Establishing a documented quality system

The standard requires suppliers to establish and document a quality system as a means of ensuring that product conforms to specified requirements. 

To establish means to set up on a permanent basis, and the requirement therefore emphasizes that the quality system should form part of the infrastructure of the organization. 

This requirement clearly defines the purpose of a quality system, that of ensuring that products conform to specified requirements. One of the principal differences between ISO 9000 and ISO/TS 16949 is the emphasis placed on internal efficiency and effectiveness. Implementing the requirements of ISO/TS 16949 will cause the waste, errors, and internal costs to be minimized. Unlike ISO 9001, ISO/TS 16949 requires the system to enable the organization to implement its quality policy and achieve its quality objectives, which after all is its purpose. This fundamental shift in concept is also behind the changes being made to ISO 9000 in the year 2000 edition. 

One of the first decisions to take should be to define the purpose of the quality system, what you want it to do, why you want to create it. Your reasons for creating a documented quality system may be to  

Ensure products and services satisfy customer requirements Maintain the standards which you have been successful in achieving Improve standards in those areas where performance is lacking Harmonize policies and practices across all departments Improve efficiency 

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