Quiz · ISO 13485:2016 2/10

Document and Record Control

10 questions80% to pass

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1Which item is a record?Choose one

An unused inspection template A draft procedure awaiting review A blank calibration schedule A completed inspection form showing actual results

2A revised procedure has been saved to Drive. What remains before it can be treated as the applicable instruction?Choose one

Only changing the file name to final The required review, approval and issue controls Only telling one operator verbally Only deleting the previous revision

3A workbench has an outdated printed instruction. What is the appropriate response?Choose one

Leave it because the electronic master is correct Ask each operator to remember the differences Control the obsolete copy and make the applicable approved version available Destroy every historical copy and its associated records

4Who may approve a document change?Choose one

The original approving function or another designated function with relevant background Whoever last opened the file Any person with technical access to edit the file Only the original individual, even when a qualified replacement is designated

5A supplier test method is necessary for your work. How should it be handled?Choose one

Treat it as uncontrolled because it is externally authored Print it once and assume it never changes Let each operator choose a convenient revision Identify it and control the applicable version and distribution

6An incorrect test value is found in a completed record. What is the best correction approach?Choose one

Overwrite the value so the record looks clean Create a replacement record using the original date without explanation Make a traceable correction that preserves the original information Delete the record and retain only the final pass result

7A training sign-off was missed yesterday. What should the coordinator avoid?Choose one

Recording the actual date of a later review Backdating a signature as if it had been made yesterday Identifying the missing evidence Following the record-correction procedure

8What should drive record retention?Choose one

Device lifetime, applicable requirements and the nature of the record A fixed annual deletion habit for every file The date a newer template was created The remaining storage space on a laptop

9What additional concern applies to a complaint record containing patient details?Choose one

Making the record accessible to every employee Removing all dates to reduce identification risk Protection against unauthorized access and disclosure Storing it only in a personal inbox

10An electronic archive is intact but its files can no longer be opened. Which control has failed?Choose one

Long-term readability and retrieval Document numbering only Identification of the record author only The distinction between a draft and a blank form