Is ISO 13485 only for medical devices ?

ISO 13485 is an international standard that specifies requirements for a comprehensive quality management system for medical device manufacturers. It is specifically designed to ensure the safety and effectiveness of medical devices and promote global harmonization and regulatory compliance.

ISO 13485 is an essential standard for medical device manufacturers, as it places a strong emphasis on risk management, traceability, and control of sterile and regulated healthcare products. This standard helps companies streamline their processes to deliver safe and effective medical devices while meeting legal obligations.

ISO 9001, on the other hand, is an international standard that outlines the criteria for a quality management system (QMS) applicable to any organization, regardless of its size or industry. It focuses on customer satisfaction by meeting customer requirements and continuously improving processes.

ISO 9001 is often used as a prerequisite for marketing medical devices in many countries. However, ISO 13485 is specifically designed for the medical device industry and outlines the requirements for a QMS that ensures compliance with regulatory standards.

ISO 13485 is an important standard for medical device manufacturers, as it helps ensure the safety and effectiveness of medical devices while promoting global harmonization and regulatory compliance..