|
|
|
 |
After World War II, the procurement division of the Armed Forces of the United States established as a US Military Standard (MIL Q 9858), a management requirement specification for the system of production in addition to the existing technical requirement specification for the products themselves. The procurement system for US Armed Forces had this additional requirement against which the quality management systems of suppliers were assessed. This quality management system assessment scheme was later adopted also by the aerospace industry and the atomic industry. From there, it began to be adopted by private industry and gradually spread throughout the private sector.
During the 1970s, in the United Kingdom, France, Germany, Canada, and other countries, there was recognition of the importance of quality control and quality assurance, particularly for industrial products with complex functions and/or high performance requirements or high cost.. Customers' demand for confidence that "suppliers consistently deliver products in satisfaction of the required specification" grew stronger and, in these countries, national standards for Quality Management Systems were developed and QMS assessment schemes were established.
During the first half of the 1980s, in order to strengthen the competitiveness of their industry and products, the Netherlands and the United Kingdom established national Accreditation Bodies and a Certification/Registration Scheme was introduced. The aim was to establish a hierarchy of checking that would give purchasers confidence that suppliers would consistently provide products and services that met specifications. An Accreditation Body would assess the competence of independent, third party Certification/Registration Bodies to audit and register companies as in conformity with a QMS standard, and publish a list of accredited bodies. The accredited Certification/Registration Bodies would audit, register and publish the names of organizations (companies, plants, etc.) that were found to be in conformity with a Quality Management System standard that was based on QMS or Quality Assurance standards recognized in respective countries or within the European Community. The purchasers could then have confidence in their suppliers because the suppliers' systems had been checked by an independent Certification/Registration Body and the Certification/Registration Body had, in turn, been checked by an Accreditation Body.
In 1978, the International Organization for Standardization (ISO) established a Technical Committee, ISO TC176, to develop standards for quality assurance. This resulted in the publication, in 1987, of the ISO 9000 series of international standards for quality management and quality assurance. Within the series, the operational standards ISO 9001, ISO 9002 and ISO 9003 specified the requirements for Quality Management Systems.
In the course of developing an international standard, the technical experts often use existing national standards from ISO member countries as a basis for discussion. This was the case with TC 176, which, in the early 1980s, drew on the existing British QMS standard BS 5750 and the existing American QMS standard, ANSI Z1-15. The approach of the American representatives was that quality assurance was a matter of concern between two parties and that any generic specification could not go beyond a set of guidelines. The British, on the other hand, wanted to develop a standard that could be used for third-party assessment in order to improve the international competitiveness of its own industry. The American position delayed the development of the ISO 9000 assessment structure, but in the end the British approach was adopted. The European export market was, however, too big for the Americans to ignore and a third party assessment structure in the United States developed rapidly in the years before 1992, when the Single European Market came into existence.
Alongside the deliberations within ISO TC 176, changes were also taking place in the British economy, which, from 1978, began the privatization of national enterprises. In order to secure the international competitiveness of newly privatized enterprises, the British launched various activities to promote "the internationalization of British standards" and the "reinforcement of the management structure of private enterprises supported by a third-party assessment based on BS 5750".
In 1979, at the conclusion of the Tokyo Round of multilateral trade negotiations, the General Agreement on Tariffs and Trade (GATT, the predecessor of the World Trade Organization) adopted the first Agreement on Technical Barriers to Trade, which became known as the GATT Standards Code. The GATT Standards Code specified that "if there is an internationally recognized standard, every country shall make efforts to accept the standard". This strengthened the importance of ISO/IEC standards, and led to greater recognition of the necessity to harmonize national and regional standards in order to prevent standards being used as obstacles to trade. Spurred by the creation of the Single European Market in 1992, the ISO 9000 series of standards spread all over the world. A key factor was the adoption by the European Community of a New Approach to conformity assessment, whereby each of the fifteen member countries agreed to reduce technical barriers to trade within Europe by recognizing that assessment results from one member country were equivalent to their own: "test it once, certify it once, sell it everywhere".
So it is that, from its beginnings in the early 1970s, regional economic cooperation in Europe gradually evolved and resulted in the introduction of a Quality Management System Certification/Registration Scheme in order to remove technical barriers within the Single European Market, and to reduce mutual distrust among member nations with different levels of industrial and technical maturity. Since purchasers of products required suppliers to register their Quality Management Systems with third-party Certification/Registration Bodies, this scheme did not stay only within the European Community, but spread to exporting countries throughout the world.
|
 |
The ISO 9000 series of standards for Quality Management Systems (QMS) are international standards for quality management and quality assurance applicable to suppliers. During the early years of economic globalization, the concept of quality assurance varied between countries and organizations/companies. It became necessary to develop standards that would provide assurance of consistent quality and thus support the free movement of goods and services. The result was the development of the ISO 9000 series of standards. As noted already, the ISO 9000 standards were based on the British standard, BS 5750, and were strongly influenced by European and American business practices and ways of thinking. This explains why the standards are strongly contract-oriented and focus on manuals, systems and verification. There is strong emphasis on requirements for "documentation", "traceability" and "monitoring". An attachment to the standards outlines a voluntary certification/registration scheme, whereby an independent third party will audit the Quality Management System of an organization and, if the system conforms to the requirements of the ISO 9000 standards, will issue a certificate of conformity and publish the results. Today, more than a hundred countries have adopted the ISO 9000 series of standards as national standards and there are approximately four hundred million companies or organizations, in 140 countries, with certified ISO 9000 Quality Management Systems.
In principle, the ISO 9000 series of standards should be reviewed every five years. In 1994, a little overdue, minor revisions of the three operational standards, ISO 9001, ISO 9002 and ISO 9003, were published. This revision did not, however, address the issue that conventional thinking attaches "quality" to a thing or product rather than to a system. A further complication was that the notion of "product" was normally applied to manufactured items and the ISO 9000 series of standards were therefore regarded as relating only to the manufacturing industry, which limited their application. The next revision, in December 2000, re-defined "product" to include services, giving ISO 9000 a broader application. The 2000 revision also brought into ISO 9000 the elements of the PDCA cycle (Plan, Do, Check, Act), which had always been the basis of Total Quality Management (TQM), and placed this concept at the hub of the activities of a certified organization.
The revision in 2000, also restated the former quality system as "Quality Management System" and focused on the importance of a commitment from top management within the organization. The title of the 2000 edition 2000 was also changed to "Quality Management Systems - requirements".
In order for an organization/company to respond to the needs of customers, information on these needs must be collected (inputs), and the products and services to be provided (outputs) must reflect these inputs. In the ISO 9001: 2000 standard, this transformation from inputs into outputs is called "process". In order to respond to constantly changing customer needs, the Quality Management System processes need to be subject to continuous improvement. ISO 9001: 2000 specifies the requirements for Quality Management Systems and describes these requirements in generic language, applicable to all sorts and sizes of businesses and organizations.
|
 |
 |
|
Registration Scheme and