ISO 9001 Document Control 2

Question 1

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

Accepted Answer

Documented information

Answer

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During a document control audit, an auditor discovers a procedure that references a superseded standard.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:

Accepted Answer

A nonconformity requiring corrective action

Answer

Referencing a superseded standard in a procedure means the document is not current and accurate, which is a nonconformity against document control requirements in Clause 7.5.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

Accepted Answer

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

Answer

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:

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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.

ISO 9001 - Certified ISO 9001 Quality Management System Auditor Practice Test

ISO 9001 - Certified ISO 9001 Quality Management System Auditor Practice Test

ISO 9001 Document Control 2