ISO 9001:2015 – Quality management systems

The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

ISO 9001:2015

ISO 9001:2015 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 the pdf Quality Management Principles. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.

Get an overview of ISO 9001 in this PowerPoint presentation.

If you want to know more about the revision of ISO 9001:2015 see our revision page.

ISO 9001:2015 specifies requirements for a quality management system when an organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

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 – Medical devices
ISO 17582 – Electoral organizations at all levels of government
ISO 18091 – Local government
ISO/TS 22163 – Business management system requirements for rail organizations
ISO/TS 29001 – Petroleum, petrochemical and natural gas industries
ISO/IEC 90003 – Software engineering