ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
ISO 9001 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:
- Requirements for a quality management system, including documented information, planning and determining process interactions
- Responsibilities of management
- Management of resources, including human resources and an organization’s work environment
- Product realization, including the steps from design to delivery
- Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action
Changes introduced in the 2015 ISO 9001 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. Some of the key updates in ISO 9001:2015 include:
- The introduction of new terminology
- Restructuring some of the information
- An emphasis on risk-based thinking to enhance the application of the process approach
- Improved applicability for services
- Increased leadership requirements