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 9001

Answer

ISO 14971

Answer

ICH Q10

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

Design controls

Answer

Corrective and preventive action

Answer

Production and process controls

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

Document all manufacturing steps

Answer

Approve new product designs

Answer

Train employees on GMP requirements

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

A record of all customer complaints

Answer

A log of manufacturing deviations

Answer

A list of approved suppliers

Question 5

In a QMS, a Management Review must include evaluation of:

Accepted Answer

Quality policy, objectives, and audit results

Answer

Marketing strategies and sales forecasts

Answer

Employee benefit plans

Answer

Competitor product performance

Question 6

The Device Master Record (DMR) required under 21 CFR Part 820 contains:

Accepted Answer

Procedures and specifications for a finished device

Answer

Records of each unit produced

Answer

Records of customer complaints

Answer

Risk management files

Question 7

Which QMS principle requires that organizations identify and manage interrelated processes as a system to improve overall efficiency?

Accepted Answer

Process approach

Answer

Customer focus

Answer

Continual improvement

Answer

Leadership commitment