ISO 13485 All-in-One Documentation and Training Package:

Our best selling products all in one package to bring you savings! Your time and resources are limited so make the most of both.

This product includes:

• ISO 13485 Quality Manual
• 27 Procedures describing Quality System Processes to meet ISO 13485 requirements
• 30 Forms and tables referenced by the Procedures
• Gap Analysis Checklist
• Online ISO 13485 Training
• Internal Audit Checklist
• Internal Auditor Training Materials Package

This is a downloadable product. You also have the option of purchasing the files on CD-Rom.

$1397

The key to an effective Quality Management System is designing the Quality Management Processes for efficiency and ease of use. The processes must be carefully thought out, well-organized, and carefully designed to work together to lead your organization to continuous improvement.

The Quality Manual and Procedures are fully integrated, related forms are included, and the Master Document List is completed and ready for your work instructions. Our documents, edited by professional technical writers, have been written in Microsoft Word so you can easily edit and customize them to make them your own. When you have questions, our experts are only an email away.

The comprehensive nature of this package makes it suitable for a variety of situations:

• Organizations that want to quickly and effectively implement ISO 13485
• Organizations implementing ISO 13485 for the first time, or organizations that want to improve their current Quality Management System
• Organizations implementing a Quality Management System without a consultant
• Consultants assisting companies with registration

The All-in-One package has been refined and proven over a ten-year period, and has helped thousands of companies achieve ISO 13485 Registration.

• Project managers leading their companies Quality Management System implementation
• Experienced ISO 13485 professionals who would like to save on time and effort during their ISO 13485 project.

Our system is the result of continual improvement of processes and procedures that have been tried, proven and improved over the last decade. They have lead thousands of companies across the globe to successful ISO 9001 Registration, and more importantly to internal improvements including productivity and profits.

The Quality Manual and Procedures are fully integrated, related forms are included, and the Master Document List is completed and ready for your work instructions.

Our documents, edited by professional technical writers, have been written in Microsoft Word so you can easily edit and customize them to make them your own.

$1397