Is ISO 13485 a regulation or standard ?

Is ISO 13485 a Regulation or Standard?

ISO 13485 is an international standard for quality management systems specifically designed for the medical device industry. While it is often referred to as a regulation, it is technically a standard that outlines the requirements for a comprehensive quality management system in the medical device industry.

ISO 9001 is a general quality management system (QMS) standard that provides a framework for organizations to establish a systematic approach to quality throughout their operations. This standard focuses on customer satisfaction, continuous improvement, and meeting regulatory requirements.

Having ISO 9001 certification demonstrates an organization's commitment to delivering consistent, high-quality products or services. It also helps streamline processes, reduce inefficiencies, and enhance overall performance.

The specifics of ISO 13485 While ISO 13485 shares similarities with ISO 9001, it is specifically designed for organizations involved in the medical device industry. This standard places greater emphasis on regulatory compliance, risk management, and the control of sterile environments.

Obtaining ISO 13485 certification demonstrates a company's dedication to ensuring the safety and effectiveness of medical devices. This standard helps organizations align with regulatory requirements in different markets, enhance product reliability, and establishes robust processes for design, development, and production of medical devices.