ISO 13485

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10 Questions

Which regulation is specifically mentioned as one of the elements of a Quality Management System?

FDA 21 CFR 820 Regulation

What is the purpose of a Quality Management System (QMS)?

To meet customer and regulatory requirements

Which ISO standard is mentioned as one of the elements of a Quality Management System?

ISO 9001

What does QMS stand for?

Quality Management System

Which of the following is NOT mentioned as one of the elements of a Quality Management System?

Product quality

Which ISO standard is mentioned as one of the elements of a Quality Management System?

ISO 13485

What is the purpose of a Quality Management System (QMS)?

All of the above

Which regulation is specifically mentioned as one of the elements of a Quality Management System?

21 CFR 820

What does QMS stand for?

Quality Management System

Which of the following is NOT mentioned as one of the elements of a Quality Management System?

Data management

Test your knowledge of ISO 13485:2016 and 21 CFR 820 regulations with this quiz. Learn about Quality Management Systems (QMS) and how they help organizations achieve quality policies and objectives. Assess your understanding of QMS and its role in meeting customer and regulatory requirements.

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