Information AboutIso 9000 |
| CATEGORIES ABOUT ISO 9000 | |
| iso standards | |
| #09000 | |
| production and manufacturing | |
| quality control | |
| quality | |
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ISO 9000 is a family of Standards for Quality Management System s. ISO 9000 is maintained by ISO, the International Organization For Standardization and is administered by accreditation and certification bodies. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) would include:
A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered." Certification to an ISO 9000 standard does not guarantee the compliance (and therefore the quality) of end products and services; rather, it certifies that consistent business processes are being applied. Although the standards originated in Manufacturing , they are now employed across a wide range of other types of organizations. A "product", in ISO vocabulary, can mean a physical object, or services, or Software . 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 ISO 9000 FAMILY ISO 9000 includes the following standards: random fing
There are many more standards in the ISO 9001 family (see of ISO 9000 standards" from ISO), many of them not even carrying "ISO 900x" numbers. For example, some standards in the 10,000 range are 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. ISO notes: "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". Note that the previous members of the ISO 9000 family, 9001, 9002 and 9003, have all been integrated into 9001. In most cases, an organization claiming to be "ISO 9000 registered" is referring to ISO 9001. CONTENTS OF ISO 9001 ''ISO 9001:2000 Quality management systems — Requirements'' is a document of approximately 30 pages which is available from the national standards organization in each country. Outline contents are as follows:
The standard specifies six compulsory documents:
In addition to these, ISO 9001:2000 requires a Quality Policy and Quality Manual (which may or may not include the above documents). Summary of ISO 9001:2000 in informal language
HISTORY OF ISO 9000 Pre ISO 9000 During WWII, there were quality problems in many British high-tech industries such as munitions, where bombs were going off in factories. The adopted solution was to require factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The name of the standard was BS 5750, and it was known as a management standard because it did not specify what to manufacture, but how to manage the manufacturing process. According to Seddon , "In 1987, the British Government persuaded the International Organisation for Standardization to adopt BS 5750 as an international standard. BS 5750 became ISO 9000." 1987 version 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 9000:1987'' was also influenced by existing U.S. and other Defense Standard s ("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. 1994 version ''ISO 9000:1994'' emphasized Quality Assurance via preventative 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. 2000 version ''ISO 9001:2000'' combines the three standards 9001, 9002, and 9003 into one, now called 9001. Design and development procedures are 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 the concept of process management front and centre. ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product.) The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is 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. Future Version : 2008 TC 176, the ISO 9001 technical committee , has started its review on the next version of ISO 9001, which will in all likelihood be termed the ISO 9001:2008 standard, assuming its planned release date of 2008 is met. Early reports are that the standard will not be substantially changed from its 2000 version. As with the release of previous versions, organizations registered to ISO 9001 will be given a substantial period to transition to the new version of the standard, assuming changes are needed; organizations registered to 9001:1994 had until December of 2003 to undergo upgrade audits. (CB) are accepted world-wide. The applying organization is assessed based on an extensive sample of its sites, functions, products, services and processes; a list of problems ("action requests" or "non-compliances") is 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. AUDITING Two types of ( External Audit ) and audits by internal staff trained for this process ( Internal Audit s). 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 judgments. 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 9001 besides other management systems like EMS ( ISO 14001), FSMS (ISO 22000) etc . 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.
DEBATE ON THE EFFECTIVENESS OF ISO 9000 The debate on the effectiveness of ISO 9000 commonly centres on the following questions: #Are the quality principles in ISO 9000:2000 of value? (Note that the version date is important: in the 2000 version ISO attempted to address many concerns and criticisms of ISO 9000:1994.) #Does it help to implement ISO 9000:2000? #Does it help to obtain ISO 9000:2000 certification? Advantages It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. "Probing the Limits: ISO 9001 Proves Ineffective" . Scott Dalgleish. ''Quality Magazine'' April 1, 2005. "Good Business Sense Is the Key to Confronting ISO 9000" Frank Barnes in ''Review of Business'', Spring 2000. The quality principles in ISO 9000:2000 are also sound, according to Wade, "Is ISO 9000 really a standard?" Jim Wade, ISO Management Systems – May-June 2002 and Barnes, who says "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Barnes also cites a survey by Lloyd's Register Quality Assurance that indicated ISO 9000 increased net profit, and another by Deloitte-Touche that reported that the costs of registration were recovered in three years. According to ''the Providence Business News'' "Reasons Why Companies Should Have ISO Certification", ''Providence Business News'', August 28, 2000., implementing ISO often gives the following advantages: #Create a more efficient, effective operation #Increase customer satisfaction and retention #Reduce audits #Enhance marketing #Improve employee motivation, awareness, and morale #Promote international trade However, a broad statistical study of 800 Spanish companies "ISO 9000 registration's impact on sales and profitability: A longitudinal analysis of performance before and after accreditation." Iñaki Heras, Gavin P.M. Dick, and Martí Casadesús. ''International Journal of Quality and Reliability Management'' Vol 19, No. 6, 2002. found that ISO registration in itself creates little improvement because companies interested in ISO have usually already made some type of commitment to quality and were performing just as well before registration. In today's service sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability. Problems A common criticism of ISO 9000 is the amount of money, time and paperwork required for registration. "So many standards to follow, so little payoff" . Stephanie Clifford. ''Inc Magazine,'' May 2005. 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." According to ISO 9000 promotes specification, control, and procedures rather than understanding and improvement. [http://money.guardian.co.uk/work/story/0,,613363,00.html "The 'quality' you can't feel" , . Chapter one of "The Case Against ISO 9000", 2nd ed., Oak Tree Press. November 2000. ISBN 1-86076-173-9 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." Paraphrased, Wade's argument is that total, blind reliance on the specifications of ISO 9000 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. Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality. "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. "ISO a GO-Go." Mark Henricks. ''Entrepreneur Magazine'' Dec 2001. Certification by an independent auditor is often seen as the problem area, and according to Barnes, "has become a vehicle to increase consulting services." In fact, ISO itself advises that ISO 9000 can be implemented without certification, simply for the quality benefits that can be achieved. ''The ISO Survey – 2005'' (abridged version, PDF, 3 MB), ISO, 2005 Summary A good overview for effective use of ISO 9000 is provided by Barnes: SEE ALSO
EXTERNAL LINKS
FURTHER READING Naveh. E., Marcus, A. (2004). "When does ISO 9000 Quality Assurance standard lead to performance improvement?", ''IEEE Transactions on Engineering Management'', 51(3), 352-363. REFERENCES |
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