This 4 hour workshop from QSG provides a comprehensive introduction to this standard.
ISO 13485:2016 is explained clause-by-clause with examples from various industries to illustrate individual concepts. Provides a general understanding of the necessary concepts of the standard and its impact on day-to-day operations of organizations in the medical devices industry.
Learning Objectives:
•Overview of ISO 13485:2016
•Understand the purpose and concepts of ISO 13485:2016
•Know the requirements of the standard and how they relate to your business
•Understand the process-based and process effectiveness principles
•Understand the PDCA model for Improvement
•Learn the relationship between ISO 14971:2007 risk management and ISO