This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard which serves as a basis for many medical device quality management system (QMS) regulations around the globe. This course covers the goals of the standard and in-depth instruction regarding Clause 4-QMS; Clause 5-Management Responsibility; Clause 6-Resource Management; Clause 7-Product Realization; and Clause 8-Measurement Analysis and Improvement.
By the end of this course you should be able to:
- Define the primary purpose of ISO 13485:2016
- Identify the general and documentation requirements of a QMS as outlined in Clause 4
- Recognize the responsibilities of management within a QMS as outlined in Clause 5
- Identify the resources needed to implement and maintain an effective QMS; and meet regulatory and customer requirements as outlined in Clause 6
- Recognize the requirements for planning and developing the processes needed for product realization as outlined in Clause 7
- Identify requirements for planning and implementing monitoring, measuring, analysis and improvement processes as outlined in Clause 8
By completing/passing this course, you will attain the certificate Medical Device Certificate
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