ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.
This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in ISO’s quality management principles. Using ISO 9001 helps ensure that customers get consistent, good-quality products and services, which in turn brings many business benefits.
Sector-specific applications of ISO 9001
ISO has a range of standards for quality management systems that are based on ISO 9001 and adapted to specific sectors and industries. These include:
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
ISO/TS 54001:2019 Quality management systems — Particular requirements for the application of ISO 9001:2015 for electoral organizations at all levels of government
ISO 18091:2019 Quality management systems — Guidelines for the application of ISO 9001 in local government
ISO/TS 22163:2017 Railway applications — Quality management system — Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements for application in the rail sector
ISO 29001:2020 Petroleum, petrochemical and natural gas industries — Sector-specific quality management systems — Requirements for product and service supply organizations
ISO/IEC/IEEE 90003:2018 Software engineering — Guidelines for the application of ISO 9001:2015 to computer software
