Scribd
Upload
207 views3 pages

Day 1

This document contains a 15 question daily test for participants of an ISO 13485:2016 Auditor/Lead Auditor Training Course. The test covers terms and definitions related to medical device quality management systems and ISO 9001. Participants are asked to choose the most appropriate answer for multiple choice questions about topics like purchased products, sterile medical devices, quality management systems, non-conformities, and validation. The test is being taken by Sandeep Kulkarni of Mindtree Ltd on April 19, 2022 as part of the training course hosted by TÜV SÜD South Asia.

Uploaded by

Sandeep kulkarni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
207 views3 pages

Day 1

This document contains a 15 question daily test for participants of an ISO 13485:2016 Auditor/Lead Auditor Training Course. The test covers terms and definitions related to medical device quality management systems and ISO 9001. Participants are asked to choose the most appropriate answer for multiple choice questions about topics like purchased products, sterile medical devices, quality management systems, non-conformities, and validation. The test is being taken by Sandeep Kulkarni of Mindtree Ltd on April 19, 2022 as part of the training course hosted by TÜV SÜD South Asia.

Uploaded by

Sandeep kulkarni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 3

TÜV SÜD SOUTH ASIA

ISO 13485:2016 Auditor / Lead Auditor Training Course


Day 1 Daily Test
Ed 2021 Rev 0 – 02.01.2021

Total marks: 15 Passing marks: 9 Duration: 45 minutes

Participant Name: SANDEEP Date: 19-04-2022


KULKARNI

Organization Name:
Mindtree Ltd

Instructions: Participants to attempt all questions. Objective of the daily test is to verify the
understanding of the participants. Participant shall encircle the most appropriate answer. All the
questions are related to the MD-QMS & ISO 9001 Terms and Definitions. Each question carries one
mark. Passing criteria is 60%.

1. “Purchased product” is
a. Product provided by a party outside the organization’s quality management system.
b. Product supplied by the customer to incorporate in the final medical device
c. Product received from other plant of the organization through “transfer”
d. All of the above
e. None of the above

2. “Sterile Medical Device”


a. Medical device manufactured by using special processes
b. Medical device intended to meet the requirement for sterility
c. Product provided by a party outside the organization’s quality management system
d. All of the above
e. None of the above

3. “Product” is result of a process


a. True
b. False
c. None of the above

4. “Post Market Surveillance”


a. Receiving and analyzing the “Customer complaint”
b. Responding to the customer on the received customer complaint
c. Systematic process to collect and analyze experience gained from medical device that
have been placed in the market
d. All of the above
e. None of the above

Page 1 of 3
TÜV SÜD SOUTH ASIA
ISO 13485:2016 Auditor / Lead Auditor Training Course
Day 1 Daily Test
Ed 2021 Rev 0 – 02.01.2021

5. “Quality Management System”


a. Set of interrelated or interacting activities
b. Part of Management System with respect to Quality
c. 4 levels of documents
d. All of the above
e. None of the above

6. “Work Environment” is set of working conditions under which work is performed


a. True
b. False
c. None of the above

7. “Quality” is
a. Degree to which a set of inherent characteristics of an object fulfills requirements
b. Degree of excellence
c. Meeting the customer requirements
d. Exceeding the customer requirements
e. None of the above

8. “Non-Conformity” is non-fulfillment of a requirement


a. True
b. False
c. None of the above

9. “Traceability” is
a. Ability to trace the history, application, or location of an object
b. Identification of material at various locations within the factory
c. Identification of material at supplier end
d. All of the above
e. None of the above

10. “Effectiveness”
a. Relationship between the results achieved and the resources used
b. Extent to which planned activities are realized and the resources used
c. Both a. and b.
d. None of the above

Page 2 of 3
TÜV SÜD SOUTH ASIA
ISO 13485:2016 Auditor / Lead Auditor Training Course
Day 1 Daily Test
Ed 2021 Rev 0 – 02.01.2021

11. “Efficiency”
a. Relationship between the results achieved and the resources used
b. Extent to which planned activities are realized and the resources used
c. Both a. and b.
d. None of the above

12. “Verification”
a. Confirmation through the provision of objective evidence that specified requirements have
been fulfilled
b. Confirmation through the provision of objective evidence that the requirements for a
specific intended use or application have been fulfilled
c. Both a. and b.
d. None of the above

13. “Validation”
a. Confirmation through the provision of objective evidence that specified requirements have
been fulfilled
b. Confirmation through the provision of objective evidence that the requirements for a
specific intended use or application have been fulfilled
c. Both a. and b.
d. None of the above

14. “Feedback” is opinions, comments, and expressions of interest in a product, service, or a


complaint handling process
a. True
b. False
c. None of the above

15. “Customer Service”


a. Interaction of the organization with the customer throughout the lifecycle of a product or
service
b. After Sales Service
c. Attending the customer complaint
d. None of the above

Page 3 of 3

You might also like