ISO AUDITOR Document & Record Control 2 — Questions and Answers
Question 1: Under ISO 9001:2015, which clause specifically addresses 'documented information'?
- Clause 6.1
- Clause 7.5 (Correct answer)
- Clause 8.1
- Clause 9.1
Correct answer: Clause 7.5
Clause 7.5 of ISO 9001:2015 covers all requirements for documented information, replacing older terms 'documents' and 'records'.
Question 2: When an auditor finds that an organization has not defined retention periods for quality records, this is best classified as:
- An observation
- A minor nonconformity (Correct answer)
- A major nonconformity
- An opportunity for improvement
Correct answer: A minor nonconformity
Failure to define retention periods violates ISO 9001:2015 clause 7.5.3(b), constituting a minor nonconformity unless widespread.
Question 3: An organization uses a shared network drive where anyone can overwrite controlled documents without a revision log. Which principle of document control is violated?
- Availability
- Protection (Correct answer)
- Distribution
- Identification
Correct answer: Protection
ISO 9001:2015 clause 7.5.3 requires protection of documented information from unintended alteration, which unrestricted overwriting violates.
Question 4: What term does ISO 9001:2015 use to encompass both 'documents' and 'records' from earlier versions of the standard?
- Quality documentation
- Controlled information
- Documented information (Correct answer)
- Registered data
Correct answer: Documented information
ISO 9001:2015 introduced the single term 'documented information' to cover what previous versions called documents and records.
Question 5: An auditor requests the procedure for calibrating test equipment and is told it exists only in the engineer's memory. What is the auditor's most appropriate action?
- Accept it if the engineer can demonstrate the process
- Raise a nonconformity for lack of required documented information (Correct answer)
- Issue an observation only
- Escalate to a major nonconformity immediately
Correct answer: Raise a nonconformity for lack of required documented information
Where the organization has determined documented information is necessary for process effectiveness, its absence is a nonconformity per clause 7.5.1.
Question 6: Which of the following best describes 'obsolete' documents in the context of ISO 9001:2015?
- Documents older than five years
- Superseded versions no longer intended for use (Correct answer)
- Documents not reviewed in the last audit cycle
- External documents not approved by management
Correct answer: Superseded versions no longer intended for use
Obsolete documents are previous revisions or cancelled documents that have been superseded and must be prevented from unintended use.
Question 7: When auditing document control, which sampling approach is most effective for detecting unauthorized changes to work instructions?
- Review only documents with the highest change frequency
- Compare current documents against the document master list and version history (Correct answer)
- Interview all staff who use the documents
- Check only documents modified in the past 30 days
Correct answer: Compare current documents against the document master list and version history
Cross-referencing current documents with the master list and version history reveals unauthorized or untracked changes most reliably.
ISO AUDITOR Document & Record Control 2
Under ISO 9001:2015, which clause specifically addresses 'documented information'?