1. Context of the organization
The context of the organization should be understood in order to determine the scope of the audit. The purpose of ISO 9001 is to ensure that quality management is consistently applied throughout the organization.
The leadership should promote a climate of quality and establish quality objectives. They should also allocate resources necessary to achieve and maintain compliance with ISO 9001.
The planning process should include the formulation of quality policies, objectives, and plans. It should also identify the resources needed to achieve compliance.
The support functions within the organization should provide resources and training necessary for quality management system implementation and compliance.
The operation of the organization should be consistent with the quality management system requirements. This includes ensuring that processes are managed effectively and that records are maintained in accordance with the standard.
6. Performance evaluation
The performance of the organization should be evaluated on a regular basis to ensure that it continues to meet the requirements of ISO 9001.
Continuous improvement is a key requirement of ISO 9001. Organizations should establish and implement processes to identify and address opportunities for improvement.