Why do we need ISO 9001

There is growing evidence of almost universal acceptance of ISO 9001 as a truly international standard. The U.K. Ministry of Defense and NATO have adopted ISO 9001 standard. The U.S. Department of Defense (DOD) has permitted the use of ISO 9001 systems in contracts, while the U.S. Food and Drug Administration (FDA) has harmonized its recent revision of the Quality System Requirements (QSR), formerly known as “Good Manufacturing Practices” regulations for medical devices, with ISO 13485 requirements.

All companies exporting products or services to the European Union (EU) may someday be contractually required to have ISO certification to sell into the market. Even today, contractual requirements are finding their way into purchase orders for products manufactured in Japan, the United States and elsewhere. 

 

Currently, the requirement for ISO 9001 registration is clearly market-driven. Officials in the EU are considering mandatory regulatory requirements relative to registration. This is especially true in regulated industries, such as medical device manufacturing and telecommunications. For example, as of the summer of 1998, a business is not allowed to sell medical devices in the EU, unless a Notified Body certifies their quality management system and / or products.

Most companies that have implemented ISO 9001 or similar systems report significant improvements in productivity due to an increase in customer satisfaction and reduction in field returns and internal failures. Effectively implemented quality systems help to define processes and develop discipline, which in turn, helps to “do things right the first time.” A published survey showed that companies that implemented a quality system for QS 9001 reduced failure rates by 40 percent and customer returns by 54 percent, reducing total cost of nonconformance by 53 percent.

Most companies that undertake the effort to implement ISO 9001 quality management systems are better prepared to satisfy their interested parties, including their customers. Some of the advantages of an effective quality system include:

• Formalized systems ensure consistent quality and punctual delivery of products to the customers;
• Fewer rejects result in less repeated work and warranty costs;
• Errors are detected at the earliest stages and not repeated;
• A simplified environment for managing periods of change or growth;
• An improved awareness of company objectives;
• Responsibilities and authorities clearly defined;
• Improved utilization of time and materials;
• Improved relationships with customers and suppliers;
• The benefits of use of a recognized logo on marketing materials, if the system is registered;
• An improved corporate quality image;
• A reduced number of customer audits; and
• An improved record management system in case of litigation.

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