MSP Document Control & Information Management 2 — Questions and Answers
Question 1: When establishing retention periods for records in a management system, which factor should be given HIGHEST priority?
- The preferences of the quality manager
- Available storage space in the organization
- Legal, regulatory, and contractual requirements (Correct answer)
- The age of the records management software
Correct answer: Legal, regulatory, and contractual requirements
Legal, regulatory, and contractual requirements must drive retention periods to ensure compliance and protect the organization from liability.
Question 2: In the context of ISO 9001:2015, 'documented information' replaces which two older terms used in ISO 9001:2008?
- Manuals and checklists
- Documents and records (Correct answer)
- Procedures and work instructions
- Policies and objectives
Correct answer: Documents and records
The 2015 revision introduced 'documented information' as a single term replacing 'documents' (to maintain) and 'records' (to retain) from the 2008 version.
Question 3: An auditor finds that a critical work instruction was updated but the revision history section was not completed. This finding would be classified as:
- An observation only, with no action required
- A nonconformity against document control requirements (Correct answer)
- A major nonconformity automatically requiring management review
- A regulatory violation requiring immediate shutdown
Correct answer: A nonconformity against document control requirements
Incomplete revision history violates the document control requirement to identify changes and current revision status, making it a nonconformity.
Question 4: Which of the following is an example of 'externally originated' documented information that must be controlled?
- The organization's own quality manual
- An internal audit checklist developed in-house
- A customer-supplied engineering drawing used in production (Correct answer)
- A corrective action report completed by an employee
Correct answer: A customer-supplied engineering drawing used in production
Customer-supplied drawings are externally originated documented information that organizations must identify and control per ISO requirements.
Question 5: In a digital document management system, what is the best control to prevent unauthorized modification of approved documents?
- Storing documents in a shared drive accessible to all employees
- Implementing role-based access controls with read-only permissions for non-approvers (Correct answer)
- Emailing documents to all staff so they each have a personal copy
- Printing documents and locking them in a cabinet
Correct answer: Implementing role-based access controls with read-only permissions for non-approvers
Role-based access controls ensure only authorized personnel can modify documents, while others have read-only access, satisfying the protection requirement.
Question 6: According to ISO management system standards, who is ultimately responsible for approving documented information before its issue?
- The external certification body auditor
- The organization must determine appropriate persons within its own structure (Correct answer)
- The ISO technical committee that authored the standard
- The regulatory authority governing the industry
Correct answer: The organization must determine appropriate persons within its own structure
ISO standards require organizations to determine their own approval authority for documented information; the standard does not prescribe who specifically must approve.
Question 7: Which term describes the practice of systematically indexing, storing, and retrieving documented information to support management system performance and audits?
- Document calibration
- Information security management
- Records management (Correct answer)
- Configuration management
Correct answer: Records management
Records management involves the systematic creation, maintenance, use, and disposal of records as evidence of management system performance.
MSP Document Control & Information Management 2
When establishing retention periods for records in a management system, which factor should be given HIGHEST priority?