ISO 9001

WHAT IS ISO 9001—QUALITY MANAGEMENT SYSTEMS?

ISO 9001 is an international management system standard that specifies requirements for a QMS. Organizations use the standard to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements, as well as the organization’s own requirements. With more than 1 million certified users, it is the most popular ISO standard, and the only standard within the ISO 9000 series of standards to which organizations can certify.

ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international organization comprised of the national standards bodies of more than 170 countries.

The process of periodic review is embedded in all ISO management systems standards and requires member bodies to examine the relevance of a standard every five years. When doing so, the member bodies can decide to continue publication without revision, revise, or discontinue issuance.

ISO 9001 has undergone revisions in 1994, 2000, 2008 and 2015:

• ISO 9001:1994 included changes to improve the control of design and development clause, as well as provide other clarifications. The roles of ISO 9002 and 9003 also were modified slightly.
• ISO 9001:2000 included significant changes to make it a process-based standard instead of one that dictates multiple documented procedures. ISO 9001, ISO 9002, and ISO 9003 were integrated into a single applicable QMS standard that allowed for justified exclusions of product realization requirements that were not applicable to the organization. Other key changes included engagement by the organization’s top leadership, key performance indicators to track performance, and continual improvement.
• ISO 9001:2008 clarified issues raised during the application of ISO 9001:2000.
• ISO 9001:2015 ensured that the standard continued to adapt to the changing environments in which organizations operate. Some key updates included:
  • The introduction of new terminology
  • Restructuring some of the information
  • Quality principles being listed for consideration when implementing the standard
  • Emphasizing risk-based thinking to enhance the application of the process approach
  • Improved applicability for services
  • Increased leadership requirements

Currently, the standard is going through another revision cycle and is expected to be published in 2026.;

Climate change consideration

In 2024, ISO passed a resolution in support of the ISO London Declaration to combat climate change, which affected ISO management system standards (MSS)—including ISO 9001. The amendment added two new statements to ISO MSSs that require organizations to consider the effects of climate change on the organization’s ability to achieve the intended results of its management system.

The amended language in ISO 9001 is shown here in red:

4.1 Understanding the organization and its context

The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended result(s) of its quality management system.

The organization shall determine whether climate change is a relevant issue.

4.2 Understanding the needs and expectations of interested parties.

The organization shall determine:

• The interested parties that are relevant to the quality management system.
• The relevant requirements of these interested parties.
• Which of these requirements will be addressed through the quality management system.

NOTE: Relevant interested parties can have requirements related to climate change.

HOW DO I GET STARTED WITH ISO 9001?

Whether you are beginning your ISO 9001 journey or transitioning to a new revision, your first step is to purchase a copy of the standard. ISO 9001 applies to any organization, regardless of size or industry. More than 1 million organizations from more than 170 countries have applied the ISO 9001 standard requirements to their QMSs.

Organizations of all types and sizes find that using the ISO 9001 standard helps them:

• Organize processes
• Improve process efficiency
• Proactively identify risks and opportunities
• Continually improve

What topics does ISO 9001 cover? ISO 9001 is based on the plan-do-check-act method and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization while using risk-based thinking to better manage the process to achieve planned results.

The standard is made up of eight sections. The first three sections provide general information about the standard, and the last five focus on requirements on how to implement it. The sections are:

• Section 1—scope: specifies that the organization must meet customer and regulatory requirements, and ensure its employees follow the organization’s policies and procedures while advancing quality through continuous improvement.
• Section 2—normative reference: provides references—those that conform to ISO 9000’s related norms—to constitute the terms of ISO 9001.
• Section 3—terms and definitions: defines the terms used in the standard with references to ISO 9000.
• Section 4—context of the organization: describes the standard’s general requirements, which encompass all activities from understanding organizational context, understanding relevant interested party requirements, determining QMS scope, and determining QMS processes, including processes and the sequence and interaction of the processes to implementing actions to achieve planned results.
• Section 5—leadership: requires the organization’s leadership to commit to the QMS and explains that leadership must be dedicated to the organization’s products, customers, and planning and review processes.
• Section 6—planning: focuses on actions to address risks and opportunities, objectives and plans to achieve them, and planning changes to the QMS.
• Section 7—support: defines the support requirements including resources required for the QMS, competence of the workforce, awareness by persons doing work under the organization’s control, internal and external communications, and documented information.
• Section 8—operation: defines the entire product and service life cycle steps in acquiring business, planning orders, design and development, external provider controls, production and service provision, and delivery.
• Section 9—performance evaluation: focuses on monitoring, measuring, analyzing, and evaluating the QMS by requiring the organization to perform periodic internal audits, monitor customer satisfaction, analyze data, and hold management reviews.
• Section 10—improvement: includes actions for nonconforming products and services, takes corrective actions, and improvements.

To ease implementation, ISO 9001 suggests adopting a process approach, which is a series of operations that transform inputs into value added output.

WHAT ARE THE BENEFITS OF ISO 9001?

ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits. Because ISO 9001 specifies the requirements for an effective QMS, using the standard helps organizations:

• Consistently provide products and services that meet customer and applicable statutory and regulatory requirements
• Increase customer, management, employee, and other interested party satisfaction
• Address risk and opportunities to be proactive so desired results are achieved
• Demonstrate conformity to QMS requirements
• Continually improve their processes
• Reduce costs

 

ISO 9001 CERTIFICATION

ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving ISO 9001 certification means that an organization has demonstrated that it:

• Follows the guidelines of the ISO 9001 standard
• Fulfills its own requirements
• Meets customer, statutory, and regulatory requirements
• Creates and maintains documentation and records

ISO 9001 certification can enhance an organization’s credibility by showing customers that the organization’s products and services meet expectations. In some instances or industries, certification is required or legally mandated. The certification process includes implementing the requirements of ISO 9001 and completing a successful registrar’s audit confirming the organization meets those requirements.

 

Organizations should consider the following as they begin preparing for ISO 9001 QMS certification:

• Certification body’s costs for ISO 9001 registration, surveillance, and recertification audits
• The organization’s current level of conformance with ISO 9001 requirements
• Resources the organization will dedicate to develop and implement the project
• Support and costs required from a consultant

 

Read "What’s the Cost?" for a checklist you can use to assess the costs of certifying to ISO 9001

Note: ASQ does not issue ISO 9001 certification.