Introduction to ISO________________________________________What are standards ?Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose. For example, the format of the credit cards, phone cards, and "smart" cards that have become commonplace is derived from an ISO International Standard. Adhering to the standard, which defines such features as an optimal thickness (0,76 mm), means that the cards can be used worldwide. International Standards thus contribute to making life simpler, and to increasing the reliability and effectiveness of the goods and services we use. ________________________________________What is ISO ?The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 100 countries, one from each country. ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. ISO's work results in international agreements which are published as International Standards. How it all started International standardization began in the electrotechnical field : the International Electrotechnical Commission (IEC) was created in 1906. Pioneering work in other fields was carried out by the International Federation of the National Standardizing Associations (ISA), which was set up in 1926. The emphasis within ISA was laid heavily on mechanical engineering. ISA's activities ceased in 1942, owing to the Second World War. Following a meeting in London in 1946, delegates from 25 countries decided to create a new international organization "the object of which would be to facilitate the international coordination and unification of industrial standards". The new organization, ISO, began to function officially on 23 February 1947. The first ISO standard was published in 1951 with the title, " Standard reference temperature for industrial length measurement ". ISO's name : a user's guide Many people will have noticed a seeming lack of correspondence between the official title when used in full, International Organization for Standardization, and the short form, ISO. Shouldn't the acronym be " IOS " ? Yes, if it were an acronym - which it is not. In fact, "ISO" is a word, derived from the Greek isos, meaning "equal ", which is the root of the prefix " iso-" that occurs in a host of terms, such as " isometric " (of equal measure or dimensions - Shorter Oxford English Dictionary) and " isonomy " (equality of laws, or of people before the law - ibid.). From "equal" to "standard", the line of thinking that led to the choice of "ISO" as the name of the organization is easy to follow. In addition, the name has the advantage of being valid in each of the organization's three official languages - English, French and Russian. The confusion that would arise through the use of an acronym is thus avoided, e.g. "IOS" would not correspond to the official title of the organization in French - Organisation internationale de normalisation. ________________________________________International standardization : What does it achieve ?Industry-wide standardization is a condition existing within a particular industrial sector when the large majority of products or services conform to the same standards. It results from consensus agreements reached between all economic players in that industrial sector - suppliers, users, and often governments. They agree on specifications and criteria to be applied consistently in the choice and classification of materials, the manufacture of products, and the provision of services. The aim is to facilitate trade, exchange and technology transfer through : ? enhanced product quality and reliability at a reasonable price, 

? improved health, safety and environmental protection, and reduction of waste, ? greater compatibility and interoperability of goods and services, ? simplification for improved usability, ? reduction in the number of models, and thus reduction in costs, ? increased distribution efficiency, and ease of maintenance. Users have more confidence in products and services that conform to International Standards. Assurance of conformity can be provided by manufacturers' declarations, or by audits carried out by independent bodies. ________________________________________Why is international standardization needed ?The existence of non-harmonized standards for similar technologies in different countries or regions can contribute to so-called "technical barriers to trade". Export-minded industries have long sensed the need to agree on world standards to help rationalize the international trading process. This was the origin of the establishrnent of ISO. International standardization is now well-established for very many technologies in such diverse fields as information processing and communications, textiles, packaging, distribution of goods, energy production and utilization, shipbuilding, banking and financial services. It will continue to grow in importance for all sectors of industrial activity for the foreseeable future. The main reasons are: Worldwide progress in trade liberalization Today's free-market economies increasingly encourage diverse sources of supply and provide opportunities for expanding markets. On the technology side, fair competition needs to be based on identifiable, clearly defined common references that are recognized from one country to the next, and from one region to the other. An industry-wide standard, internationally recognized, developed by consensus arnong trading partners, serves as the language of trade. Interpenetration of sectors No industry in today's world can truly claim to be completely independent of components, products, rules of application, etc., that have been developed in other sectors. Bolts are used in aviation and for agricultural machinery; welding plays a role in mechanical and nuclear engineering. and electronic data processing has penetrated all industries. Environmentally friendly products and processes, and recyclable or biodegradable packaging are pervasive concerns. Worldwide communications systems The computer industry offers a good example of technology that needs quickly and progressively to be standardized at a global level. ISO's OSI (Open Systems Interconnection) is the best-known series of International Standards in this area. Full compatibility among open systems fosters healthy competition among producers, and offers real options to users since it is a powerful catalyst for innovation, improved productivity and cost-cutting. Global standards needs for emerging technologies Standardization programmes in completely new fields are now being developed. Such fields include advanced materials, the environment, life sciences, urbanization and construction. In the very early stages of new technology development, applications can be imagined but functional prototypes do not exist. Here, the need for standardization is in defining terminology and accumulating databases of quantitative information. Developing countries Development agencies are increasingly recognizing that a standardization infrastructure is a basic condition for the success of economic policies aimed at achieving sustainable development. Creating such an infrastructure in developing countries is essential for improving productivity, market competitiveness, and export capability. ________________________________________Who makes up ISO ?A member body of ISO is the national body "most representative of standardization in its country". It follows that only one such body for each country is accepted for membership. The member bodies have four principal tasks: 

? informing potentially interested parties in their country of relevant international standardization opportunities and initiatives, ? organizing so that a concerted view of the country's interests is presented during international negotiations leading to standards agreements, ? ensuring that a secretariat is provided for those ISO technical committees and subcommittees in which the country has an interest, ? providing their country's share of financial support for the central operations of ISO, through payment of membership dues. A correspondent member is usually an organization in a country which does not yet have a fully developed national standards activity. Correspondent members do not take an active part in the technical work, but are entitled to be kept fully informed about the work of interest to them. ISO has also established a third category, subscriber membership, for countries with very small economies. These subscribers pay reduced membership fees that nevertheless allow them to maintain contact with international standardization. ________________________________________Who does the work ?The technical work of ISO is highly decentralized, carried out in a hierarchy of some 2 700 technical committees, subcommittees and working groups. In these committees, qualified representatives of industry, research institutes, government authorities, consumer bodies, and international organizations from all over the world come together as equal partners in the resolution of global standardization problems. The major responsibility for administrating a standards committee is accepted by one of the national standards bodies that make up the ISO membership - AFNOR, ANSI, BSI, CSBTS, DIN, SIS, etc. The member body holding the secretariat of a standards committee normally appoints one or two persons to do the technical and administrative work. A committee chairman assists committee members in reaching consensus. Generally, a consensus will mean that a particular solution to the problem at hand is the best possible one for international application at that time. The Central Secretariat in Geneva acts to ensure the flow of documentation in all directions, to clarify technical points with secretariats and chairmen, and to ensure that the agreements approved by the technical committees are edited, printed, submitted as draft International Standards to ISO member bodies for voting, and published. Meetings of technical committees and subcommittees are convened by the Central Secretariat, which coordinates all such meetings with the committee secretariats before setting the date and place. Although the greater part of the ISO technical work is done by correspondence, there are, on average, a dozen ISO meetings taking place somewhere in the world every working day of the year. Each member body interested in a subject has the right to be represented on a committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The publication ISO Memento provides information on the scope of responsibility, organizational structure and secretariats for each ISO technical committee. Detailed rules of procedure for the technical work are given in the ISO/IEC Directives. A list of the 500 international organizations in liaison with ISO's technical committees and subcommittees is given in the publication ISO Liaisons. ________________________________________What fields are covered ?The scope of ISO is not limited to any particular branch; it covers all standardization fields except electrical and electronic engineering, which is the responsibility of IEC. The work in the field of information technology is carried out by a joint ISO/IEC technical committee (JTC 1). ________________________________________What's in a standard ?What does an ISO standard look like? It can be anything from a four-page document to a 1000-page tome, including twice the weight of the standard itself in informative annexes. It may specify the tasks that a certain range of equipment must be able to perform, or describe in detail an apparatus and its

safety features. It may contain symbols, definitions, diagrams, codes, test methods, etc. ? m, kg, s, A, K, mol, cd are the symbols representing the seven base units of the universal system of measurement known as SI (Syst?me international d'unit?s). The SI system is covered by a series of 14 International Standards. ? Paper sizes. The original standard was published by DIN in 1922. Now used worldwide as ISO 216. ? A well-designed symbol conveys a clearcut message in a multilingual world. The same symbols for automobile controls are displayed in cars all over the world, no matter where they are manufactured. ? Safety of wire ropes : used on oil rigs, on fishing vessels, in mines, in all types of building operations, for lifts and cable cars, etc. ISO International Standards systematically define basic characteristics such as size, surface finish, type of construction, tensile grade of the wire, minimum breaking load and linear mass. ? The ISO international codes for country names, currencies and languages help to eliminate duplication and incompatibilities in the collection, processing and dissemination of information. As resource-saving tools, universally understandable codes play an important role in both automated and manual documentation. ? The ISO film speed code, among many other photographic equipment standards, has been adopted worldwide making things simpler for the general user. ? The internationally standardized freight container enables all components of a transport system - air and seaport facilities, railways, highways, and packages - to interface efficiently. ? The diversity of screw threads for identical applications used to represent an important technical obstacle to trade. It caused maintenance problems, and lost or damaged nuts or bolts could not easily be replaced. A global solution is supplied in the ISO standards for ISO metric screw threads. ________________________________________How are ISO standards developed ?ISO standards are developed according to the following principles: ? ConsensusThe views of all interests are taken into account: manufacturers, vendors and users, consumer groups, testing laboratories, governments, engineering professions and research organizations. ? Industry-wideGlobal solutions to satisfy industries and customers worldwide. ? VoluntaryInternational standardization is market-driven and therefore based on voluntary involvement of all interests in the market-place. There are three main phases in the ISO standards development process. The need for a standard is usually expressed by an industry sector, which communicates this need to a national member body. The latter proposes the new work item to ISO as a whole. Once the need for an International Standard has been recognized and formally agreed, the first phase involves definition of the technical scope of the future standard. This phase is usually carried out in working groups which comprise technical experts from countries interested in the subject matter. Once agreement has been reached on which technical aspects are to be covered in the standard, a second phase is entered during which countries negotiate the detailed specifications within the standard. This is the consensus-building phase. The final phase comprises the formal approval of the resulting draft International Standard (the acceptance criteria stipulate approval by two-thirds of the ISO members that have participated actively in the standards development process, and approval by 75 % of all members that vote), following which the agreed text is published as an ISO International Standard. Most standards require periodic revision. Several factors combine to render a standard out of date: technological evolution, new methods and materials, new quality and safety requirements. To take account of these factors, ISO has established the general rule that all ISO standards should be reviewed at intervals of not more than five years. On occasion, it is necessary to revise a standard earlier. To accelerate the standards process (handling of proposals, drafts, comment reviews, voting, publishing, etc.) ISO makes use of information technology and programme management methods. 

To date, ISO's work has resulted in 9 300 International Standards, representing some 170 700 pages in English and French (terminology is often provided in other languages as well). A list of all ISO standards appears in the ISO Catalogue. ________________________________________How is ISO's work financed ?The financing of ISO closely reflects its decentralized mode of operation with, on the one hand, the financing of the Central Secretariat activities and, on the other hand, the financing of the technical work as such of the technical secretariats. The financing of the Central Secretariat derives from member body subscriptions (70 %) and revenues from the sale of the Organization's standards and other publications (30 %). The subscriptions required of member bodies for financing the operations of the Central Secretariat are expressed in units and calculated in Swiss francs (CHF). The number of units that each member body is invited to pay is calculated on the basis of economic indicators of gross national product (GNP), and value of imports and exports. The value of the subscription unit is set each year by the ISO Council. The ISO member bodies bear the expenditure necessary for the operation of the individual technical secretariats for which they are responsible. It is generally estimated that the operating expenditure of the Central Secretariat (about 27 million Swiss francs in 1994) represents about one-fifth of the total cost of financing the ISO administrative operations. To that, one must also add the value of the voluntary contributions of some 30 000 experts in terms of time, travel and organization of meetings. While no precise calculation has ever been made to assess in figures this contribution of fundamental knowledge to the work of ISO, it is nevertheless certain that this expenditure amounts to several hundred million Swiss francs each year. ________________________________________World systemISO and IEC ISO does not work alone in international standardization. It collaborates very closely with its partner,the International Electrotechnical Commission, IEC. An agreement reached in 1976 defines responsibilities: the IEC covers the field of electrical and electronic engineering, all other subject areas being attributed to ISO. When necessary, attribution of responsibility for work programmes to ISO or IEC is made by mutual agreement. In specific cases of mutual interest, joint technical bodies or working groups are set up. Common working procedures ensure efficient coordination and the widest possible global application. ISO and IEC are not part of the United Nations, but have many technical liaisons with the specialized UN agencies. Several are actively involved in international standardization such as the International Telecommunication Union, the World Health Organization, the Food and Agriculture Organization, the International Atomic Energy Agency, etc. The relationship with regional standardization ISO maintains close working relations with regional groups of standards bodies. In practice, the members of such regional groups are also members of ISO and the principle is generally accepted that ISO standards are taken as the basis for whatever standards are required to meet the particular needs of a given geographical region. ISO and CEN (European Committee for Standardization), for example, have defined procedures for the development of standards that will be acceptable both as European Standards and as International Standards. The benefits for industry are wide-reaching. With the motto, "Do it once, do it right, do it internationally", being practised, industry does not need to be involved in both European and international fora in the same areas. ________________________________________Searching for informationEnquiries about standards involve those of ISO and a number of recognized standards agreed within other international technical organizations. There are, in addition, several hundred thousand standards and technical regulations in use throughout the world containing special requirements for a particular country or region. Finding information about all these standards, technical regulations, or related testing and certification activities, can be a heavy task. 

ISONET, the ISO Information Network, is there to ease the problem. This is a worldwide network of national standards information centres which have cooperatively developed a system to provide rapid access to information about standards, technical regulations, and testing and certification activities currently used in different parts of the world. Members of this network - usually the ISO member for any given country - act effectively as "specialized enquiry points" in the dissemination of information and in identifying the relevant sources of information for solving specific problems. The Agreement on Technical Barriers to Trade, drawn up under the General Agreement on Tariffs and Trade (GATT)*, calls upon its signatories to establish in each country an enquiry point capable of answering questions about the standards, technical regulations and certification systems in force in that country. In many countries, the ISONET enquiry point and the GATT enquiry point are one and the same. * The future World Trade Organization (WTO). ________________________________________Consulting and training servicesISO and many of its members are actively involved in consulting and training services which include seminars on the application of standards in quality assurance systems, technical assistance to exporters concerning standards requirements in other countries, workshops on consumer involvement in standardization, and conferences and symposia covering recent developments in testing and certification. For the particular needs of its developing country members, ISO operates a special programme consisting of training seminars, publication of development manuals, and various other kinds of expert assistance. This programme, which is supported by governmental aid agencies and ISO members from several industrialized countries, provides an important mechanism through which developing countries may accelerate the advancement of their national standardization and quality assurance systems. The international collaborative network of standardization and standards-related activities is open to all interests and is directly accessible through the ISO members or the ISO Central Secretariat in Geneva. ________________________________________What's news in international standardization?The main publications of ISO are, of course, International Standards. ISO also issues a number of other publications which include the ISO Catalogue, standards handbooks, guides and several informative books and pamphlets. The leaflet Publications other than International Standards provides details. News of the various aspects of standardization work, standards in process, new International Standards and other publications, committee meetings and feature articles on standards are presented in the monthly ISO Bulletin. ISO 9000 News, published six times a year, is part of an ISO 9000 Forum package which entitles Forum members to a subscription to the monthly ISO Bulletin, the opportunity to attend ISO-organized application symposia, information on new and revised editions of the ISO 9000 series, and on sources of training material. Forum services also include special publications relevant to ISO 9000. ________________________________________

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ISO 9000 and ISO 14000In 1987, the first ISO 9000 standard was released. But it was not until 1992, when trade throughout Europe began opening up and multinational companies in the U.S. had to meet ISO 9000 requirements in Europe, that the standard was finally implemented in the United States. ISO 9000 has become synonymous with quality. ISO 9000 translates "quality management" into a continuously improving process designed to meet or exceed customer and regulatory requirements.ISO 14000 has become synonymous with quality environmental matters. ISO 14000 translates "environmental management" into a continuously improving process designed to minimize harmful environment effects while improving environmental performance. The original set of ISO 14000

standards were published in 1997. ISO 9000:1994 Series OverviewThe original set of quality assurance standards, commonly known as ISO 9000, was published in 1987 by ISO. The standard was initially based on British Standard 5750 and modified as appropriate to address issues of all member nations. The ISO 9000 series of standards are translated into many different languages and must be equal in all languages. This has resulted in the wording of the standard to be somewhat awkward at times.The purpose of the ISO 9000 standard initially (1987 & 1994 revisions) was to provide a company with the minimum requirements for a quality system to be effective in providing customers with products of a consistent quality that met their requirements. Certification or Registration (the terms are used interchangeably) to ISO 9001, 9002 or 9003 provided customer organizations with confidence that a supplier had implemented an appropriate quality system, therefore providing a more reliable quality of product. If problems with the quality of products should arise, the customer complaint and corrective action system would ensure correction of the problem and prevention of recurrence.The standards were updated in 1994 (ISO9000:1994) and again in December 2000 (ISO 9000:2000). All companies certified to one of the earlier ISO9000:1994 standards are required to re-certify under the latest ISO9000:2000 standard by December 2003 in order to maintain certification. This section is provided for reference only.The old ISO 9000:1994 Series was a set of five individual, but related, international standards on quality management and quality assurance. They are generic in nature and not specific to any particular product or service. These standards were developed with the goal of effectively documenting the quality system elements to be implemented in order to maintain an efficient quality system in a company. However, the standards themselves do not specify the means to be used for implementing the quality system elements. ISO 9000 is the first standard in the series and is entitled "Quality Management and Quality Assurance Standards - Guidelines for Selection and Use." This section presents an overview of the whole set and guidelines for use of the rest of the series.ISO 9001, 9002 and 9003 are quality system models for external quality assurance. These three models are actually successive subsets of each other.ISO 9001 is the most comprehensive, which covers design, manufacturing, installation and service.ISO 9002 covers production, installation and servicing.ISO 9003 covers only final product inspection and testing. Under ISO9000:1994, The company would have chosen one of the above "auditable" standards to measure its quality system against. It would serve as the guideline for an independent third party audit of company operations against the requirements of the appropriate standard. ISO 9004 is the fifth in the series. It provides guidelines for internal use by a producer developing its own quality system to meet business needs and take advantage of opportunities. QS-9000 and other Sector RequirementsSeveral industries have adopted their own requirements based on the ISO standards. The automotive industry created QS-9000, which incorporates ISO 9001 along with additional auto industry specific requirements. The aerospace industry created AS9000 and the telephone industry has created TL 9000. [ ^Back to Top^ ]Transitioning from ISO 9000:1994 to ISO 9000:2000The International Organization for Standardization is chartered to revise and update the standard approximately every five years. Considering the effort involved in revising, translating, and obtaining agreement from the various nations, it is no wonder that the revisions have taken six to seven years.The changes to ISO 9000 were officially released 15 December 2000. All companies certified to one of the earlier ISO 9000:1994 standards have three years from the release date to re-certify under the latest ISO 9000:2000 standard in order to maintain certification.There were 20 required elements included in the ISO 9001:1994 auditable standards which served as guidelines to personnel for ensuring complete and thorough quality assurance system development and documentation. The new ISO 9000:2000 standard is now formed around eight management

principles that use a process cycle instead of discrete elements. Therefore, the 20 required elements have been replaced by new standards that resemble the old elements.[ ^Back to Top^ ]ISO 9000:1994 to ISO 9000:2000 GapAre you struggling with the latest ISO 9000:2000 standard? All companies certified to one of the earlier ISO 9000:1994 standards have three years from the release date (15 December 2000) to re-certify under the latest ISO 9000:2000 standard in order to maintain certification. That means companies certified to ISO 9000 must re-certify to ISO 9000:2000 by December 15, 2003.What Steps Do You Need To Take To Re-Certify? 1. Understand the new ISO9000:2000 Standard. 2. Understand the key changes from the ISO 9000:1994 to the 2000 standard. 3. Identify the gaps in your company ISO 9000:1994 Quality Management System (QMS) as compared to the new ISO 9001:2000 version of the International Standard. 4. Identify the maturity or effectiveness of your company QMS, (the degree to which the organization QMS meets the needs of the business and its' customers). 5. Identify the gaps, if any, in the organization technical skills and knowledge which may prevent the organization from successfully transitioning to the new ISO 9001:2000 version of the International Standard. 6. Provide a MS Project plan outlining the phases, activities and tasks your company must take in order to achieve ISO 9001:2000 registration. 7. Address the gaps and improve the effectiveness of your company QMS 8. Optionally, identify and integrate new software tools that can be used to simplify the continuous process improvement required by the new standard. Is There A Faster Way?Yes. If you are an ISO 9000:1994 registered organization looking for a simple, plain language explanation of how your existing ISO registered Quality Management System (QMS) meets the requirements of ISO 9001:2000, then the Bizmanualz Gap Analysis is for you. It is an opportunity for your ISO registered company to objectively review the degree to which your QMS meets the everyday needs of your business and your customers. 

What is ISO 9000?Quality is something every company strives for and is often times very difficult to achieve. Complications concerning efficiency and quality present themselves everyday in business, whether an important document cannot be found or a consumer finds a product not up to their expectations. How can a company increase the quality of its products and services? The answer is ISO 9000.As standards go, ISO 9000 is one of the most widely recognized in the world. ISO 9000 is a quality management standard that presents guidelines intended to increase business efficiency and customer satisfaction. The goal of ISO 9000 is to embed a quality management system within an organization, increasing productivity, reducing unnecessary costs, and ensuring quality of processes and products.ISO 9001:2008 is applicable to businesses and organizations from every sector. The process oriented approach makes the standard applicable to service organizations as well. Its general guidelines allow for the flexibility needed for today's diverse business world.How does ISO 9000 work?ISO 9000 is set up as a collection of guidelines that help a company establish, maintain, and improve a quality management system. It is important to stress that ISO 9000 is not a rigid set of requirements, and that organizations have flexibility in how they implement their quality management system. This freedom allows the ISO 9000 standard to be used in a wide range of organizations, and in businesses large and small.One important aspect of ISO 9000 is its process-oriented approach. Instead of looking at a company's departments and individual processes, ISO 9000 requires that a company look at "the big picture." How do processes interact? Can they be integrated with one another? What are the important aspects of products and services?

Once this process-oriented approach is implemented, various audits can be done as a check of the effectiveness of your quality management system. There are three main types of audits ? 1st, 2nd, and 3rd party audits. An internal audit is a 1st party audit. ISO 9000 encourages (and requires) this type of audit so that an organization can get feedback quickly from those who know the company best. However, this audit process cannot be viewed as impartial. Therefore, 2nd party audits allow for a consumer to evaluate the performance on an organization. As an alternative to a 2nd party audit, many companies choose to become certified with ISO 9000 through a 3rd party audit. In this case, an independent certification body comes into an organization and evaluates it in terms of the ISO 9000 guidelines. If an organization meets the requirements of the standard, it becomes certified in ISO 9000 and carries a seal of quality recognized throughout the world.Why is ISO 9000 important?The importance of ISO 9000 is the importance of quality. Many companies offer products and services, but it is those companies who put out the best products and services efficiently that succeed. With ISO 9000, an organization can identify the root of the problem, and therefore find a solution. By improving efficiency, profit can be maximized.As a broad range of companies implement the ISO 9000 standards, a supply chain with integrity is created. Each company that participates in the process of developing, manufacturing, and marketing a product knows that it is part of internationally known, reliable system.Not only do businesses recognize the importance of the ISO 9000, but also the customer realizes the importance of quality. And because the consumer is most important to a company, ISO 9000 makes the customer its focus.What are the ISO 9000 Principles?1. A Customer Focus

As stated before, the customer is the primary focus of a business. By understanding and responding to the needs of customers, an organization can correctly targeting key demographics and therefore increase revenue by delivering the products and services that the customer is looking for. With knowledge of customer needs, resources can be allocated appropriately and efficiently. Most importantly, a business's dedication will be recognized by the customer, creating customer loyalty. And customer loyalty is return business.2. Good Leadership

A team of good leaders will establish unity and direction quickly in a business environment. Their goal is to motivate everyone working on the project, and successful leaders will minimize miscommunication within and between departments. Their role is intimately intertwined with the next ISO 9000 principle.3. Involvement of people

The inclusion of everyone on a business team is critical to its success. Involvement of substance will lead to a personal investment in a project and in turn create motivated, committed workers. These people will tend towards innovation and creativity, and utilize their full abilities to complete a project. If people have a vested interest in performance, they will be eager to participate in the continual improvement that ISO 900 facilitates.4. Process approach to quality management

The best results are achieved when activities and resources are managed together. This process approach to quality management can lower costs through the effective use of resources, personnel, and time. If a process is controlled as a whole, management can focus on goals that are important to the big picture, and prioritize objectives to maximize effectiveness.5. Management system approach

Combining management groups may seem like a dangerous clash of titans, but if done correctly can result in an efficient and effective management system. If leaders are dedicated to the goals of an

organization, they will aid each other to achieve improved productivity. Some results include integration and alignment of key processes. Additionally, interested parties will recognize the consistency, effectiveness, and efficiency that come with a management system. Both suppliers and customers will gain confidence in a business's abilities.6. Continual Improvement

The importance of this principle is paramount, and should a permanent objective of every organization. Through increased performance, a company can increase profits and gain an advantage over competitors. If a whole business is dedicated to continual improvement, improvement activities will be aligned, leading to faster and more efficient development.Ready for improvement and change, businesses will have the flexibility to react quickly to new opportunities.7. Factual approach to decision making

Effective decisions are based on the analysis and interpretation of information and data. By making informed decisions, an organization will be more likely to make the right decision. As companies make this a habit, they will be able to demonstrate the effectiveness of past decisions. This will put confidence in current and future decisions.8. Supplier relationships

It is important to establish a mutually beneficial supplier relationship; such a relationship creates value for both parties. A supplier that recognizes a mutually beneficial relationship will be quick to react when a business needs to respond to customer needs or market changes. Through close contact and interaction with a supplier, both organizations will be able to optimize resources and costs.Why is root cause analysis and systemic corrective action so important in management system standards, such as ISO 9001?When problem solving, it is important to find the cause of problem in order to develop a solution. Sometimes, the most obvious cause is not the right one. This is why ISO 9000 stresses the importance of finding the root cause(s) of a problem. There may be multiple, subtle reasons why a process isn't working correctly, and finding the actual causes will lead a company one step closer to a solution and implementation of corrective actions.The goal of finding root causes is to improve the way problems are managed. Becoming adept in recognizing the root causes of a problem will lead to a reduced impact, a containment of error, and the prevention of recurrence. Identifying and correcting root causes will also lead to the reduction of unnecessary efforts which in turn will lower the cost of maintaining quality. As more and more corrective actions are taken, processes will become more stable, and continual improvement will face less interruptions. How does ISO 9000 interact with other standards?ISO 9000 is the standard for a quality management system that closely resembles many other management systems. These other systems, based on health, safety, the environment, and business continuity, can be integrated into an overarching business management system. Benefits of this system include aligned interests, reduced costs, and improved efficiency. With one of these systems in place, it is easier to implement any of the others; many documents required for a different standard are already prepared, and personnel are already accustomed to the audit process. Using multiple standards will not only increase the efficiency of an organization, but increase the integrity of its operations.What does ISO 9000 mean to me and my company?ISO 9000 is a standard created to make the attainment of quality, consistent products easier by providing specific steps for development of an organization's quality management system. This quality management system is meant to monitor the progress of a product or service as it goes through each stage of production, from development to testing to assembly to customer feedback.One cornerstone of ISO 9000 is continual improvement. No company should ever be satisfied with the conditions of a process at the given moment; they should always be looking for ways to make these

processes more efficient and effective. ISO 9000 was written with the business world's insatiable desire for excellence in mind. This is why continual improvement is a requirement of the standard ? to inspire progress and the pursuit of perfection.ISO 9000 is an internationally recognized standard, and that may seem daunting for some smaller businesses. How are they going to implement the same standard adopted by multi-national corporations? Quite easily, actually. ISO 9000 is a flexible standard that lays down requirements for an organization to follow, but allows the organization to fulfill these requirements any way they choose. This increases ISO 9000's scope of effectiveness, allowing a wide range of companies to create quality management systems that match their needs.ISO 9000 is seen in every sector of the business world, and its success is a testament to its worth. With a focus on customer satisfaction, products and services improve and flourish under ISO 9000's quality management system. With a combination of continual improvement and corrective actions ? tenets of ISO 9000 ? a business will create processes that run smoothly and efficiently.How will ISO 9000 benefit my small business?A good foundation builds a good business, and ISO 9000 is a good foundation for small businesses that want to expand their market. By introducing a quality management system like ISO 9000 to a small business, the quality of processes will increase and costs due to inefficiency will decrease. In addition, a small business will be able to advertise their use of the internationally recognized ISO 9000. This may create business opportunities that were not available before an objectively verified quality management system was in place.Having management systems in place, such as ISO 9000, will also help when selling a business. The integrity and value of a small business will be apparent with well-documented processes and proof of quality. ISO 9000 will ensure the reputation of your business in any situation.

ISO 9000From Wikipedia, the free encyclopediaJump to: navigation, searchISO 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.Marketing departments take advantage of public confusion and ignorance about ISO 9000. Goods and services outstanding proclaim their ISO 9000 STATUS. Most consumers suppose that ISO 9000 is the same as ISO 9001.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[hide]? 1 ISO 9000 series of standards ? 2 Contents of ISO 9001 o 2.1 Summary of ISO 9001:2008 in informal language 

o 2.2 1987 version o 2.3 1994 version o 2.4 2000 version o 2.5 Certification ? 3 Auditing ? 4 Industry-specific interpretations ? 5 Debate on the effectiveness of ISO 9000 o 5.1 Advantages o 5.2 Problems o 5.3 Summary ? 6 Headline text ? 7 See also ? 8 References ? 9 Further reading ? 10 External links 

[edit] ISO 9000 series of standardsISO 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 9004:2009 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. 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.[edit] Contents of ISO 9001

ISO 9001 certification of a fish wholesaler in TsukijiISO 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 

o Section 1: Scope o Section 2: Normative Reference o Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000) ? Pages 2 to 14 o Section 4: Quality Management System o Section 5: Management Responsibility o Section 6: Resource Management o Section 7: Product Realization o 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).[edit] 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. o 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. [edit] 1987 versionISO 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][edit] 1994 versionISO 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][edit] 2000 versionThe Portuguese ISO 9001 certification imageISO 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[edit] CertificationISO 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 (C  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.[edit] AuditingTwo 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. Here's an article on how to make a good audit great.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.[edit] Industry-specific interpretationsThe 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. 

[edit] Debate on the effectiveness of ISO 9000The 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? [edit] AdvantagesIt 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][edit] ProblemsA 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.[edit] SummaryA good overview for effective use of ISO 9000 is provided by Barnes: [2]"Good business judgment is needed to determine its proper rol