4.1.0 Documentation Requirements – General

Purpose

The organisation is required to establish, document, implement and maintain a quality management system and to continually improve its effectiveness in accordance with the requirements of the International Standard ISO9001-2008.

In order to do this, the organisation must;

• determine the processes that must be included in the quality management system and how these should be applied throughout the organisation. These processes include those for management, provision of resources, product realisation, measurement, analysis and improvement.
• determine the relationship and interaction of these processes with one another,
• determine methods and criteria necessary to effectively operate and control the processes,
• provide the necessary resources and information to support the operation and monitoring of these processes,
• monitor, measure where applicable, and then analyse these processes,
• implement actions that are necessary to achieve the planned results and provide continual improvement of these processes. The management of the processes must be carried out in a manner that complies with the requirements of the International Standard ISO9001-2008.
• When the organisation decides to outsource any process that may affect the product’s conformity to requirements, it must ensure that it maintains control over these processes. The type and extent of control necessary will be defined within the quality management system but must include compliance with all customer, statutory and regulatory requirements. In addition, the controls should cover the potential impact of the outsourced process on the organisation’s capability to provide product that conforms to requirements and the degree to which the control for the process is shared. The level of control that may be achieved through the application of Clause 7.4 (Purchasing) should also be considered.

Procedure

• [enter-your-company-name-here] has established, documented, implemented and maintains a Quality Management System in accordance with the requirements of the International Standard ISO9001-2008. The organisation is pro-active in the management of the system; monitoring and continually improving it to ensure that it is compliant with the standard and meets the needs of its customers.
• [enter-your-company-name-here] considered the entire organisation to determine the process that were required for its Quality Management System and the application of these processes.
• In developing the relationship and order of the processes, the organisation considered the interaction of these at all levels.
• [enter-your-company-name-here] has determined relevant criteria and methodology to ensure that both the operation and control of these processes is effective.
• [enter-your-company-name-here]’s top management are committed to ensuring the provision of resources and information necessary to support the operation and monitoring of the processes associated with its Quality Management System.
• As part of its policy of continual improvement, [enter-your-company-name-here] fully supports the monitoring, measurement (where applicable) and analysis of the processes associated with its Quality Management System.
• Any actions necessary to achieve the planned results and continual improvement of the organisation’s processes will be implemented and supported by top management.
• [enter-your-company-name-here] will ensure that the development and management of its processes shall be in accordance with the requirements of the international standard ISO9001-2008.

• The organisation does not outsource any process that affects product conformity to the requirements of its Quality Management System.

or

• The organisation will outsource certain processes that may affect product conformity to the requirements of its Quality Management System. These processes and the control measures employed are detailed within the Quality Management System.