BSI’s "Implementing ISO 13485:2003" course introduces the concepts needed to understand, develop, and implement a quality management system as outlined in the medical devices standard ISO 13485:2003. This course also discusses the use of ISO 14971:2001, which contains key principles and guidance for risk management. PD ISO/TR 14969:2004, a document that provides guidance for the application of the requirements in ISO 13485:2003, will also be used as a learning tool. Experienced instructors explain how to integrate ISO 13485:2003 system implementation with the overall business, prepare for audits, and achieve ISO 13485:2003 registration. Exercises prepare students to identify key requirements, create documentation, develop project plans, and prepare a scope map.
Students receive comprehensive course manuals with reference materials.
This is an introductory course designed for individuals with little or no previous knowledge of implementing a quality management system. Basic knowledge of ISO 9001:2008 or ISO 13485:2003 would be beneficial.
