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ISO 9000 is a family of ISO (the International Organization for Standardization) standards for quality management systems. ISO 9000 was developed from the British Standards Institution's BS 5750. The ISO 9000 standards are maintained by ISO and administered by accreditation and certification bodies. Although the standards originated in manufacturing, they are now employed across a wide range of other types of organizations. In fact, according to ISO in 2004, "service sectors now account by far for the highest number of ISO 9001:2000 certificates - about 31% of the total" - source: the ISO Survey 2004 Some countries re-label ISO 9000 as a national standard. (e.g. IR 9000 in Iran and TS-ISO-9000 in Turkey). ISO 9000 does not guarantee the quality of end products and services; rather, it certifies that consistent business processes are being applied. History Errors committed in manufacturing have been an impetus for creating quality standards. For example, in World War I, a high percentage of shells failed to explode. This was traced to different definitions of an inch by the two major UK armaments manufacturers, leading to calibration standards. During World War II, the United Kingdom had a serious problem with accidental detonations in weapons factories. In an attempt to solve the problem, the Ministry of Defence placed inspectors in the factories to oversee the production process. To supply to the Government, a company had to write up the procedure for making their product, have the procedure approved by the Ministry and ensure that their workers followed the procedure. None of the early commercial Quality Gurus, such as Walter Shewhart, W. Edwards Deming or Phillip Crosby advocated rigorous adherence to written Procedures as a method of achieving or improving quality. In 1959, the United States developed Quality Program Requirements, 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 United Kingdom Government led the first national campaign for quality and reliability with the slogan "Quality is everybody's business." In 1969, the UK and Canada developed quality assurance standards for suppliers. By this time, suppliers were being assessed by any number of their customers. In 1969, a UK committee report on the subject recommended that suppliers' methods should be assessed against a generic standard of quality assurance, to avoid duplication of effort. In 1971, the British Standards Institution (BSI) 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, though none of the assessing bodies at that time accepted any legal liability for the quality of their decisions. The collapse of a jetty at Dover, which had been assessed by LRQA, an assessing body, and the subsequent court case forced a rethink. Through the 1970s, BSI organized meetings with industry to set a common standard. The result was BS 5750 in 1979, which however much consulation there was, turned out to be an almost exact replica of the DEF-STAN 05-21/24 series of military quality assurance Standards, driven by a Rear Admiral Spikernell who took over as Director General of BSI after a spell in charge of military purchasing. 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. In 1982 the UK government produced a White Paper No. 8621 entitled "Standards, Quality and International Competitiveness". This introduced the concept of certification of a company's management system as a marketing tool. Obviously, an independent third party was needed to ensure fairness. The original idea in the white paper was that BSI would partner with trade associations to produce industry sector-specific variants of BS 5750, but since these variants were never allowed to exceed the basic requirements of BS 5750, and few trade bodies had the necessary resources, BSI became the first de facto assessors. The lack of technical expertise in the first assessors, and the inevitable fact that the first generation of assessors were trained by people with purely military quality assurance skills caused many problems. At the time, military procurement contracts were given on a cost-plus basis, so on-costs such as inspection, internal auditing and procedure writing became profit centers. Revisions The standard has evolved over several revisions. Contents Like all properly-written Standards (see BS 0:2005 A standard for standards.), ISO 9000 seeks to set criteria which achieve a goal and is not prescriptive as to methods. The requirements come in Sections 4 to 8. In each of these areas, ISO 9001:2000 seeks to set out key requirements, which if met will ensure consistency. In the standard, there are 6 documents that ISO specifies: In addition to these, ISO 9001:2000 requires a Quality Policy and Quality Manual (which may or may not include the above documents). Certification ISO does not itself certify organizations. Many countries have formed accreditation bodies to authorize certification bodies, which audit organizations applying for ISO 9001 compliance certification. It is important to note that it is not possible to be certified to ISO 9000. Although commonly referred to as ISO 9000:2000 certification, the actual standard to which an organization's quality management can be certified is ISO 9001:2000. 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 world-wide. The applying organization 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 the management. If there are no major problems on this list, the certification body will issue an ISO 9001 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 three years. In contrast to the Capability Maturity Model there are no grades of competence within ISO 9001. However, there are various approaches which attempt to measure quality in a way that is not simply pass or fail, as is the case with ISO 9001. One such scheme is BSI Benchmark, which evaluates the progress of an organization's management system by measuring the degree of application of the eight management principles which underlie the ISO 9000 standards. Auditing 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's supposed to, find out where it can improve, and to correct or prevent problems identified. 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": How this led to preventive actions was not clear. The 2000 standard uses the process approach. While auditors perform similar functions, they are expected to go beyond mere auditing for rote "compliance" by focusing on risk, status and importance. This means they are expected to make more judgements on what is effective, rather than merely adhering to what is formally prescribed. The difference from the previous standard can be explained thus: Under the 1994 version, the question was broadly "Are you doing what the manual says you should be doing?", whereas under the 2000 version, the question is more "Will this process help you achieve your stated objectives? Is it a good process, or is there a way to do it better?". The ISO 19011 standard for auditing applies to ISO 9000. ISO 9000 document suite ISO 9000 is composed of the following sections: 2000. There are many different standards which are referenced in ISO 9001 family. A lot of them do not even carry "ISO 900x" numbers. For example, parts of the 10,000 range are also considered part of the 9000 family: ISO 10007:1995 discusses Configuration management, which for most organizations is just one element of a complete management system. A complete list of documents in the ISO 9000 family is maintained here 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 ISO 9001. However, even ISO (the International Organization for Standardization) itself is critical of the widespread emphasis on certification to ISO 9001 "The emphasis on certification tends to overshadow the fact that there is an entire family of ISO 9000 standards ... organizations stand to obtain the greatest value when the standards in the new core series are used in an integrated manner, both with each other and with the other standards making up the ISO 9000 family as a whole". Get the best of out of the ISO 9000 family. Industry-specific interpretations The ISO 9001 standard is generalized and abstract. 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 (US), professional soccer teams (Mexico) and city councils (UK)—have successfully implemented ISO 9001:2000 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. Criticisms of ISO 9000 Many companies have found the transition to conforming to ISO 9000 difficult. This, along with doubts about the fundamental value of the standard, has spawned many criticisms, including: There are few objective metrics showing any effectiveness for ISO 9001. 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. Quality programmes are notoriously difficult to quantify as Crosby warned in Quality is Free back in 1979, long before the first of these standards emerged. When an organization is measuring nothing, the only "quality costs" it knows are the basics of scrap and rework, and often even these are not being tracked effectively. Once a formal system is introduced, much more accurate data starts to emerge and initial costs of quality often appear to increase. Toyota abandoned the standard in 2000, moving back to their in-house Toyota Production System. One of the most concise and well-regarded statements of how to achieve quality is Deming's 14 points. A comparison of the principles of even ISO 9001:2000 against the 14 points still shows a considerable mismatch. Quality consultants A rarely examined aspect of ISO 9000 is the consultant. In the UK the government initiated a program called the "Quality Initiative" with a TV advert showing paperwork being blown out of the window by the consultant. There were very few qualification requirements for the early consultants and the Quality Initiative rapidly became a paperwork-producing exercise using the recently-invented word processor. Success in the Quality Initiative was based on completion of the project rather than certification, quality improvement or bottom-line improvements for the customer. For quality consultants to be effective, they need to have a good understanding both of ISO 9001 and the sector or company they are seeking to apply it to. Effective ISO 9001 implementation is supposed to lead to improved productivity, efficiency, consistency and client service. If ISO 9001 is not delivering this, then it has not been effectively implemented, and the fault may very well lie with the consultant. Dr. Jack E. Small, in his book ISO 9000 for Executives said, "There is no substitute for practical experience! One of the most important ingredients an ISO 9000 consultant can bring is that they have actually been a part of an ISO 9000 registration (rather than merely talking about it). Experience will often allow clients to avoid costly mistakes and most certainly will reduce the learning curve—which will always prove to be a good investment.". The Institute of Quality Assurance runs a Management Consultants Register which provides an organisation seeking assistance with the names of three consultants with the required expertise. Related standards See also Critical links | |||||||
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