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Here's how it works. You decide that you need to develop a quality management system that meets the new Quality Standard. That's your mission. You choose to follow this path because you feel the need to control or improve the quality of your products and services, to reduce the costs associated with poor quality, or to become more competitive. Or, you choose this path simply because your customers expect you to do so or because a governmental body has made it mandatory. You then develop a quality management system that meets the requirements specified by ISO 9001:2000 (ISO 9002 and 9003 have been dropped).
To develop such a quality management system, there are at least two approaches. A Gap Analysis or following a detailed System Development Plan. If a organization has already got a quality management system and if it is happy with the way it operates, then a Gap Analysis to upgrade to the new ISO 9001 2000 standard is suggested. A Gap Analysis will tell exactly what is needed to meet the ISO 9001 2000 Quality Management Standard. It will help to identify the gaps that exist between the new ISO Standard and the organization's processes. Once the gaps are identified, steps can be taken to fill the gaps. By following this incremental approach, the organization will not only comply with the new ISO 9001 Standard, but also improve the overall performance of the organization's processes.
However, if the organization hasn’t got a quality management system or is not happy with the one already existing, then ISO 9001 2000 Process Oriented Quality Management System Development Plan is suggested to develop quality management system. If the organization follows the detailed steps that make up the System Development Plan, it will end up with a quality management system that will meet the needs and ISO's requirements. Once the organization’s quality management system has been fully developed and implemented, it has to carry out an Internal Audit to ensure that the organization met every single ISO 9001 2000 requirement.
When the organization is ready with the quality management system, a Registrar may be entrusted with auditing of the effectiveness of quality management system. If the auditors like what they see, they will certify that the organization’s quality system has met ISO's requirements. They will then issue an official certificate to the organization and they will record its achievement in their registry.
The firm can announce to the world that the quality of its products and services is managed, controlled, and assured by registered ISO 9001 Quality Management System!
However, there is no need to be registered. ISO does not require formal registration (certification). The organization can be in compliance without being registered by an accredited auditor. But, the customers are more likely to believe thatb the organization have an effective quality management system if an independent external auditor confirms.
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