scope

In a Deloitte survey, 94% of respondents recognized quality management as a core driver of customer satisfaction. Meeting or surpassing customer expectations builds loyalty and trust, especially in competitive industries where quality is critical. Here are five key considerations to keep in mind when defining your QMS scope:

• Range of Products and Services
  Determine which products and services are covered within your QMS scope. This ensures all quality efforts focus on the offerings that impact your business most significantly.
• Multi-Site and Activity Inclusion
  If your organization operates across multiple sites or has varied activities, outline which locations and functions are part of the QMS. This way, you maintain consistency in quality across all operational areas.
• External Process and Service Providers
  Account for outsourced processes, products, and services in your scope to ensure that external parties meet your quality standards, reinforcing a reliable end-to-end experience.
• Centralized Support Functions
  Identify common support services like HR or IT that contribute to quality objectives. Integrating these centralized functions within your QMS ensures uniform quality support across the organization.
• Site-Specific Requirements and Instructions
  Document any processes or requirements unique to a specific location in your QMS scope. So, if you are defining the scope, you need to focus on effective instructions related to the site.

By considering these elements, you’ll set a strong foundation for your QMS. We have listed 10 clauses or requirements that will help you define the scope of the quality management system. Contact BPR Hub to get additional resources and expertise to streamline your quality management journey.  

What are the requirements of ISO 9001:2015?

ISO 9001:2015 is built around 10 key clauses that outline its requirements. These clauses ensure that organizations develop, implement, and maintain an effective quality management system (QMS). Here’s an overview:

1. Scope: Defines the purpose of the standard, focusing on enhancing customer satisfaction through consistent quality and continual improvement.

2. Normative References: Lists reference documents essential for understanding and applying ISO 9001 requirements.

3. Terms and Definitions: Clarifies terminology used within the standard to ensure a common understanding across organizations.

4. Context of the Organization: Requires organizations to:

•  Understand their internal and external environments.
• Identify stakeholders and their needs.
• Define the scope of the QMS.

5. Leadership: Emphasizes the role of top management in:

• Demonstrating leadership and commitment.
• Establishing a quality policy.
• Assigning roles and ensuring accountability.

6. Planning: Focuses on:

• Identifying risks and opportunities.
• Setting quality objectives.
• Planning changes to the QMS effectively.

7. Support: Covers the resources needed to implement and maintain the QMS, including:

• People
• Infrastructure
• Training and awareness
• Communication
• Documented information (control and accessibility)

8. Operation: Addresses the actual processes required to deliver products or services, including:

• Planning and control
• Requirements for products/services
• Design and development
• Supplier management
• Production and service delivery
• Managing nonconforming outputs

9. Performance Evaluation: Focuses on monitoring, measuring, analyzing, and evaluating the QMS through:

• Internal audits
• Management reviews
• Customer satisfaction metrics

10. Improvement: Ensures the organization continually improves by:

• Addressing nonconformities
• Taking corrective actions
• Driving innovation and enhancing processes

These are the criteria that will help you better define the scope of the QMS. But what are the steps to follow to do it correctly? Let’s find out.

How to Define the Scope of the Quality Management System? 

Below are the five key steps to guide your organization in defining the QMS scope. Each step highlights what’s essential for creating a clear, actionable scope that aligns with ISO standards and supports smooth operations.

Step 1: Create a Scope Statement

Begin by developing a comprehensive scope statement. This statement outlines the essential elements that your QMS will cover, serving as a reference for all quality activities. Key components of the scope statement should include:

• Products and Services: Specify the primary products or services managed within the QMS. This helps focus quality efforts on core offerings.
• Processes: List the key processes involved in production or service delivery that directly impact quality.
• Departments and Teams: Identify the departments or functions within your organization that will be included in the QMS, such as production, customer service, or procurement.

This statement is fundamental for setting clear expectations within your organization and serves as a baseline for audits, ensuring transparency and focus on critical areas.

Step 2: Identify Physical Locations and Products

A clear QMS scope also identifies the specific locations, products, and, if relevant, industries to which it applies. This means detailing the physical sites where the QMS will be active, such as headquarters, branches, or operational departments. Including the types of products or services produced within the QMS ensures that quality standards are applied consistently across all outputs. 

Additionally, if the QMS pertains to specific industries—such as healthcare, manufacturing, or technology—this relevance should be specified. This level of detail provides clarity for external stakeholders, as well as within the organization, on where the QMS scope applies and where it does not.

Step 3: Alignment with ISO 9001:2015 Standards

ISO 9001:2015 includes specific criteria for determining the scope of the quality management system, as mentioned above. Aligning your scope with these standards is essential for compliance, as it helps demonstrate to auditors that your organization’s scope is comprehensive and meets industry expectations. 

By adhering to ISO guidelines, you establish a commitment to quality management that is recognized globally. This alignment also simplifies the certification process and gives customers confidence that your organization upholds high-quality standards.

Step 4: Document a Concise Scope Statement

Once the scope is defined, capture it in a concise statement that is easily understandable by both internal teams and external stakeholders. Avoid jargon and keep the statement straightforward. This statement should clarify the QMS boundaries, outlining what is included without overwhelming details. Documenting the scope concisely is essential for audits and serves as a quick reference point for management reviews and quality assessments.

Step 5: Justify Non-Applicable Requirements

There may be specific ISO 9001:2015 requirements that do not apply to your organization. It’s important to clearly state any exclusions in the QMS scope and justify them appropriately. Common justifications include:

• Process Justification: If certain processes don’t apply to your organization (such as those used in manufacturing when you provide only services), document these exclusions with a rationale.
• Product or Service Justification: Exclude products or services that fall outside the organization’s primary offerings, such as legacy products that are no longer actively produced or sold.
• Operational Context Justification: If unique operational factors make some requirements irrelevant, such as geographic limitations or regulatory exceptions, document these specifics in the scope.

Log into the BPR Hub’s Document Hub to achieve an effective and compliant QMS. Since these steps are not easy to follow primarily, mistakes may happen. And that’s not the end of the road. Scroll to the next section to get ideas about some common challenges you may face in this process.

Common Mistakes to Avoid to Define the Scope of the Quality Management System

Avoiding common mistakes when defining the scope of the quality management system can ensure a strong foundation for effective quality management. Given the rapidly growing quality management software market, which was valued at $9.92 billion in 2023, investing time in correctly setting up your QMS scope is essential for long-term success. Here are three common pitfalls to avoid:

• Unclear Scope Boundaries: Without precise boundaries, your QMS may lack direction, leading to inconsistent quality efforts. Define all included locations, departments, and processes to ensure clarity.
• Overlooking Stakeholder Needs: Ignoring key stakeholder and compliance requirements can weaken your QMS. Address customer and regulatory needs to enhance alignment and effectiveness.
• Unjustified Process Exclusions: Excluding critical processes without reason creates quality gaps. Only exclude non-essential processes and document clear justifications for each.

Since defining the scope of a quality management system is crucial, you should consider a cloud-based platform to manage your QMS. 

Choose BPR Hub to Define the Scope of the Quality Management System

Choosing the right partner to define the scope of the quality management system is crucial. But with BPR Hub, you gain a powerhouse of resources tailored to simplify and elevate every step of the process. Here’s why BPR Hub is the best choice for businesses serious about quality management and ISO 9001 certification.

• Real-Time Compliance Management
  With live compliance data integration, BPR Hub keeps you audit-ready and informed, minimizing risks and enabling proactive decision-making.
• Boosted Efficiency in Production
  Our platform is designed to enhance production management, improving output and reducing waste, so your operations run smoothly.
• Automated Workflow Innovation
  Automate complex compliance tasks effortlessly, allowing your team to focus on high-impact work instead of getting bogged down by manual tasks.

With trusted accreditations from the United Accreditation Foundation (UAF) and the Standards Council of Canada (SCC), BPR Hub’s tools meet rigorous industry standards, giving you peace of mind on the path to quality excellence.

Get Started with BPR Hub today to improve your QMS journey with confidence, compliance, and clarity.

Frequently Asked Questions

1. Can a QMS scope be updated after implementation?

Yes, the QMS scope can and should be updated when necessary. Businesses evolve, and so do their operations, products, or market focus. For instance, if your organization expands to new locations or introduces new products, you should revisit your QMS scope to ensure alignment with these changes. Regular reviews and audits help keep the scope relevant and effective.

2. What is the role of leadership in defining the QMS scope?

Leadership plays a critical role in defining the QMS scope. They provide the strategic direction and resources needed for its successful implementation. Top management must align the scope with the organization’s goals, communicate its importance to employees, and ensure it integrates with overall business objectives. Their commitment directly influences the QMS's success.

3. Are there industry-specific considerations when defining a QMS scope?

Absolutely. Different industries have unique regulatory requirements, operational complexities, and customer expectations that impact the QMS scope. For example:

• In manufacturing, the scope often includes production lines, raw material sourcing, and supplier management.
• In healthcare, regulatory compliance and patient safety take precedence.
• In IT services, data security and service delivery timelines might be critical.
  Tailoring the scope to industry needs ensures better compliance and effectiveness.

5. How can a poorly defined scope affect ISO 9001 certification?

A poorly defined QMS scope can lead to several issues during certification audits, such as:

• Non-compliance: Missing critical processes or requirements.
• Confusion: Lack of clarity about roles and responsibilities.
• Audit Failures: Exclusions or errors that raise red flags for auditors.
  Defining a clear and accurate scope minimizes these risks and sets the foundation for successful certification.

6. What is the relationship between QMS scope and risk management?

The QMS scope directly influences risk management by defining the areas that need monitoring and improvement. A comprehensive scope ensures that all significant risks—whether operational, legal, or customer-related—are addressed. It helps organizations proactively identify and mitigate risks, ensuring continuous compliance and quality improvement.