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Document Control Flashcards

7 cards from real ISO 9001 practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. Which term does ISO 9001:2015 use in place of the older terms 'documents' and 'records'?

    Answer: Documented information

    ISO 9001:2015 replaced the separate terms 'documents' and 'records' with the unified term 'documented information' to simplify and modernize the standard.

  2. During a document control audit, an auditor discovers a procedure that references a superseded standard. This finding is best classified as:

    Answer: A nonconformity requiring corrective action

    Referencing a superseded standard in a procedure means the document is not current and accurate, which is a nonconformity against document control requirements in Clause 7.5.

  3. What must an organization determine when creating and updating documented information according to ISO 9001:2015 Clause 7.5.2?

    Answer: Identification and description, format and media, and review and approval for suitability

    Clause 7.5.2 requires documented information to have appropriate identification, format/media, and review/approval to ensure suitability and adequacy.

  4. An auditor asks to see the document approval records for the quality manual. The organization cannot produce any approval evidence. The auditor should:

    Answer: Raise a nonconformity against Clause 7.5.2 for lack of evidence of approval

    ISO 9001:2015 Clause 7.5.2 requires documented information to be reviewed and approved for suitability and adequacy; absence of approval evidence is a nonconformity.

  5. Which of the following is a key audit question when evaluating an organization's document distribution controls?

    Answer: Are the right people receiving the right documents in a timely manner?

    Effective distribution control ensures that relevant documented information is available to those who need it when they need it, which is a core control requirement.

  6. In an electronic document management system, version control is best demonstrated by:

    Answer: Unique revision numbers, timestamps, and access logs showing current version in use

    Electronic systems demonstrate version control through unique identifiers, audit trails, and mechanisms that ensure users access only the current approved version.

  7. According to ISO 9001:2015, documented information retained as evidence of conformity (records) must be:

    Answer: Legible, readily identifiable, and retrievable

    ISO 9001:2015 Clause 7.5.3 requires that documented information used as evidence of conformity be protected to remain legible, identifiable, and retrievable.