- International Organization for Standards. Automatic alerting for new ISO standards
Search results
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
This third edition of ISO 13485 cancels and replaces the second edition ( ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. It also incorporates the Technical Corrigendum ISO 13485:2003/Cor.1:2009.
ISO 13485 is an international standard that outlines the requirements for a Quality Management System in the medical device industry. This standard is specific to medical devices and covers the entire life cycle of a device, from design and development to production, installation, and servicing.
ISO 13485 is the harmonized standard for Quality management system (QMS) in the medical device industry. ISO 13485 focuses on patient safety by ensuring the consistent quality throughout the entire lifecycle of medical devices, from design and production to disposal.
ISO 13485 is the internationally accepted standard a medical device organization can implement to demonstrate compliance with MedTech legislations. Obtaining an ISO 13485 Certification with BSI ensures worldwide recognition for your organization compliance with ISO 13485 requirements.
