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ISO 9000 is a family of standards related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders.[1] The standards are published by the International Organization for Standardization (ISO) and are available through national standards bodies. ISO 9000 deals with the fundamentals of quality management systems [2], including the eight management principles on which the family of standards is based.[2][3]
ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.[4] Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations in over 170 countries[5] are independently certified, making ISO 9001 one of the most widely used management tools in the world today. Despite widespread use, however, the ISO certification process has been criticized at times as being wasteful and not being useful for all organizations.[6][7][8][9][10]
The ISO 9000 family of standards was originally built on several British standards developed in the early 1970s: BS 9000, BS 5179, and BS 5750. These quality assurance standards were initially related to the electronics manufacturing industry and set guidelines on managing supply-side quality through auditing and contractual documentation.[11] However, the history of ISO 9000 can be traced back even further to the publication of the United States Department of Defense MIL-Q-9858 standard in 1959. MIL-Q-9858 was revised into the NATO AQAP series of standards in 1969, which in turn were revised into the BS 5179 series of guidance standards published in 1974, and finally revised into the BS 5750 series of requirements standards in 1979.[12][13]
As the idea of company certification of meeting a certain level of quality became more attractive, the push for a more rigorous international standard (primarily led by the British Standards Institute [BSI][14]) resulted in the creation of the ISO 9000 family in 1987.[11] Originally based on BS 5750, the ISO 9000 family started out with three quality management models and a set of guidelines for following them[15][16]:
In 1994, the ISO 9000 standards were updated to place focus on the importance of quality control and preventative action, and emphasize the need for the documentation of procedures.[16][17]
In 2000, ISO 9001, 9002, and 9003 were combined into ISO 9001:2000, with a major shift in focus towards quality management versus quality control as well as a focus on process management, "the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product."[17] It directed manufacturers to carefully examine client requirements in order to design and improve processes and improve customer satisfaction.[16]
The 2008 changes to ISO 9001 were minimal, clarifying and simplifying language while making it more consistent with other standards.[17][16]
The ISO 9004 guidelines document was updated in 2009 "to promote a sustainable business approach" that focused on all stakeholders.[16]
An updated version of ISO 9001 is expected at the end of 2015 if the ISO members vote favorably in the second quarter of 2015.[18] With the revision the scope of the standard will not change. An essential change, however, will affect the structure. The new ISO 9001:2015 will follow the so-called high-level structure. This, and the uniform use of core texts and terms, will enable an identical structure for all management systems.[19]
The global adoption of ISO 9001 may be attributable to a number of factors. Many major purchasers require their suppliers to hold ISO 9001 certification. In addition to several stakeholders' benefits, a number of studies have identified significant workflow and financial benefits for organizations certified to ISO 9001. Examples include:
1. In 2002, Heras et al. found superior return on assets compared to otherwise similar organizations without certification and demonstrated that this was statistically significant and not a function of organization size.[20]
2. A 2003 study of 146 Singapore-based companies by Chow-Chua et al. found improved financial performance, though with the caveat "that while certification leads to better overall financial performance, non‐listed certified firms experience better documentation procedures, higher perceived quality of products or services, and more effective communication among employees than listed certified firms."[21]
3. That same year Rajan and Tamimi showed that ISO 9001 certification resulted in superior stock market performance and suggested that shareholders were richly rewarded for investing in the certified companies.[22]
4. In 2005, Corbett et al. showed in 2005 similar superior performance, atating that "three years after certification, the certified firms do display strongly significant abnormal performance under all control-group specifications."[23]
5. That same year, Sharma linked increases in "operating efficiency, growth in sales, and overall financial performance" gains with ISO 9000 certification.[24]
6. Naveha and Marcus claimed in 2007 that manufacturers in the U.S. automotive industry that implemented ISO 9001 saw superior operational performance soon after.[25]
7. A 2011 survey from The British Assessment Bureau showing 44 percent of their certified clients had won new business due to becoming certified.[26]
8. More recently, in 2019, Domingues et al. surveyed a worldwide collection of IRCA (International Register of Certified Auditors) QM ISO 9001 Auditors, noting that "relying on third-party auditor's feedback brings a more independent perspective than studies based on quality managers or consultants' views." They hypothesized that organizations seeking certification would see the most sustainable business improvements by turning to quality auditors. The authors indeed found that having "competent and experienced auditors is essential to ensure a credible and accountable certification process to all stakeholders," which aligned well with other research "that found that organizations that adopt early planning, carry on ISO 9001:2015 training, and ensure they have the necessary competences, reported the soundest benefits and fewer difficulties in successfully implementing ISO 9001:2015."[27]
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.[23] may suggest it. Other researchers such as Heras et al. have suggested 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.[20]
A common criticism of the ISO 9000 family of standards is the amount of money, time, and paperwork required for registration. In 2003, writing for Quality Magazine, engineer Scott Dalgleish emphasized that "[u]nder ISO, every quality system enhancement triggers enormous documentation changes that make quality managers question whether the benefits of the change are worth the effort."[28] In a piece for Inc. magazine in 2005, journalist Stephanie Clifford told the story of Delaware North Companies, which spent nearly 18 months and $115,000 just to certify their guest services management division.[6]
Others have chosen not to adopt the standard because of the perceived risks and uncertainty of not knowing if there are direct relationships to improved quality as well as doubts about what kind and how many resources will be needed. Other perceived risks include how much certification will cost, increased bureaucratic processes, and risk of poor company image if the certification process fails.[29] Critics like John Seddon, a leading global authority on the service industry, claim ISO 9001 promotes specification, control, and procedures rather than understanding and improvement.[8] Others like business improvement specialist Jim Wade have argued that ISO 9001 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality, ... [undermining] the need for an organization to set its own quality standards."[30] In short, Wade argues that reliance on the specifications of ISO 9001 does not guarantee a successful quality system.
The standard has been seen as especially prone to failure when a company is interested in certification before quality.[8] Certifications have in fact often been based on customer contractual requirements rather than a desire to actually improve quality.[31][32] "If you just want the certificate on the wall, chances are you will create a paper system that doesn't have much to do with the way you actually run your business," said ISO's Roger Frost in 2001.[32] Certification by an independent auditor is often seen as the problem area, and according to Barnes, it "has become a vehicle to increase consulting services."[31]
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