CRAP Quality Management Systems

Question 1

Which international standard provides the framework for a Quality Management System (QMS) most widely adopted in the medical device industry?

Accepted Answer

ISO 13485

Answer

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?

Accepted Answer

Purchasing controls

Answer

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:

Accepted Answer

Identify and eliminate causes of nonconformities

Answer

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?

Accepted Answer

A compilation of records that describes the design history of a finished device

Answer

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:

Accepted Answer

Quality policy, objectives, and audit results

Answer

Management reviews must assess quality objectives, audit results, customer feedback, and process performance to ensure the QMS remains effective.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP Quality Management Systems