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ISO 9000

 

A family of standards and guidelines for quality in the manufacturing and service industries from the International Organization for Standardization (ISO). ISO 9000 defines the criteria for what should be measured. ISO 9001 covers design and development. ISO 9002 covers production, installation and service, and ISO 9003 covers final testing and inspection. ISO 9000 certification does not guarantee product quality. It ensures that the processes that develop the product are documented and performed in a quality manner.

First Popular in Europe

Initially popular in Europe, ISO 9000 certification began to increase in the U.S. in the early 1990s. Certification requires exacting documentation and demonstrations in practice over time. The process, which can take up to a year, involves two major players in addition to the company being certified. A consultant provides (and may help implement) a plan for documenting the company's ISO system. Once documented, a registrar interviews the company's management and line staff to make sure that the new system, as documented, has been effectively implemented. Only a few dozen companies worldwide are authorized to conduct such audits for the issuance of ISO 9000 certificates. See ISO and ISO 9000-3.

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ISO 9000 is a set of international standards of quality management that have become increasingly popular for large and small companies alike. "ISO is grounded on the 'conformance to specification' definition of quality, " wrote Francis Buttle in the International Journal of Quality and Reliability Management. "The standards specify how management operations shall be conducted. ISO 9000's purpose is to ensure that suppliers design, create, and deliver products and services which meet predetermined standards; in other words, its goal is to prevent non-conformity." Used by both manufacturing and service firms, ISO 9000 had been adopted by more than 100 nations as their national quality management/quality assurance standard by the end of 1997.

This quality standard was first introduced in 1987 by the International Organization for Standards (ISO) in hopes of establishing an international definition of the essential characteristics and language of a quality system for all businesses, irrespective of industry or geographic location. Initially, it was used almost exclusively by large companies, but by the mid-1990s, increasing numbers of small-and mid-sized companies had embraced ISO 9000 as well. In fact, small and moderate-sized companies account for much of the growth in ISO 9000 registration over the past several years. The total number of ISO 9000 registrations in the United States increased from a little more than 2, 200 in 1993 to more than 17, 000 in 1998; of those 17, 000 registrations, nearly 60 percent were held by companies with annual sales of $100 million or less.

The increased involvement of small and midsized firms in seeking ISO 9000 registration is generally attributed to several factors. Many small businesses have decided to seek ISO 9000 certification because of their corporate customers, who began to insist on it as a method of ensuring that their suppliers were paying adequate attention to quality. Other small business owners, meanwhile, have pursued ISO 9000 certification in order to increase their chances of securing new business or simply as a means of improving the quality of their processes. "The pressure for companies to become ISO 9000-certified is absolutely increasing and will continue to increase, " predicted one management consultant in an interview with Nation's Business. "The question many smaller companies have to ask is when, not if, they [will] get ISO 9000-registered."

Elements of Iso 9000 Quality Management Systems

The standards of ISO 9000 detail 20 requirements for an organization's quality management system in the following areas:

  • Management Responsibility
  • Quality System
  • Order Entry
  • Design Control
  • Document and Data Control
  • Purchasing
  • Control of Customer Supplied Products
  • Product Identification and Tractability
  • Process Control
  • Inspection and Testing Control of Inspection, Measuring, and Test Equipment
  • Inspection and Test Status
  • Control of Nonconforming Products
  • Corrective and Preventive Action
  • Handling, Storage, Packaging, and Delivery
  • Control of Quality Records
  • Internal Quality Audits
  • Training
  • Servicing
  • Statistical Techniques

Models of Iso 9000

The ISO 9000 quality standards are broken down into three model sets—ISO 9001, ISO 9002, and ISO 9003. Each of these models, noted Industrial Management contributors Stanislav Karapetrovic, Divakar Rajamani, and Walter Willborn, "stipulate a number of requirements on which an organization's quality system can be assessed by an external party (registrar)" in accordance with the ISO's quality system audits standard. "A quality system, " they added, "involves organizational structure, processes, and documented procedures constituted towards achieving quality objectives."

Each of the three sets concentrates on a different quality area. ISO 9001 is the most wide-ranging, for it specifies the various operating requirements in such areas as product design and development, production, installation, and servicing. ISO 9002 is concerned with quality assurance at the production and installation stages. ISO 9003 covers testing and inspections. As Karapetrovic, Rajamani, and Willborn noted, "if the minimum requirements are met [for the above operating areas], a registrar accredited by a national accreditation institution issues a certificate of compliance and the organization's quality system becomes ISO 9001, 9002, or 9003 registered."

It is worth noting that certification is handed out for individual quality systems, not companies; this means that one company may hold more than one ISO 9000 registration. Moreover, Harvey R. Meyer pointed out in Nation's Business that "the standards do not certify the quality of a product or service. Rather, they attest that a company has fully documented its quality-control processes and consistently adheres to them. If that's done, quality products and services generally follow."

In addition to ISO 9000, two related quality standards emerged in American industries in the late 1990s. ISO 14000, also known as the Environmental Management Systems Standards, is intended to combine environmental management systems with the ISO 9000 quality system. The second system, QS9000 is an adaptation of ISO 9000 to meet the specific needs of the "big three" American automobile manufacturers—Ford, General Motors, and Daimler Chrysler. Both systems were expected to have a substantial impact on U.S. companies.

Advantages of Iso 9000

The advantages associated with ISO 9000 certification are numerous, as both business analysts and business owners will attest. These benefits, which can impact nearly all corners of a company, range from increased stature to bottom-line operational savings. They include:

  • Increased marketability—Nearly all observers agree that ISO 9000 registration provides businesses with markedly heightened credibility with current and prospective clients alike. Basically, it proves that the company is dedicated to providing quality to its customers, which is no small advantage whether the company is negotiating with a long-time customer or endeavoring to pry a potentially lucrative customer away from a competitor. This benefit manifests itself not only in increased customer retention, but also in increased customer acquisition and heightened ability to enter into new markets; indeed, ISO 9000 registration has been cited as being of particular value for small and mid-sized businesses hoping to establish a presence in international markets.
  • Reduced operational expenses—Sometimes lost in the many discussions of ISO 9000's public relations cache is the fact that the rigorous registration process often exposes significant shortcomings in various operational areas. When these problems are brought to light, the company can take the appropriate steps to improve its processes. These improved efficiencies can help companies garner savings in both time and money. "The cost of scrap, rework, returns, and the employee time spent analyzing and troubleshooting various products are all considerably reduced by initiating the discipline of ISO 9000, " confirmed Richard B. Wright in Industrial Distribution.
  • Better management control—The ISO 9000 registration process requires so much documentation and self-assessment that many businesses that undergo its rigors cite increased understanding of the company's overall direction and processes as a significant benefit.
  • Increased customer satisfaction—Since the ISO 9000 certification process almost inevitably uncovers areas in which final product quality can be improved, such efforts often bring about higher levels of customer satisfaction. In addition, by seeking and securing ISO 9000 certification, companies can provide their clients with the opportunity to tout their suppliers' dedication to quality in their own business dealings.
  • Improved internal communication—The ISO 9000 certification process's emphasis on self-analysis and operations management issues encourages various internal areas or departments of companies to interact with one another in hopes of gaining a more complete understanding of the needs and desires of their internal customers.
  • Improved customer service—The process of securing ISO 9000 registration often serves to refocus company priorities on pleasing their customers in all respects, including customer service areas. It also helps heighten awareness of quality issues among employees.
  • Reduction of product-liability risks—Many business experts contend that companies that achieve ISO 9000 certification are less likely to be hit with product liability lawsuits, etc., because of the quality of their processes.
  • Attractiveness to investors—Business consultants and small business owners alike agree that ISO-9000 certification can be a potent tool in securing funding from venture capital firms.

Disadvantages of Iso 9000

Despite the many advantages associated with ISO 9000, however, business owners and consultants caution companies to research the rigorous certification process before committing resources to it. Following is a list of potential hurdles for entrepreneurs to study before committing to an initiative to gain ISO 9000 certification:

  • Owners and managers do not have an adequate understanding of the ISO 9000 certification process or of the quality standards themselves—Some business owners have been known to direct their company's resources toward ISO 9000 registration, only to find that their incomplete understanding of the process and its requirements results in wasted time and effort.
  • Funding for establishing the quality system is inadequate—Critics of ISO 9000 contend that achieving certification can be a very costly process, especially for smaller firms. Indeed, according to a 1996 Quality Systems Update survey, the average cost of ISO certification for small firms (those registering less than $11 million in annual sales) was $71, 000.
  • Heavy emphasis on documentation—The ISO 9000 certification process relies heavily on documentation of internal operating procedures in many areas, and as Meyer stated, "many say ISO's exacting documentation requirements gobble up time. Indeed, there are horror stories about companies losing substantial business because a documentation obsession redirected their priorities." According to Nation's Business, small business owners need to find an appropriate balance between ISO documentation requirements, which are admittedly "one is ISO 9000's hallmarks, " and attending to the fundamental business of running a company: "Strike a balance among obsessively writing down every employee's task, offering training for the work, and letting common sense dictate how a task is to be performed."
  • Length of the process—Business executives and owners familiar with the ISO 9000 registration process warn that it is a process that takes many months to complete. The 1996 Quality Systems Update survey indicated that it took businesses an average of 15 months to move from the early stages of the process to passage of the final audit, and that processes of 18-20 months or even longer were not that uncommon.

Selecting a Leader for the Iso 9000 Registration Process

ISO 9000 experts and businesses that have gone through the rigorous process of certification agree that businesses that appoint someone to guide the process are much more likely to be able to undergo the process in a healthy, productive manner than are firms that have murky reporting relationships. Hiring an outside consultant is one option for businesses. "An ISO 9000 advisor could give you a rough sketch of the registration process and help you get started, " stated Nation's Business. "Or the consultant could counsel you through the entire process, writing the company's quality policy statement and even specific operating procedures." In addition, firms should hire an ISO-9000 registrar with a background in their industry, legitimacy with international customers, and knowledge of small business issues.

Some small firms choose to appoint an employee as their ISO 9000 representative rather than hire an outside consultant. Many companies have done this successfully, but small business owners should take great care in making this decision. "The ISO 9000 representative [should be] a person who encompasses a genuine and passionate commitment to quality and success, knowledge of processes and systems within the company, and power to influence employees at all levels, " wrote Karapetrovic, Rajamani, and Willborn. "He should be familiar with the standards. If this is not the case, there are ample training opportunities available to acquire sufficient expertise."

For more information on ISO 9000 registration, small business owners can contact several different organizations, including the American Society for Quality and American National Standards Institute.

Further Reading:

Buttle, Francis. "ISO 9000: Marketing Motivations and Benefits." International Journal of Quality and Reliability Management. July 1997.

Johnson, P.L. ISO 9000: Meeting the New International Standards. McGraw-Hill, 1993.

Kanji, G.K. "An Innovative Approach to Make ISO 9000 Standards More Effective." Total Quality Management. February 1998.

Karapetrovic, Stanislav, Divakar Rajamani, and Walter Willborn. "ISO 9000 for Small Business: Do It Yourself." Industrial Management. May-June 1997.

Meyer, Harvey R. "Small Firms Flock to Quality System." Nation's Business. March 1998.

Rabbit, J.T. The ISO 9000 Book: A Global Competitor's Guide to Compliance and Registration. Quality Resources, 1993.

Rayner, P., and L.J. Porter. "BS 5750/ISO 9000: The Experience of Small and Medium-Sized Firms." International Journal of Quality and Reliability Management. Vol. 8, no. 6, 1991.

Simmons, Bret L., and Margaret A. White. "The Relationship between ISO 9000 and Business Performance: Does Registration Really Matter?" Journal of Managerial Issues. Fall 1999.

Van der Wiele, Tom, et al. "ISO 9000 Series and Excellence Models: Fad to Fashion to Fit." Journal of General Management. Spring 2000.

Voehl, F., P. Jackson, and D. Ashton. ISO 9000: An Implementation Guide for Small to Mid-Sized Businesses. St. Lucie Press, 1994.

Wilson, L.A. "Eight-Step Process to Successful ISO 9000 Implementation: A Quality Management System Approach." Quality Progress. January 1996.

Wright, Richard B. "Why We Need ISO 9000." Industrial Distribution. January 1997.

See also: Quality Control; Total Quality Management

Wikipedia: ISO 9000
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ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. The rules are updated, as the requirements motivate changes over time.

Some of the requirements in ISO 9001:2008 (which is one of the standards in the ISO 9000 family) include

  • a set of procedures that cover all key processes in the business;
  • monitoring processes to ensure they are effective;
  • keeping adequate records;
  • checking output for defects, with appropriate and corrective action where necessary;
  • regularly reviewing individual processes and the quality system itself for effectiveness; and
  • facilitating continual improvement

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 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied.

Although the standards originated in manufacturing, they are now employed across several types of organizations. A "product", in ISO vocabulary, can mean a physical object, services, or software.

Contents

ISO 9000 series of standards

ISO 9000 includes the following standards:

  • ISO 9000:2005 Quality management systems – Fundamentals and vocabulary describes fundamentals of quality management systems, which form the subject of the ISO 9000 family, and defines related terms.
  • ISO 9001:2008 Quality management systems – Requirements is intended for use in any organization regardless of size, type or product (including service). It provides a number of requirements which an organization needs to fulfill to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for continual (i.e. planned) improvement of the Quality Management System, for which ISO 9004:2000 provides many hints.

This is the only implementation for which third-party auditors can grant certification. It should be noted that certification is not described as any of the 'needs' of an organization as a driver for using ISO 9001 (see ISO 9001:2000 section 1 'Scope') but does recognize that it may be used for such a purpose (see ISO 9001:2000 section 0.1 'Introduction').

  • ISO 9004:2000 Quality management systems - Guidelines for performance improvements covers continual improvement. This gives you advice on what you could do to enhance a mature system. This document very specifically states that it is not intended as a guide to implementation. An example of a Practical Guide to ISO 9001 presentation can be found here ISO 9001 a Practical Guide to Implementation

There are many more standards in the ISO 9001 series (see "List 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 group: 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 series 9002 and 9003 have 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 certification of a fish wholesaler in Tsukiji

ISO 9001:2008 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:

  • Page iv: Foreword
  • Pages v to vii: Section 0 Introduction
  • Pages 1 to 14: Requirements
    • Section 1: Scope
    • Section 2: Normative Reference
    • Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)
  • Pages 2 to 14
    • Section 4: Quality Management System
    • Section 5: Management Responsibility
    • Section 6: Resource Management
    • Section 7: Product Realization
    • Section 8: Measurement, analysis and improvement

In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.

  • Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
  • Page 23: Bibliography

The standard specifies six compulsory documents:

  • Control of Documents (4.2.3)
  • Control of Records (4.2.4)
  • Internal Audits (8.2.2)
  • Control of Nonconforming Product / Service (8.3)
  • Corrective Action (8.5.2)
  • Preventive Action (8.5.3)

In addition to these, ISO 9001:2008 requires a Quality Policy and Quality Manual (which may or may not include the above documents).

Summary of ISO 9001:2008 in informal language

  • The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.
  • Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.
  • Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source.
    • You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.
  • When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs.
  • You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness (note: you need a documented procedure for internal audits).
  • You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.

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 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

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]

2000 version

The Portuguese ISO 9001 certification image

ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, 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 center ("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.

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.[1]

ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There are no new requirements. Explanation of changes 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.[1] Practical Guide to Implementing ISO 9001:2008

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. 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 worldwide.

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, or after it receives a satisfactory improvement plan from the management showing how any problems will be resolved, the certification body will issue an ISO 9001 certificate for each geographical site it has visited.

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 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 judgments.

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

  • Tell me what you do (describe the business process)
  • Show me where it says that (reference the procedure manuals)
  • Prove that this is what happened (exhibit evidence in documented records)

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 judgments 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.

  • 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 AS9100.
  • PS 9000 is an application of the standard for Pharmaceutical Packaging Materials. The Pharmaceutical Quality Group (PQG) of the Institute of Quality Assurance (IQA) has developed PS 9000:2001. It aims to provide a widely accepted baseline GMP framework of best practice within the pharmaceutical packaging supply industry. It applies ISO 9001: 2000 to pharmaceutical printed and contact packaging materials.
  • 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 16949:2002 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2000. The emphasis on a process approach is stronger than in ISO 9001:2000. ISO/TS 16949:2002 contains the full text of ISO 9001:2000 and automotive industry-specific requirements.
  • TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is 4.0 and unlike ISO 9001 or the above sector standards, TL 9000 includes standardized product measurements that can be benchmarked. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry.
  • ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with ISO 9001:2000.
  • 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.

Debate on the effectiveness of ISO 9000

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

  1. Are the quality principles in ISO 9001:2000 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).
  2. Does it help to implement an ISO 9001:2000 compliant quality management system?
  3. Does it help to obtain ISO 9001:2000 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.[1][2] The quality principles in ISO 9000:2000 are also sound, according to Wade,[3] and Barnes, [2] 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 which indicated that ISO 9000 increased net profit, and another by Deloitte-Touche which reported that the costs of registration were recovered in three years. According to the Providence Business News [4], implementing ISO often gives the following advantages:

  1. Create a more efficient, effective operation
  2. Increase customer satisfaction and retention
  3. Reduce audits
  4. Enhance marketing
  5. Improve employee motivation, awareness, and morale
  6. Promote international trade
  7. Increases profit
  8. Reduce waste and increases productivity

However, a broad statistical study of 800 Spanish companies [5] found that ISO 9000 registration in itself creates little improvement because companies interested in it have usually already made some type of commitment to quality management and were performing just as well before registration.[1]

Problems

A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration.[6] 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."[2]

According to Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement. [7][8] 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." [3] Paraphrased, Wade's argument is 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.[7] Certifications are in fact often based on customer contractual requirements rather than a desire to actually improve quality.[2][9] "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.[9] Certification by an independent auditor is often seen as the problem area, and according to Barnes, "has become a vehicle to increase consulting services." [2] In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved. [10]

Another problem reported is the competition among the numerous certifying bodies, leading to a softer approach to the defects noticed in the operation of the Quality System of a firm.

Abrahamson[11] argued 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.

Summary

A good overview for effective use of ISO 9000 is provided by Barnes: [2]

"Good business judgment is needed to determine its proper role for a company... Is certification itself important to the marketing plans of the company? If not, do not rush to certification... Even without certification, companies should utilize the ISO 9000 model as a benchmark to assess the adequacy of its quality programs."

See also

References

  1. ^ a b "Probing the Limits: ISO 9001 Proves Ineffective". Scott Dalgleish. Quality Magazine April 1, 2005.
  2. ^ a b c d e f "Good Business Sense Is the Key to Confronting ISO 9000" Frank Barnes in Review of Business, Spring 2000.
  3. ^ a b "Is ISO 9000 really a standard?" Jim Wade, ISO Management Systems – May-June 2002
  4. ^ "Reasons Why Companies Should Have ISO Certification", Providence Business News, August 28, 2000.
  5. ^ "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.
  6. ^ "So many standards to follow, so little payoff". Stephanie Clifford. Inc Magazine, May 2005.
  7. ^ a b "The 'quality' you can't feel", John Seddon, The Observer, Sunday November 19, 2000
  8. ^ "A Brief History of ISO 9000: Where did we go wrong?". John Seddon. Chapter one of "The Case Against ISO 9000", 2nd ed., Oak Tree Press. November 2000. ISBN 1-86076-173-9
  9. ^ a b "ISO a GO-Go." Mark Henricks. Entrepreneur Magazine Dec 2001.
  10. ^ The ISO Survey – 2005 (abridged version, PDF, 3 MB), ISO, 2005
  11. ^ Abrahamson, E. (1996). "Managerial fashion." Academy of Management Review. 21(1):254-285.

Further reading

  • Bamford, Robert; Deibler, William (2003). ISO 9001: 2000 for Software and Systems Providers: An Engineering Approach (1st ed.). CRC-Press. ISBN 0849320631, ISBN 978-0849320637
  • 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.

External links


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