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ISO 13485 Quality Manual

A quality manual and Procedure package are the key documents of a quality management system. The ISO 13485 standard was designed for companies in the medical devices business. 13485store.com provides a documented ISO 13485 quality manual and procedure package for implementing an ISO 13485 quality management system in the organization. This is fully-customizable quality manual meets the requirements to implement an ISO 13485 quality management system in an organization. It contains procedures and processes projected for planning, designing and implementation of activities which have an impact on product quality.

ISO13485 quality manual and procedures include:

1. The key role of the QMS (quality management system)
   
   
2. Quality objectives which support an organization’s efforts for achieving quality policies. These quality objectives are measurable against performance goals.
   
   
3. Detailed quality management system procedures and processes
   
   
4. Relationship between the QMS processes.
   
   
5. Describes the structure of quality management system
   
   
6. Justification of inclusion of new application and exclusion of previous applications used in quality management system.
   
   
7. Text to address of each requirement of the ISO 13485 Standard
   
   
8. Flow chart of processes
   
   
9. Required and recommended procedures for quality management system.

The ISO 13485 quality manual and procedures provided by the 13485store.com is very easy to understand. All the documents in the quality manual are written and edited by professional technical writers. The documents are in Microsoft word format for easy editing. Any organization who deals in selling the medical devices can implement quality management system without hiring a professional outside consultant.

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. Contact us to buy this ISO 13485 quality manual.