1. Iso 9001 Standards List
2. Iso Standard List
3. Iso Standards Explained
4. New Iso Standard Changes

Buy AS/NZS ISO Risk management - Principles and guidelines from SAI Global. It provides a common approach in support of standards dealing with specific. The ISO 9000 family of quality management systems (QMS) standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of quality management systems, including the seven quality management principles upon which the family of.

The International Organization for Standardization (ISO/ˈaɪsoʊ/) is an international standard-setting body composed of representatives from various national standards organizations.

Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial and commercial standards. It is headquartered in Geneva, Switzerland,^[3] and works in 164 countries.^[1]

It was one of the first organizations granted general consultative status with the United Nations Economic and Social Council.

• 5Structure
  • 5.1IEC joint committees
• 8International Standards and other publications

Overview[edit]

The International Organization for Standardization is an independent, non-governmental organization, the members of which are the standards organizations of the 164^[1] member countries. It is the world's largest developer of voluntary international standards and facilitates world trade by providing common standards between nations. Over twenty thousand standards have been set covering everything from manufactured products and technology to food safety, agriculture and healthcare.^[3]

Use of the standards aids in the creation of products and services that are safe, reliable and of good quality. The standards help businesses increase productivity while minimizing errors and waste. By enabling products from different markets to be directly compared, they facilitate companies in entering new markets and assist in the development of global trade on a fair basis. The standards also serve to safeguard consumers and the end-users of products and services, ensuring that certified products conform to the minimum standards set internationally.^[3]

Language usage[edit]

The three official languages of the ISO are English (with Oxford spelling), French, and Russian.^[2]

Name and abbreviations[edit]

The name of the organization in French is Organisation internationale de normalisation, and in Russian, Международная организация по стандартизации (Mezhdunarodnaya organizatsiya po standartizatsii). ISO is not an acronym. The organization adopted ISO as its abbreviated name in reference to the Greek word isos (ίσος, meaning 'equal'),^[4] as its name in the three official languages would have different acronyms. During the founding meetings of the new organization, the Greek word explanation was not invoked, so this meaning may have been made public later.^[5]

ISO gives this explanation of the name: 'Because 'International Organization for Standardization' would have different acronyms in different languages (IOS in English, OIN in French), our founders decided to give it the short form ISO. ISO is derived from the Greek isos, meaning equal. Whatever the country, whatever the language, the short form of our name is always ISO.'^[6]

Both the name ISO and the ISO logo are registered trademarks, and their use is restricted.^[7]

History[edit]

The organization today known as ISO began in 1928^[dubious] as the International Federation of the National Standardizing Associations (ISA). It was suspended in 1942^[8] during World War II, but after the war ISA was approached by the recently formed United Nations Standards Coordinating Committee (UNSCC) with a proposal to form a new global standards body. In October 1946, ISA and UNSCC delegates from 25 countries met in London and agreed to join forces to create the new International Organization for Standardization; the new organization officially began operations in February 1947.^[9]

Structure[edit]

ISO is a voluntary organization whose members are recognized authorities on standards, each one representing one country. Members meet annually at a General Assembly to discuss ISO's strategic objectives. The organization is coordinated by a Central Secretariat based in Geneva.^[10]

A Council with a rotating membership of 20 member bodies provides guidance and governance, including setting the Central Secretariat's annual budget.^[10][11]

The Technical Management Board is responsible for over 250 technical committees, who develop the ISO standards.^{[10][12][13][14]}

IEC joint committees[edit]

ISO has formed two joint committees with the International Electrotechnical Commission (IEC) to develop standards and terminology in the areas of electrical and electronic related technologies.

ISO/IEC JTC 1[edit]

ISO/IEC Joint Technical Committee 1 (JTC 1) was created in 1987 to '[d]evelop, maintain, promote and facilitate IT standards',^[15] where IT refers to information technology.

ISO/IEC JTC 2[edit]

ISO/IEC Joint Technical Committee 2 (JTC 2) was created in 2009 for the purpose of '[s]tandardization in the field of energy efficiency and renewable energy sources'.^[16]

Membership[edit]

ISO has 163 national members.^[1]

ISO has three membership categories:^[1]

• Member bodies are national bodies considered the most representative standards body in each country. These are the only members of ISO that have voting rights.
• Correspondent members are countries that do not have their own standards organization. These members are informed about ISO's work, but do not participate in standards promulgation.
• Subscriber members are countries with small economies. They pay reduced membership fees, but can follow the development of standards.

Participating members are called 'P' members, as opposed to observing members, who are called 'O' members.

Financing[edit]

ISO is funded by a combination of:^[17]

• Organizations that manage the specific projects or loan experts to participate in the technical work.
• Subscriptions from member bodies. These subscriptions are in proportion to each country's gross national product and trade figures.
• Sale of standards.

International Standards and other publications[edit]

ISO's main products are international standards. ISO also publishes technical reports, technical specifications, publicly available specifications, technical corrigenda, and guides.^[18][19]

International standards

These are designated using the format ISO[/IEC] [/ASTM] [IS] nnnnn[-p]:[yyyy] Title, where nnnnn is the number of the standard, p is an optional part number, yyyy is the year published, and Title describes the subject. IEC for International Electrotechnical Commission is included if the standard results from the work of ISO/IEC JTC1 (the ISO/IEC Joint Technical Committee). ASTM (American Society for Testing and Materials) is used for standards developed in cooperation with ASTM International. yyyy and IS are not used for an incomplete or unpublished standard and may under some circumstances be left off the title of a published work.

Iso 9001 Standards List

Technical reports

These are issued when a technical committee or subcommittee has collected data of a different kind from that normally published as an International Standard,^[18] such as references and explanations. The naming conventions for these are the same as for standards, except TR prepended instead of IS in the report's name.

For example:

• ISO/IEC TR 17799:2000 Code of Practice for Information Security Management
• ISO/TR 19033:2000 Technical product documentation — Metadata for construction documentation

Technical and publicly available specifications

Technical specifications may be produced when 'the subject in question is still under development or where for any other reason there is the future but not immediate possibility of an agreement to publish an International Standard'. A publicly available specification is usually 'an intermediate specification, published prior to the development of a full International Standard, or, in IEC may be a 'dual logo' publication published in collaboration with an external organization'.^[18] By convention, both types of specification are named in a manner similar to the organization's technical reports.

For example:

• ISO/TS 16952-1:2006 Technical product documentation — Reference designation system — Part 1: General application rules
• ISO/PAS 11154:2006 Road vehicles — Roof load carriers

Technical corrigenda

ISO also sometimes issues 'technical corrigenda' (where 'corrigenda' is the plural of corrigendum). These are amendments made to existing standards due to minor technical flaws, usability improvements, or limited-applicability extensions. They are generally issued with the expectation that the affected standard will be updated or withdrawn at its next scheduled review.^[18]

ISO guides

These are meta-standards covering 'matters related to international standardization'.^[18] They are named using the format 'ISO[/IEC] Guide N:yyyy: Title'.

For example:

• ISO/IEC Guide 2:2004 Standardization and related activities — General vocabulary
• ISO/IEC Guide 65:1996 General requirements for bodies operating product certification

Document copyright[edit]

ISO documents are copyrighted and ISO charges for most copies. It does not, however, charge for most draft copies of documents in electronic format. Although they are useful, care must be taken using these drafts as there is the possibility of substantial change before they become finalized as standards. Some standards by ISO and its official U.S. representative (and, via the U.S. National Committee, the International Electrotechnical Commission) are made freely available.^[20][21]

Key Features. Through the use of high-quality illustrations, relevant clinical cases, and concise, focused text, it's a perfectly accessible introduction to the workings of the human immune system, with an emphasis on clinical relevance. Their experience as teachers, course directors, and lecturers helps them to distill the core information required to understand this complex field. In this updated edition of Basic Immunology, the authors continue to deliver a clear, modern introduction to immunology, making this the obvious choice for today's busy students.

Standardization process[edit]

A standard published by ISO/IEC is the last stage of a long process that commonly starts with the proposal of new work within a committee. Here are some abbreviations used for marking a standard with its status:^{[22][23][24][25][26][27][28]}

• PWI – Preliminary Work Item
• NP or NWIP – New Proposal / New Work Item Proposal (e.g., ISO/IEC NP 23007)
• AWI – Approved new Work Item (e.g., ISO/IEC AWI 15444-14)
• WD – Working Draft (e.g., ISO/IEC WD 27032)
• CD – Committee Draft (e.g., ISO/IEC CD 23000-5)
• FCD – Final Committee Draft (e.g., ISO/IEC FCD 23000-12)
• DIS – Draft International Standard (e.g., ISO/IEC DIS 14297)
• FDIS – Final Draft International Standard (e.g., ISO/IEC FDIS 27003)
• PRF – Proof of a new International Standard (e.g., ISO/IEC PRF 18018)
• IS – International Standard (e.g., ISO/IEC 13818-1:2007)

Abbreviations used for amendments:^{[22][23][24][25][26][27][28][29]}

• NP Amd – New Proposal Amendment (e.g., ISO/IEC 15444-2:2004/NP Amd 3)
• AWI Amd – Approved new Work Item Amendment (e.g., ISO/IEC 14492:2001/AWI Amd 4)
• WD Amd – Working Draft Amendment (e.g., ISO 11092:1993/WD Amd 1)
• CD Amd / PDAmd – Committee Draft Amendment / Proposed Draft Amendment (e.g., ISO/IEC 13818-1:2007/CD Amd 6)
• FPDAmd / DAM (DAmd) – Final Proposed Draft Amendment / Draft Amendment (e.g., ISO/IEC 14496-14:2003/FPDAmd 1)
• FDAM (FDAmd) – Final Draft Amendment (e.g., ISO/IEC 13818-1:2007/FDAmd 4)
• PRF Amd – (e.g., ISO 12639:2004/PRF Amd 1)
• Amd – Amendment (e.g., ISO/IEC 13818-1:2007/Amd 1:2007)

Other abbreviations:^{[26][27][29][30]}

• TR – Technical Report (e.g., ISO/IEC TR 19791:2006)
• DTR – Draft Technical Report (e.g., ISO/IEC DTR 19791)
• TS – Technical Specification (e.g., ISO/TS 16949:2009)
• DTS – Draft Technical Specification (e.g., ISO/DTS 11602-1)
• PAS – Publicly Available Specification
• TTA – Technology Trends Assessment (e.g., ISO/TTA 1:1994)
• IWA – International Workshop Agreement (e.g., IWA 1:2005)
• Cor – Technical Corrigendum (e.g., ISO/IEC 13818-1:2007/Cor 1:2008)
• Guide – a guidance to technical committees for the preparation of standards

International Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a process with six steps:^[24][31]

• Stage 1: Proposal stage
• Stage 2: Preparatory stage
• Stage 3: Committee stage
• Stage 4: Enquiry stage
• Stage 5: Approval stage
• Stage 6: Publication stage

The TC/SC may set up working groups (WG) of experts for the preparation of a working drafts. Subcommittees may have several working groups, which can have several Sub Groups (SG).^[32]

It is possible to omit certain stages, if there is a document with a certain degree of maturity at the start of a standardization project, for example a standard developed by another organization. ISO/IEC directives allow also the so-called 'Fast-track procedure'. In this procedure a document is submitted directly for approval as a draft International Standard (DIS) to the ISO member bodies or as a final draft International Standard (FDIS) if the document was developed by an international standardizing body recognized by the ISO Council.^[24]

The first step—a proposal of work (New Proposal) is approved at the relevant subcommittee or technical committee (e.g., SC29 and JTC1 respectively in the case of Moving Picture Experts Group – ISO/IEC JTC1/SC29/WG11). A working group (WG) of experts is set up by the TC/SC for the preparation of a working draft. When the scope of a new work is sufficiently clarified, some of the working groups (e.g., MPEG) usually make open request for proposals—known as a 'call for proposals'. The first document that is produced for example for audio and video coding standards is called a verification model (VM) (previously also called a 'simulation and test model'). When a sufficient confidence in the stability of the standard under development is reached, a working draft (WD) is produced. This is in the form of a standard but is kept internal to working group for revision. When a working draft is sufficiently solid and the working group is satisfied that it has developed the best technical solution to the problem being addressed, it becomes committee draft (CD). If it is required, it is then sent to the P-members of the TC/SC (national bodies) for ballot.

The CD becomes final committee draft (FCD) if the number of positive votes is above the quorum. Successive committee drafts may be considered until consensus is reached on the technical content. When it is reached, the text is finalized for submission as a draft International Standard (DIS). The text is then submitted to national bodies for voting and comment within a period of five months. It is approved for submission as a final draft International Standard (FDIS) if a two-thirds majority of the P-members of the TC/SC are in favour and not more than one-quarter of the total number of votes cast are negative. ISO will then hold a ballot with National Bodies where no technical changes are allowed (yes/no ballot), within a period of two months. It is approved as an International Standard (IS) if a two-thirds majority of the P-members of the TC/SC is in favour and not more than one-quarter of the total number of votes cast are negative. After approval, only minor editorial changes are introduced into the final text. The final text is sent to the ISO Central Secretariat, which publishes it as the International Standard.^[22][24]

Products named after ISO[edit]

The fact that many of the ISO-created standards are ubiquitous has led, on occasion, to common use of 'ISO' to describe the actual product that conforms to a standard. Some examples of this are:

• Many CD images end in the file extension 'ISO' to signify that they are using the ISO 9660 standard file system as opposed to another file system—hence CD images are commonly referred to as 'ISOs'. Virtually all computers with CD-ROM drives that can read CDs use this standard. Some DVD-ROMs also use ISO 9660 file systems.
• Photographic film's sensitivity to light (its 'film speed') is described by ISO 6, ISO 2240 and ISO 5800. Hence, the film's speed is often referred to by its ISO number.
• As it was originally defined in ISO 518, the flash hot shoe found on cameras is often called the 'ISO shoe'.
• ISO 11783, which is marketed as ISOBUS.
• ISO 13216, which is marketed as ISOFIX.

Criticism[edit]

With the exception of a small number of isolated standards,^[20] ISO standards are normally not available free of charge, but for a purchase fee,^[33] which has been seen by some as too expensive for small open source projects.^[34]

The ISO/IEC JTC1 fast-track procedures ('Fast-track' as used by OOXML and 'PAS' as used by OpenDocument) have garnered criticism in relation to the standardization of Office Open XML (ISO/IEC 29500). Martin Bryan, outgoing Convenor of ISO/IEC JTC1/SC34 WG1, is quoted as saying:^[35]

I would recommend my successor that it is perhaps time to pass WG1’s outstanding standards over to OASIS, where they can get approval in less than a year and then do a PAS submission to ISO, which will get a lot more attention and be approved much faster than standards currently can be within WG1.

The disparity of rules for PAS, Fast-Track and ISO committee generated standards is fast making ISO a laughing stock in IT circles. The days of open standards development are fast disappearing. Instead we are getting 'standardization by corporation'.

The computer security entrepreneur and Ubuntu founder Mark Shuttleworth commented on the Standardization of Office Open XML process by saying: 'I think it de-values the confidence people have in the standards setting process', and alleged that ISO did not carry out its responsibility. He also noted that Microsoft had intensely lobbied many countries that traditionally had not participated in ISO and stacked technical committees with Microsoft employees, solution providers and resellers sympathetic to Office Open XML:^[36]

When you have a process built on trust and when that trust is abused, ISO should halt the process.. ISO is an engineering old boys club and these things are boring so you have to have a lot of passion … then suddenly you have an investment of a lot of money and lobbying and you get artificial results. The process is not set up to deal with intensive corporate lobbying and so you end up with something being a standard that is not clear.

See also[edit]

• American National Standards Institute (ANSI)
• BSI Group, also known as British Standards Institution
• CSA Group, also known as Canadian Standards Association
• Deutsches Institut für Normung (DIN) – National standards organisation of Germany, the German Institute for Standardization
• Ente Nazionale Italiano di Unificazione (UNI), Italian National Standardization Body
• European Committee for Standardization (CEN)
• Global Reporting Initiative for sustainability information and linking up with reporting on their 17#GlobalGoals indicators
• GOST, a set of technical standards maintained by the Euro-Asian Council for Standardization, Metrology, and Certification
• Interface 2010, the Interface Marketing Supplier Integration Institute
• International Electrotechnical Commission (IEC)
• International Telecommunication Union – Specialised agency of the United Nations
• Standardization – Implementation of technical standards based on the consensus of different parties
• Standards organization – Organization that develops standards

• ISO divisions
  • ISO/TC 37 'Terminology and other language and content resources', a fundamental ISO standardization committee

References[edit]

1. ^ ^abcde'ISO members'. International Organization for Standardization. Retrieved 26 January 2018.
2. ^ ^ab'How to use the ISO Catalogue'. ISO.org. Archived from the original on 4 October 2007.
3. ^ ^abc'About ISO'. ISO. Archived from the original on 4 October 2007.
4. ^'About ISO'. ISO. Archived from the original on 19 September 2012.
5. ^'Friendship among equals'(PDF). ISO. (page 20)
6. ^'About us'. www.iso.org. Retrieved 25 June 2018.
7. ^'ISO name and logo'. ISO. Archived from the original on 19 September 2012.
8. ^'A Brief History of ISO'. University of Pittsburgh.
9. ^Friendship among equals – Recollections from ISO's first fifty years(PDF), International Organization for Standardization, 1997, pp. 15–18, ISBN92-67-10260-5, archived(PDF) from the original on 26 October 2012
10. ^ ^abc'Structure and governance'. International Organization for Standardization. Archived from the original on 19 September 2012.
11. ^'Council'. International Organization for Standardization. Archived from the original on 3 November 2012.
12. ^'Technical committees'. International Organization for Standardization. Archived from the original on 19 September 2012.
13. ^'Who develops ISO standards?'. International Organization for Standardization. Archived from the original on 19 September 2012.
14. ^'Governance of technical work'. International Organization for Standardization. Archived from the original on 19 September 2012.
15. ^'ISO/IEC JTC 1'. International Organization for Standardization. Archived from the original on 15 December 2011.
16. ^'ISO/IEC JPC 2 Joint Project Committee – Energy efficiency and renewable energy sources – Common terminology'. International Organization for Standardization. Archived from the original on 6 October 2012.
17. ^'General information on ISO'. ISO. Archived from the original on 5 October 2007.
18. ^ ^abcdeThe ISO directives are published in two distinct parts:
    • 'ISO/IEC Directives, Part 1: Procedures for the technical work'(PDF). ISO/IEC. 2012. Archived from the original(PDF) on 13 June 2012. Retrieved 17 July 2012.
    • 'ISO/IEC Directives, Part 2: Rules for the structure and drafting of International Standards'(PDF). ISO/IEC. 2011. Archived from the original(PDF) on 16 October 2011. Retrieved 17 July 2012.
19. ^ISO. 'ISO/IEC Directives and ISO supplement'. Archived from the original on 16 May 2008.
20. ^ ^ab'Freely Available Standards'. ISO. 1 February 2011.
21. ^'Free ANSI Standards'. Archived from the original on 3 April 2007.
22. ^ ^abc'About MPEG'. chiariglione.org. Archived from the original on 21 February 2010.
23. ^ ^abcISO. 'International harmonized stage codes'. Archived from the original on 4 October 2007.
24. ^ ^abcdefISO. 'Stages of the development of International Standards'. Archived from the original on 12 August 2007.
25. ^ ^abc'The ISO27k FAQ – ISO/IEC acronyms and committees'. IsecT Ltd. Archived from the original on 24 November 2005.
26. ^ ^abcISO (2007). 'ISO/IEC Directives Supplement – Procedures specific to ISO'(PDF). Archived(PDF) from the original on 12 January 2012.
27. ^ ^abcISO (2007). 'List of abbreviations used throughout ISO Online'. Archived from the original on 12 August 2007.
28. ^ ^abc'US Tag Committee Handbook'(DOC). March 2008.
29. ^ ^abcISO/IEC JTC1 (2 November 2009), Letter Ballot on the JTC 1 Standing Document on Technical Specifications and Technical Reports(PDF)
30. ^ISO. 'ISO deliverables'. Archived from the original on 12 August 2007.
31. ^ ^abISO (2008), ISO/IEC Directives, Part 1 – Procedures for the technical work, Sixth edition, 2008(PDF), archived from the original(PDF) on 14 July 2010, retrieved 1 January 2010
32. ^ISO, IEC (5 November 2009). 'ISO/IEC JTC 1/SC 29, SC 29/WG 11 Structure (ISO/IEC JTC 1/SC 29/WG 11 – Coding of Moving Pictures and Audio)'. Archived from the original on 28 January 2001. Retrieved 7 November 2009.
33. ^'Shopping FAQs'. ISO. Archived from the original on 5 October 2007.
34. ^Jelliffe, Rick (1 August 2007). 'Where to get ISO Standards on the Internet free'. oreillynet.com. Archived from the original on 24 November 2007. The lack of free online availability has effectively made ISO standard irrelevant to the (home/hacker section of the) Open Source community.
35. ^'Report on WG1 activity for December 2007 Meeting of ISO/IEC JTC1/SC34/WG1 in Kyoto'. iso/jtc1 sc34. Archived from the original on 12 August 2007.
36. ^'Ubuntu's Shuttleworth blames ISO for OOXML's win'. ZDNet.com. 1 April 2008. Archived from the original on 4 April 2008.

Further reading[edit]

• Kuert, Willy (1997). 'Friendship Among Equals – Recollections from ISO's first fifty years'(PDF). ISO. Archived(PDF) from the original on 26 October 2012.
• Yates, JoAnne; Murphy, Craig N. (Fall 2006). 'Coordinating International Standards: The Formation of the ISO'(PDF). Archived(PDF) from the original on 22 September 2010.MIT Innovations and Entrepreneurship Seminar Series.

External links[edit]

• Official website
  • Publicly Available Standards, with free access to a small subset of the standards.
  • Online Browsing Platform (OBP), access to most up to date content in ISO standards, graphical symbols, codes or terms and definitions.

The ISO 9000 family of quality management systems (QMS) standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.^[1]ISO 9000 deals with the fundamentals of quality management systems,^[2] including the seven quality management principles upon which the family of standards is based.^[2][3][4] ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.^[5]

Third-party certification bodies provide independent confirmation that organisations meet the requirements of ISO 9001^[6]. Over one million organisations worldwide^[7] 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^[8][9] as being wasteful and not being useful for all organizations.^[10][11]

• 7Evolution of ISO 9000 standards
• 10Effectiveness

Background[edit]

ISO 9000 was first published in 1987 by ISO (International Organisation for Standardization).^[12] It was based on the BS 5750 series of standards from BSI that were proposed to ISO in 1979.^[13] 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 UK's Def Stan 05-21 and 05-24. Large organizations which supplied government procurement agencies often had to comply with a variety of quality assurance requirements for each contract awarded which led the defence industry to adopt mutual recognition of NATO AQAP, MIL-Q and Def Stan standards. Eventually, ISO 9000 was adopted as a suitable option, instead of forcing contractors to adopt multiple - and often similar - requirements.^[14]

Reasons for use[edit]

The global adoption of ISO 9001 may be attributable to a number of factors. In the early days, the ISO 9001 (9002 and 9003) requirements were intended to be used by procuring organizations^{[clarification needed]}, as the basis of contractual arrangements with their suppliers. This helped reduce the need for 'supplier development'^[vague] 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 product, business type (design responsibility, manufacture only, distribution, servicing etc.) and risk to the procurer. If a chosen supplier was weak on the controls of their measurement equipment (calibration), and hence QC/inspection results, that specific requirement would be invoked in the contract. The adoption of a single Quality Assurance requirement also lead 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 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, a number of studies have identified significant financial benefits for organizations certified to ISO 9001, with an ISO analysis of 42 studies showing that implementing the standard does enhance financial performance.^[15] Corbett et al. showed that certified organizations achieved superior return on assets^[16] compared to otherwise similar organizations without certification.^[17]

Heras et al. found similarly superior performance^[18] and demonstrated that this was statistically significant and not a function of organization size.^[19] Naveha and Marcus claimed that implementing ISO 9001 led to superior operational performance in the U.S. automotive industry.^[20] Sharma identified similar improvements in operating performance and linked this to superior financial performance.^[21] Chow-Chua et al. showed better overall financial performance was achieved for companies in Denmark.^[22] 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.^[23]

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)^[18] may suggest it. Other writers, such as Heras et al. (2002),^[19] have suggested 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.^[24] Internal process improvements in organizations lead to externally observable improvements.^[25][26] 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.^[27]

Global adoption[edit]

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

ISO 9000 series Quality Management Principles[edit]

The ISO 9000 series are based on seven quality management principles (QMP)^[35]

The seven quality management principles are:

• QMP 1 – Customer focus
• QMP 2 – Leadership
• QMP 3 – Engagement of people
• QMP 4 – Process approach
• QMP 5 – Improvement
• QMP 6 – Evidence-based decision making
• QMP 7 – Relationship management

Principle 1 – Customer focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Principle 2 – Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.

Principle 3 – Engagement of people

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.

Principle 4 – Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Principle 5 – Improvement

Improvement of the organization's overall performance should be a permanent objective of the organization.

Principle 6 – Evidence-based decision making

Effective decisions are based on the analysis of data and information.

Principle 7 – Relationship management

An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

Contents of ISO 9001:2015[edit]

ISO 9001:2015 Quality management systems — Requirements is a document of approximately 30 pages which is 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.^[36][37]

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, however, 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 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.

Certification[edit]

The International Organization for Standardization (ISO) does not certify organisations itself. Numerous certification bodies exist, which audit organisations and, upon success, issue ISO 9001 compliance certificates. 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,^[38] while accreditation bodies operate under ISO/IEC 17011.^[39]

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 will issue a certificate. Where major nonconformities are identified, the organization will present 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 will issue a certificate. The certificate is limited by a certain scope (e.g., production of golf balls) and will display the addresses to which the certificate refers.

An ISO 9001 certificate is not a once-and-for-all award but must be renewed at regular intervals recommended by the certification body, usually once every three years. 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[edit]

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[edit]

ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' 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.^{[citation needed]}

1994 version[edit]

ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.^{[citation needed]}

Iso Standard List

2000 version[edit]

ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and ISO 9003. Design and development procedures were required only if a company does, in fact, engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing front and centre the concept of process management (the monitoring and optimisation of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.

ISO 9000 Requirements include:

• Approve documents before distribution;
• Provide correct version of documents at points of use;
• Use your records to prove that requirements have been met; and
• Develop a procedure to control your records.

2008 version[edit]

Iso Standards Explained

ISO 9001:2008 in essence re-narrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.

ISO 9001 is supplemented directly by two other standards of the family:

• ISO 9000:2005 'Quality management systems. Fundamentals and vocabulary'
• ISO 9004:2009 'Managing for the sustained success of an organization. A quality management approach'

Other standards, like ISO 19011 and the ISO 10000 series, may also be used for specific parts of the quality system.

2015 version[edit]

In 2012, ISO TC 176 - responsible for ISO 9001 development - celebrated 25 years of implementing ISO 9001,^[40] 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 'beginning of a new era in the development of quality management systems.'^[41] 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.^[42]

The new ISO 9001:2015 management system standard helps ensure that consumers get reliable, desired quality goods and services. This further increases benefits for a business.^[43]

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.^[44]

Some of the key changes include:

• High-Level Structure of 10 clauses is implemented. Now all new 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 a preventive tool and encourages continuous improvement
• Less prescriptive requirements for documentation: the organisation can now decide what documented information it needs and what format it should be in
• Alignment with other key management system standards through the use of a common structure and core text^[45]
• Inclusion of Knowledge Management principles
• Quality Manual & Management representative (MR) are no longer mandatory

Auditing[edit]

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 process of review and assessment to verify that the system is working as it is supposed to, to find out where it can improve, and to correct or prevent identified problems. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgements.

Industry-specific interpretations[edit]

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 9001:2000 systems.

Over time, various industry sectors have wanted to standardise 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 which doesn't include the ISO 9001:2015 requirements but still refer to them and works as 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 5.0. 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 R5.0 contains the full text of ISO 9001:2008.
• 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 devices 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 22000 Food Safety Management Systems.

Effectiveness[edit]

The debate on the effectiveness of ISO 9000 commonly centres 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. Organizations that implement an ISO system without this desire and commitment often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits.
2. 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.
3. 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 will 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 will a company be able to sustain improvements in the customer's experience.
4. 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[edit]

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.^[46] The quality principles in ISO 9000:2000 are also sound, according to Wade ^[47] and Barnes, who says that 'ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive'.^[48] 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.^[46] According to ISO^[49] 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[edit]

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.^[8] 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'.^[50] 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.^{[citation needed]}

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'.^[48] 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'.^[9]

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.^[46] According to John Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement.^[10] 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'.^[47] 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.^[10] Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality.^[48][51] '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', said ISO's Roger Frost.^[51] Certification by an independent auditor is often seen as the problem area, and according to Barnes, 'has become a vehicle to increase consulting services'.^[48]

Dalgleish argues that 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.'^[52] In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved.^[53]

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.^[54]

Pickrell argues^{[citation needed]} 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 which is 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.

See also[edit]

• Conformity assessment—Containing ISO published standards
• ISO 10006—Quality management—Guidelines to quality management in projects
• 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
• ISO/TS 16949—Quality management system requirements for automotive-related products suppliers
• ISO/IEC 27001—Information security management
• ISO 39001—Road traffic safety management
• ISO 50001—Energy Audit
• AS 9100—aerospace industry implementation of ISO 9000/1

References[edit]

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Further reading[edit]

• Bamford, Robert; Deibler, William (2003). ISO 9001: 2000 for Software and Systems Providers: An Engineering Approach (1st ed.). CRC-Press. ISBN0-8493-2063-1, ISBN978-0-8493-2063-7
• 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.
• Naveh, E. (1999). ISO 9000 survey'99: An analytical tool to assess the costs, benefits and savings of ISO 9000 registration. QSU Publishing Company.
• Bacivarov, Ioan (Coordinating Editor) (2015). Special issue 'ISO9001:2015'. Asigurarea Calitatii - Quality Assurance 21 (83), ISSN1224-5410

External links[edit]

• ISO/TC 176, SC 2 - ISO committee responsible for developing ISO 9000 standards

New Iso Standard Changes