This one day workshop is designed to provide top management with the information and tools necessary to initiate and actively support the implementation and maintenance of an ISO 9001:2000, ISO 13485:2003, QSR 21 CFR 820 or AS9100B Quality Management System.  Workbook exercises will be conducted.  

• Basis and Interrelationship of Standards
• Emphasis
• Benefits
• Eight Management Principles
• Understanding the Process Approach
• Implementing the Process Approach
• System Approach to Management
• Key Management Requirements of the Standard
• Scope of Approval
• The Registration Process
• Registrar Selection
• The Secret to Success

Deliverables:  The outputs of the workshop will provide a solid basis upon which to build the Quality System and will define and establish the following guidlines.   A Certificate of Completion will be issued.

• The Quality Policy
• Key Processes of the Company
• Quality Objectives that will be used when establishing process operations
• Performance measures to the Quality Objectives
• Training Effectiveness
• Continual Improvement activities

Implementation/Documentation Training for Project Team

This workshop is designed to provide one day of intensive training for the Project Implementation Team in the specifics of implementation and documentation for the Quality Management System. This will involve instruction and practice in the construction of the Quality Manual, flowcharts and procedures, and basic review of the requirements of the Standard. To fully complete this training, the Project Team will construct a process flowchart and/or procedure for a designated process and participate in the development of the Quality Manual.

Deliverables: The outputs of this workshop will provide the Project Team with the tools and knowledge to fully implement the Quality System and maintain its documentation.  A Certificate of Completion will be issued.