CRAP Quality Management Systems 1 — Questions and Answers
Question 1: Which international standard provides the framework for a Quality Management System (QMS) most widely adopted in the medical device industry?
- ISO 9001
- ISO 13485 (Correct answer)
- ISO 14971
- ICH Q10
Correct answer: ISO 13485
ISO 13485 is the internationally recognized standard specifically designed for QMS requirements in the medical device industry.
Question 2: Under 21 CFR Part 820, the FDA's Quality System Regulation, which element is required to ensure that purchased components meet specified requirements?
- Design controls
- Purchasing controls (Correct answer)
- Corrective and preventive action
- Production and process controls
Correct answer: Purchasing controls
21 CFR Part 820.50 requires purchasing controls to ensure that all purchased or otherwise received products and services conform to specified requirements.
Question 3: A Corrective and Preventive Action (CAPA) system is required under FDA QSR primarily to:
- Document all manufacturing steps
- Identify and eliminate causes of nonconformities (Correct answer)
- Approve new product designs
- Train employees on GMP requirements
Correct answer: Identify and eliminate causes of nonconformities
CAPA systems under 21 CFR Part 820.100 are designed to identify the root cause of nonconformities and prevent their recurrence.
Question 4: Which of the following best describes a Design History File (DHF) in the context of FDA QSR?
- A record of all customer complaints
- A compilation of records that describes the design history of a finished device (Correct answer)
- A log of manufacturing deviations
- A list of approved suppliers
Correct answer: A compilation of records that describes the design history of a finished device
Per 21 CFR Part 820.30(j), the DHF must contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan.
Question 5: In a QMS, a Management Review must include evaluation of:
- Marketing strategies and sales forecasts
- Quality policy, objectives, and audit results (Correct answer)
- Employee benefit plans
- Competitor product performance
Correct answer: Quality policy, objectives, and audit results
Management reviews must assess quality objectives, audit results, customer feedback, and process performance to ensure the QMS remains effective.
Question 6: The Device Master Record (DMR) required under 21 CFR Part 820 contains:
- Records of each unit produced
- Procedures and specifications for a finished device (Correct answer)
- Records of customer complaints
- Risk management files
Correct answer: Procedures and specifications for a finished device
The DMR, per 21 CFR 820.181, contains or references device specifications, production processes, quality assurance procedures, and packaging/labeling specifications.
Question 7: Which QMS principle requires that organizations identify and manage interrelated processes as a system to improve overall efficiency?
- Customer focus
- Process approach (Correct answer)
- Continual improvement
- Leadership commitment
Correct answer: Process approach
The process approach principle recognizes that consistent, predictable results are achieved more effectively when processes are understood and managed as an interconnected system.
CRAP Quality Management Systems 1
Which international standard provides the framework for a Quality Management System (QMS) most widely adopted in the medical device industry?