Multiple choice template
Why ISO 13485 – Awareness test
Name: Date:
Read each question carefully, write, or select the correct answer.
1. Name and explain three implementation processes obtained by being part of the ISO 13485:2016
a.________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
b.________________________________________________________________________________________
__________________________________________________________________________________________
c.________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
2. A quality management system consists of:
a) policies,
b) procedures,
c) work instructions
d) records.
e) None of the above
f) All of the above
3. ISO 13485:2016 is:
a) An international standard that specifies requirements for a quality management system (QMS) for
organizations involved in the design, development, production, installation, and servicing of medical
devices.
b) Applicable to companies in the medical device industry, and any size
c) NOT a mandatory standard for all organizations, even those involved in the design, production,
installation, or servicing of medical devices.
d) it is often NOT a requirement for regulatory approval in many countries, and it's NOT considered a
valuable tool for achieving a higher level of quality control in the medical device industry.
A&B - TRUE
C&D - FALSE
4. What does PDCA stand for?
a) Plan, Do, Check, Act
b) Plan, Do, Confirm, Action
c) Prepare, Do, Check, Act
d) Plan, Delegate, Confirm, Action
5. A quality policy is -
a) A formal statement from an organization's leadership outlining their commitment to quality, customer
satisfaction, and continuous improvement
b) A Quality Policy is not a set of specific instructions on how to do things, but rather a high-level
statement of an organization's commitment to quality.
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Name of Test
Name: Date:
Type the test instructions here. For example, instruct the student to write a short paragraph in response to each of the following
questions.
1. Write your questions here. Students will write their response in the text box:
2. Write your questions here. Students will write their response in the text box:
3. Write your questions here. Students will write their response in the text box:
4. Write your questions here. Students will write their response in the text box:
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True/False Template
Name of Test
Name: Date:
Type the test instructions here. For example, instruct the student to read each question carefully, and then write T (true) or F (false)
on the line next to the question.
a. Type the question here.
b. Type the question here.
c. Type the question here.
d. Type the question here.
e. Type the question here.
f. Type the question here.
g. Type the question here.
h. Type the question here.
i. Type the question here.
j. Type the question here.
