Certified Biomedical Equipment Technician (CBET) Practice Exam 2025 – Comprehensive All-In-One Guide for Exam Success!

ISO 13485 is a specific standard that pertains to quality management systems in the medical device industry. It focuses on ensuring that organizations involved in the design, production, installation, and servicing of medical devices are able to demonstrate their ability to provide medical devices that consistently meet both customer and regulatory requirements.

This standard emphasizes the importance of a systematic approach to quality management and outlines the processes necessary to achieve effective product quality while complying with applicable regulations. It covers various aspects, including risk management, input and output measurements, and continuous improvement, ensuring that organizations do not just meet requirements but also enhance customer satisfaction.

The other options relate to different areas of compliance and regulatory standards. For example, environmental management systems address environmental impact rather than product quality, while occupational safety guidelines focus on worker safety, and product testing standards pertain to specific performance and safety testing of devices rather than the overarching quality management practices established by ISO 13485.