ISO AUDITOR Document & Record Control 3 — Questions and Answers
Question 1: 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?
- Internal audit reports
- Customer specifications received from a client (Correct answer)
- Management review minutes
- Corrective action requests
Correct 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.
Question 2: An auditor finds records stored in a flooded basement with no backup copies elsewhere. Which control requirement has the organization failed to meet?
- Legibility
- Retrieval
- Storage and preservation (Correct answer)
- Retention period definition
Correct answer: Storage and preservation
Clause 7.5.3 requires adequate storage and preservation of documented information to prevent deterioration or loss.
Question 3: Under ISO 9001:2015, who is ultimately responsible for ensuring documented information remains suitable and adequate?
- The document controller
- Top management (Correct answer)
- The QMS consultant
- The internal audit team
Correct answer: Top management
Top management is accountable for QMS effectiveness, including the suitability of documented information, per clauses 5.1 and 7.5.
Question 4: 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:
- Adequate document control with minor delay
- A nonconformity related to distribution and point-of-use control (Correct answer)
- An opportunity for improvement only
- Acceptable practice if staff are verbally informed
Correct 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Outdated documents at the point of use violate the distribution and availability requirements of ISO 9001:2015 clause 7.5.3.
Question 5: Which of the following is NOT explicitly required by ISO 9001:2015 for control of documented information?
- Distribution and access controls
- Retention and disposition
- A specific document numbering system (Correct answer)
- Protection from unintended alteration
Correct answer: A specific document numbering system
ISO 9001:2015 does not prescribe a specific numbering or coding system; organizations define their own identification approach.
Question 6: A manufacturing company retains completed inspection checklists for only 6 months, but relevant regulatory requirements mandate 5 years. This represents:
- An acceptable internal decision
- A nonconformity against the applicable statutory/regulatory requirement (Correct answer)
- A risk to be documented in the risk register only
- An observation for the next audit cycle
Correct 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.
Question 7: 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?
- Legibility
- The document cannot be controlled for currency and revision (Correct answer)
- Availability at point of use
- Identification of the responsible author
Correct 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.
ISO AUDITOR Document & Record Control 3
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?