ISO, Quality Assurance & Requirements

ISO 9000

Quality Assurance

Requirements

As we move into the next century, the terms quality assurance, quality management, and total quality control are becoming the new buzz words. Actually they are more than buzz words; they are reality for many American companies as well as foreign ones. The concept of total quality control (TQC) has been widely practiced in Japan for over a decade and is a way of life for Korean companies as well. With the collapse of the Berlin Wall, the unification of Germany, the European Common Market, the dismantling of the Communist party, and Asian communities beginning to band together, one international quality assurance standard for all nations seems to be most practical.
This chapter will discuss the latest requirements for these international
standards.

Introduction to ISO 9000 Standards

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies (ISO member bodies) that is headquartered in Geneva, Switzerland. The American National Standards Institute (ANSI) is the representative organization for the United States within the International Organization for Standardization federation. The purpose of the International Organization for Standardization is to develop internationally recognized standards to facilitate commerce worldwide and to enhance product safety.
The work of preparing international standards is normally carried out through ISO technical committees. Each member body or country interested in a subject for which a technical committee has been established has the right to be represented on the committee. In 1979, Technical Committee 176, Quality Assurance, was formed and in 1985 the ISO 9000 Series of Standards was circulated in draft form to the member bodies for approval. In 1987, following approval by a majority of the member bodies, the ISO 9000 Series of Standards became an international standard recognized worldwide.
Since the United States is a member of the International Organization for Standardization, the ISO 9000 series was concurrently adopted as an ANSI standard, the Q90 Series of Standards. ISO 9000
series standards and the ANSI Q90 series are identical in content. The ISO 9000–Q90 series consists of five standards:



The first document is ISO 9000, which is essentially an overview and guide for the series. This standard is entitled “Quality Management and Quality Assurance Standards—Guidelines for Selection and Use.”This document lists the reference standards applicable to the other standards, definitions useful for the establishment of an ISO quality assurance system, and characteristics of quality systems and gives generic quality assurance and control requirements regarding quality management, quality assurance, and quality control.
The next three documents (9001, 9002, 9003) provide three levels of generic quality system requirements that must be addressed within an ISO 9000 quality assurance program. The most stringent, ISO 9001, entitled “Quality Systems—Model for Quality Assurance in Design/ Development; Production, Installation, and Servicing,” establishes a model or guide for the manufacturer of pressure vessels to use in establishing a quality assurance program for design and/or development of their product. This ISO 9001 program includes 20 different quality
 points. Table 12.1 lists the 20 attributes and compares the requirements of ISO 9001 quality assurance requirements with those of ASME Code Section III, Nuclear Quality Assurance, requirements. There are close similarities. Note that the nuclear quality assurance program does not list statistical process control (SPC) nor does it address service (after service). Generally speaking, a holder of an ASME Code Section III Code symbol stamp already has many facets of an ISO 9001 program in place

Table. Comparison of Quality Assurance Requirements between ISO 9001

and ASME NQA-1

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