CBA Practice Questions - ASQ Certified Biomedical Auditor Exam - CBA Practice Questions

Question 1

Which of the following BEST describes the primary purpose of a third-party audit?

To assess a supplier's quality system on behalf of the purchasing organization To evaluate a company's own processes for internal improvement To provide an independent, impartial assessment of an organization's quality management system To verify that a competitor's products meet regulatory requirements

Correct Answer:

To provide an independent, impartial assessment of an organization's quality management system

Question 2

Under ISO 13485:2016, which clause specifically requires the organization to establish and maintain a quality manual?

Clause 4.1 Clause 4.2.2 Clause 5.4 Clause 7.1

Correct Answer:

Clause 4.2.2

Question 3

A biomedical auditor discovers that a medical device manufacturer has been implementing changes to device design without updating the Design History File. Which FDA 21 CFR Part 820 section is most directly violated?

820.30 — Design Controls 820.40 — Document Controls 820.80 — Receiving, In-Process, and Finished Device Acceptance 820.100 — Corrective and Preventive Action

Correct Answer:

820.30 — Design Controls

Question 4

Which standard provides the primary framework for conducting medical device quality management system audits, covering audit principles, managing an audit programme, and performing audits?

ISO 13485:2016 ISO 14971:2019 ISO 19011:2018 FDA 21 CFR Part 820

Correct Answer:

ISO 19011:2018

Question 5

During a supplier audit, an auditor observes that the supplier's employees are following undocumented procedures that differ from the written SOPs. How should the auditor classify this finding?

Observation only, since no regulatory requirement is cited Nonconformance, because actual practice does not conform to documented procedures Opportunity for improvement, because the undocumented practices may be more efficient Minor nonconformance only if the difference creates a product risk

Correct Answer:

Nonconformance, because actual practice does not conform to documented procedures

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About this Exam

Prepare with the CBA Practice Questions - ASQ Certified Biomedical Auditor Exam practice quiz. This question bank includes 100 questions covering auditor, device, medical, audit, and quality. Use it to review important concepts, identify knowledge gaps, and build confidence for the related exam, course, or assessment.

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CBA Practice Questions - ASQ Certified Biomedical Auditor Exam

This practice set contains 100 questions from the matching question bank and focuses on auditor, device, medical, audit, and quality. Work through each question carefully, review the provided solutions, and revisit topics that need more study before your next attempt.

This is an independent study resource intended for practice and review; it is not an official examination or an endorsement by any organization named in the title.

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CBA Practice Questions - ASQ Certified Biomedical Auditor Exam

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