ISO 13485 Quiz - Vee Care Asia

ISO 13485 Quiz

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1. ISO 13485 is an internationally recognized standard.

a) True

b) False

2. A quality system process may not have inputs.

a) True

b) False

3. Any clause could be excluded from the Quality System with justification

a) True

b) False

4. A medical device file must be maintained for each device or device family

a) True

b) False

5. Quality system record must be retained for at least the lifetime of the device

a) True

b) False

6. Installation manual is a tier 3 controlled document

a) True

b) False

7. Product release test is a quality system record.

a) True

b) False

8. All process output could be fully verified

a) True

b) False

9. Only non-conforming products after delivery shall be controlled

a) True

b) False

10. All complaints will result in Corrective and Preventive Action

a) True

b) False

1. Which of the following is the correct sequence of a Quality System Set-up Process?

a) Form a task Team > Create QMS Process > Document QMS Process > Implement QMS Process > Monitor QMS Process

b) Create QMS Process > Form a task Team > Document QMS Process > Implement QMS Process > Monitor QMS Process

c) Document QMS Process > Form a task Team > Create QMS Process > Implement QMS Process > Monitor QMS Process

d) Create QMS Process > Document QMS Process > Implement QMS Process > Form a task Team > Monitor QMS Process

e) None of the above

2. Which of the following is NOT a role to be taken by a contract manufacturer?

a) Design and Development

b) Manufacturing

c) Packaging

d) Sterilization

e) Sales and Distribution

3. The purpose of quality system records (Tier-4 Document) is to

a) Define Quality System approach and responsibility

b) Define whom, what, when in a quality system process

c) Answer how the quality system process is being implemented

d) Demonstrate how the quality system is working

e) None of the above

4. Which of the following is not an element of a Medical Device File (Device Master Record)?

a) Device descriptions

b) Manufacturing Process

c) Sales and Distribution Process

d) Purchasing Process

e) Product Release Process

5. A Controlled Quality System Document should be:-

a) Prepared by appropriate personnel

b) Reviewed by proper personnel

c) Version controlled

d) Retained per regulatory requirement and/or manufacturer defined

e) All of the above

6. Quality System shall be retained no less than ___ years from the medical device released by the manufacturer.

a) 1 year

b) 2 years

c) 3 years

d) 4 years

e) 15 years

7. The roles of the management representative shall include the following except:

a) Ensure required quality system process are documented

b) Report to management on quality system effectiveness

c) Meet financial objectives

d) Escalate needs for improvement

e) Ensure awareness of regulatory and customer requirements

8. Which of the following is NOT a management review input?

a) Customer Feedback

b) Internal Audit Results

c) Latest Regulatory Requirements

d) Process Performance

e) None of the above

9. Which of the following is the most effective training methodology for operating complex machinery?

a) Classroom training on production manual

b) eLearning on production manual

c) Simulators training with evaluation test

d) On-job training

e) Observation on an experienced operation staff

10. Which of the following NOT an infrastructure item?

a) Staff dormitory

b) Warehouse

c) Good Delivery Vehicle

d) Packaging Machine

e) Quality System Software

11. Which of the following is NOT work environment requirement?

a) Staff clothing

b) Lighting

c) Humidity

d) Ventilation

e) Chair comfort

12. Which of the following is the correct sequence of the customer-related process?

a) Define customer requests > Work out product requirements > Review product requirements > Evaluate Capability > Communicate with customers

b) Work out product requirements > Define customer requests > Review product requirements > Evaluate Capability > Communicate with customers

c) Review product requirements > Work out product requirements > Define customer requests > Evaluate Capability > Communicate with customers

d) Work out product requirements > Evaluate Capability > Define customer requests > Review product requirements > Communicate with customers

e) Communicate with customers > Work out product requirements > Define customer requests > Review product requirements > Evaluate Capability

13. Which of the following is the correct sequence of the design and development process?

a) Design Input Review > Design Output Review > Intended Use Review > Validation and Verification > Design Transfer

b) Intended Use Review > Design Input Review > Design Output Review > Design Transfer > Validation and Verification

c) Intended Use Review > Design Input Review > Design Output Review > Validation and Verification > Design Transfer

d) Intended Use Review > Design Input Review > Design Output Review > Validation and Verification > Design Transfer

e) Design Input Review > Intended Use Review > Design Output Review > Validation and Verification > Design Transfer

14. Which of the following is NOT a quality subprocess of the purchasing process?

a) Process for purchasing device-related supplies

b) Process for purchasing supporting product or services

c) Process for listing new product

d) Process for listing new supplier

e) None of the above

15. Which of the following is not a production control activity?

a) Certifying production equipment

b) Qualifying production personnel

c) Making measuring and monitoring equipment available

d) Process validation

e) Inventory control

16. Which of the following activity may NOT require process validation?

a) Injection moulding

b) Software installation

c) Packaging

d) Welding

e) Sterilization

17. Which of the following is NOT a proactive market surveillance activity?

a) Customer Complaints

b) Competitor analysis

c) Vigilance database search

d) Product Release Analysis

e) Sales Data Analysis

18. Which of the following is NOT a step in the complaint handling process?

a) Receive and record Information

b) Investigate complaint

c) Initiate product rework

d) Determine whether it is reportable

e) Determine if CAPA requires

19. Which of the following is NOT a data analysis input?

a) Feedback

b) Sales Revenue

c) Process Conformity

d) Supplier Performance

e) Audit

20. Which of the following is the correct sequence of the CAPA control process?

a) Define Root Cause > Research Solution > Verify solution works > Implement Solution

b) Define Root Cause > Verify solution works > Research Solution > Implement Solution

c) Define Root Cause > Research Solution > Implement Solution > Verify solution works

d) Define Root Cause > Implement Solution > Research Solution > Verify solution works

e) None of the above

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