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One of the basic facts about ISO 9000 is that it doesn’t certify the quality of a product or service.
Its purpose is to provide a quality system or business processes that will provide a consistent method doing things in a business. It was designed this way so that it could be applied to any business and in any country in the world.
If it was to prescribe a certain level of quality, such as allowable errors, it would have never been approve by businesses and countries all over the world.
ISO 9000 should be viewed as a basic foundation for a management system for the quality of product and services. It needs to be supplemented with business practices such TQM and Malcolm Baldrige that stress customer satisfaction and continuous improvement.