The ISO 9000 reference article from the English Wikipedia on 24-Jul-2004
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ISO 9000

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ISO 9000 specifies requirements for a Quality Management System overseeing the production of a product or service. It is not a standard for ensuring a product or service is of quality; rather, it attests to the process of production, and how it will be managed and reviewed.

ISO 9000 was originally created by the British Standard Institute as BS 5750. The standard is now maintained by ISO (the International Organization for Standardization) and administered by accreditation and certification bodies.

Table of contents
1 History
2 Revisions
3 Certification
4 Auditing
5 ISO 9000 document suite
6 Industry-specific interpretations
7 Criticisms of ISO 9000
8 Related standards
9 External links

History

In World War II, Britain had a serious problem with bombs going off in munitions factories. In an attempt to solve the problem, the Ministry of Defence placed inspectors in munitions factories. To supply to the Government, a company had to write up the procedure for making their product, have the procedure inspected by the Ministry and ensure their workers followed these procedures.

This, and similar problems in the nuclear and power generation industries over the following decades, were symptoms of rapid technological advance in manufacturing. Advances in science were pushed into technology and thence into manufacturing too fast to be properly managed. Furthermore, managers were seen as too often basing decisions on paper reports rather than on understanding what was happening on the factory floor.

In 1959, the United States developed Quality Program Requirements, MIL-Q-9858a, a quality standard for military procurement, detailing what suppliers had to do to achieve conformance. By 1962, NASA had similarly developed Quality System Requirements for its suppliers. In 1968, NATO adopted the AQAP (Allied Quality Assurance Procedures) specifications for the procurement of NATO equipment.

The idea of quality assurance spread beyond the military. In 1966, the UK Government led the first national campaign for quality and reliability with the slogan "Quality is everybody's business." In 1969, the Central Electricity Generating Board (UK) and Ontario Hydro (Canada) developed quality assurance standards for suppliers.

By this time, suppliers were being assessed by any number of their customers. It was widely recognised that this was a very wasteful duplication of effort. In 1969, a UK committee report on the subject recommended that suppliers' methods should be assessed against a generic standard of quality assurance.

In 1971, the British Standard Institute published the first UK standard for quality assurance, BS 9000, which was developed for the electronics industry. In 1974, BSI published BS 5179, Guidelines for Quality Assurance.

In order to shift the burden of inspection from the customer, quality assurance was guaranteed by the supplier through third-party inspection.

Through the 1970s, BSI organised meetings with industry to set a common standard. The result was BS 5750 in 1979. Key industry bodies agreed to drop their own standards and use it instead. The purpose of BS 5750 was to provide a common contractual document, demonstrating that industrial production was controlled.

Revisions

The standard has evolved over several revisions.

Certification

ISO does not itself certify organisations. Its national members act as accreditation bodies to authorise certification bodies, which audit organisations applying for ISO 9000 compliance certification. Both the accreditation bodies and the certification bodies charge fees for their services.

The applying organisation is assessed based on an extensive sample of its sites, functions, products, services, and processes and a list of problems ("action requests" or "non-compliances") made known to management. If there are no major problems on this list, the certification body will issue an ISO 9000 certificate for each geographical site it has visited once it receives a satisfactory improvement plan from the management showing how any problems will be resolved.

An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body — usually around 3 years.

Auditing

Two types of auditing are required by the standard: auditing by the external certification body and audits by internal staff trained for this process. The aim is a continual process of assessment, leading to corrective and preventive actions, is maintained throughout the scope of the certified organisation. 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.

Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing":

Under the 2000 standard, the auditor performs a similar function but is required to make more value judgements on what is effective, rather than adhering safely to the formalism of what is prescribed.

ISO 9000 document suite

ISO 9000 is composed of the following sections:

There are over 20 different members of the ISO 9000 family, most of them not explicitly referred to as "ISO 900x". For example, parts of the 10,000 range are also considered part of the 9000 family: ISO 10007:1995 discusses how to maintain a large system while changing individual components.

To the casual reader, it is usually sufficient to understand that when an organization claims to be "ISO 9000 compliant", it means they conform to one of the specifications of ISO 9000:2000. (Note that certification to ISO 9000:1994 is not valid after 14 December 2003.)

The ISO website and documentation give more detail on what each specification entails. Many have seemingly subtle variations.

Industry-specific interpretations

As the paragraphs and clauses of the ISO 9000 standard have always been very generalised and abstract, they have to be carefully interpreted to make sense within a particular organisation. Developing software is not like making cheese or offering counseling services, yet the ISO 9000 guidelines can potentially be applied to each of these industries.

Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace.

Criticisms of ISO 9000

Criticisms of ISO 9000 generally concern inappropriate misapplication or extension of its use in companies, and the effect this can have on organizational culture.

These problems were particularly pronounced with the ISO 9000:1994 revision. The 2000 revision was in part an attempt to address such criticisms.

There are few or no objective metrics showing any effectiveness for ISO 9000. In 1997, two people took the BSI to the Advertising Standards Authority for claiming in an advertisement that ISO 9001 "improves productivity ... almost always gives an immediate result in terms of productivity and efficiency, and that means cost reductions ... pays for itself ... Staff morale is better because they understand what is expected of them and each other," whilst being unable to produce any objective metrics to substantiate these assertions. The complaint was upheld.

In Japan, amidst complaints of ISO 9000 undermining world-class thinking, Toyota abandoned the standard in 2000, moving back to their in-house Toyota Production System.

Related standards

ISO 14000 exists to ensure that the manufacture of a product has the lowest possible environmental ramifications. Like ISO 9000, it pertains to how a product is produced, rather than how it is designed.

External links

Critical links