International Organization for Standardization
PDF (Portable Document Format)
ISO 9001 is one of ISO‘s most well-known standards, with more than 1.1 million certificates worldwide. It provides requirements to help companies demonstrate that they can offer their customers consistent, good quality products and services. It also provides a framework to help them streamline their processes and become more efficient at what they do. ISO 9001 can be used by organizations of all types and sizes. The standard has inspired a series of documents for sector-specific applications including for the automotive sector, the medical sector, local governments and more.
This International Standard 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 this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise.
Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization.