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CPMS Risk Management & Quality Assurance Flashcards

6 cards from real CPMS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. What does a Quality Management System (QMS) in the context of medical software development primarily ensure?

    Answer: Consistent processes and controls to meet regulatory and customer requirements for quality

    A QMS provides a structured framework of processes and controls to ensure medical software consistently meets regulatory requirements and customer quality expectations.

  2. Which standard defines quality management system requirements specifically for medical device organizations?

    Answer: ISO 13485:2016

    ISO 13485:2016 specifies QMS requirements specifically for organizations involved in the design, production, and servicing of medical devices.

  3. In medical software quality assurance, what is the purpose of a Corrective and Preventive Action (CAPA) system?

    Answer: To investigate nonconformities, determine root causes, and implement actions to prevent recurrence

    CAPA systems investigate nonconformities and defects, identify root causes, and implement both corrective actions to fix current issues and preventive actions to stop recurrence.

  4. What is 'nonconformance' in medical software quality management?

    Answer: A failure to meet a specified requirement, standard, or regulatory obligation

    Nonconformance is any failure to meet a specified requirement, standard, or regulatory obligation that must be documented and addressed through the QMS.

  5. Which process ensures that a medical software supplier meets quality and regulatory requirements before their product is used?

    Answer: Supplier qualification and audit process

    Supplier qualification involves evaluating and auditing vendors to confirm they meet required quality and regulatory standards before their software or components are incorporated.

  6. In a medical software QMS, what is the primary goal of an internal audit?

    Answer: To verify that the QMS is effectively implemented and conforms to planned arrangements and standards

    Internal audits verify that QMS processes are effectively implemented, conform to planned arrangements, and meet the requirements of applicable standards.