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ISO 9000 family

The ISO 9000 family is a set of international standards for quality management systems . It was developed in March 1987 by the International Organization for Standardization (IS...

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The ISO 9000 family is a set of international standards for quality management systems. It was developed in March 1987 by the International Organization for Standardization (ISO). The goal of these standards is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. The standards were designed to fit into an integrated management system.[1] The ISO refers to the set of standards as a "family", bringing together the standard for quality management systems and a set of "supporting standards",[2] and their presentation as a family facilitates their integrated application within an organisation.[3] ISO 9000 deals with the fundamentals and vocabulary of QMS,[4] including the seven quality management principles that underlie the family of standards.[4][5][6] ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.[7] A companion document, ISO/TS 9002, provides guidelines for the application of ISO 9001.[8] ISO 9004 gives guidance on achieving sustained organizational success.[9]

Third-party certification bodies confirm that organizations meet the requirements of ISO 9001. Over one million organizations worldwide[10] are independently certified, making ISO 9001 one of the most widely used management tools in the world today. However, the ISO certification process has been criticised [11][12] as being wasteful and not being useful for all organizations.[13][14]

History

In March 1979, BSI published the world's first quality management systems standard, BS 5750, as part of a response to growing concerns about the quality. BS 5750 supplied the template for the development of the ISO 9000 series in March 1987, by ISO.[15][16] However, its history can be traced back some twenty years before that, to the publication of government procurement standards, such as the United States Department of Defense MIL-Q-9858 standard in 1959, and the United Kingdom's Def Stan 05–21 and 05–24. Large organizations that supplied government procurement agencies often had to comply with a variety of quality assurance requirements for each contract awarded, which led the defense industry to adopt mutual recognition of NATO AQAP, MIL-Q, and Def Stan standards. Eventually, industries adopted ISO 9000 instead of forcing contractors to adopt multiple—and often similar—requirements.[17]

Reasons for use

The global adoption of ISO 9001 may be attributable to several factors. In the early days, the ISO 9001 (9002 and 9003) requirements were intended to be used by procuring organizations, such as contractors and design activities, as the basis of contractual arrangements with their suppliers. This helped reduce the need for subcontract supplier quality development by establishing basic requirements for a supplier to assure product quality. The ISO 9001 requirements could be tailored to meet specific contractual situations, depending on the complexity of the product, business type (design responsibility, manufacture only, distribution, servicing, etc.), and risk to the procurer. For example, the food industry combined the ISO 9000 series with HACCP as a single management system.[18][19] If a chosen supplier was weak in the controls of their measurement equipment (calibration), and hence QC/inspection results, that specific requirement would be invoked in the contract. Adopting a single quality assurance requirement also leads to cost savings throughout the supply chain by reducing the administrative burden of maintaining multiple sets of quality manuals and procedures.

A few years later, the UK Government took steps to improve national competitiveness following the publication of a white paper on Standards, Quality and International Competitiveness, Cmd 8621,[20] and Third-Party Certification of Quality Management Systems was born under the auspices of the National Accreditation Council of Certification Bodies (NACCB), which has become the United Kingdom Accreditation Service (UKAS).

In addition to many stakeholders' benefits, several studies have identified significant financial benefits for organizations certified to ISO 9001, with an ISO analysis of 42 studies showing that implementing the standard enhances financial performance.[21] Corbett et al. showed that certified organizations achieved a superior return on assets[22] compared to otherwise similar organizations without certification.[23]

Heras et al. found similarly superior performance[23] and demonstrated that this was statistically significant and not a function of organization size.[24] Naveha and Marcus claimed that implementing ISO 9001 led to superior operational performance in the U.S. automotive industry.[25] Sharma identified similar improvements in operating performance and linked this to superior financial performance.[26] Chow-Chua et al. showed better overall financial performance was achieved for companies in Denmark.[27] Rajan and Tamimi (2003) showed that ISO 9001 certification resulted in superior stock market performance and suggested that shareholders were richly rewarded for the investment in an ISO 9001 system.[28]

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. (2005),[23] may suggest it. Other writers, such as Heras et al. (2002),[24] have indicated 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.

The mechanism for improving results has also been the subject of much research. Lo et al. (2007) identified operational improvements (e.g., cycle time reduction, inventory reductions) as following from certification.[29] Internal process improvements in organizations lead to externally observable improvements.[30][31] The benefit of increased international trade and domestic market share, in addition to the internal benefits such as customer satisfaction, interdepartmental communications, work processes, and customer/supplier partnerships derived, far exceeds any and all initial investment.[32]

Global adoption

The increase in ISO 9001 certification is shown in the tables below.

ISO 9000 series quality management principles

The ISO 9000 series are based on seven quality management principles (QMPs),[40] namely:

Contents of ISO 9001:2015

A fish wholesaler in Tsukiji, Japan advertising its ISO 9001 certification

ISO 9001:2015 Quality management systems – Requirements is a document of approximately 30 pages available from the national standards organization in each country. Only ISO 9001 is directly audited against for third-party assessment purposes.

Contents of ISO 9001:2015 are:

  • Section 1: Scope
  • Section 2: Normative references
  • Section 3: Terms and definitions
  • Section 4: Context of the organization
  • Section 5: Leadership
  • Section 6: Planning
  • Section 7: Support
  • Section 8: Operation
  • Section 9: Performance evaluation
  • Section 10: Continual improvement

Essentially, the layout of the standard is similar to the previous ISO 9001:2008 standard in that it follows the plan–do–check–act (PDCA) cycle in a process-based approach but is now further encouraging this to have risk-based thinking (section 0.3.3 of the introduction). The purpose of the quality objectives is to determine the conformity of the requirements (customers and organizations), facilitate effective deployment, and improve the quality management system.[41][42]

Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10. Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into account.

La norma ya no especifica que la organización deba emitir y mantener procedimientos documentados, pero la ISO 9001:2015 exige que la organización documente cualquier otro procedimiento necesario para su funcionamiento eficaz. La norma también exige que la organización emita y comunique una política de calidad documentada , un alcance del sistema de gestión de la calidad y objetivos de calidad. La norma ya no exige que las organizaciones que cumplen con la norma emitan un Manual de Calidad formal. La norma sí exige la conservación de numerosos registros, tal como se especifica a lo largo de la misma. Como novedad en la versión de 2015, se exige que la organización evalúe los riesgos y las oportunidades (sección 6.1) y determine los problemas internos y externos relevantes para su propósito y dirección estratégica (sección 4.1). La organización debe demostrar cómo se cumplen los requisitos de la norma, mientras que la función del auditor externo es determinar la eficacia del sistema de gestión de la calidad. Las organizaciones que buscan más información en lo que puede ser un área muy técnica suelen solicitar ejemplos de interpretación e implementación más detallados.

Proceso de dar un título

La Organización Internacional de Normalización (ISO) no certifica directamente a las organizaciones. Existen numerosos organismos de certificación que auditan a las organizaciones y emiten certificados de conformidad con la norma ISO 9001 tras superar la auditoría. Si bien se la suele denominar certificación "ISO 9000", la norma real con la que se puede certificar el sistema de gestión de la calidad de una organización es la ISO 9001:2015 (la ISO 9001:2008 expiró alrededor de septiembre de 2018). Muchos países han creado organismos de acreditación para autorizar ("acreditar") a los organismos de certificación. Tanto los organismos de acreditación como los de certificación cobran tarifas por sus servicios. Los distintos organismos de acreditación tienen acuerdos mutuos entre sí para garantizar que los certificados emitidos por uno de los organismos de certificación acreditados (OC) sean aceptados en todo el mundo. Los propios organismos de certificación operan bajo otra norma de calidad, la ISO/IEC 17021, [ 43 ] mientras que los organismos de acreditación operan bajo la ISO/IEC 17011. [ 44 ]

An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products, services, and processes. The auditor presents a list of problems (defined as "nonconformities", "observations", or "opportunities for improvement") to management. If there are no major nonconformities, the certification body issues a certificate. Where major nonconformities are identified, the organization presents an improvement plan to the certification body (e.g., corrective action reports showing how the problems will be resolved); once the certification body is satisfied that the organization has carried out sufficient corrective action, it issues a certificate. The certificate is limited by a particular scope (e.g., production of golf balls) and displays the addresses to which the certificate refers.

An ISO 9001 certificate is not a once-and-for-all award but must be renewed, in accordance with the requirements of ISO 17021, at regular intervals recommended by the certification body, usually once every three years.[45] There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard) or it is not. In this respect, ISO 9001 certification contrasts with measurement-based quality systems.

Evolution of ISO 9000 standards

The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.

1987 version

ISO 9000:1987 had the same structure as the British Standard BS 5750, with three specifications for quality management systems, the selection of which was based on the scope of activities of the organization:

  • ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
  • ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
  • ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.

ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent.

versión de 1994

La norma ISO 9000:1994 hizo hincapié en el aseguramiento de la calidad mediante acciones preventivas, en lugar de limitarse a verificar el producto final, y siguió exigiendo pruebas de cumplimiento con procedimientos documentados. Al igual que con la primera edición, la desventaja fue que las empresas tendieron a implementar sus requisitos creando una gran cantidad de manuales de procedimientos y viéndose abrumadas por la burocracia ISO. En algunas empresas, la adaptación y mejora de los procesos podían incluso verse obstaculizadas por el sistema de gestión de la calidad.

versión 2000

La norma ISO 9001:2000 sustituyó a las tres normas anteriores de 1994: ISO 9001 , ISO 9002 e ISO 9003. Los procedimientos de diseño y desarrollo solo se exigían si la empresa, efectivamente, creaba nuevos productos. La versión de 2000 buscaba un cambio radical en la concepción, priorizando el concepto de gestión de procesos (el seguimiento y la optimización de las tareas y actividades de la empresa, en lugar de la mera inspección del producto final). Asimismo, exigía la participación de la alta dirección para integrar la calidad en el sistema empresarial y evitar la delegación de funciones de calidad a personal administrativo de menor jerarquía. Otro objetivo era mejorar la eficacia mediante indicadores de rendimiento de procesos: la medición numérica de la efectividad de las tareas y actividades. Se explicitaron las expectativas de mejora continua de procesos y el seguimiento de la satisfacción del cliente.

Los requisitos de la norma ISO 9000 incluyen:

  • Aprobar los documentos antes de su distribución;
  • Proporcione la versión correcta de los documentos en los puntos de uso;
  • Utilice sus registros para demostrar que se han cumplido los requisitos; y
  • Desarrolle un procedimiento para controlar sus registros.

versión 2008

La norma ISO 9001:2008, en esencia, reformula la ISO 9001:2000. La versión de 2008 solo introdujo aclaraciones a los requisitos existentes de la ISO 9001:2000 y algunos cambios destinados a mejorar la coherencia con la ISO 14001:2004 . No se añadieron nuevos requisitos. Por ejemplo, en la ISO 9001:2008, basta con comprobar que un sistema de gestión de la calidad que se esté actualizando cumpla con las aclaraciones introducidas en la versión modificada.

La norma ISO 9001 se complementa directamente con otras dos normas de la misma familia:

  • ISO 9000:2005 "Sistemas de gestión de la calidad. Fundamentos y vocabulario"
  • ISO 9004:2009 "Gestión para el éxito sostenido de una organización. Un enfoque de gestión de la calidad"

También se pueden utilizar otras normas, como la ISO 19011 y la serie ISO 10000, para partes específicas del sistema de calidad.

versión 2015

In 2012, ISO/TC 176 – responsible for ISO 9001 development – celebrated 25 years of implementing ISO 9001[46] and concluded that it was necessary to create a new QMS model for the next 25 years. They subsequently commenced the official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as the "beginning of a new era in the development of quality management systems".[47] As a result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed; however, the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.[48]

The new ISO 9001:2015 management system standard helps ensure that consumers can secure reliable, desired quality goods and services. This further increases benefits for a business.[49]

The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with "risk-based thinking", and employing the Plan-Do-Check-Act cycle at all levels in the organization.[50]

Some of the key changes include:

  • High-Level Structure of 10 clauses is implemented. Now all new management system standards released by ISO will have this high-level structure
  • Greater emphasis on building a management system suited to each organization's particular needs
  • A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
  • Risk-based thinking throughout the standard makes the whole management system function as a preventive tool and encourages continuous improvement
  • Less prescriptive requirements for documentation: the organization can now decide, in addition to the mandatory documents and records, what documented information it needs and in what format it should be
  • Alignment with other key management system standards through the use of a common structure and core text[51]
  • Inclusion of knowledge management principles
  • Quality Manuals and management representatives (MR) are no longer mandatory.

El «pensamiento basado en el riesgo» se considera una evolución del enfoque tradicional de gestión de riesgos, que se enmarcaba como responsabilidad de un «gestor de riesgos», hacia un enfoque que concibe la gestión de riesgos como «una forma fundamental de pensar y tomar decisiones en toda la organización». La ISO y el Foro Internacional de Acreditación (IAF) han publicado una guía conjunta sobre prácticas de auditoría que abarca el pensamiento basado en el riesgo. [ 52 ]

Revisión de cuentas

Para obtener la certificación según la norma, se requieren dos tipos de auditoría: una realizada por un organismo de certificación externo (auditoría externa) y otra por personal interno capacitado para este proceso (auditorías internas). El objetivo es un proceso continuo de revisión y evaluación para verificar que el sistema funcione correctamente, identificar áreas de mejora y corregir o prevenir los problemas detectados. Se considera beneficioso que los auditores internos realicen auditorías fuera de su línea de gestión habitual para garantizar la independencia en sus juicios. El Grupo de Prácticas de Auditoría ISO 9001 proporciona documentación de apoyo. Este grupo está integrado por expertos, auditores y profesionales de sistemas de gestión de la calidad (SGC), provenientes del Comité Técnico ISO 176 de Gestión de la Calidad y Aseguramiento de la Calidad (ISO/TC 176) y del Foro Internacional de Acreditación (IAF).

Interpretaciones específicas de la industria

La norma ISO 9001 es genérica; sus partes deben interpretarse cuidadosamente para que tengan sentido dentro de una organización específica. Desarrollar software no es como hacer queso u ofrecer servicios de asesoramiento , pero las directrices de la ISO 9001, al ser directrices de gestión empresarial, pueden aplicarse a ambas actividades. Dicho esto, no es necesario citar directrices, libros de texto o revistas científicas o industriales. Diversas organizaciones —departamentos de policía (Estados Unidos), equipos de fútbol profesional (México) y ayuntamientos (Reino Unido)— han implementado con éxito sistemas ISO 9001.

Con el tiempo, diversos sectores industriales han buscado estandarizar sus interpretaciones de las directrices dentro de su propio mercado. Esto se debe, en parte, a la necesidad de garantizar que sus versiones de la norma ISO 9000 incluyan sus requisitos específicos, pero también a la intención de asegurar que auditores con la formación y experiencia adecuadas sean quienes las evalúen e incluso certifiquen según dicha interpretación.

  • Las directrices de TickIT son una interpretación de la norma ISO 9000 elaborada por la Junta de Comercio del Reino Unido para adaptarla a los procesos de la industria de las tecnologías de la información, especialmente al desarrollo de software.
  • AS9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt & Whitney, Rockwell-Collins, Sikorsky Aircraft, Textron Aviation and Sundstrand. The current version is AS9100D.
  • PS 9000 produced by The Pharmaceutical Quality Group a group within The CQI. The group publishes documents related to management of quality in the pharmaceutical sector.
  • QS 9000 was an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It included techniques such as FMEA and APQP. QS 9000 has now been replaced by IATF 16949.
  • IATF 16949:2016 is a sector scheme agreed upon by major automotive manufacturers (American, Japanese and European manufacturers); the latest version is based on ISO 9001:2015. The ISO/TS 16949:2009 standard was completely revised and reissued by IATF (International Automotive Task Force). IATF 16949:2016 is now a stand-alone standard that doesn't include the ISO 9001:2015 requirements but still refers to them and works as an additional automotive-specific requirement to ISO 9001.
  • TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry. The TL 9000 standard is made up of two handbooks: the QMS Requirements Handbook, and the QMS Measurement Handbook. The current versions of the Requirements and Measurements Handbooks are 6.0. Unlike ISO 9001 or other sector-specific standards, TL 9000 includes standardized product and process measurements that must be reported into a central repository, which allows organizations to benchmark their performance in key process areas against peer organizations. TL 9000 R6.0 contains the full text of ISO 9001:2015.
  • La norma ISO 13485 :2016 es el equivalente a la ISO 9001 en el sector médico. Se trata de una norma independiente. Dado que la ISO 13485 es relevante para los fabricantes de dispositivos médicos (a diferencia de la ISO 9001, que es aplicable a cualquier sector), y debido a las diferencias entre ambas normas en lo que respecta a la mejora continua, el cumplimiento de la ISO 13485 no implica necesariamente el cumplimiento de la ISO 9001 (y viceversa).
  • La norma ISO/IEC 90003 :2014 proporciona directrices para la aplicación de la norma ISO 9001 al software informático.
  • La norma ISO/TS 29001 establece los requisitos del sistema de gestión de la calidad para el diseño, desarrollo, producción, instalación y mantenimiento de productos para las industrias del petróleo, petroquímica y gas natural. Es equivalente a la especificación API Q1, pero sin el anexo del monograma.
  • La norma ISO 18091 establece las directrices para la aplicación de la norma ISO 9001 en el gobierno local. [ 53 ]
  • ISO/TS 54001 es el sistema de gestión de la calidad con requisitos particulares para la aplicación de ISO 9001:2015 para organizaciones electorales en todos los niveles de gobierno. [ 54 ]
  • La norma ISO/IEC 17025:2017 es el sistema de gestión de la calidad aplicable únicamente a los laboratorios de ensayo y calibración.

Eficacia

El debate sobre la eficacia de la norma ISO 9000 suele centrarse en las siguientes cuestiones:

  1. ¿Son valiosos los principios de calidad de la norma ISO 9001?
  2. ¿Resulta útil implementar un sistema de gestión de calidad que cumpla con la norma ISO 9001?
  3. ¿Ayuda obtener la certificación ISO 9001?

La eficacia del sistema ISO que se implementa depende de varios factores, entre los que destacan los siguientes:

  1. Compromiso de la alta dirección para supervisar, controlar y mejorar la calidad. Los altos directivos deben participar activamente en las actividades de gestión de la calidad, comenzando por la definición de una estrategia de calidad para la organización.
  2. Motivos para adoptar la norma. Los motivos internos, como el deseo genuino de mejorar la calidad del producto, los procesos de la empresa y la eficiencia de los procesos, tienden a facilitar la implementación de la norma y a aumentar la eficacia de la certificación. Las organizaciones que implementan un sistema ISO sin este deseo suelen optar por la vía más económica para obtener un certificado y pasan por alto las áreas problemáticas detectadas en las auditorías. Los motivos externos (como la presión de las partes interesadas o la demanda de los clientes) tienden a generar menores beneficios de la certificación. [ 55 ]
  3. Realizar un análisis adecuado del contexto interno de la empresa que desea adoptar la norma, prepararse para la implementación de la norma (por ejemplo, capacitación), planificar la implementación de la norma en la organización y la receptividad organizacional (personal, cultura) a la implementación de la norma. [ 56 ]
  4. The degree of effective implementation of the standard (i.e., internalization of the standard in the processes of the organization).[57] 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.
  5. 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.
  6. 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.[58] The quality principles in ISO 9000:2000 are also sound, according to Wade [59] and Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive".[60] 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.[58] According to the ISO,[61] the 2015 version of the standard brings the following benefits:

  1. 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.
  2. Organizations can identify and address the risks associated with their organization.
  3. 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.
  4. 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.
  5. Organizations will meet necessary statutory and regulatory requirements.
  6. 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.[11] 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".[62] The level of minimum documentation for a minimum scope organization has been greatly reduced, going from ISO 9001:2000 to ISO 9001:2008 to ISO 9001:2015.

According to Barnes:

"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."[60]

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".[12]

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.[58] According to John Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement.[13]

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".[59] In short, Wade argues that reliance on the specifications of ISO 9001 does not guarantee a successful quality system.

The standard is seen as especially prone to failure when a company is interested in certification before quality.[13] Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality.[60][63] ISO's Roger Frost suggested:

"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."[63]

Certification by an independent auditor is often seen as the problem area, and according to Barnes, "has become a vehicle to increase consulting services".[60]

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."[64] In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved.[65]

Abrahamson argues that fashionable management discourse such as quality circles tends to follow a lifecycle in the form of a bell curve, possibly indicating a management fad.[66]

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.[67]

Pickrell argues 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.

Lastly, the standard itself is proprietary, and not open to inspection by the general public.

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.[68] 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.[69][70] 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.[71]
  • 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.[69][71][72]
  • 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.[68]
  • Some of the customers may no longer demand certification.[73]
  • Some companies may have considered their ISO 9001 certification as a first step into quality management [69] 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 toward other more demanding quality management systems (e.g., total quality management (TQM), Six Sigma, lean manufacturing).[74]
  • Financial distress.[72]
  • Expected performance after decertification.[74][75]
  • Improper ISO 9001 implementation.[76]
  • and other reasons.[74]

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.[68][71][74] 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).[74] The propensity of a given organization to lose its certification can be estimated, depending on several factors specific to the organization:

  • Initial certification motives[74][77]
  • Certification barriers overcome during certification[74][77]
  • Certification benefits achieved[74][77]
  • Decertification motives held[74][77]
  • Expected performance after decertification[75]
  • Other factors[74]

See also

  • Quality management system – Sum of product fitness processes in a business
  • ISO 8000 – International standard for Data Quality and Enterprise Master Data
  • ISO/IEC 42001 – Artificial intelligence management system (shares High-Level Structure with ISO 9001)

References

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  2. ↑International Organization for Standardization, What is the ISO 9000 family of standards on quality management?, accessed on 20 September 2024
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  60. 1234Barnes, Frank (Spring 2000). "Good Business Sense Is the Key to Confronting ISO 9000". Review of Business. Archived from the original on 27 February 2009.
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  63. ^ Henricks , Mark (diciembre de 2001). "ISO un GO-Go" . Revista Emprendedor .
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  72. 12Simon, Alexandra; Kafel, Piotr (1 October 2018). "Reasons for decertification of ISO 9001. An empirical study". Innovar. 28 (70): 69–80. doi:10.15446/innovar.v28n70.74449. ISSN 2248-6968.
  73. ↑Chiarini, Andrea; Brunetti, Federico (3 October 2019). "What really matters for a successful implementation of Lean production? A multiple linear regression model based on European manufacturing companies". Production Planning & Control. 30 (13): 1091–1101. doi:10.1080/09537287.2019.1589010. ISSN 0953-7287. S2CID 149820591.
  74. 12345678910Ferreira, Luís M. F. R.; Cândido, Carlos J. F. (1 March 2021). "Factors influencing firm propensity for ISO 9001 withdrawal: Evidence on decertification tendency and antecedents". International Journal of Production Economics. 233 108024. doi:10.1016/j.ijpe.2020.108024. hdl:10400.1/14954. ISSN 0925-5273. S2CID 233861800.
  75. 12Cândido, Carlos J. F.; Ferreira, Luís M. F. R. (7 November 2021). "Determinants of expected performance after ISO 9001 certification withdrawal". Total Quality Management & Business Excellence. 33 (15–16): 1691–1717. doi:10.1080/14783363.2021.1997142. hdl:10400.1/17548. ISSN 1478-3363. S2CID 243854704.
  76. ↑Alič, Milena (5 June 2014). "Impact of ISO 9001 certification cancellation on business performance: a case study in Slovenian organisations". Total Quality Management & Business Excellence. 25 (7–8): 790–811. doi:10.1080/14783363.2014.906107. ISSN 1478-3363. S2CID 153397112.
  77. 1234Cândido, Carlos J. F.; Ferreira, Luís M. F. R. (14 May 2021). "ISO 9001 internal decertification motivations: exploring barriers and benefits of certification as withdrawal antecedents". Production Planning & Control. 34 (4): 330–344. doi:10.1080/09537287.2021.1916638. hdl:10400.1/16969. ISSN 0953-7287. S2CID 236572508.

Further reading

  • Bamford, Robert; Deibler, William (2003). ISO 9001: 2000 for Software and Systems Providers: An Engineering Approach (1st ed.). CRC-Press. ISBN 0-8493-2063-1, ISBN 978-0-8493-2063-7
  • Naveh, E.; Marcus, A. (2004). "When Does the ISO 9000 Quality Assurance Standard Lead to Performance Improvement? Assimilation and Going Beyond". IEEE Transactions on Engineering Management. 51 (3): 352. doi:10.1109/TEM.2004.830864. S2CID 19656993.
  • Naveh, E. (1999). ISO 9000 survey'99: An analytical tool to assess the costs, benefits and savings of ISO 9000 registration. QSU Publishing Company.
  • An abstract of the 2007's ISO survey of certificates
  • The ISO Survey
  • Bacivarov, Ioan (Coordinating Editor) (2015). Special issue "ISO9001:2015". Asigurarea Calitatii – Quality Assurance 21 (83), ISSN 1224-5410
  • ISO website