ISO-9000 Standard

 

Quality management has always been a critical aspect of semiconductor manufacturing, given the complex processes of fabricating, assembling, and testing semiconductor devices.  As such, semiconductor companies have always tried to set up quality management systems that meet world-class standards. 

     

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Over the last few years, the ISO-9000 has become the most popular quality standard in the semiconductor industry, with practically all major semiconductor companies rushing to get ISO-9000-certified. In fact, semiconductor companies not ISO-certified would find it difficult to do business, given that certification is a basic requirement of would-be customers.  The ISO-9000 series of standards was developed by the International Organization for Standardization

    

ISO-9000 currently has three quality standards:  the ISO-9000:2000, the ISO-9001:2000, and the ISO-9004:2000.  Of these, only the ISO-9001:2000 outlines specific requirements for compliance, while the ISO-9000:2000 and the ISO-9004:2000 merely present information or guidelines. 

    

All of these quality standards are process-oriented, and not product-oriented.  This means that ISO-9000 is more particular about how a company conducts its processes, and not what products it ships or level of product quality it has.  The main objective of ISO is to facilitate international trade by providing a single internationally-accepted set of standards for everybody's reference.

                  

Table 1. ISO9000-2000's Standards and Guidelines

Standards and Guidelines

Purpose

ISO 9000:2000

Quality Management Systems - Fundamentals and Vocabulary

                 

-  Establishes a starting point for understanding the standards

-  Defines the fundamental terms and definitions used in the ISO 9000 family to avoid confusion in their use

                 

ISO 9001:2000

Quality Management Systems - Requirements

                 

- Defines the requirements for assessing the ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction 

- Now the only standard in the ISO 9000 family against which third-party certification can be carried out

                 

ISO 9004:2000

Quality Management Systems - Guidelines for performance improvements

                 

- Provides guidance for continual improvement of the quality management system to benefit all parties through sustained customer satisfaction

                 

                

The first ISO standards were published in 1987, which were revised in 1994 as the ISO-9000:1994. The next and latest revision of ISO standards was released in 2000, and is therefore referred to as "ISO-9000:2000 Standards".  The ISO-9000:2000, being process-oriented, can be applied to virtually any industry worldwide, and is certainly widely embraced in the semiconductor industry.

  

The ISO-9000:1994 had 3 standards: the ISO-9001:1994, the ISO-9002:1994, and the ISO-9003:1994.  ISO-9002:1994 and ISO-9003-1994 had been dropped, so companies who are certified to any of these two standards only should be re-certified to the ISO-9001:2000.  Companies certified to the ISO-9001:1994 need to update their quality systems to the ISO-9001:2000 requirements for future recertification.

        

Getting ISO-certified will not only bring about customer orders, it will also bring about efficiency and cost-effectiveness as a result of better process controls, operational systems, and problem resolution mechanisms.    

         

The process of getting ISO 9000-certified generally consists of the following steps: 1) development of a quality management system that meets the ISO 9000 standards; 2) conduct of internal audits to ensure that the quality system is working as planned; 3) invitation of an accredited external auditing body to audit the quality system and its implementation; 4) receipt of accreditation if the external auditor approved of the system; and 5) conduct of regular surveillance audits to maintain the certification.  

                   

See Also:  The ISO-14000The QS-9000The TS-16949The AS-9100The TL-9000The ISO-13485;

Quality Systems

 

     

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