ISO 13485:2003 (Rs.5000/-)
Know about ISO 13485:2003 Certification?
Many professionals in the medical device industry do not know much about quality systems that they are overdose. This article provides an overview of quality systems of medical devices, and then a general description of the requirements of ISO 13485, the international standard for quality management systems for medical devices.
Medical devices can be simple or complex, but they can all benefit from design and manufacture according to ISO 13485: 2003, the most widely used QMS standard for medical devices.
ISO 13485 is a regulatory standard intended to meet customer requirements, including regulatory requirements, and to maintain the efficiency of a quality management system.
In ISO 13485, compliance with requirements includes compliance with regulatory requirements. Thus, for devices used in the United States to comply with ISO 13485, manufacturers must also comply with the QS Reg. standard. As a regulation, QS Reg. Is often more specific than ISO 13485, particularly in the areas of claims handling, labeling control and documentation. ISO 13485 is structured similarly to ISO 9001: 2000 and is actually 90% the same as the general standard for quality management systems.
What is ISO 13485?
ISO 13485 Medical Device - Quality Management System - Requirements for regulatory purposes is a standard of the International Organization for Standardization (ISO) first published in 1996; It represents the requirements of a complete quality management system for the design and manufacture of medical products.
What is the purpose of ISO 13485?
ISO 13485 was written to help medical device manufacturers design quality management systems that establish and maintain the efficiency of their processes. This ensures the design, development, production, installation, and delivery of safe medical devices for intended use.
What is the difference between ISO 9001 and ISO 13485?
Objectives and Results: The requirements of ISO 9001 are strongly oriented to customer satisfaction, while the ISO 13485 standard places greater emphasis on the safety and efficiency of medical devices.
What is the latest version of ISO 13485?
ISO 13485, Medical Device - Quality Management System - Requirements for regulatory purposes, is an internationally recognized standard that establishes requirements for a quality management system specific to the medical device industry. It has recently been revised with a new edition published in March 2016.
Who needs ISO 13485 certification?
ISO 13485, Medical Devices - Quality Management System - Requirements for regulatory purposes, is an internationally recognized standard for organizations involved in the medical device industry. Companies use compliance with this standard to obtain certification of their quality management system.