ISO 9001—Meaning, Requirements and Beginner’s Guide

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To keep any business running smoothly and successfully, it needs a structured framework that minimizes risk, enhances efficiency, and keeps quality levels consistently high. Without this framework, companies can struggle to retain customers, and struggle with wastage and inefficient operations—all of which can impact revenue and profitability.

One way to implement a framework focused on quality is through a Quality Management System (QMS) certified to ISO 9001. While many organizations understand the need for business plans, risk assessments and operational policies, you may be wondering about the meaning of ISO 9001, its definition and how a QMS can support an organization’s goals.

ISO 9001 is the international standard that requires organizations to manage their systems and processes with the goal of consistently providing services that meet customer and applicable statutory and regulatory requirements, and facilitate opportunities to enhance customer satisfaction through the use of a Quality Management System. In 2022, 29,579 ISO 9001 certifications were awarded to U.S. organizations.

Read on to learn more in our ISO 9001 beginner’s guide—including ISO 9001 meaning and definition, the standard requirements, and how your organization can achieve ISO 9001 certification.

ISO 9001 Meaning and Definition

ISO 9001 is the internationally recognized standard for Quality Management Systems (QMS). Developed by the International Organization for Standardization, it provides a set of criteria to build, implement, and maintain a QMS with the goal of consistently providing products or services that meet or exceed customer and applicable statutory and regulatory requirements, while enhancing customer satisfaction. The latest version of this standard is ISO 9001:2015.

ISO 9001 focuses on customer satisfaction, continuous improvement, and the active involvement of management and employees in a process-oriented approach. This is done using a QMS to focus consistently on enhancing customer satisfaction of products and services, and more efficient business operations that meet statutory and regulatory requirements.

What Is a Quality Management System?

A Quality Management System (QMS) is a formalized framework that an organization can use to guide its processes towards achieving quality objectives.

It covers a collection of policies, procedures, and performance guidelines which help ensure that an organization’s products or services meet established quality standards, regulatory requirements, and customer expectations. A robust QMS promotes efficiency, consistency, and continual operations improvements.

Adopting a QMS can help organizations continuously improve, increasing efficiency and customer satisfaction, reducing operational risks, and attaining a proactive process-oriented approach to operational performance. The resulting improvement in communication and coordination can also enhance decision-making within the organization, leading to long-term success.

Read our full guide to Quality Management Systems.

ISO 9001 - what is a quality management system

What Are the Benefits of the ISO 9001 Standard?

By implementing a Quality Management System and becoming ISO 9001 certified, your organization can enjoy a wide range of benefits, such as:

  • Enhanced Professional Reputation—ISO 9001 certification can increase your organization’s credibility, demonstrating your commitment to quality and customer satisfaction.
  • Improved Quality—The standard promotes a quality and continuous improvement culture, directly leading to better products or services.
  • Operational Efficiency and Excellence—By streamlining processes and establishing clear guidelines, ISO 9001 can help reduce operational errors and internal inefficiencies.
  • Increased Customer Satisfaction—ISO 9001 helps ensure products or services meet customer expectations and regulatory requirements, which can increase customer satisfaction and loyalty.
  • Better Risk Management—Implementing ISO 9001 helps identify and manage operational risks, ensuring sustained business performance and resilience.
  • Access to New Markets— Some clients or sectors require ISO 9001 certification, so certification can open new business opportunities.

Want to learn more? Sign up for our free online ISO 9001 training course to get started.

Does My Business Need ISO 9001 Certification?

Any business or organization can benefit from ISO 9001 certification. If you aim to improve operational efficiency, improve quality across processes, increase customer satisfaction and loyalty, or access new markets, being ISO 9001 certified could give you the tools and structured framework to do it as efficiently and effectively as possible.

Some industries or potential clients may also require your organization to have an ISO 9001 certification to work with them.

However, ISO certification does involve an investment of time and resources. Therefore, weighing these potential benefits against the costs is essential to determine if ISO 9001 certification is right for your organization.

Does My Business Need ISO 9001 Certification?

ISO 9001 Requirements

There are several requirements businesses must fulfill before they can become ISO 9001 certified. ISO 9001 lays out the criteria for a quality management system. It is based on several quality management principles, including a strong customer focus, the involvement of high-level company management, a process-oriented approach, and continuous improvement of the system.

The ISO 9001 standard is divided into ten distinct sections:

    1. Scope—This clause defines the purpose of ISO 9001 and outlines its applicability. It establishes that the standard provides specific QMS requirements that an organization needs to fulfill to achieve customer and regulatory satisfaction.
    2. Normative References—This section refers to the relevant associated standards or publications that are indispensable for applying the standard.
    3. Terms and Definitions—This clause sets out all the relevant terms and definitions an organization needs to correctly understand and interpret the ISO 9001 standard.
    4. Context of the Organization—This section requires organizations to identify and understand the internal and external factors that can affect, both positively or negatively, the outcomes of their QMS. It also mandates organizations to understand the needs and expectations of interested parties, such as customers and regulatory bodies.
    5. Leadership—This clause emphasizes the role of ‘top management’ in leading and promoting the QMS within the organization. It includes setting a customer-focused quality policy, ensuring KPIs align with the company’s direction, establishing roles and responsibilities, and promoting continual improvement.
    6. Planning—This is all about proactively planning for quality. This involves addressing potential operational risks and opportunities, setting QMS objectives, and planning how to integrate these into the QMS processes.
    7. Support—This clause outlines the requirements for supporting the QMS’s operation. This includes the necessary resources, employee awareness of the QMS, communication strategies and maintaining documented information.
    8. Operation—This section is about the execution of planned activities. It details requirements for planning, product requirements review, design, controlling external providers, creating and releasing products and services, and controlling nonconforming process outputs.
    9. Performance Evaluation—Here, the standard specifies the importance of monitoring, measuring, analyzing and evaluating the QMS to ensure it’s functioning as expected. This includes internal audits and management reviews.
    10. Improvement—The final clause is about maintaining a consistent focus on improvement. This involves evaluating where continual improvements can be made, correcting any non-conformities identified, and carrying out preventative actions to eliminate the causes of potential future problems.

By meeting these requirements, an organization can achieve ISO 9001 certification, demonstrating their commitment to providing high quality for their customers. Download our free ISO 9001 checklist and start your ISO journey with us today.

What Is Continuous Improvement?

Continuous improvement is an ongoing effort to enhance an organization’s products, services, or processes. It’s one of the core principles of the ISO 9001 standard and a crucial part of understanding ISO 9001 meaning and definition.

Organizations achieve continuous improvement by systematically reviewing their QMS for effectiveness and efficiency, identifying areas for potential improvement, and implementing changes. This might involve improving process efficiency, enhancing customer satisfaction, or reducing waste. Continuous improvement is about creating a culture where improvements are consistently identified and implemented.

What is continuous improvement?

How To Get ISO 9001 Certification

Before your organization can achieve ISO 9001 certification, you must first fulfill all the ISO requirements listed above.

Not sure where to begin? Orion Registrar provides complete ISO 9001 Quality Management System certification services to help your organization achieve ISO 9001 certification. We also offer specialist ISO 9001 training courses for people looking to expand their understanding and execution of these quality management principles.

Read our step-by-step guides on how to achieve an ISO certification with us, how to write an ISO 9001 quality policy and corrective and preventive actions for ISO 9001.

Interested in our services? Apply for a free quote.

Written by

Julian Russell

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