THE ISO 9000 QUALITY STANDARDS
A quality assurance system may be defined as the organizational structure, responsibilities, procedures, processes, and resources for implementing quality managers
Quality systems are created to help organizations ensure their products and services satisfy customer expectations by meeting their specifications. These systems cover a wide variety of activities encompassing a product's entire life cycle including planning, controlling, measuring, testing and reporting, and improving quality levels throughout the development and manufacturing process. ISO 9000 describes quality lements in generic terms that can be applied to any business regardless of the products or services offered.
The ISO 9000 standards have been adopted by many countries including all members of the European Community, Canada, Mexico, the United States, Australia, New Zealand, and the Pacific Rim. Countries in Latin and South America have also shown interest in the standards.
After adopting the standards, a country typically permits only ISO registered companies to supply goods and services to government agencies and public utilities. Telecommunication equipment and medical devices are examples of product categories that must be supplied by ISO registered companies. In turn, manufacturers of these products often require their suppliers to become registered. Private companies such as automobile and computer manufacturers frequently require their suppliers to be ISO registered as well.
To become registered to one of the quality system models contained in ISO 9000, a company's quality system and operations are scrutinized by third party auditors for compliance to the standard and for effective operation.
Upon successful registration, a company is issued a certificate from a registration body represented by the auditors. Semi-annual surveillance audits ensure continued compliance to the standard.
The ISO Approach to Quality Assurance Systems
The ISO 9000 quality assurance models treat an enterprise as a network of interconnected processes. For a quality system to be ISO compliant, these processes must address the areas identified in the standard and must be documented and practiced as described.
ISO 9000 describes the elements of a quality assurance system in general terms. These elements include the organizational structure, procedures, processes, and resources needed to implement quality planning, quality control, quality assurance, and quality improvement. However, ISO 9000 does not describe how an organization should implement these quality system elements. Consequently, the challenge lies in designing and implementing a quality assurance system that meets the standard and fits the company's products, services, and culture.
The ISO 9001 Standard
ISO 9001 is the quality assurance standard that applies to software engineering. The standard contains 20 requirements that must be present for an effective quality assurance system. Because the ISO 9001 standard is applicable to all engineering disciplines, a special set of ISO guidelines have been developed to help interpret the standard for use in the software process.
The requirements delineated by ISO 9001 address topics such as management responsibility, quality system, contract review, design control, document and data control, product identification and traceability, process control, inspection and testing, corrective and preventive action, control of quality records, internal quality audits, training, servicing, and statistical techniques. In order for a software organization to become registered to ISO 9001, it must establish policies and procedures to address each of the requirements just noted (and others) and then be able to demonstrate that these policies and procedures are being followed.
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