Duration - 2 Days
Course Description
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 14971:2007, which contains key principles and guidance for risk management. PD CEN ISO/TR 14969:2005, “Medical devices – quality management systems – guidance on the application of 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.
Learning Objectives
- Understand Quality Mangement Definitions, Concepts, and Guidelines
- Understand the Process Approach
- Interpret All Clauses of ISO 13485:2003
- Understand the Role of Mangement In ISO 13485:2003 Implementation
- Understand the Proper USe of ISO/TR 14969:2004
- Learn Best Practice Processes to Implement each Clause of ISO 13485:2003
- Prepare for an Audit
- Plan for Registration
Who Should Attend
- Anyone involved in defining, planning, or implementing an ISO 13485:2003-based quality management system
- Management representatives
- Implementation team members
Prerequisite
This is an introductory course designed for individuals with little or no previous knowledge of implementing a quality management system. Basic knowledge of medical devices, ISO 9001:2000, or ISO 13485:2003 would be beneficial.
Course Logistics
Certificates of attendance are provided at the conclusion of the course.
Student : Instructor Ratio – 20:1
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