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ISO 13485:2016 - Quality Management Systems for Medical Devices
ISO 13485:2016 is the third edition of ISO 13485 standard and it is titled Medical devices -- Quality management systems -- Requirements for regulatory purposes. The updated standard explains the requirements for a quality management system (QMS) where an organization can demonstrate its capability to supply medical devices and associated services so that the organization can fulfill customer and relevant regulatory requirements consistently. ISO 13485:2016 can also be utilized by vendors or external parties that offer services or products to medical device organizations.This course begins by covering the context of the publication of this ISO standard and reviews the various regulations standards of earlier editions of this publication. Then the course highlights important terminology which are grouped under different titles. The course explains all the requirements of ISO 13485 including specific requirements of quality management system management responsibilities together with resource management requirements of product realization such as planning for the QMS design and development of product purchasing controls and production management etc. The course also covers the Clause - 8 of ISO 13485 standard as a separate module that explains all about measurement analysis and improvement.If you’re interested in ISO or regulatory affairs as a future career or if you’re an ISO professional seeking to keep up to date with the latest ISO 13485 standard then this clear and simple course is for you. Understanding ISO 13485:2016 is of vital importance for all professionals working in the medical device sector. So start this free online course today and in just 3 hours you’ll be up to date with the new changes in this important ISO standard.
Disclaimer: Product information, including title, description, and images, is sourced/provided by our affiliate partner, Alison US CA.
Disclaimer: Some of the links on this website are affiliate links, meaning we may earn a commission if you click through and make a purchase. This comes at no additional cost to you.
By clicking the button above, you acknowledge that you will be redirected to a third-party website and agree to their terms and conditions.
Product information, including title, description, and images, is sourced/provided by our affiliate partner, Alison US CA.
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Refer a friend and earn 0.05 CEC when they click the link, plus an additional 1.00 CEC if they register. Share this Product and boost your earnings together!
Log in to manage favorites.
Similar Products
-
ISO 55001 - Fundamentals of the Asset Management System
-
ISO 37001 - Anti-Bribery Management System (ABMS)
-
ISO 20000 - Principles of IT Service Management System (ITSM)
-
ISO 26000 - Business Practices for Corporate Social Responsibility
-
ISO 31000:2018 - Enterprise Risk Management Framework for Risk Leaders
Share this product with a friend:
Refer a friend and earn 0.05 CEC when they click the link, plus an additional 1.00 CEC if they register. Share this Product and boost your earnings together!