ISO 9000 family


The ISO 9000 family is a set of international standards for quality management systems. It was developed in March 1987 by the International Organization for Standardization. The goal of these standards is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. The standards were designed to fit into an integrated management system. The ISO refers to the set of standards as a "family", bringing together the standard for quality management systems and a set of "supporting standards", and their presentation as a family facilitates their integrated application within an organisation. ISO 9000 deals with the fundamentals and vocabulary of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. A companion document, ISO/TS 9002, provides guidelines for the application of ISO 9001. ISO 9004 gives guidance on achieving sustained organizational success.
Third-party certification bodies confirm that organizations meet the requirements of ISO 9001. Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. However, the ISO certification process has been criticised as being wasteful and not being useful for all organizations.

History

In March 1979, BSI published the world's first quality management systems standard, BS 5750, as part of a response to growing concerns about the quality. BS 5750 supplied the template for the development of the ISO 9000 series in March 1987, by ISO. However, its history can be traced back some twenty years before that, to the publication of government procurement standards, such as the United States Department of Defense MIL-Q-9858 standard in 1959, and the United Kingdom's Def Stan 05–21 and 05–24. Large organizations that supplied government procurement agencies often had to comply with a variety of quality assurance requirements for each contract awarded, which led the defense industry to adopt mutual recognition of NATO AQAP, MIL-Q, and Def Stan standards. Eventually, industries adopted ISO 9000 instead of forcing contractors to adopt multiple—and often similar—requirements.

Reasons for use

The global adoption of ISO 9001 may be attributable to several factors. In the early days, the ISO 9001 requirements were intended to be used by procuring organizations, such as contractors and design activities, as the basis of contractual arrangements with their suppliers. This helped reduce the need for subcontract supplier quality development by establishing basic requirements for a supplier to assure product quality. The ISO 9001 requirements could be tailored to meet specific contractual situations, depending on the complexity of the product, business type, and risk to the procurer. For example, the food industry combined the ISO 9000 series with HACCP as a single management system. If a chosen supplier was weak in the controls of their measurement equipment, and hence QC/inspection results, that specific requirement would be invoked in the contract. Adopting a single quality assurance requirement also leads to cost savings throughout the supply chain by reducing the administrative burden of maintaining multiple sets of quality manuals and procedures.
A few years later, the UK Government took steps to improve national competitiveness following the publication of a white paper on Standards, Quality and International Competitiveness, Cmd 8621, and Third-Party Certification of Quality Management Systems was born under the auspices of the National Accreditation Council of Certification Bodies, which has become the United Kingdom Accreditation Service.
In addition to many stakeholders' benefits, several studies have identified significant financial benefits for organizations certified to ISO 9001, with an ISO analysis of 42 studies showing that implementing the standard enhances financial performance. Corbett et al. showed that certified organizations achieved a superior return on assets compared to otherwise similar organizations without certification.
Heras et al. found similarly superior performance and demonstrated that this was statistically significant and not a function of organization size. Naveha and Marcus claimed that implementing ISO 9001 led to superior operational performance in the U.S. automotive industry. Sharma identified similar improvements in operating performance and linked this to superior financial performance. Chow-Chua et al. showed better overall financial performance was achieved for companies in Denmark. Rajan and Tamimi showed that ISO 9001 certification resulted in superior stock market performance and suggested that shareholders were richly rewarded for the investment in an ISO 9001 system.
While the connection between superior financial performance and ISO 9001 may be seen from the examples cited, there remains no proof of direct causation, though longitudinal studies, such as those of Corbett et al., may suggest it. Other writers, such as Heras et al., have indicated that while there is some evidence of this, the improvement is partly driven by the fact that there is a tendency for better-performing companies to seek ISO 9001 certification.
The mechanism for improving results has also been the subject of much research. Lo et al. identified operational improvements as following from certification. Internal process improvements in organizations lead to externally observable improvements. The benefit of increased international trade and domestic market share, in addition to the internal benefits such as customer satisfaction, interdepartmental communications, work processes, and customer/supplier partnerships derived, far exceeds any and all initial investment.

Global adoption

The increase in ISO 9001 certification is shown in the tables below.
20002001200220032004200520062007
409,421510,616561,747567,985660,132773,867896,929951,486
2008200920102011201220132014-
982,8321,064,7851,118,5101,111,6981,096,9871,126,4601,138,155-

RankCountryNo. of certificates
1China342,801
2Italy168,960
3Germany55,363
4Japan45,785
5India41,016
6United Kingdom40,200
7Spain36,005
8United States33,008
9France29,122
10Australia19,731

RankCountryNo. of certificates
1China297,037
2Italy138,892
3Russian Federation62,265
4Spain59,854
5Japan59,287
6Germany50,583
7United Kingdom44,849
8India33,250
9United States25,101
10Korea, Republic of24,778

RankCountryNo. of certificates
1China257,076
2Italy130,066
3Japan68,484
4Spain59,576
5Russian Federation53,152
6Germany47,156
7United Kingdom41,193
8India37,493
9United States28,935
10Korea, Republic of23,400

ISO 9000 series quality management principles

The ISO 9000 series are based on seven quality management principles, namely:
QMP 1Customer focusOrganizations depend on their customers, both direct and indirect, and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
QMP 2LeadershipLeaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.
QMP 3Engagement of peoplePeople at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.
QMP 4Process approachA desired result is achieved more efficiently when activities and related resources are managed as a process.
QMP 5ImprovementImprovement of the organization's overall performance should be a permanent objective of the organization.
QMP 6Evidence-based decision makingEffective decisions are based on the analysis of data and information.
QMP 7Relationship managementAn organization and its external providers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.