Clause 1.2, Application

The scope of your quality management system should be based on the nature of your products and realization processes, as well as, the result of risk assessment, commercial considerations, and contractual, statutory, and regulatory requirements. If you choose to implement a system with limited scope, this should be clearly defined in your quality manual and other publicly available documents to avoid confusing or misleading customers.

If you have overall responsibility for product realization, the fact that a specific process such as design or manufacturing is outsourced is not adequate justification for excluding that process from your system. You still have to exercise sufficient control to ensure the outsourced processes are performed according to the relevant requirements of ISO 9001:2000.

The Guidance on ISO 9001:2000 clause 1.2, Application, provides guidance on defining the scope of your quality management system, determining permissible exclusions, and identifying any outsourced processes. The document gives examples of applying the ISO 9001:2000 requirements in eight different industry scenarios.

To see the guidance for Clause 1.2, go to: <>.