Home » ISO 9001 to ISO 13485 Quality Manual and Procedures

ISO 9001/ISO 13485 QMS Upgrade Package

This package includes instructions and the additional procedures and forms that you need in order to upgrade your quality system from ISO 9001 to ISO 13485. It is designed for the organization that has already implemented ISO 9001 and is ready to upgrade to ISO 13485.

NOTE: It is assumed that you have in place a COMPLETE ISO 9001 QMS! If not, you may need to purchase Additional 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.

Compare ISO 13485 and ISO 9001

All documents are written in MS Word or format for ease of editing.

• Document numbering system already created for solid Document Control
  
  
  
• View list of included procedures and forms

Contents:

Here's what you get in the ISO 9001 and ISO 13485 Quality Manual and Procedure Package:

Upgrade Instructions

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

• Please review ISO 13485 Documentation Requirements to understand what you need.
  
  
• View ISO 13485 procedure sample

5 related forms

• View ISO 13485 Form sample

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.