体系标准认证

HOME > 体系标准认证 > ISO13485 体外诊断/|医疗器械

ISO 13485 (In Vitro Diagnostic Devices / Medical Devices Quality Management System) 概要

ISO 13485:2016 is an international standard that specifies quality management system requirements for the life cycle of medical devices, such as design and development, production, storage and distribution, installation, service and final disposal. ISO 13485:2016 requirements enable the complementation of process systems within an organization to meet customer and regulatory requirements for safety and performance. It can also demonstrate to internal and external organizations, including certification bodies, an organization's ability to provide medical devices and related services that meet customer and regulatory requirements.
ISO 13485 (In Vitro Diagnostic Devices / Medical Devices Quality Management System) 特征和背景
IS0 13485:2003 was revised as a single standard on July 15, 2003 with the intention of unifying regulatory requirements that are applied differently in each country by stipulating the requirements for the quality management system of organizations that provide medical devices and related services. It is based on the ISO 9001:2000 standard that stipulates the requirements for the quality management system of a 'general organization', and special requirements in the medical device field have been added to the requirements. The European Union (EU) also accepted it as a European standard in July 2003, the third edition of the ISO 13485 standard was revised on March 1, 2016, and it was adopted as EN ISO 13485:2016 in Europe.

ISO 13485 (In Vitro Diagnostic Devices / Medical Devices Quality Management System) 要求事项的构成

No. 題目

ISO 13485 (In Vitro Diagnostic Devices / Medical Devices Quality Management System) 引进的效果和必要性

  • 1. Management of the entire product process through implementation and maintenance of the medical device quality management system
    2. Proactive quality management and continuous quality improvement
    3. Increase sales through stable response to customers' management system implementation requirements
    4. Improving corporate image and enhancing external competitiveness

    ISO 13485:2016 Necessity
    1. If a medical device is to be sold under its own name in the market of the European Union, ISO 13485 certificate must be submitted.
    2. In the case of in vitro diagnostic equipment or reagent companies, if they have ISO 13485:2016 certificate, they can issue their own performance test report and submit it as a record during GMP audit.
    3. Since Korean GMP is a standard based on ISO 13485, it is easy for organizations that have established the ISO 13485 system to obtain a Korean medical device manufacturing license.
The U.S Certification Body is constantly striving to become an excellent client-satisfied company by securing sincere and experienced judges to help domestic and foreign companies implement ISO 13485 and is confident that it can overcome various crises in the future by establishing and implementing internationally recognized quality systems.