ISO 9001:2015
ISO 9001 is defined as an international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently deliver 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 against which organizations can certify.
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. The various sections of the standard provide information on a wide range of topics, such as:
- QMS requirements, including documented information, planning and determining process interactions
- Responsibilities of the management
- Resource management, including human resources and the work environment of the organization
- Product realization, including stages from design to delivery
- Measure, analyze and improve the QMS through activities such as internal audits and corrective and preventive actions
The changes introduced in the ISO 9001 2015 revision are designed to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. Some of the key updates to ISO 9001:2015 include:
- Introduction of new terminology
- Restructuring of some information
- Emphasis on risk-based thinking to improve application of process approach
- Improved usability for services
- Increased leadership requirements