You have to pass the CMDA exam to receive the certification from ASQ. To increase the effectiveness of your study and make you familiar with the actual exam pattern, we have prepared this ASQ Medical Device Auditor sample questions. Our Sample ASQ Certified Medical Device Auditor Practice Exam will give you more insight about both the type and the difficulty level of the questions on the ASQ Medical Device Auditor exam.
However, we are strongly recommending practice with our Premium ASQ Certified Medical Device Auditor (CMDA) Practice Exam to achieve the best score in your actual ASQ CMDA Exam. The premium practice exam questions are more comprehensive, exam oriented, scenario-based and exact match of ASQ Certified Medical Device Auditor exam questions.
ASQ Medical Device Auditor Sample Questions:
01. The impact of nonconformances in an audit report is significant. What is the primary purpose of detailing these impacts?
a) To allocate blame to specific individuals
b) To highlight areas for improvement
c) To assess the financial loss only
d) To promote alternative products
02. Auditor independence ensures that the audit is free from ________ bias.
a) Technical
b) Financial
c) Personal
d) Educational
03. What are the benefits of including graphic presentation in an audit report?
(Select two)
a) Simplifies complex data for better understanding
b) Enhances the visual appeal of the report
c) Replaces the need for written content
d) Assists in highlighting key findings
04. FDA CPG 7382.845 is critical for understanding the FDA's criteria for _______ based on quality system audit results.
a) regulatory action
b) market approval
c) financial penalties
d) product recalls
05. Monitoring of which elements is crucial in a controlled environment?
(Multiple correct answers)
a) Bioburden
b) Endotoxins
c) Employee mood
d) Color of the walls
06. For products that require traceability under 21 CFR 820, which of the following is essential?
a) Tracking the product through its entire life cycle
b) Maintaining a customer database
c) Ensuring the product is cost-effective
d) Prioritizing product aesthetics
07. Under the RoHS directive, which of the following substances is restricted?
a) Water
b) Lead
c) Sugar
d) Plastic
08. In preparing for an audit, which aspects are crucial?
(Choose two)
a) Deciding on the lunch menu
b) Choosing the color of the audit report cover
c) Establishing the audit type
d) Verifying audit authority
09. When applying the elements of CAPA, which of the following is critical in ensuring the effectiveness of corrective actions?
a) Prioritizing actions based on financial impact
b) Focusing on actions with the easiest implementation
c) Prioritizing actions based on risk
d) Assigning responsibility based on department seniority
10. Effective auditors should possess which of the following skills?
(Choose two)
a) Ability to play a musical instrument
b) Attention to detail
c) Problem-solving skills
d) Proficiency in video editing
Answers:
Question: 01
Answer: b |
Question: 02
Answer: c |
Question: 03
Answer: a, d |
Question: 04
Answer: a |
Question: 05
Answer: a, b |
Question: 06
Answer: a |
Question: 07
Answer: b |
Question: 08
Answer: c, d |
Question: 09
Answer: c |
Question: 10
Answer: b, c |
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