Скачать с ютуб Understanding Quality Management Systems - What is ISO 13485? в хорошем качестве

Understanding Quality Management Systems - What is ISO 13485?

This Video is an introduction to the international Quality Management Standard ISO 13485. It discusses about what is ISO 13485? Who uses ISO 13485 and why they need to use this quality management system standard. Medical Devices are regulated world wide, and each country or jurisdiction have their own medical device regulations that describe what is required to happen before you can sell medical devices in those countries. This is to ensure that medical devices are as safe as possible before being sold into those countries. Nearly all medical device regulations in the world require some sort of quality management system to ensure that medical devices are designed and developed, manufactured, maintained and monitored through out their lifecycle. Using an international standard is one way medical device manufacturers, distributors and other stakeholder organizations can cover the requirements of multiple medical device regulation jurisdictions at the same time. Due to the standard being international, many countries allow its use to cover their medical device regulatory requirements for quality assurance, for example in the EU for CE marking and in the UK for UKCA marking are two areas where the use of ISO 13485 covers the QA needs for both regulations. In the USA the FDA are also looking at the use of ISO 13485 to cover the Quality Assurance Requirements of their regulation. ISO 13485 is a certifiable standard where the holder organisation is audited by a certification (or notified) body and given a certificate which is usually valid for a period of 3 to 5 years, with annual surveillance audits carried out to ensure that the quality management system is being maintained. 🌐 *Connect With Us:* www.patientguard.com If you are looking for Quality Assurance Templates to help you with your Quality Management System then head over to: https://qmsregs.com