ISO 9001 Document Control 1 — Questions and Answers
Question 1: According to ISO 9001:2015, which clause specifically addresses the control of documented information?
- Clause 7.5 (Correct answer)
- Clause 6.1
- Clause 8.1
- Clause 9.2
Correct answer: Clause 7.5
Clause 7.5 of ISO 9001:2015 covers the requirements for documented information, including its creation, update, and control.
Question 2: When an auditor reviews documented information, which of the following is NOT typically verified as a control requirement?
- Distribution and access
- Storage and preservation
- Retention and disposition
- Employee salary records (Correct answer)
Correct answer: Employee salary records
Employee salary records are HR/payroll data and are not part of the QMS documented information control requirements under ISO 9001.
Question 3: What is the primary purpose of maintaining documented information in a QMS?
- To demonstrate conformity to requirements and effective QMS operation (Correct answer)
- To satisfy external auditor curiosity
- To comply with accounting standards
- To track employee performance
Correct answer: To demonstrate conformity to requirements and effective QMS operation
ISO 9001:2015 requires documented information to provide evidence of conformity and to support the effective operation of the QMS.
Question 4: During an audit, an auditor finds that a work instruction has been revised but the revision date has not been updated. This is an example of:
- A nonconformity related to document control (Correct answer)
- An opportunity for improvement only
- A major finding requiring immediate shutdown
- Normal document management practice
Correct answer: A nonconformity related to document control
Failure to update revision dates on documents is a nonconformity against ISO 9001 Clause 7.5.2, which requires documents to include appropriate identification and revision status.
Question 5: Which of the following best describes 'documented information of external origin' under ISO 9001:2015?
- Customer specifications, regulatory standards, and supplier documents needed for QMS operation (Correct answer)
- Internal memos between departments
- Meeting minutes from management reviews
- Corrective action requests issued internally
Correct answer: Customer specifications, regulatory standards, and supplier documents needed for QMS operation
External origin documented information includes items such as customer drawings, regulatory requirements, and industry standards that the organization identifies as necessary for QMS planning and operation.
Question 6: An organization stores its quality records only in paper format in an unlocked cabinet accessible to all staff. Which ISO 9001 requirement is most likely being violated?
- Protection of documented information (Correct answer)
- Identification of documented information
- Distribution of documented information
- Creation of documented information
Correct answer: Protection of documented information
ISO 9001:2015 Clause 7.5.3.2 requires organizations to control documented information to ensure it is protected from loss of confidentiality, improper use, or loss of integrity.
Question 7: When auditing document control, an auditor should confirm that obsolete documents are:
- Identified to prevent unintended use, and retained only if required with suitable identification (Correct answer)
- Destroyed immediately upon revision
- Kept in the same location as current documents
- Distributed to all staff as reference material
Correct answer: Identified to prevent unintended use, and retained only if required with suitable identification
ISO 9001:2015 requires that obsolete documents be identified to prevent unintended use; if retained for any purpose, they must be marked appropriately.
ISO 9001 Document Control 1
According to ISO 9001:2015, which clause specifically addresses the control of documented information?