ISO 9000

From LIMSWiki
Revision as of 18:50, 19 February 2015 by Shawndouglas (talk | contribs) (Added history. Saving and adding more.)
Jump to navigationJump to search

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.[3][2]

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 worldwide[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[6][7] as being wasteful and not being useful for all organizations.[8][9][10]

History

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]:

  • 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.[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]

Further reading

  • Bamford, Robert; Deibler, William (2003). ISO 9001: 2000 for Software and Systems Providers: An Engineering Approach (1st ed.). CRC-Press. ISBN 0849320631, ISBN 978-0849320637
  • Naveh. E., Marcus, A. (2004). "When does ISO 9000 Quality Assurance standard lead to performance improvement?", IEEE Transactions on Engineering Management, 51(3), 352–363.
  • http://www.iso.org/iso/survey2007.pdf - An abstract of the 2007's ISO survey of certificates.
  • http://www.iso.org/iso/survey2008.pdf - An abstract of the 2008's ISO survey of certificates.

References

  1. Poksinska, B.; Dahlgaard, J.J.; Antoni, M. (2002). "The state of ISO 9000 certification: A study of Swedish organisations". The TQM Magazine 14 (5). http://www.emeraldinsight.com/journals.htm?articleid=842040&show=abstract. Retrieved 2010-11-22. 
  2. 2.0 2.1 Tsim, Y.C.; Yeung, V. W. S.; Leung, E. T. C. (2002). "An adaptation to ISO 9001: 2000 for certified organisations". Managerial Auditing Journal 17 (5). http://www.emeraldinsight.com/journals.htm?articleid=868561&show=abstract. Retrieved 2010-11-22. 
  3. Beattie, K.R.; Sohal, A.S. (1999). "Implementing ISO 9000: A study of its benefits among Australian organizations". Total Quality Management 1 (1): 95–106. http://www.informaworld.com/smpp/content~db=all~content=a713600335. Retrieved 28 February 2012. 
  4. "ISO 9001:2008 - Quality management systems -- Requirements". International Organization for Standardization. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=46486. Retrieved 28 February 2012. 
  5. "ISO 9001 certifications top one million mark, food safety and information security continue meteoric increase". International Organization for Standardization. 25 October 2010. http://www.iso.org/iso/pressrelease.htm?refid=Ref1363. Retrieved 28 February 2012. 
  6. Clifford, Stephanie (1 May 2005). "So many standards to follow, so little payoff". Inc. Magazine. http://www.inc.com/magazine/20050501/management.html. Retrieved 28 February 2012. 
  7. Wilson, Ian (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. Seddon, John (18 November 2000). "The 'quality' you can't feel". The Observer. http://www.guardian.co.uk/money/2000/nov/19/workandcareers.madeleinebunting. Retrieved 28 February 2012. 
  9. Seddon, John (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 1-86076-173-9. http://www.systemsthinking.co.uk/3-1-article.asp. 
  10. O'Connor, Patrick D.T. O'Connor (1991). "ISO 9000: Help or Hoax". http://www.pat-oconnor.co.uk/iso9000.htm. Retrieved 28 February 2012. 
  11. 11.0 11.1 "The history of ISO 9000". The British Assessment Bureau. 4 April 2012. http://www.british-assessment.co.uk/articles/the-history-of-iso-9000. Retrieved 19 February 2015. 
  12. Miura, Akio (September 2004). "MIL-Q-9858A, the Origin of ISO 9001". Tech Journal. ASQ. http://asq.org/fdc/2012/06/mil-q-9858a-the-origin-of-iso-9001.html?shl=109629. Retrieved 19 February 2015. 
  13. 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. 
  14. "ISO 9001 Whitepaper: The history and future of ISO 9001" (PDF). BSI. http://www.bsigroup.com/LocalFiles/EN-HK/ISO%20revision%20video/ISO_9001_Whitepaper_-_the_history_and_future_of_ISO_9001.pdf. Retrieved 19 February 2015. 
  15. "History of ISO 9000 at a glance". Standards Consultants Ltd. http://www.standardsconsultants.com/iso-9000-overview. Retrieved 19 February 2015. 
  16. 16.0 16.1 16.2 16.3 16.4 "ISO 9000:1987". International Organization for Standardization. http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_detail_ics.htm?csnumber=16529. Retrieved 19 February 2015. 
  17. 17.0 17.1 17.2 "History and Evolution of ISO 9000". Kaizen Consulting Group. http://www.kcg.com.sg/history-iso9000.html. Retrieved 19 February 2015. 
  18. Calabrese, Rick (3 December 2014). "Countdown to ISO 9001:2015". Quality Digest. Quality Digest. http://www.qualitydigest.com/inside/quality-insider-article/countdown-iso-90012015.html. Retrieved 19 February 2015. 
  19. Croft, Nigel H. (28 August 2012). "ISO 9001:2015 and beyond - Preparing for the next 25 years of quality management standards". International Organization for Standardization. http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1633. Retrieved 19 February 2015.