ISO 9001 Quality Manuals

Clause 4.1 requires an organization to establish, document, implement and maintain a quality management system and continually improve the quality management system effectiveness.

Clause 4.1 requires an organization to

- determine the processes needed for the quality management system
- determine the sequence and interaction of these processes
- determine criteria and methods needed to ensure that both the operation and control of these processes are effective
- ensure the availability of resources and information to support the operation and monitoring of these processes
- monitor, measure, and analyse the processes
- implement actions necessary to achieve planned results and continual improvement

Clause 4.1 requires an organization to manage the processes in accordance with the requirements of the ISO 9001: 2008 standard.

Clause 4.1 requires that when an organization outsources any process that can affect product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to must be defined within the quality management system.

Quality management system processes should include management activities, provision of resources, product realization, measurement, analysis and improvement.

An outsourced process is a process which the organization chooses to have performed by an external party but is still a part of the quality management system. The organization still assumes responsibility of conformity to all customer, statutory and regulatory requirements for all outsourced processes. The control applied to the outsourced process can be influenced by the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements, the degree to which the control for the process is shared, and the capability of achieving the necessary control through the application of purchasing procedures

All of our manual packages come with our comprehensive guide to the process of implementing an ISO 9001 compliant Quality Management System