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Oana MOLCU

ISO 9000
The ISO 9000 family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product. The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill. Third party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. Despite widespread use, however, the ISO certification process has been criticized as being wasteful and not being useful for all organizations.

ISO 9001
ISO 9001:2008 Quality management systems Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards: ISO 9000:2005 Quality management systems Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization A quality management approach.

Only ISO 9001 is directly audited against for third party assessment purposes. The other two standards are supplementary and contain deeper information on how to sustain and improve quality management systems; they are therefore not used directly during third party assessment.

The standard specifies that the organisation shall issue and maintain the following six documented procedures: - Control of Documents (4.2.3) - Control of Records (4.2.4) - Internal Audits (8.2.2) - Control of Nonconforming Product / Service (8.3) - Corrective Action (8.5.2) - Preventive Action (8.5.3)

In addition to these procedures, ISO 9001:2008 requires the organization to document any other procedures required for its effective operation. The standard also requires the organisation to issue and communicate a documented quality policy, a Quality Manual (which may or may not include the documented procedures) and numerous records, as specified throughout the standard.

ISO 9001 Introduction to Quality Management


ISO 9001 is an international quality management standard. It is rapidly becoming the most popular quality standard in the world. Thousands of organizations in over 100 countries have adopted it, and many more are in the process of doing so. Why? Because it controls quality. It saves money. Customers expect it. And competitors use it. ISO 9001 applies to all types of organizations. It doesn't matter what size they are or what they do. It can help both product and service oriented organizations achieve standards of quality that are recognized and espected throughout the world. ISO is the International Organization for Standardization. It is located in Switzerland and was established in 1947 to develop common international standards in many areas. Its members come from over 150 national standards bodies. ISO's purpose is to facilitate international trade by providing a single set of standards that people everywhere would recognize and respect.

How does ISO 9001 2008 work?


Here's how it works. You decide that you need to develop a quality management system that complies with the ISO 9001 requirements. 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. In the course of doing so, you may also wish to consult the ISO 9000 definitions and the ISO 9004 guidelines. But how do you develop such a quality management system? There are at least two approaches. You can either do a gap analysis or follow a detailed quality management system development plan. If you've already got a functioning quality management system, we suggest that you carry out a gap analysis. A gap analysis will tell you exactly what you need to do to meet the ISO 9001 standard. It will help you to identify the gaps that exist between the ISO 9001 standard and your organization's processes. Once you know where the gaps are, you can take steps to fill your gaps.

How does ISO 9001 2008 work?


By following this incremental approach, you will not only comply with the ISO 9001 standard, but you will also improve the overall effectiveness of your organization's quality management system. A gap analysis will also help you to figure out how much time it will take and how much it will cost to bring your QMS into compliance with the ISO 9001 standard. However, if you don't have a quality management system or you're starting from scratch, we suggest that you use an ISO 9001 process-based QMS development plan to develop your quality management system.

Once your QMS has been fully developed and implemented, you may wish to carry out an internal compliance audit to ensure that it complies with the ISO 9001 2008 requirements. Once you're sure that your QMS is fully compliant, you're ready to ask a registrar (certification body) to audit the effectiveness of your QMS. If your auditors like what they see, they will certify that your QMS has met ISO's requirements.

How does ISO 9001 2008 work?

While ISO 9001 is specifically designed to be used for certification purposes, you don't have to become certified. ISO does not require formal certification (registration). You can simply establish a compliant QMS and then announce to the world that it complies with the ISO 9001 standard. Of course, your compliance claim may have more credibility in the marketplace if an independent registrar has audited your QMS and agrees with your claim.

Why is ISO 9001 2008 important?


ISO 9001 is important because of its orientation. While the content itself is useful and important, the content alone does not account for its widespread appeal. ISO 9001 is important because of its international orientation. Currently, ISO 9001 is supported by national standards bodies from more than 150 countries. This makes it the logical choice for any organization that does business internationally or that serves customers who demand an international standard of excellence. ISO 9001 is also important because of its systemic orientation. We think this is crucial. Many people wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesn't go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality management system, you will never achieve a worldclass standard of quality. Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9001 is important.

Bibliography

http://en.wikipedia.org/wiki/List_of_ISO_standards http://www.praxiom.com/iso-intro.htm http://en.wikipedia.org/wiki/ISO_9000#Contents_of_ISO_9001 http://www.iso.org/iso/iso900014000/iso9000/page_not_found?pathinfo=http://www.iso.org/iso/ iso9000-14000/iso9000/iso9000index.html