ISO 13485 Quality Manual and Procedures

Building your QMS is a cornerstone of any successful ISO 13485 Registration. But why take the risk of starting from scratch? With our fully-customizable Quality Manual and Procedures package you will have all the processes and documents you need.

All you have to do it edit and customize each element to suit your own organization and needs. The Quality Manual and Procedures package is ideally suited for organizations and consultants in search of a proven, simple pathway to successful Registration.

ON SALE $697 $397

This is a fast and inexpensive solution for:

• ISO 13485 Beginners implementing for the first time
• Organizations implementing ISO 13485
• Organizations implementing a Quality Management System without a consultant
• Consultants assisting companies with 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.

Here's what you get in the ISO 13485 Quality Manual and Procedure Package:

ISO 13485 Quality Manual, in MS Word format for ease of editing. The Manual includes:

• Text to address each requirement of the ISO 13485 Standard
• Text to assist you with customizing your Manual
• An example process flow chart
• Referenced required and recommended procedures for your quality management system.
• The sections of the Quality Manual correspond with the sections of the ISO 13485 Standard.
• Procedure and Form numbers relate to the section in the Quality Manual.
• View sample page from Quality Manual (pdf)

27 Quality System Procedures designed to be the foundation of your customized quality management system.

• They are easy to use and ready to edit using MS Word.
• Document numbering system already created for solid Document Control
  
  View sample procedure (pdf)
  

30 related forms prepared in MS Word and Excel.

• View of sample form (pdf)
• View list of procedures and forms

Master Document List is completed and ready for your work instructions.

Profit from the years of work that have gone into creating and refining this package. 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.

Our ISO professionals have done the hard part for you. 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 Registration, and more importantly to internal improvements including productivity and profits.

Every purchase is backed by our guarantee, and comes with full customer support. If for any reason, you are not satisfied with our products, let us know within 15 days and you will receive a full and total refund. In addition, if you ever have any questions or comments, you can call us toll-free at 1-(877) 942-6572.

Order your copy of the Quality Manual and Procedures package TODAY.

ON SALE $697 $397