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SUBJECT: ISO 9000 Quality System Standard

ALPHANUMERIC IDENTIFIER:

BRIEF DESCRIPTION: ISO 9000 is a quality system focusing on processes. A well designed, implemented and managed ISO 9000 quality system provides confidence that the output of the process will meet customer expectations. The standard focuses on a three-part cycle: planning, control, and documentation. ISO 9000 is applied for either management purposes or for registration purposes. Firms seek registration for competitive reasons or for reducing the number of supplier quality assurance (SQA) audits they must undergo. An accredited third party registration body awards registration.

KEYWORDS: ISO 9000, Quality Standards, Process, Quality Assurance.

OVERVIEW:

The ISO 9000 series of International Standards for quality management and quality assurance has been adopted in more than 90 countries and is being implemented by thousands of manufacturing or service organizations in both public and private sectors. ISO 9000 is a Quality Management System specification standard known worldwide for doing business. The requirements of the Standard are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages, from production through servicing. The requirements include management, leadership, a pro-active and well-trained work force, customer feedback, measurement, documentation, internal audits, continuous improvement, and third party validation.

The ISO 9000 Standard is generic and independent of any specific industry or economic sector. It can be applied to any product, tangible (assemblies or processed materials) or intangible (knowledge or concepts), or a combination of both. It is equally applicable to both small and large companies, including service providers and distributors. Companies usually initiate an ISO 9000 project due to customer demand. When properly implemented, the ISO 9000 management system saves money, reduces costs, and increases product quality and employee productivity. Savings can reach at least 10% of revenues just by reducing or eliminating the cost of scrap, rework, waste, and returns.

The ISO standard represents an international consensus on good management practice. Its primary aim is to give organizations guidelines on what constitutes an effective quality management system. The standard ISO 9004 gives guidelines on the elements of quality management and a quality system. The family also includes three quality assurance models ISO 9001 for design/development, production, installation and servicing, ISO 9002 for production and installation, and ISO 9003 for final inspection and test. QS 9000 is a more mature version of ISO 9000, and reflects the needs of the automotive industry. QS prescribes that specific quality planning and standard quality control techniques be in place in order to achieve certification.

The organization should carry out the auditing to verify that it is managing its processes effectively. In addition, it may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their needs. Organizations also use the services of an independent certification body to obtain an ISO 9000 certificate of conformity. This option has proved extremely popular because of the perceived credibility of an independent verification. It may thus avoid multiple audits by the organization’s clients, or reduce the frequency or duration of client audits. The certificate can also help establish the organization’s credentials as a reliable business partner to potential clients, especially when supplier and customer are new to each other, or removed geographically from one another. In some countries, government departments and public authorities are requiring companies bidding for procurement contracts to be ISO 9000 certificate holders. In certain industrial sectors, companies are requiring their suppliers to comply with ISO 9000. The client company may verify compliance itself, or may require the supplier to have an ISO 9000 certificate issued by an independent certification body.

 REFERENCES:

• ISO 9000 Meeting the New International Standards, Perry L. Johnson (McGraw-Hill, 1993), American Society for Quality Control, Milwaukee, WI

ACKNOWLEDGEMENT: This is a March 29, 1999 revision by Gene Goodson of an assignment for OM742 contributed by XXX Litwin.