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.

The ISO 13485 Quality Manual and Procedure Package includes:

40 page 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

• 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.

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

30 related forms prepared in MS Word and Excel.

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

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.