Editing ISO 9000 family (section)

==Effectiveness==
{{Original research|section|date=May 2013}}

The debate on the effectiveness of ISO 9000 commonly centers on the following questions:
# Are the quality principles in ISO 9001 of value?
# Does it help to implement an ISO 9001-compliant quality management system?
# Does it help to obtain ISO 9001 certification?

The effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which are:
# Commitment of senior management to monitor, control, and improve quality. Senior managers must be strongly involved in the quality management activities, starting with the definition of a quality strategy for the organisation. 
# Motivations to adopt the standard. Internal motivations such as a genuine desire to improve the product quality, company processes, and process efficiency tend to facilitate the implementation of the standard and to increase the effectiveness of the certification. Organizations that implement an ISO system without this desire often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits. External motivations (such as stakeholder pressure or customer demand) tend to produce lower certification benefits.<ref>{{Cite journal |last1=Ferreira |first1=Luís M. F. R. |last2=Cândido |first2=Carlos J. F. |date=2021-03-01 |title=Factors influencing firm propensity for ISO 9001 withdrawal: Evidence on decertification tendency and antecedents |url=https://www.sciencedirect.com/science/article/pii/S092552732030373X |journal=International Journal of Production Economics |language=en |volume=233 |pages=108024 |doi=10.1016/j.ijpe.2020.108024 |s2cid=233861800 |issn=0925-5273}}</ref>
# Making a convenient analysis of the internal context of the company that wants to adopt the standard, preparing for the implementation of the standard (e.g. training), planning for the implementation of the standard in the organisation, and the organisational (personnel, culture) receptivity to the implementation of the standard.<ref>{{Cite journal |last1=Esgarrancho |first1=Sandra |last2=Cândido |first2=Carlos J. F. |date=2020-01-02 |title=Firm preparation for ISO 9001 certification – the case of the hotel industry in Portugal |url=https://doi.org/10.1080/14783363.2017.1404428 |journal=Total Quality Management & Business Excellence |volume=31 |issue=1–2 |pages=23–42 |doi=10.1080/14783363.2017.1404428 |hdl=10400.1/13394 |s2cid=158500304 |issn=1478-3363|hdl-access=free }}</ref> 
# The degree of effective implementation of the standard (i.e., internalization of the standard in the processes of the organization).<ref>{{Cite journal |last1=Boiral |first1=Olivier |last2=Roy |first2=Marie-Josée |date=2007-02-06 |title=ISO 9000: integration rationales and organizational impacts |url=https://www.emerald.com/insight/content/doi/10.1108/01443570710720630/full/html |journal=International Journal of Operations & Production Management |language=en |volume=27 |issue=2 |pages=226–247 |doi=10.1108/01443570710720630 |issn=0144-3577}}</ref>  That is, how well the ISO system integrates into current business practices.  Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual instead of creating a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary.
# How well the ISO system focuses on improving the customer experience.  The broadest definition of quality is "Whatever the customer perceives good quality to be."  This means that a company doesn't necessarily have to make a product that never fails; some customers have a higher tolerance for product failures if they always receive shipments on-time or have a positive experience in some other dimension of customer service.  An ISO system should take into account all areas of the customer experience and the industry expectations, and seek to improve them on a continual basis.  This means taking into account all processes that deal with the three stakeholders (customers, suppliers, and organization). Only then can a company sustain improvements in the customer's experience.
# How well the auditor finds and communicates areas of improvement.  While ISO auditors may not provide consulting to the clients they audit, there is the potential for auditors to point out areas of improvement.  Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard; however, to most executives, this is like speaking a foreign language.  Auditors that can clearly identify and communicate areas for improvement in language and terms executive management understands facilitate action on improvement initiatives by the companies they audit.  When management doesn't understand why they were non-compliant and the business implications associated with non-compliance, they simply ignore the reports and focus on what they do understand.

===Advantages===
Proper quality management can improve business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation.<ref name="sroufe">Sroufe, Robert and Sime Curkovic, "An examination of ISO 9000:2000 and supply chain quality assurance." Journal of Operations Management, Volume 26, Issue 4, July 2008, Pages 503–520</ref> The quality principles in ISO 9000:2000 are also sound, according to Wade <ref name="wade"/> and Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive".<ref name="barnes"/> Sroufe and Curkovic, (2008) found benefits ranging from registration required to remain part of a supply base, better documentation, to cost benefits, and improved involvement and communication with management.<ref name="sroufe"/> According to the ISO,<ref>{{cite web|title=Debunking the myths|url=https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/iso_9001_debunking_the_myths.pdf|website=Iso.org|publisher=International Organization for Standardization|access-date=7 July 2017|archive-date=19 August 2017|archive-url=https://web.archive.org/web/20170819021915/https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/iso_9001_debunking_the_myths.pdf|url-status=dead}}</ref> the 2015 version of the standard brings the following benefits:
# By assessing their context, organizations can define who is affected by their work and what they expect. This enables clearly stated business objectives and the identification of new business opportunities.
# Organizations can identify and address the risks associated with their organization.
# By putting customers first, organizations can make sure they consistently meet customer needs and enhance customer satisfaction. This can lead to more repeat customers, new clients and increased business for the organization.
# Organizations work in a more efficient way as all their processes are aligned and understood by everyone. This increases productivity and efficiency, bringing internal costs down.
# Organizations will meet necessary statutory and regulatory requirements.
# Organizations can expand into new markets, as some sectors and clients require ISO 9001 before doing business.

===Criticisms of ISO 9001 certification===
A common criticism of ISO 9000 and 9001 is the amount of money, time, and paperwork required for a complete implementation, and later, when needed, ISO 9001 certification.<ref name="clifford" /> Dalgleish cites the "inordinate and often unnecessary paperwork burden" of ISO, and says that "quality managers feel that ISO's overhead and paperwork are excessive and extremely inefficient".<ref name="dalgleish 2003">{{cite web |first=Scott |last=Dalgleish |url=http://www.qualitymag.com/articles/84308-probing-the-limits-br-iso-9000-more-hindrance-than-help |title=Probing the Limits – ISO 9000: More Hindrance Than Help |work=Quality Magazine |date=2003-05-05 |access-date=2015-06-10 }}</ref> The level of minimum documentation for a minimum scope organization has been greatly reduced,{{clarifyme|date=April 2024}} going from ISO 9001:2000 to ISO 9001:2008 to ISO 9001:2015.{{fact|date=April 2024}}

According to Barnes: {{quote|"Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed."<ref name="barnes">{{cite web |url=http://www.allbusiness.com/specialty-businesses/713376-1.html |title=Good Business Sense Is the Key to Confronting ISO 9000 |first=Frank |last=Barnes |work=Review of Business |date=Spring 2000|archive-url=https://web.archive.org/web/20090227121123/http://www.allbusiness.com/specialty-businesses/713376-1.html|archive-date=2009-02-27}}</ref>}}

Wilson suggests that ISO standards "elevate inspection of the correct procedures over broader aspects of quality", and therefore, "the workplace becomes oppressive and quality is not improved".<ref name="wilson" />

One study showing reasons for not adopting this standard include the risks and uncertainty of not knowing if there are direct relationships to improved quality, and what kind and how many resources will be needed.  Additional risks include how much certification will cost, increased bureaucratic processes and risk of poor company image if the certification process fails.<ref name="sroufe"/> According to [[John Seddon]], ISO 9001 promotes specification, [[Control (management)|control]], and procedures rather than [[understanding]] and improvement.<ref name="seddon" />

Wade argues that ISO 9000 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".<ref name="wade">{{cite web |url=http://www.bin.co.uk/IMS_May_2002.pdf |title=Is ISO 9000 really a standard? |first=Jim |last=Wade |publisher=ISO Management Systems |date=May–June 2002 |access-date=2006-05-10 |archive-url=https://web.archive.org/web/20060707162351/http://www.bin.co.uk/IMS_May_2002.pdf |archive-date=2006-07-07 |url-status=dead }}</ref> In short, Wade argues that reliance on the specifications of ISO 9001 does not guarantee a successful quality system.{{fact|date=April 2024}}

The standard is seen as especially prone to failure when a company is interested in certification before quality.<ref name="seddon"/> Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality.<ref name="barnes"/><ref name="henricks"/> ISO's Roger Frost suggested: {{quote|"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."<ref name="henricks">{{cite web |url=http://www.entrepreneur.com/magazine/entrepreneur/2001/december/46342.html |title=ISO a GO-Go |first=Mark |last=Henricks |work=Entrepreneur Magazine |date=December 2001}}</ref>}}

Certification by an independent auditor is often seen as the problem area, and according to Barnes, "has become a vehicle to increase consulting services".<ref name="barnes"/>

Dalgleish argues: "...[while] quality has a positive effect on return on investment, market share, sales growth, better sales margins, and competitive advantage,...taking a quality approach is unrelated to ISO 9000 registration."<ref name="dalgleish 2005">{{cite web |first=Scott |last=Dalgleish |url=http://www.qualitymag.com/articles/84308-probing-the-limits-br-iso-9000-more-hindrance-than-help |title=Probing the Limits: ISO 9001 Proves Ineffective |work=Quality Magazine |date=2005-04-01 |access-date=2015-06-06}}</ref> In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved.<ref name="isosurvey">{{cite web |url=http://www.iso.org/iso/en/iso9000-14000/pdf/survey2005.pdf |title=The ISO Survey – 2005 |version=Abridged version |publisher=ISO |year=2005}}</ref>

Abrahamson argues that fashionable management discourse such as [[Quality Circles]] tends to follow a [[Enterprise life cycle|lifecycle]] in the form of a [[Normal distribution|bell curve]], possibly indicating a [[management fad]].<ref>{{cite journal |jstor=258636 |pages=254–285 |last1=Abrahamson |first1=E. |title=Management Fashion |volume=21 |issue=1 |journal=The Academy of Management Review |year=1996 |doi=10.5465/amr.1996.9602161572}}</ref>

Dytz argues that ISO 9001 certification is based on 7 management principles and that companies are free to develop their internal tools and working methods, however, the model adopted to audit and certify companies does not evaluate the effectiveness of these methods. Even when there is still a superficial analysis of this effectiveness, mainly due to the time available to audit these companies, the certifications do not distinguish two companies with the same business model, with regard to their internal capacity and quality of management.<ref>Dytz, Andre (2019). WHY DO ISO 9001 COMPANIES FAIL?A reflection for board members, consultants and certification bodies</ref>

Pickrell argues{{citation needed|date=September 2016}} that ISO systems merely gauge whether the processes are being followed. It does not gauge how good the processes are or whether the correct parameters are being measured and controlled to ensure quality. Furthermore, when unique technical solutions are involved in the creation of a new part, ISO does not validate the robustness of the technical solution—a key part of advanced quality planning. It is not unheard of for an ISO-certified plant to display poor quality performance due to poor process selection and/or poor technical solutions.{{fact|date=April 2024}}

Lastly, the standard itself is proprietary, and not open to inspection by the general public.{{fact|date=April 2024}}

=== Reasons for Loss of ISO 9000 Certification ===
ISO 9001 certification has a three-year validity period. At the end of this period, every certified organization must renew its certificate. Not all organizations are successful in their renewal. Some organizations are not able to renew the certificate, because they do not conform to all requirements, and others simply decide not to renew the certificate.<ref name=":0">{{Cite journal|last1=Cândido|first1=Carlos J.F.|last2=Coelho|first2=Luís M.S.|last3=Peixinho|first3=Rúben M.T.|date=2016-01-04|title=The financial impact of a withdrawn ISO 9001 certificate|url=https://www.emerald.com/insight/content/doi/10.1108/IJOPM-11-2014-0540/full/html|journal=International Journal of Operations & Production Management|language=en|volume=36|issue=1|pages=23–41|doi=10.1108/IJOPM-11-2014-0540|issn=0144-3577|hdl=10400.1/7379|hdl-access=free}}</ref> There are several reasons why an organization may lose or decide not to renew its ISO 9000 certification:

* Some companies may think that the total cost outweighs the certification benefits.<ref name=":2">{{Cite journal|last1=Lo|first1=Liang Kang|last2=Chang|first2=Dong Shang|date=2007-04-15|title=The difference in the perceived benefits between firms that maintain ISO certification and those that do not|url=https://doi.org/10.1080/00207540600733709|journal=International Journal of Production Research|volume=45|issue=8|pages=1881–1897|doi=10.1080/00207540600733709|s2cid=108464851|issn=0020-7543}}</ref><ref>{{Cite journal|last1=Sansalvador|first1=Manuel E.|last2=Brotons|first2=José M.|date=2015-12-02|title=Valuation of the option of abandoning ISO 9001 certification: an empirical study in Spain|url=https://doi.org/10.1080/14783363.2014.929231|journal=Total Quality Management & Business Excellence|volume=26|issue=11–12|pages=1255–1268|doi=10.1080/14783363.2014.929231|s2cid=154059597|issn=1478-3363}}</ref> This is the most cited reason for voluntary decertification, but some research suggests that economic underperformance is not the reason why firms lose the certification.<ref name=":3">{{Cite journal|last1=Cândido|first1=Carlos J.F.|last2=Coelho|first2=Luís M.S.|last3=Peixinho|first3=Rúben M.T.|date=2019-06-05|title=Why firms lose their ISO 9001 certification: Evidence from Portugal|url=https://www.tandfonline.com/doi/full/10.1080/14783363.2019.1625266|journal=Total Quality Management & Business Excellence|volume=32|issue=5–6|language=en|pages=632–651|doi=10.1080/14783363.2019.1625266|issn=1478-3363|hdl=10400.1/14067|s2cid=201319741|hdl-access=free}}</ref>
* In some industries, there may be too many competitors already certified which may create the sensation that the potential for competitive advantage gained from (re)certification is lower.<ref name=":2" /><ref name=":3" /><ref name=":4">{{Cite journal|last1=Simon|first1=Alexandra|last2=Kafel|first2=Piotr|date=2018-10-01|title=Reasons for decertification of ISO 9001. An empirical study|journal=Innovar|volume=28|issue=70|pages=69–80|doi=10.15446/innovar.v28n70.74449|issn=2248-6968|doi-access=free}}</ref>
* Some companies may believe that they have internalized the certification benefits into their processes and do not feel the need for formal certification as they can continue to conform to the ISO 9001 standard without formal registration within a certification body.<ref name=":0" />
* Some of the customers may no longer demand certification.<ref>{{Cite journal|last1=Chiarini|first1=Andrea|last2=Brunetti|first2=Federico|date=2019-10-03|title=What really matters for a successful implementation of Lean production? A multiple linear regression model based on European manufacturing companies|url=https://www.tandfonline.com/doi/full/10.1080/09537287.2019.1589010|journal=Production Planning & Control|language=en|volume=30|issue=13|pages=1091–1101|doi=10.1080/09537287.2019.1589010|s2cid=149820591|issn=0953-7287}}</ref>
* Some companies may have considered their ISO 9001 certification as a first step into quality management <ref name=":2" /> and now want to evolve their quality management systems by advancing to other alternative certifications (e.g., IATF 16949:2016, in the automobile industry) or towards other more demanding quality management systems (e.g., TQM, six sigma, lean).<ref name=":1" />
* Financial distress.<ref name=":4" />
*Expected performance after decertification.<ref name=":1" /><ref name=":5">{{Cite journal|last1=Cândido|first1=Carlos J. F.|last2=Ferreira|first2=Luís M. F. R.|date=2021-11-07|title=Determinants of expected performance after ISO 9001 certification withdrawal|url=https://doi.org/10.1080/14783363.2021.1997142|journal=Total Quality Management & Business Excellence|volume=33 |issue=15–16 |pages=1691–1717|doi=10.1080/14783363.2021.1997142|s2cid=243854704|issn=1478-3363}}</ref>
*Improper ISO 9001 implementation.<ref>{{Cite journal|last=Alič|first=Milena|date=2014-06-05|title=Impact of ISO 9001 certification cancellation on business performance: a case study in Slovenian organisations|url=http://www.tandfonline.com/doi/abs/10.1080/14783363.2014.906107|journal=Total Quality Management & Business Excellence|language=en|volume=25|issue=7–8|pages=790–811|doi=10.1080/14783363.2014.906107|s2cid=153397112|issn=1478-3363}}</ref>
* and other reasons.<ref name=":1">{{Cite journal|last1=Ferreira|first1=Luís M. F. R.|last2=Cândido|first2=Carlos J. F.|date=2021-03-01|title=Factors influencing firm propensity for ISO 9001 withdrawal: Evidence on decertification tendency and antecedents|url=https://www.sciencedirect.com/science/article/pii/S092552732030373X|journal=International Journal of Production Economics|language=en|volume=233|page=108024|doi=10.1016/j.ijpe.2020.108024|s2cid=233861800|issn=0925-5273}}</ref>

=== Propensity for Loss of ISO 9000 Certification ===
According to the latest data made available by ISO, approximately 60,000 organizations lose the certification every year.<ref name=":0" /><ref name=":3" /><ref name=":1" /> Given that there are approximately 1,000,000 certified organizations worldwide, and that 1/3 of these (approx. 333,333) must renew the certificate every year, the yearly average propensity for ISO 9001 withdrawal can be estimated roughly at 18% (60,000/333,333).<ref name=":1" /> The propensity of a given organization to lose its certification can be estimated, depending on several factors specific to the organization:

* initial certification motivations;<ref name=":1" /><ref name=":6">{{Cite journal|last1=Cândido|first1=Carlos J. F.|last2=Ferreira|first2=Luís M. F. R.|date=2021-05-14|title=ISO 9001 internal decertification motivations: exploring barriers and benefits of certification as withdrawal antecedents|url=https://doi.org/10.1080/09537287.2021.1916638|journal=Production Planning & Control|volume=34 |issue=4 |pages=330–344|doi=10.1080/09537287.2021.1916638|s2cid=236572508|issn=0953-7287}}</ref>
* certification barriers that were overcome during certification;<ref name=":1" /><ref name=":6" />
* certification benefits achieved;<ref name=":1" /><ref name=":6" />
* decertification motivations held;<ref name=":1" /><ref name=":6" />
* expected performance after decertification;<ref name=":5" />
*and other factors.<ref name=":1" />