Document Control Audit 7.5.3

Is documented information controlled to ensure that is is available and suitable for use, where and when it is needed?

Is documented information adequately protected from loss of confidentiality, improper use, or loss of integrity?

Is document distribution, access, retrieval and use addressed in the QMS documentation?

Is version control of controlled documents addressed in the QMS documentation?

Is retention and disposition of controlled documents addressed in the QMD documentation?

Is removal or other suitable identification control present to prevent the use of obsolete controlled documents?

Has the organization determined which external documents are necessary for the planning and operation of the QMS?

Are controlled documents retained as evidence of conformity protected from unintended alteration?

If maintained electronically, are controlled documents protected from loss, unauthorized changes, unintended alteration, corruption, or physical damage?

Are documents maintained to provide information that will attest to inspection reports from repair stations, purchase orders/contracts, certificates of conformity, authorized releases, nonconformances, or corrective actions, lot or batch trace, or documented information of storage, preservation, or shelf life condition of commodities in the possession of the organization?