EN ISO 13485:2016, 2-day course
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This course explains the requirements of the standard and describe its interpretation and application. The course provides a basic understanding of the requirements and how to design, deploy and maintain a working quality management system. Having a quality management system according to ISO 13485:2016 is, in many cases, a prerequisite to getting a CE-mark.
Topics
- ISO 13485 – History, purpose, scope and future
- Quality management system – The big picture, CE-marking
- Relation with ISO 9001 / LVFS / MDD / MDR
- Requirements and interpretation of EN ISO 13485:2016
- Quality management systems
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement