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ASQ Certified Medical Device Auditor Free Sample Questions

Description

Covers auditing fundamentals and roles, audit preparation, performance and reporting, medical device quality management system regulations, risk management and design control, and quality tools.

12 free sample questions135 in the full practice test

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CMDA Sample Questions

  1. Question 1

    Beginner

    Auditing Fundamentals · Types of Audits

    During an annual review, the quality assurance director tasks a compliance specialist with verifying that the newly implemented automated assembly line meets all documented operational parameters and yields. What type of audit is specifically being requested?

    Answer and explanation

    Correct answer: D

    A process audit examines an activity or operation against specific instructions or standards to ensure it is operating within established limits, such as verifying the parameters and yields of an automated assembly line.

  2. Question 2

    Intermediate

    Auditing Fundamentals · Ethical, Legal, and Professional Issues

    True or False: According to the ASQ Code of Ethics, if an auditor discovers a critical safety defect that management refuses to address, their duty of confidentiality strictly prohibits them from notifying external regulatory bodies under any circumstances.

    Answer and explanation

    Correct answer: B

    The ASQ Code of Ethics mandates that professionals hold paramount the safety, health, and welfare of the public. If management refuses to act on a critical safety defect, the duty to public safety supersedes the duty of confidentiality to the employer or client.

  3. Question 3

    AdvancedMultiple answers

    Auditing Fundamentals · Audit Roles and Responsibilities

    While conducting a third-party audit of a contract manufacturer, the lead auditor encounters a highly specialized laser-welding technique. A technical expert is brought in to assist. Which TWO of the following accurately describe the technical expert's boundaries and responsibilities? (Select TWO)

    Answer and explanation

    Correct answers: B, D

    Because technical experts are not qualified auditors, ISO 19011 dictates they must operate under the direction of an auditor and be accompanied by one.

    According to ISO 19011, a technical expert provides specific knowledge or expertise to the audit team but does not act as an auditor.

  4. Question 4

    Intermediate

    Auditing Fundamentals · Types of Audits

    While reviewing complaint files during a routine surveillance audit, an external auditor notices that patient medical records, including unredacted names and treatment histories, are attached to the investigation forms. What is the optimal immediate action the auditor should take?

    Answer and explanation

    Correct answer: C

    Auditors must maintain data privacy. Viewing unredacted patient data (PHI) is a privacy violation. The auditor must stop, notify management of the issue, and request properly redacted documents (de-identified data) to continue evaluating the complaint handling process.

  5. Question 5

    Intermediate

    Auditing and Inspection Processes · Audit Preparation and Planning

    Prior to initiating a supplier qualification audit for a new critical component vendor in Germany, the lead auditor is finalizing the audit plan. Given the limited two-day on-site window, which tactical auditing strategy is best suited to efficiently verify the traceability of raw materials from the finished goods backward?

    Answer and explanation

    Correct answer: B

    Backward tracing is the tactical strategy of starting with a finished output (e.g., a released component) and tracing its history backward through production records to the original raw material inputs, effectively verifying traceability.

  6. Question 6

    Beginner

    Auditing and Inspection Processes · Audit Preparation and Planning

    When assembling a team for an internal QMS audit, the audit program manager must select individuals based on specific criteria. Which of the following characteristics is most critical for ensuring the objectivity of the audit process?

    Answer and explanation

    Correct answer: B

    A fundamental principle of auditing (ISO 19011) is independence. To remain objective, auditors must not audit their own work or have direct responsibility for the areas they are auditing.

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