ISO 9001:2008 Requirements – QMS

ISO 9001:2008 Requirements – Quality Management System
Establish, document, implement, and maintain a quality management system. Continually improve its effectiveness in accordance with ISO 9001 requirements. Implement the system to:? Determine processes needed for the quality management system (and their application throughout the organization)? Determine process sequence and interaction? Determine criteria and methods for process operation and control? Ensure resources and supporting information are available? Monitor, measure where applicable, and analyze these processes? Implement actions to achieve planned results and continual process improvementManage these processes in accordance with ISO 9001 requirements. Define the type and extent of control applied to any outsourced processes that affect product conformity to requirements.NOTE 1: Processes needed for the quality management system include the processes for management activities (see 5), provision of resources (see 6), product realization (see 7), and measurement, analysis, and improvement (see 8).NOTE 2: An outsourced process is a process the organization needs for its quality management system, and which the organization chooses to have performed by an external party.NOTE 3: Ensuring control over outsourced processes does not absolve your organization of the responsibility to conform to all customer, statutory, and regulatory requirements. The type and extent of control applied to an outsourced process can be influenced by factors such as:? Potential impact of the outsourced process on your organization’s capability to provide product that conforms to requirements? Degree to which the control for the process is shared? Capability of achieving the necessary control through the application of 7.4