Document & Record Control Flashcards
7 cards from real ISO AUDITOR practice questions. Tap to flip, then mark Knew It or Still Learning โ missed cards come back until you master them.
Read the first 7 Document & Record Control flashcards as text
Under ISO 9001:2015, which clause specifically addresses 'documented information'?
Answer: Clause 7.5
Clause 7.5 of ISO 9001:2015 covers all requirements for documented information, replacing older terms 'documents' and 'records'.
When an auditor finds that an organization has not defined retention periods for quality records, this is best classified as:
Answer: A minor nonconformity
Failure to define retention periods violates ISO 9001:2015 clause 7.5.3(b), constituting a minor nonconformity unless widespread.
An organization uses a shared network drive where anyone can overwrite controlled documents without a revision log. Which principle of document control is violated?
Answer: Protection
ISO 9001:2015 clause 7.5.3 requires protection of documented information from unintended alteration, which unrestricted overwriting violates.
What term does ISO 9001:2015 use to encompass both 'documents' and 'records' from earlier versions of the standard?
Answer: Documented information
ISO 9001:2015 introduced the single term 'documented information' to cover what previous versions called documents and records.
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?
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.
Which of the following best describes 'obsolete' documents in the context of ISO 9001:2015?
Answer: Superseded versions no longer intended for use
Obsolete documents are previous revisions or cancelled documents that have been superseded and must be prevented from unintended use.
When auditing document control, which sampling approach is most effective for detecting unauthorized changes to work instructions?
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.