Quality Management Systems Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Management Systems flashcards as text
Which international standard provides the framework for a Quality Management System (QMS) most widely adopted in the medical device industry?
Answer: ISO 13485
ISO 13485 is the internationally recognized standard specifically designed for QMS requirements in the medical device industry.
Under 21 CFR Part 820, the FDA's Quality System Regulation, which element is required to ensure that purchased components meet specified requirements?
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.
A Corrective and Preventive Action (CAPA) system is required under FDA QSR primarily to:
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.
Which of the following best describes a Design History File (DHF) in the context of FDA QSR?
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.
In a QMS, a Management Review must include evaluation of:
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.
The Device Master Record (DMR) required under 21 CFR Part 820 contains:
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.
Which QMS principle requires that organizations identify and manage interrelated processes as a system to improve overall efficiency?
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.