ISO 13485: What You Need to Know (Automobiles & Vehicles - Auto Parts & Services)
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Item ID 2973957 in Category: Automobiles & Vehicles - Auto Parts & Services
ISO 13485: What You Need to Know | |
ISO 13485: What You Need to Know The ISO 13485 is an international standard that specifies requirements for a quality management system specifically tailored for the medical device industry. It is designed to ensure that medical devices are consistently produced and controlled to meet regulatory requirements and customer expectations. The standard is based on the ISO 9001 quality management system, but it includes additional requirements specific to the medical device industry. ISO 13485 is recognized globally and is often a prerequisite for regulatory compliance in many countries. Key Requirements of ISO 13485: Management Responsibility: The standard requires top management to demonstrate leadership and commitment to the quality management system. This includes establishing a quality policy, defining roles and responsibilities, and ensuring the availability of necessary resources. Risk Management: ISO 13485 emphasizes the importance of risk management throughout the product lifecycle. This includes identifying and assessing risks associated with the development, production, and use of medical devices. Design and Development: The standard includes specific requirements for the design and development of medical devices, including design inputs, verification, validation, and design changes. Process Control: ISO 13485 requires organizations to establish and maintain documented procedures for controlling processes that are critical to the quality of the medical devices. Supplier Management: The standard emphasizes the need to evaluate and select suppliers based on their ability to provide products and services that meet the organization’s requirements.  | |
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| Target State: All States Target City : shanghai Last Update : 30 August 2024 8:19 AM Number of Views: 32 | Item Owner : chinamoldmaker Contact Email: Contact Phone: 021-52913487 |
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2025-01-21 (0.385 sec)