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. 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 , including the eight management principles on which the family of standards is based.
ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill. Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over a million organizations in over 170 countries 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.
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. 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.
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]) resulted in the creation of the ISO 9000 family in 1987. Originally based on BS 5750, the ISO 9000 family started out with three quality management models and a set of guidelines for following them:
- ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing
- ISO 9002:1987 Model for quality assurance in production, installation, and servicing
- ISO 9003:1987 Model for quality assurance in final inspection and test
- ISO 9004.1:1987 Quality management and quality system elements - Part 1: Guidelines
Changes to ISO 9000
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.
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." It directed manufacturers to carefully examine client requirements in order to design and improve processes and improve customer satisfaction.
The 2008 changes to ISO 9001 were minimal, clarifying and simplifying language while making it more consistent with other standards.
The ISO 9004 guidelines document was updated in 2009 "to promote a sustainable business approach" that focused on all stakeholders.
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. 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.
Adoption of the standard
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.
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."
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.
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."
5. That same year, Sharma linked increases in "operating efficiency, growth in sales, and overall financial performance" gains with ISO 9000 certification.
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.
7. A 2011 survey from The British Assessment Bureau showing 44 percent of their certified clients had won new business due to becoming certified.
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."
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 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.
Criticisms of the standard
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." 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.
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. 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. 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." 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. Certifications have in fact often been based on customer contractual requirements rather than a desire to actually improve quality. "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. 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."
- Abuhav, I. (2017). ISO 9001:2015 - A Complete Guide to Quality Management Systems. CRC Press. pp. 428. ISBN 9781498733212. https://books.google.com/books?id=NmUlDgAAQBAJ.
- ISO 9000 at the International Organization for Standardization
This article reuses a few elements from the Wikipedia article.
- ↑ Poksinska, B.; Jörn Dahlgaard, J.; Antoni, M. (2002). "The state of ISO 9000 certification: A study of Swedish organizations". The TQM Magazine 14 (5): 297–306. doi:10.1108/09544780210439734.
- ↑ 2.0 2.1 Tsim, Y.; Yeung, V.; Leung, E. (2002). "An adaptation to ISO 9001:2000 for certified organisations". Managerial Auditing Journal 17 (5): 245–50. doi:10.1108/02686900210429669.
- ↑ Beattie, K.R. (2010). "Implementing ISO 9000: A study of its benefits among Australian organizations". Total Quality Management 10 (1): 95–106. doi:10.1080/0954412998090.
- ↑ "ISO 9001:2015 Quality management systems — Requirements". International Organization for Standardization. September 2015. https://www.iso.org/standard/62085.html. Retrieved 16 April 2020.
- ↑ "ISO 9000 Family Quality Management". International Organization for Standardization. https://www.iso.org/iso-9001-quality-management.html. Retrieved 16 April 2020.
- ↑ 6.0 6.1 Clifford, S. (1 May 2005). "So many standards to follow, so little payoff". Inc. Magazine. https://www.inc.com/magazine/20050501/management.html. Retrieved 16 April 2020.
- ↑ Wilson, I. (4 June 2010). "Is ISO the way to go? Some say, Not So". Westgard QC, Inc. http://james.westgard.com/the_westgard_rules/2010/06/iso-not-so.html. Retrieved 28 February 2012.
- ↑ 8.0 8.1 8.2 Seddon, J. (18 November 2000). "The 'quality' you can't feel". The Guardian. https://www.theguardian.com/money/2000/nov/19/workandcareers.madeleinebunting. Retrieved 16 April 2020.
- ↑ Seddon, J. (2000). "Chapter 1: A Brief History of ISO 9000 - Where did we go wrong?". The Case Against ISO 9000 (2nd ed.). Oak Tree Press. ISBN 1860761739. Archived from the original on 18 January 2012. https://web.archive.org/web/20120118194114/http://www.systemsthinking.co.uk/3-1-article.asp. Retrieved 16 April 2020.
- ↑ O'Connor, P.D.T. (1991). "ISO 9000: Help or Hoax". Archived from the original on 16 June 2013. https://web.archive.org/web/20130616091145/http://www.pat-oconnor.co.uk/iso9000.htm. Retrieved 16 April 2020.
- ↑ 11.0 11.1 "The history of ISO 9000". The British Assessment Bureau. 4 April 2012. Archived from the original on 04 August 2013. https://web.archive.org/web/20130804070737/http://www.british-assessment.co.uk/articles/the-history-of-iso-9000/. Retrieved 16 April 2020.
- ↑ Miura, A. (September 2004). "MIL-Q-9858A, the Origin of ISO 9001". Tech Journal. ASQ. Archived from the original on 10 August 2017. https://web.archive.org/web/20170810051200/http://asq.org/fdc/2012/06/mil-q-9858a-the-origin-of-iso-9001.html?shl=109629. Retrieved 07 January 2022.
- ↑ Lamprecht, James L. (2000). "Chapter 12: The ISO 9000 Phenomenon and the Privatization of Military Standards". Quality and Power in the Supply Chain: What Industry Does for the Sake of Quality. Newnes. pp. 125–148. ISBN 9780750673433. https://books.google.com/books?id=fSFlJSZLgfgC&pg=PA132. Retrieved 19 February 2015.
- ↑ "ISO 9001 Whitepaper: The history and future of ISO 9001" (PDF). BSI. March 2014. https://www.bsigroup.com/LocalFiles/en-IN/Resources/ISO%209001/ISO-9001-Whitepaper-the-history-and-future-of-ISO%209001.pdf. Retrieved 16 April 2020.
- ↑ "History of ISO 9000 at a glance". Standards Consultants Ltd. Archived from the original on 08 January 2014. https://web.archive.org/web/20140108051024/http://www.standardsconsultants.com/iso-9000-overview. Retrieved 16 April 2020.
- ↑ 16.0 16.1 16.2 16.3 16.4 "ISO 9000:1987". International Organization for Standardization. https://www.iso.org/standard/16529.html. Retrieved 16 April 2020.
- ↑ 17.0 17.1 17.2 "History and Evolution of ISO 9000". Kaizen Consulting Group. Archived from the original on 11 June 2013. https://web.archive.org/web/20130611083052/http://www.kcg.com.sg/history-iso9000.html. Retrieved 16 April 2020.
- ↑ Calabrese, R. (3 December 2014). "Countdown to ISO 9001:2015". Quality Digest. Quality Circle Institute, Inc. https://www.qualitydigest.com/inside/quality-insider-article/countdown-iso-90012015.html. Retrieved 16 April 2020.
- ↑ Croft, N.H. (28 August 2012). "ISO 9001:2015 and beyond - Preparing for the next 25 years of quality management standards". International Organization for Standardization. Archived from the original on 16 February 2015. https://web.archive.org/web/20150216111440/http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1633. Retrieved 16 April 2020.
- ↑ 20.0 20.1 Heras, Iñaki; Dick, Gavin P.M.; Casadesús, Martí (2002). "ISO 9000 registration's impact on sales and profitability: A longitudinal analysis of performance before and after accreditation". International Journal of Quality & Reliability Management 19 (6): 774–791. doi:10.1108/02656710210429618.
- ↑ Chow-Chua, Clare; Goh, Mark; Wan, Tan Boon (2003). "Does ISO 9000 certification improve business performance?". International Journal of Quality & Reliability Management 20 (8): 936–953. doi:10.1108/02656710310493643.
- ↑ Rajan, Murli; Tamimi, Nabil (2003). "Payoff to ISO 9000 Registration". The Journal of Investing 12 (1): 71–77. doi:10.3905/joi.2003.319536.
- ↑ 23.0 23.1 Corbett, Charles J.; Montes-Sancho, María J.; Kirsch, David A. (2005). "The Financial Impact of ISO 9000 Certification in the United States: An Empirical Analysis". Management Science 51 (7): 1607–16. doi:10.1287/mnsc.1040.0358.
- ↑ Sharma, Divesh S. (2005). "The association between ISO 9000 certification and financial performance". The International Journal of Accounting 40 (2): 151–172. doi:10.1016/j.intacc.2005.01.011.
- ↑ "ISO 9001 proven to help win new business". The British Assessment Bureau. 25 May 2011. Archived from the original on 28 July 2013. https://web.archive.org/web/20130728164740/http://www.british-assessment.co.uk/news/iso-9001-proven-to-help-win-new-business. Retrieved 16 April 2020.
- ↑ Domingues, J.P.; Reis, A.M.; Fonseca, L.M. et al. (2019). "The Added Value of the ISO 9001:2015 International Standard from an Auditor's Perspective: A CB-SEM Based Evaluation". International Journal for Quality Research 13 (4): 967–86. doi:10.24874/IJQR13.04-15.
- ↑ Dalgleish, S. (5 May 2003). "ISO 9000: More Hindrance than Help". Quality Magazine. BNP Media. https://www.qualitymag.com/articles/84308-probing-the-limits-br-iso-9000-more-hindrance-than-help. Retrieved 16 April 2020.
- ↑ Sroufe, Robert; Curkovic, Sime (July 2008). "An examination of ISO 9000:2000 and supply chain quality assurance". Journal of Operations Management 26 (4): 503–520. doi:10.1016/j.jom.2007.06.006.
- ↑ Wade, Jim (May–June 2002). "Is ISO 9000 really a standard?" (PDF). ISO Management Systems. pp. 17–20. Archived from the original on 03 January 2007. https://web.archive.org/web/20070103143212/http://www.bin.co.uk/IMS_May_2002.pdf. Retrieved 16 April 2020.
- ↑ 31.0 31.1 Barnes, F. (22 March 2000). "Good Business Sense Is the Key to Confronting ISO 9000". AllBusiness. AllBusiness.com, Inc. https://www.thefreelibrary.com/Good+Business+Sense+Is+the+Key+to+Confronting+ISO+9000.-a073182519. Retrieved 16 April 2020.
- ↑ 32.0 32.1 Henricks, Mark (01 Decenber 2001). "ISO a Go-Go". Entrepreneur Magazine. Entrepreneur Media, Inc. https://www.entrepreneur.com/article/46342. Retrieved 19 February 2015.