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Accreditation and Quality Assurance

, Volume 9, Issue 1–2, pp 39–43 | Cite as

ISO 9001 has had no effect on quality in the in vitro medical diagnostics industry

  • Jan S. KrouwerEmail author
General Paper

Abstract

ISO 9001 certification (currently ISO 9000:2000) implies that an organization is managed in a quality manner. ISO certification is primarily achieved by audits that show that a company follows its own procedures. These procedures are prepared by the company with few ISO requirements. ISO procedures are flawed in two ways: they can represent only part of what an organization does within a process, and they often lack sufficient detail. The latter limitation allows both adequate and inadequate tasks. Often, people pay attention to ISO only when audits are imminent, which contrasts with other quality initiatives that have goals directly related to quality with frequent measurements and continual involvement by staff. There does not appear to be any connection between company successes or failures and ISO certification, and failing an ISO audit is a rare event. All of this leads one to conclude that ISO 9001 has had no effect on quality. In addition, there is a danger that “flexible” or so-called horizontal ISO standards that lack detail will supplant more traditional standards, which prescribe a procedure that has been agreed to by a consensus of experts. Improving ISO 9001 starts with recognizing its limitations. Recommendations regarding ISO certification include: dropping it, minimizing resource allocation to it, and trying to change it.

Keywords

ISO 9000 Quality Certification ISO 9001 In vitro medical diagnostics 

References

  1. 1.
    Seddon J (2000) The case against ISO 9000. Bristol Bus Sch Teach Res Rev 2, Spring 2000, ISSN 1468–4578http://www.uwe.ac.uk/bbs/trr/Issue2/Is2–1_1.htm Cited 12 May 2003
  2. 2.
    Davenport H, Prusak L (1998) Working knowledge: how organizations manage what they know. Harvard Business School Press, Cambridge, Mass.http://www.cio.com/archive/021598/excerpt.html. Cited 14 May 2003
  3. 3.
    KcLain KK (1994) Med Device Diagn Ind 1:166Google Scholar
  4. 4.
    Krouwer JS (2002) Accred Qual Assur 7:461–467CrossRefGoogle Scholar
  5. 5.
    Burton TM (1999) Wall Street J November 3:3, 18Google Scholar
  6. 6.
    Jan S. Krouwer (2002) Assay development and evaluation: a manufacturer’s perspective. AACC, Washington D.C.Google Scholar
  7. 7.
    Powers DM, Greenberg N (1999) Scand J Clin Lab Invest 59:539–43PubMedGoogle Scholar
  8. 8.
    Krause MS (1996) Clin Chem 42:1561–1565PubMedGoogle Scholar
  9. 9.
    Seddon J (2000). The case against ISO 9000: a systems thinker’s criticism of ISO9000 and ISO 9000. Oak Tree, DublinGoogle Scholar
  10. 10.
    Westgard JW (2003) Enron and Quality—when opposites detract!http://www.westgard.com/essay43.htm. Cited 14 May 2003
  11. 11.
    Dalgleish S (2002) ISO 9000: More Hindrance Than Help Quality Magazine, http://www.qualitymag.com/CDA/ArticleInformation/features/BNP_Features_Item/0,6425,98538,00.html. Cited 14 May 2002
  12. 12.
    Iversen W (2002) Eliminate ISO 9000? Quality Magazine, http://www.qualitymag.com/CDA/ArticleInformation/features/BNP_Features_Item/0,6425,98902,00.html. Cited 14 May 2002
  13. 13.
    Iversen W (2002) Silent ISO majority? Quality Magazine, http://www.qualitymag.com/CDA/ArticleInformation/features/BNP_Features_Item/0,6425,98569,00.html. Cited 14 May 2002

Copyright information

© Springer-Verlag 2004

Authors and Affiliations

  1. 1.Krouwer ConsultingSherbornUSA

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