ISO 9001 is an international standard for a quality management system (QMS) that provides a framework for processes to ensure that an organization can consistently meet customer and regulatory requirements. It is part of the ISO 9000 family of quality management system standards and is the only standard within this series that can be certified. Certification to ISO 9001 means that an organization has met the requirements in ISO 9001 and has demonstrated that it follows international quality standards with a focus on consistent improvement.

ISO 9001:2015 is the current version of the standard, which was published in September 2015. It is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on many topics, such as customer focus, leadership, risk management, and continuous improvement.

Certification to ISO 9001 can enhance an organizations credibility by showing customers that its products and services meet expectations. It can also be a requirement or legally mandated in some instances or industries. The certification process includes implementing the requirements of ISO 9001 and then completing a successful registrars audit confirming the organization meets those requirements.