Document & Record Control Flashcards
7 cards from real ISO AUDITOR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Document & Record Control flashcards as text
ISO 9001:2015 requires that documented information of external origin be identified and controlled. Which of the following is an example of such external documented information?
Answer: Customer specifications received from a client
Customer specifications are externally originated documented information that must be identified and controlled under clause 7.5.3.
An auditor finds records stored in a flooded basement with no backup copies elsewhere. Which control requirement has the organization failed to meet?
Answer: Storage and preservation
Clause 7.5.3 requires adequate storage and preservation of documented information to prevent deterioration or loss.
Under ISO 9001:2015, who is ultimately responsible for ensuring documented information remains suitable and adequate?
Answer: Top management
Top management is accountable for QMS effectiveness, including the suitability of documented information, per clauses 5.1 and 7.5.
An organization's master document list shows Revision 3 of a procedure, but auditors find Revision 2 in active use on the shop floor. This is evidence of:
Answer: A nonconformity related to distribution and point-of-use control
Outdated documents at the point of use violate the distribution and availability requirements of ISO 9001:2015 clause 7.5.3.
Which of the following is NOT explicitly required by ISO 9001:2015 for control of documented information?
Answer: A specific document numbering system
ISO 9001:2015 does not prescribe a specific numbering or coding system; organizations define their own identification approach.
A manufacturing company retains completed inspection checklists for only 6 months, but relevant regulatory requirements mandate 5 years. This represents:
Answer: A nonconformity against the applicable statutory/regulatory requirement
ISO 9001:2015 clause 7.5.3 requires retention in a manner meeting applicable requirements, including statutory and regulatory mandates.
During an audit, an employee shows the auditor a laminated work instruction that cannot be updated if the process changes. What control concern does this raise?
Answer: The document cannot be controlled for currency and revision
Laminated static copies cannot be revised when the process changes, risking use of outdated instructions, violating currency control requirements.