INTERNAL AUDIT CHECKLIST
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4 Quality Management System Observation/Comments Results4.1 General Requirements
Has your organization established amanagement system (QMS) givingconsideration to:a)
Identifying the processesneeded and the application of theprocesses throughout theorganization:b)
Determining the sequence andinteraction of the processes?c)
Determining the criteria andmethods for operation and controlof the processes?d)
Ensuring the availability of resources and information tosupport the processes?e)
Monitoring, measuring andanalyzing these processes?f)
Implementing actions to achieveplanned results and the continualimprovement?If your organization out sources anyprocesses that affects product conformity,are the outsourced process controlled andidentified?
Additional questions4.2 Documentation Requirements4.2.2 Quality Manual
Does your organization have a qualitymanual? Does it include the following:a)
The scope of your QMS and justifications and details of anyexclusionsb)
The documented procedures for theQMS or reference them?c)
A description of interactionsbetween the processes of the QMS?