ISO 9001 Document Control 2 — Questions and Answers
Question 1: Which term does ISO 9001:2015 use in place of the older terms 'documents' and 'records'?
- Documented information (Correct answer)
- Quality records
- Controlled documents
- Management artifacts
Correct 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.
Question 2: During a document control audit, an auditor discovers a procedure that references a superseded standard. This finding is best classified as:
- A nonconformity requiring corrective action (Correct answer)
- A minor observation with no impact
- An audit program deficiency
- A management system strength
Correct 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Referencing a superseded standard in a procedure means the document is not current and accurate, which is a nonconformity against document control requirements in Clause 7.5.
Question 3: What must an organization determine when creating and updating documented information according to ISO 9001:2015 Clause 7.5.2?
- Identification and description, format and media, and review and approval for suitability (Correct answer)
- Cost per page, printing vendor, and paper weight
- Employee signature, department head approval, and CEO signature only
- File size, font type, and page margins
Correct 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.
Question 4: An auditor asks to see the document approval records for the quality manual. The organization cannot produce any approval evidence. The auditor should:
- Raise a nonconformity against Clause 7.5.2 for lack of evidence of approval (Correct answer)
- Accept the quality manual as approved by default
- Request a new manual be written during the audit
- Close the audit with no finding as the manual exists
Correct 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.
Question 5: Which of the following is a key audit question when evaluating an organization's document distribution controls?
- Are the right people receiving the right documents in a timely manner? (Correct answer)
- How many copies are printed per month?
- Does the CEO personally distribute all documents?
- Are documents sent by courier or email?
Correct 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.
Question 6: In an electronic document management system, version control is best demonstrated by:
- Unique revision numbers, timestamps, and access logs showing current version in use (Correct answer)
- Printing all documents and storing paper copies
- Using email to share latest versions without version numbers
- Allowing any employee to update documents freely
Correct 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.
Question 7: According to ISO 9001:2015, documented information retained as evidence of conformity (records) must be:
- Legible, readily identifiable, and retrievable (Correct answer)
- Printed on company letterhead only
- Stored exclusively in physical format
- Destroyed after 12 months in all cases
Correct 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.
ISO 9001 Document Control 2
Which term does ISO 9001:2015 use in place of the older terms 'documents' and 'records'?