The ISO 13485 Champion class is designed for persons that have the extra time to spare to really learn the standard.  The pace is comfortable and allows the students and the instructors the chance to engage and interact, to ask-and-answer questions in an environment that is conducive to a thorough understanding of the intent of the ISO 13485:2003 standard.

Course Hours:  Day One 8a-5p, Day Two 8a-noon

Course Objectives: 

• Create successful graduates that have demonstrated competency in the are of Quality Management Systems.
• Make students aware of the new structure of the standard.
• Make students aware of the intent of the new changes and its new emphasis on customer satisfaction and processes.
• Learn about the increased emphasis on top management commitment and responsibility.
• Understand the process model used as the basis for the new standard.
• Understand the affect on you, your business, and your QMS system.
• Understand the eight Quality Management Principles on which the revision is based.
• Understand the Planning and Documentation needs of the new standard in order to better plan for resource allocation.
• Understand the objective evidence needed to show conformance and effectiveness of the Quality Management System
• Highlighted discussion of the changes and additions to the ISO standard.

Course Agenda:

• Brief history of Quality leading up to the ISO series of standards
• Synopsis of the changes made at each revision level of the ISO13485 standard
• Understand the financial impact of an effective QMS and how to convert it into dollar and cents language that your management team can understand
• A comfortably paced and detailed discussion of the clauses 4-8 that comprise the new ISO 13485:2003 standard focused on the Medical Device Directive
• Detailed discussion of the changes and intent of changes 
• Discussion of the process model 
• Discussion and review of the eight quality management principles. 
• Discussion of the required and 'Implied to be required' procedures. 
• What auditors will look for? How the audit will be performed.
• How to create best practice systems that represent the evolution of the QMS ISO9001:2000 and ISO 13485:2003
  

Related, complementary courses:

• ISO 13485 Lead Auditor
• Root Cause- Corrective Actions
• QMS Process Auditing
• Six Sigma Yellow Belt