Description This course introduces the concepts needed to understand, develop, and implement a quality management system as outlined in the medical devices standard ISO 13485. The course also discusses the use of ISO 14971, which contains key principles and guidance for risk management.ISO/TR 14969, a document that provides guidance for the application of the requirements in ISO 13485, will also be used as a learning tool.Experienced instructors explain how to integrate ISO 13485 system implementation with the overall business, prepare for audits, and achieve ISO 13485 registration.Exercises prepare students to identify key requirements, create documentation, develop project plans, and prepare a scope map.
Larry Whittington is the instructor
for all the highlighted classes.
Learning Objective
Understand Quality Management Definitions, Concepts, and Guidelines
Understand the Process Approach
Interpret All Clauses of ISO 13485:2003
Understand the Role of Management 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
Course Materials Students receive comprehensive course manuals with reference materials, including copies of:
ISO 9000:2000
ISO 13485:2003
ISO 14971:2001
ISO/TR 14969:2004
Audience
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 ISO 9001:2000 or ISO 13485:2003 would be beneficial.
Duration The course is taught as a two day class, from 8:00 AM - 5:30 PM.
CEUs The student certificates display 1.6 continuing education units for the class.
Fee The class is $995 per student. To confirm your enrollment, pre-payment will be required.
Contact If you have any questions about this course,
please call us at 770-517-7944 or send an e-mail to Larry@WhittingtonAssociates.com.
