ISO 13485:2016 Medical Devices Quality Management System Course


Understanding and Implementation Course


This is a 5-day training course aimed at enhancing the knowledge and skills needed to successfully implement a Medical Devices Quality Management System based on ISO 13485. The 5th day is reserved for the Assessment of Learning. Learners will get Certificates of Competency on passing Assessment.


Who should attend?


* Individuals involved in Quality Management

* Individuals seeking to gain knowledge about the main processes of Quality Management Systems (MDQMS)

* Individuals interested to pursue a career in Quality Management


What will you learn?


1. Introduction to ISO 13485:2016 Medical Devices Quality Management System [MDQMS]

* Standards & Regulatory Requirements

* Key Quality Concepts.

* ISO 13485:2016 Medical Devices Quality Management System clauses 4 to 10.

2. Initiation of & Planning for the Implementation of MDQMS [PLAN].

3. Implementation of MDQMS [DO]

4. Monitor, Measure & Analyse Data [CHECK]

5. Continually Improve MDQMS processes [ACT]


How will you benefit?


* Learn how to implement a Quality Management System within your organization to enable better response to customer requirements and market changes.

* Learn how to transition your organization to meet the new requirements of the ISO standard.

* Understand the conformance requirements associated with your stated Quality policy.

* Learn how to implement, maintain, and continually improve your organization’s MDQMS.


Understanding and Implementation Course


* Training course materials containing practical examples

* Lunch and Refreshments (for face to face training)

* Certificate


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