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WorksheetsISO 13485:2016 Awareness 2026
Total questions: 12
Worksheet time: 2mins
Which of the following is the internal audit clause number in ISO 13485?
8.2.6
8.2.4
8.5.2
4.1.6
The definition “combination of the probability of occurrence of harm and the severity of that harm” is called ........
Hazard
Risk
Traceability
Criticality
Which of these is an example of audit criteria?
SOP
Quality Manual
FDA QMSR
all of the above
What is the benefit of audit checklist preparation?
Time management
Formal audit approach
Assist the new auditors
all of the above
The below information is true on type of document and record that needs to be checked during an internal audit exercise for compliance with clause number 6.2.
Training SOP
Training Attendance Record
Training Effectiveness Evaluation record such as test paper
All of the above
Based on ISO 13485:2016 requirements, audit conclusion on effectiveness of the QMS must be documented in the.....
audit plan
audit checklist
audit report
None of the above
The below statement is the definition for ________."The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Action must be taken without undue delay".
Corrective Action
Preventive Action
Correction
Remedial action
Which of the statement below to demonstrate evidence of conformity to ISO 13485:2016 is FALSE?
Appointment of QMR done via internal memo or an email
Management responsibilities documented in JD
Quality Policy approved by Managers.
Quality manual approved by MD
Which of the below statement based on evidence of conformity to ISO 13485:2016 is FALSE?
Changes made to QMS documents does not need to be tracked
External documents such as ISO standard need to be controlled.
Retention period for QMS documents must be defined.
Changes made to a record must be traceable
Which of the below statement to demonstrate evidence of conformity to ISO 13485:2016 is TRUE?
Quality Manual documentation is optional
Medical device file includes Purchase order
Changes in process parameter does not need to be tracked
Risk assessment activity must be based on the safety and performance of device.
Which of the below records based on documentation to demonstrate evidence of conformity to ISO 13485:2016 is not required?
Quality Policy & objectives monitoring
Finished Product QC Testing records
Risk Register
Supplier's Employee Name List and Qualification
Which of the below records on Internal Audit based on documentation to demonstrate evidence of conformity to clause 8.2.4 ISO 13485:2016 is not required?
Internal Audit SOP
Internal Audit Report
Internal Auditor Qualification Records
Internal Auditor Plant Safety Training Records
