Measurement, Analysis and Improvement - Lesson Summary.Measurement, Analysis and Improvement - Learning Outcomes.Operations of Quality Management System - Lesson Summary.Product Realization – Purchasing and Production.Product Realization – Planning to Design and Development.Management Responsibility and Resource Management.

Operations of Quality Management System - Learning Outcomes.Operations of Quality Management System (QMS) Introduction to ISO 13485:2016 (Medical Devices' QMS) - Lesson Summary.

Publication of ISO 13485:2016 and Context of Publication.

Quality Management System of Medical Devices' Suppliers and Manufacturers.

Introduction to ISO 13485:2016 (Medical Devices' QMS) - Learning Outcomes.

Introduction to ISO 13485:2016 (Medical Devices' QMS) 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. Understanding ISO 13485:2016 is of vital importance for all professionals working in the medical device sector. 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. The course also covers the Clause - 8 of ISO 13485 standard as a separate module that explains all about measurement, analysis and improvement.

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. Then the course highlights important terminology which are grouped under different titles. 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. ISO 13485:2016 can also be utilized by vendors or external parties that offer services or products, to medical device organizations. 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 is the third edition of ISO 13485 standard, and it is titled 'Medical devices - Quality management systems - Requirements for regulatory purposes'.

En iso 13485 2016