This International Standard can be used by internal and external parties.
The requirements specified in this Standard are complementary to requirements for products and services. It employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. 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. The process approach enables an organization to plan its processes and their interactions.
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.
This Standard is based on the quality management principles described in ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization’s performance when applying the principle.
These principles are:
- Customer focus;
- Leadership;
- Engagement of people;
- Process approach;
- Improvement;
- Evidence-based decision making;
- Relationship management.
Scope
- Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
- 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.