CPMS CPMS Risk Management & Quality Assurance 2 — Questions and Answers
Question 1: What does a Quality Management System (QMS) in the context of medical software development primarily ensure?
- That all employees receive annual performance reviews
- Consistent processes and controls to meet regulatory and customer requirements for quality (Correct answer)
- That software is developed using only FDA-approved programming languages
- That medical software is priced competitively in the market
Correct 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.
Question 2: Which standard defines quality management system requirements specifically for medical device organizations?
- ISO 9001:2015
- ISO 13485:2016 (Correct answer)
- IEC 62304:2006
- ISO 14971:2019
Correct answer: ISO 13485:2016
ISO 13485:2016 specifies QMS requirements specifically for organizations involved in the design, production, and servicing of medical devices.
Question 3: In medical software quality assurance, what is the purpose of a Corrective and Preventive Action (CAPA) system?
- To schedule routine software updates and patches
- To investigate nonconformities, determine root causes, and implement actions to prevent recurrence (Correct answer)
- To document user complaints without requiring investigation
- To track employee attendance during software development
Correct 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.
Question 4: What is 'nonconformance' in medical software quality management?
- Software that has not yet been validated
- A failure to meet a specified requirement, standard, or regulatory obligation (Correct answer)
- A user preference that differs from the software design
- A feature request submitted after initial development
Correct 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.
Question 5: Which process ensures that a medical software supplier meets quality and regulatory requirements before their product is used?
- Supplier qualification and audit process (Correct answer)
- Change control review
- Software validation testing
- Adverse event reporting
Correct 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.
Question 6: In a medical software QMS, what is the primary goal of an internal audit?
- To identify employees for performance improvement plans
- To verify that the QMS is effectively implemented and conforms to planned arrangements and standards (Correct answer)
- To test software functionality in the production environment
- To review financial expenditures on software development
Correct 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.
CPMS CPMS Risk Management & Quality Assurance 2
What does a Quality Management System (QMS) in the context of medical software development primarily ensure?