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QW Academy - What is ISO 9001?

The history of standards for contemporary quality management systems traces back to 1959. Then, the U.S. Department of Defense released a quality management program under the designation MIL-Q-9858. For nearly three decades, this standard was primarily used in the U.S. defense and aerospace industries. In the mid 1960s, the former Soviet Union introduced a national standard (KC YKP) in an attempt to manage quality across the country.

In 1979, the British Standards Institution (BSI) developed the first commercial standard for quality systems that became known as BS 5750. That same year, BSI issued its first certificate to a small cement plant in England for compliance with BS 5750. It took almost another decade for the international community to recognize the benefits of standards for quality systems.

In 1987, ISO completed and released its 9000 series of standards, incorporating most of the elements of BS 5750 into its ISO 9001 standard. The ISO 9000 series of standards first gained popularity in Europe, when the European Union (EU), under the title EN 29000, adopted ISO 9000. By the late 1980ís, BS 5750 and ISO 9000 standards had reached the U.S. market.

The latest ISO 9001 registration data shows impressive growth. The number of ISO 9001 certifications issued worldwide for quality management systems reached 670,399 at the end of 2004, an increase of 35 percent over the previous year, according to ISO. This increase in new ISO 9001 certificates is the highest recorded since the organization launched its annual ISO survey in 1993.

ISO 9001 standard is not product specific and can be used by a wide range of manufacturing and service companies. Long time ago, I saw a flag-size poster on a theater in Singapore bragging about its registration to the ISO 9001 standard. One of my European colleagues recently mentioned that he received an application to register a church choir.

The ISO 9001 standard requires that a company develops and implements a basic quality management system, using the specific elements to ensure the company is capable of maintaining uniformity of its processes and, as a result, provides its customers with a consistent quality of products and services. ISO 9001:2000 comprises a series of standards outlining the requirements for quality management systems. There are three core standards in this group:

ISO 9000:2000 - Vocabulary
ISO 9001:2008 - Requirements
ISO 9004:2000 - Guide for performance improvement

The processes required by ISO 9001:2000, which are applicable to the company's QMS, but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system. For example, if a company sub-contracts manufacturing or other activities, the company is still responsible for these processes. To ensure that these outsourced processes are in compliance with applicable requirements, a company may use supplier audits. Check our Product page to see how our products can help you developing your management system.

Call us today if you have questions about ISO 9001, ISO 13485 or ISO 14001 management systems!

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