ISO 9001 is the world’s leading quality management system (QMS) standard, with over 1.47 million certificates issued. It is essential for boosting organizational success, profits and market potential.
The standard specifies the requirements for establishing a QMS to achieve quality policies and objectives while operating to meet customer and stakeholder needs and applicable laws and regulations.
ISO 9001 certification demonstrates your commitment to quality, effective processes, training staff and producing impeccable products or services.
ISO 9001 is currently being revised, with the new version expected in 2026. For the latest updates, transition guidance and further information, please visit our dedicated page.
As the world’s leading testing, inspection and certification company, with decades of experience, we can help you along the path to certification.
Our global network of experts and end-to-end services are ready to help you navigate compliance with ease. Your audit can include a gap assessment and benchmarking. We will determine your level of quality management and provide advice on how to achieve ongoing improvement.
We also have a range of complementary services, including ISO 9001 training and integrated management systems certification.
A definition of quality is part of the core vocabulary for quality management. It is found in ISO 9000:2015 and applies to all ISO quality management standards, including ISO 9001.
Quality is defined as the “degree to which a set of inherent characteristics (or distinguishing features) of an object fulfills requirements.” An object here is defined as anything perceivable or conceivable, such as a product, service, process, person, organization, system or resource.
ISO 9001 helps any organization, regardless of size and sector, improve its performance, meet customer expectations and demonstrate commitment to quality.
With more than 1.47 million certificates issued to organizations in 189 countries, ISO 9001 is the most widely adopted QMS standard.
It is part of the ISO 9000 family, which outlines seven quality management principles, including a strong customer focus and continual improvement.
ISO 9001 is the only certifiable standard within the family, although certification is not mandatory.
The ISO 9001 standard has seven management principles:
ISO 9001 covers a multitude of topics, including:
ISO 9001 certification is essential for demonstrating to stakeholders and customers the organization’s commitment and ability to consistently deliver high-quality products or services.
Checking that the QMS works is vital. The standard recommends that an organization performs internal audits to check its QMS functionality. Invite an independent certification body, such as SGS, to verify the QMS’s compliance. Alternatively, ask clients to audit the QMS.
The certification process includes:
Certification is not a one-off event, but an ongoing process. To maintain certification, organizations must continually monitor and enhance their QMS. This includes undergoing regular audits and reviewing performance against objectives to stay competitive and achieve long-term success.
ISO 9001 has been adapted to specific sectors and industries, including ISO 13485 (medical devices QMS).
ISO 9001’s harmonized structure is compatible with other management system standards, allowing seamless integration.
Organizations can align or integrate their QMS with other standards to leverage synergy and increase management efficiency.
ISO 9001 is compatible with other ISO management system standards, enabling an integrated approach to managing various organizational capabilities and processes.