CAPA Regulatory Compliance & Quality Standards 1

Question 1

What is the purpose of regulatory compliance in the CAPA process?

Accepted Answer

To meet legal and industry requirements

Answer

Regulatory compliance ensures that the organization adheres to laws, regulations, and standards that govern its operations.

Question 2

Which regulatory body oversees CAPA requirements for medical devices in the U.S.?

Accepted Answer

FDA

Answer

The FDA sets CAPA requirements as part of the Quality System Regulation (QSR) for medical device manufacturers.

Question 3

What does ISO 13485 focus on?

Accepted Answer

Medical device quality management systems

Answer

ISO 13485 is an international standard that outlines quality management system requirements for medical devices.

Question 4

Which of the following is a benefit of aligning with quality standards?

Accepted Answer

Improved quality and reduced risk

Answer

Aligning with quality standards helps improve product quality, increase customer satisfaction, and reduce compliance risks.

Question 5

What is the role of documentation in compliance with quality standards?

Accepted Answer

To demonstrate compliance and traceability

Answer

Documentation ensures traceability, consistency, and provides evidence of compliance during audits.

(CAPA) Corrective and Preventive Action Certified Practice Test