Home » ISO 13485 Quality Manual and Procedures

ISO 13485 Quality Manual, Procedures & Forms

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.

If a company meets the requirements of ISO 13485:2003, they should easily be able to meet the FDA Quality System Requirements (QSR). Compare ISO 13485 and FDA QSR (21CFR-820)

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

• Document numbering system already created for solid Document Control
  
  
• Master Document List is completed and ready for your work instructions.
  
  
• View list of included procedures and forms

Contents:

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

ISO 13485 Quality Manual:

• 40 pages in MS Word format for ease of editing
  • View ISO 13485 Quality Manual sample
• Text to address each requirement of the ISO 13485 Standard

27 Quality System Procedures (which can be purchased separately) designed to be the foundation of your customized quality management system.

•  Covering ALL the sections of the standard - not just the minimum.
  Please review ISO 13485 Documentation Requirements to understand what you need.
  
  
• View ISO 13485 procedure sample

30 related forms (Can be purchased as a pack).

• View ISO 13485 Form sample

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.