ISO 9000

ISO 9000 was first published in 1987 by the International Organization for Standardization (ISO).[13] It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979.[14] 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.[15]

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. [16] [17] 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 cmd 8621, 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.[18] Corbett et al. showed that certified organizations achieved a superior return on assets[19] compared to otherwise similar organizations without certification.[20]

Heras et al. found similarly superior performance[20] and demonstrated that this was statistically significant and not a function of organization size.[21] Naveha and Marcus claimed that implementing ISO 9001 led to superior operational performance in the U.S. automotive industry.[22] Sharma identified similar improvements in operating performance and linked this to superior financial performance.[23] Chow-Chua et al. showed better overall financial performance was achieved for companies in Denmark.[24] 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.[25]

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),[20] may suggest it. Other writers, such as Heras et al. (2002),[21] 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.[26] Internal process improvements in organizations lead to externally observable improvements.[27][28] 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.[29]

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

The ISO 9000 series are based on seven quality management principles (QMP)[37]

The seven quality management principles are:

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 as follows:

• 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 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.[38][39]

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.

The standard no longer specifies that the organization shall issue and maintain documented procedures, but ISO 9001:2015 requires the organization to document any other procedures required for its effective operation. The standard also requires the organization to issue and communicate a documented quality policy, a quality management system scope, and quality objectives. The standard no longer requires compliant organizations to issue a formal Quality Manual. The standard does require the retention of numerous records, as specified throughout the standard. New for the 2015 release is a requirement for an organization to assess risks and opportunities (section 6.1) and to determine internal and external issues relevant to its purpose and strategic direction (section 4.1). The organization must demonstrate how the standard's requirements are being met, while the external auditor's role is to determine the quality management system's effectiveness. More detailed interpretation and implementation examples are often sought by organizations seeking more information in what can be a very technical area.

The International Organization for Standardization (ISO) does not certify organizations themselves. Numerous certification bodies exist that audit organizations and issue ISO 9001 compliance certificates upon success. Although commonly referred to as "ISO 9000" certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2015 (ISO 9001:2008 expired around September 2018). Many countries have formed accreditation bodies to authorize ("accredit") the certification bodies. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the accredited certification bodies (CB) are accepted worldwide. Certification bodies themselves operate under another quality standard, ISO/IEC 17021,[40] while accreditation bodies operate under ISO/IEC 17011.[41]

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.[42] 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.

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.

Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual review and assessment process to verify that the system is working as it is supposed to, find out where it can improve, and correct or prevent identified problems. It is considered healthier for internal auditors to audit outside their usual management line to bring a degree of independence to their judgements. Supporting papers are provided by the ISO 9001 Auditing Practices Group. This is constituted as an informal group of quality management system (QMS) experts, auditors, and practitioners, drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).

The ISO 9001 standard is generic; its parts must be carefully interpreted to make sense within a particular organization. Developing software is not like making cheese or offering counseling services, yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations—police departments (United States), professional soccer teams (Mexico), and city councils (UK)—have successfully implemented ISO 9001 systems.

Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.

• The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development.
• 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, and Sundstrand. The current version is AS9100D.
• PS 9000 * QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS 16949.
• ISO/TS 16949:2009 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2008. The emphasis on a process approach is stronger than in ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and automotive industry-specific requirements. After the new edition of ISO 9001:2015 the ISO/TS 16949:2009 was also 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. It is important to note that TL 9000 R6.0 contains the full text of ISO 9001:2015.
• ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 does not necessarily mean compliance with ISO 9001 (and vice versa).
• ISO/IEC 90003:2014 provides guidelines for the application of ISO 9001 to computer software.
• ISO/TS 29001 is quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries. It is equivalent to API Spec Q1 without the Monogram annex.
• ISO 18091 is the guidelines for the application of ISO 9001 in local government.[49]
• ISO/TS 54001 is the Quality management system with particular requirements for the application of ISO 9001:2015 for electoral organizations at all levels of government.[50]
• ISO 17025:2017 is the Quality Management System applicable only to Testing and Calibration Laboratories.

The debate on the effectiveness of ISO 9000 commonly centers on the following questions:

1. Are the quality principles in ISO 9001 of value?
2. Does it help to implement an ISO 9001-compliant quality management system?
3. 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:

1. 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.
2. 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.[51]
3. Making a convenient analysis of the internal context of the company that wants to adopt the standard, prepararing 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. [52]
4. The degree of effective implementation of the standard (i.e., internalization of the standard in the processes of the organization). [53] 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.

ISO 9001 certification has a three-year validity period. At the end of this period, every certified organization must renew its certificate. Unfortunately, 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.[64] 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.[65][66] 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.[67]
• 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.[65][67][68]
• 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.[64]
• Some of the customers may no longer demand certification.[69]
• Some companies may have considered their ISO 9001 certification as a first step into quality management [65] 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).[70]
• Financial distress.[68]
• Expected performance after decertification.[70][71]
• Improper ISO 9001 implementation.[72]
• and other reasons.[70]

• ISO 10006—Quality management—Guidelines to quality management in projects
• ISO 10012—Measurement management systems — Requirements for measurement processes and measuring equipment
• ISO 10014—Quality management—Managing an organization for quality results — Guidance for realizing financial and economic benefits
• ISO 13485—Medical devices—Quality management systems—Requirements for regulatory purposes
• ISO 14001—Environmental management standards
• ISO 19011—Guidelines for quality management systems auditing and environmental management systems auditing
• IATF 16949—Quality management system requirements for automotive-related products suppliers
• ISO/IEC 27001—Information security management
• ISO 37001—Anti-bribery management systems
• ISO 39001—Road traffic safety management
• ISO 50001—Energy Audit
• AS 9100—aerospace industry implementation of ISO 9000/1
• Annex SL
• Conformity assessment—Containing ISO published standards
• International Accreditation Forum
• International Organization for Standardization
• ISO/TC 176
• List of ISO standards
• Management system
• PDCA
• Quality management
• Quality management system
• Standardization
• Test management
• Verification and Validation

• 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 Family of Standards