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 (ISO). 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",International Organization for Standardization, What is the ISO 9000 family of standards on quality management?, accessed on 20 September 2024 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 (9002 and 9003) 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 (design responsibility, manufacture only, distribution, servicing, etc.), 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 (calibration), 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,Ministry of Defence, Defence Standard 00-970 / Volume 2 / Issue 1, Design and Airworthiness Requirements for Service Aircraft Volume 1 - Aeroplanes Book 1 (Parts 0 to 3) and Third-Party Certification of Quality Management Systems was born under the auspices of the National Accreditation Council of Certification Bodies (NACCB), which has become the United Kingdom Accreditation Service (UKAS).
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 (2003) 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. (2005), may suggest it. Other writers, such as Heras et al. (2002), 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. (2007) identified operational improvements (e.g., cycle time reduction, inventory reductions) 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. + Worldwide total of ISO 9001 certificates (end of each year) 2000 2001 2002 2003 2004 2005 2006 2007 409,421 510,616 561,747 567,985 660,132 773,867 896,929 951,486 2008 2009 2010 2011 2012 2013 2014 982,832 1,064,785 1,118,510 1,111,698 1,096,987 1,126,460 1,138,155
+Top 10 countries for ISO 9001 certificates (2014) Rank Country No. of certificates 1 China 342,801 2 Italy 168,960 3 Germany 55,363 4 Japan 45,785 5 India 41,016 6 United Kingdom 40,200 7 Spain 36,005 8 United States 33,008 9 France 29,122 10 Australia 19,731
+Top 10 countries for ISO 9001 certificates (2010)Source: ISO Survey 2010 Rank Country No. of certificates 1 China 297,037 2 Italy 138,892 3 Russian Federation 62,265 4 Spain 59,854 5 Japan 59,287 6 Germany 50,583 7 United Kingdom 44,849 8 India 33,250 9 United States 25,101 10 Korea, Republic of 24,778
+ Top 10 countries for ISO 9001 certificates (2009) Rank Country No. of certificates 1 China 257,076 2 Italy 130,066 3 Japan 68,484 4 Spain 59,576 5 Russian Federation 53,152 6 Germany 47,156 7 United Kingdom 41,193 8 India 37,493 9 United States 28,935 10 Korea, Republic of 23,400
ISO 9000 series quality management principles
The ISO 9000 series are based on seven quality management principles (QMPs), namely: + The seven quality management principlesQMP 1 Customer focus Organizations 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 2 Leadership Leaders 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 3 Engagement of people People 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 4 Process approach A desired result is achieved more efficiently when activities and related resources are managed as a process. QMP 5 Improvement Improvement of the organization's overall performance should be a permanent objective of the organization. QMP 6 Evidence-based decision making Effective decisions are based on the analysis of data and information. QMP 7 Relationship management An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
ISO 9001:2015 Quality management systems – Requirements is a document of approximately 30 pages available from the national standards organization in each country. Only ISO 9001 is directly audited against for third-party assessment purposes.
Contents of ISO 9001:2015 are: Section 1: Scope Section 2: Normative references Section 3: Terms and definitions Section 4: Context of the organization Section 5: Leadership Section 6: Planning Section 7: Support Section 8: Operation Section 9: Performance evaluation Section 10: Continual improvement
Essentially, the layout of the standard is similar to the previous ISO 9001:2008 standard in that it follows the plan–do–check–act (PDCA) cycle in a process-based approach but is now further encouraging this to have risk-based thinking (section 0.3.3 of the introduction). The purpose of the quality objectives is to determine the conformity of the requirements (customers and organizations), facilitate effective deployment, and improve the quality management system.
Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10. Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into account.
The standard no longer specifies that the organization shall issue and maintain documented procedures, but ISO 9001:2015 requires the organization to document any other procedures required for its effective operation. The standard also requires the organization to issue and communicate a documented quality policy, a quality management system scope, and quality objectives. The standard no longer requires compliant organizations to issue a formal Quality Manual. The standard does require the retention of numerous records, as specified throughout the standard. New for the 2015 release is a requirement for an organization to assess risks and opportunities (section 6.1) and to determine internal and external issues relevant to its purpose and strategic direction (section 4.1). The organization must demonstrate how the standard's requirements are being met, while the external auditor's role is to determine the quality management system's effectiveness. More detailed interpretation and implementation examples are often sought by organizations seeking more information in what can be a very technical area.
Certification