The structure and complexity of the management system
The structure, size and complexity of the organisation and its processes
Geography of areas to be audited
Historic information
Customer (contract specific) or regulatory requirements
Internal requirements
Available resources
Methodology of audits
Structure of individual audits, i.e.:
By department
By product
By process
Audit trails
Carried out by following natural paths of information, products or processes
Forward audits: real-time based on current activities
Backward audits: historical based on completed activities (particularly good to test traceability)
Auditing in ‘processes’ (process approach)
The following illustration shows a typical series of interrelated processes within an example organisation. In this example the ‘inspection and delivery’ process is selected and a typical checklist of audit criteria to determine if the process is effectively performing.