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ISO 13485:2016 Clause by Clause Classroom Training
Level of Difficulty
Beginner (no knowledge at all of the topic).
This two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016. The course introduces the concepts needed to understand, develop, and implement a quality management system.
ISO 13485:2016 is an internationally agreed upon set of standard quality management system (QMS) requirements for any company involved in the design, production, installation, servicing and manufacturing of medical devices. ISO 13485:2016 contains 8 clauses as part of its requirements. In this course participants will gain an understanding of the contents of each clause.