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
During a document control audit, the auditor finds that approved documents lack a revision date. Which element of document identification is missing?
Answer: Date of issue or revision
ISO 9001:2015 requires documented information to include identification data such as title, date, and revision status to distinguish versions.
Which of the following best represents a risk-based approach to document control?
Answer: Prioritizing review and control rigor based on the consequence of using incorrect or outdated documents
Risk-based thinking (clause 6.1) applied to document control means higher-risk processes receive more rigorous review and access controls.
A process owner updates a work instruction without going through the change approval process and distributes it informally. What type of finding is this?
Answer: A nonconformity for bypassing the document change control process
Unauthorized changes bypass the review and approval controls required by clause 7.5.2, making this a nonconformity.
Which of the following is the best indicator that an organization has effective document control?
Answer: Staff consistently using current, approved documents and unable to access obsolete ones
Effective document control is demonstrated when current documents are in use and obsolete versions are inaccessible at the point of use.
ISO 9001:2015 allows organizations to use documented information in any format and on any media. What constraint still applies?
Answer: The format must allow for adequate control, legibility, and retrievability
Regardless of format or media, documented information must remain legible, retrievable, and appropriately controlled per clause 7.5.
An auditor samples five customer order records and finds two are illegible due to faded ink on thermal paper. This is a nonconformity against which requirement?
Answer: Legibility and retrievability of records
Clause 7.5.3 requires documented information to remain legible; illegible records fail to provide the required evidence of conformity.
When an organization transitions from paper-based to electronic document control, the auditor should verify that:
Answer: The electronic system maintains equivalent controls for access, protection, version management, and retrievability
The transition must preserve all document control requirements of clause 7.5.3 regardless of the media used.