ISO 9000:2005 describes the fundamentals of quality management systems, which form the subject of the ISO 9000 family, and defines related terms.

It is applicable to the following:

a) organizations seeking advantage through the implementation of a quality management system;

b) organizations seeking confidence from their suppliers that their product requirements will be satisfied;

c) users of the products;

d) those concerned with a mutual understanding of the terminology used in quality management (e.g. suppliers, customers, regulators);

e) those internal or external to the organization who assess the quality management system or audit it for conformity with the requirements of ISO 9001 (e.g. auditors, regulators, certification/registration bodies);

f) those internal or external to the organization who give advice or training on the quality management system appropriate to that organization;

g) developers of related standards.

 

The process approach is used in this Standard, which includes the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

Process Approach – The process approach allows an organization to plan its processes and how they interact with one another process within the organization.

PDCA Cycle – The PDCA cycle allows an organization to ensure that its processes are adequately resourced and managed and that opportunities for improvement are identified and pursued. Risk-Based Thinking – Risk-based thinking enables an organization to identify the factors that may cause its processes and quality management system to deviate from the expected results, implement preventive controls to mitigate negative effects, and capitalize on opportunities as they arise.