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International Organization for Standardization (ISO: 9000)

A German company wins a huge contract to sell components to a factory in North Carolina. A Swiss firm becomes the leading supplier of power line filters in the U.S. A Japanese electronics conglomerate outbids several European manufacturers for a project in South America. These are not isolated events, but rather an indication that we have entered a new age in commerce.

Today, more and more business and industry leaders realize that in order to thrive, or even survive, in the new global economy, their companies must become truly world-class. And that means quality. Quality in your products and services. Quality in your practices and procedures. Quality you maintain and you can prove - because it is documented. Quality is used as a competitive weapon and to survive in the global market scenario. And that is the reason for the growing move to ISO 9000 certification. ISO 9001 is for quality management. Quality refers to all those features of a product (or service) which are required by the customer. Quality management means what the organization does to ensure that its products or services satisfy the customer's quality requirements and comply with any regulations applicable to those products or services. ISO 9000 is a standard in which to conduct business. It is a set of rules which should be followed in order to meet the needs and understand the wants of customers. The standard is generic. ISO 9000 is an important standard in the industry today. When companies choose to implement ISO 9000, they must think of not only the short-term transition period, but also the long-term future of the organization. Too often, companies do not see this, and implement ISO 9000 simply to remain competitive due to outside pressure. This can lead to failure of the implementation, and even to the point of failure of the company due to the loss in quality that may have existed before the implementation. ISO 9000 allows an organization to follow guidelines that will not only improve the relationship with customers, but the relationships that exist within the firm. Improvements will allow a company to produce superior products for

customers, while allowing the morale and worker productivity to improve inside the organization.

Need for Standardization

Standardization is the temporary crystallization of the best acceptable solution to a recurring problem, formulated in a scientific and systematic fashion by pulling the knowledge of all those who are concerned with the problem, and is subjected to review and revision by common consent. Company standardization is now an important effective management tool for improving quality and productivity. Quality and standardization are two prerequisites for a company to market its products and services in the competitive business environment. Quality thus begins with standards. Quality encompasses safety, reliability, durability, performance and acceptability of products by consumers. Standardization promotes overall economy, taking due care of functional and safety requirement.

Levels of Standardization
There exists a multi-tier standardization system; Company/ Inplant Standards, National Standards like BIS, Regional Standards like Euro-norms, International Standards like ISO Standardization. Standardization of each of these levels should make the maximum use of standards issued by the proper organization of the next higher level.

ISO: 9000
The term ISO stands for the International Organization for Standardization. You would reasonably assume that it ought to be IOS, but it isn't. Apparently, the term ISO was chosen (instead of IOS), because iso in Greek means equal, and ISO wanted to convey the idea of equality - the idea that they develop standards to place organizations on an equal footing. ISO is located in Switzerland and was established in 1947 to develop common international standards in many areas. Its member came from over 130 national standard bodies. ISO first published its quality standards in 1987, revised them in 1994, and then republished an updated version in 2000. Standards presently applicable are known as ISO: 2000 Standards, and facilitate international trade by providing a single set of standards that people everywhere in the world, would recognize and respect.

History of ISO:9000
ISO: 9000 was formulated by International Organizational for Standardization in order to meet the requirements of internationally uniform quality system. The European Nation trade has reached an understanding that the post 1992 trade transaction would be dealt only with those companies who have registered ISO:9000 quality system. The developed countries started producing their own standard. In 1972, BSI UK published BS 4891-A guide to quality assurance. In 1974, MIL standards were introduced. In 1975, BSI published BS 5179 in three parts drawn from the contents of defence standards 05-21 series. To meet growing awareness of quality in industries BS 5750 standard was developed by BSI in 1979. Further in 1981, guides were published for the usage of BS 5750. ISO revised BS:5750 in 1987 as ISO:9000 series of standards on quality system. More than forty countries have adopted them as EN 29000. In India BIS (Bureau of Indian Standards) published IS:14000 series as quality system standard.

ISO:9000 Series of Standards in General

With increased focus on quality issues worldwide, the ISO brought 7 standards. One on standard terminology (ISO 8402), 5 standards(known as ISO 9000 series) and another standard on auditing quality system (ISO 10011-1 to 10011-3). ISO 8402: Quality system- Vocabulary ISO 9000: Quality systems- Guidelines for selection and use of standards on quality system. ISO 9001 : Quality systems- Model for quality assurance in design/ development, production, installation and servicing. ISO 9002 : Quality systems- Model for quality assurance in production and

installation. ISO 9003 : Quality systems- Model for quality assurance in final inspection and test. ISO 9004 : Quality management and quality system elements Guidelines. ISO 10011-1 to ISO 10011-3 : Guidelines for auditing quality system.

ISO : 8402 : 1986 (IS 1399 : 1988) Vocabulary

This gives the definition of various terms (for example, Quality, Inspection, Reliability, Specification etc.) used in the development of standards on quality systems. The definitions given in this standard are for use in understanding the Quality Concepts, preparation of Quality Standards and for use in communication to avoid ambiguity in understanding the terms related to quality. The definitions of few important terms related to quality as given in ISO : 8402 standard are given below. Quality : Quality is the totality of features and characteristics of a product or service that bears on its ability to satisfy stated or implied needs. Inspection : Inspection implies the activities such as measuring, examining, testing, grading one or more characteristics of a product or service and comparing these with specified requirements to determine conformity. Reliability : It is the ability of an item to perform a required function under stated conditions for stated period of time. Grade : Grade is an indicator of category or rank related to features or characteristics that cover different sets of needs for products or services intended for the same functional use. Quality Policy : It is the overall quality intentions and direction of an organization as regards quality, as formally expressed as top management. Quality Management : The aspect of overall management function that determines and implements the quality policy. Quality Loop ; Quality Spiral : It is the conceptual model of interacting activities that influence the quality of a product or service in the various stages ranging from the identification needs to the assessment of whether these needs have been satisfied.

Quality Assurance : All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality. Quality Control : The operational techniques and activities that are used to fulfill requirements for quality. Quality System : The organizational structure, responsibilities, procedures, processes and resources for implementing quality management. Quality Audit : A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. Defect : It implies the non-fulfillment of intended usage requirements. Specification : It implies the document that prescribes the requirements with which the product or service has to conform.

ISO : 9000 (IS 14000) Quality Management and Quality Assurance Standard
ISO Standard has given different models for adoption which relate to the state of the product or service at which the quality of the later needs assurance. This standard gives guidelines for the selection and use of appropriate model.

ISO 9001 : 1987 (IS 14001 : 1988) Model for Quality Assurance in Design/Development, Production, Installation and Servicing
A product or service has to pass through several stages after it is conceived and before it is supplied to the customer. Even after it is supplied to the user, a necessity may arise to keep a follow up action; so that the user does not face any problem or difficulties in using the product. ISO : 9001 standard gives a model of quality assurance at all stages starting from designing the product and continuing even after the product is delivered to the customer. ISO 9001 applies to industries who design, produce, install product and provide service after sale as per the requirements of the customer. Some specific examples are heat exchangers, coolers, filters, extraction columns etc. for process industries. In these cases the customer states his application and the supplier works out the final design, makes changes if required. A set of specifications is then prepared, after the design requirements are mutually agreed. The manufacturer has to open his manufacturing stages to the customer so as to enable the customer to judge the suppliers capability of manufacturing the product as per his requirements.

After the product is manufactured, and inspected for conformance with specifications it should be installed by the supplier at the customers premise s and trial run should be conducted. Even after installation, the supplier has to provide necessary services for maintenance of equipment for trouble-free performance.

ISO : 9002 : 1987 (IS :14002 : 1988) Model for Quality Assurance in Production and Installation
Some products require quality assurance only during production and till they are delivered to the customer/or installed in his premises. ISO : 9002 gives a model quality assurance for such products. In such cases the manufacturer gives his own design to meet customers requirements has only to prove the production process is capable of producing the product/equipment as per the requirements of the customer; and that the supplier can install the product/equipment at the customers premises satisfacto rily. Civil structures, construction of bridge etc. are the examples. So, this model is applicable where the assurance of quality is required only during production and upto satisfactory installation.

ISO : 9003 ; 1987 (IS : 14004 ; 1988) Model for Quality Assurance in Final Inspection and Test
Certain products require quality assurance only after they are manufactured i.e. at the time of supply. The customer is not concerned with how they are manufactured. He is interested only in getting the product of desired quality as stated by the supplier/or by him. ISO 9003 standard gives a model of quality assurance in such cases. Examples of such products are : domestic appliances, petroleum products, components used in the assembly of manufacture of bigger items such as automobiles etc. Most of the consumer items also fall in this category.

ISO : 9004 ; 1987 (IS : 14004 : 1991) Quality Management and Quality System Elements guidelines
ISO : 9001, 9002 and 9003 apply where a contract between supplier and contractor exists. In non-contractual situations companies may adopt ISO : 9004 which gives guidelines for quality management. It is essential to build confidence of the customer that the organization can supply the desired quality of products or service. The organization has to take several integrated steps in managing all matters which have direct or indirect effect on its image to deliver the products of desired quality. These integrated efforts of the organization towards maintaining the quality culture is Quality management. All these element of quality management taken together make the quality system. ISO : 9004 ; 1987 gives guidelines comprising different elements of a quality management system.

ISO : 10011-1 ; 1990 to 10011-3(1990) IS : 14011 Part 1 ; 1990 to IS : 14011 Part 3 : 1990 Guidelines for Auditing Quality Systems
The Quality system has to be checked from time to time for its proper functioning : It has to be adopted or modified to meet the demand of the time, otherwise the system will lose its effectiveness or fail to meet the requirements of time. It is also necessary to show to the users that the system is functioning well in its expected objectives. ISO : 10011-1 describes the rule of auditors, their responsibilities, the elements of auditing, executing the audit, reporting etc. ISO : 10011-2 deals with the qualification criteria for quality system auditors; their capabilities to perform the audit and their freedom from influence. It also gives guidelines for evaluating auditor candidates. ISO 10011 part-3 deals with establishment of audit function. It says that the management should establish a separate quality and function outside the quality system implementation.

Outstanding Features of ISO : 9000 Series of Standards

There are number of outstanding features about the ISO : 9000 series of quality assurance system standards. (1) The elements of ISO : 9000 quality systems are not new. Some or all the elements are always under practice by every organization in its business activities. The important features of ISO : 9000 are the integration of all activities which have a direct or indirect effect on the quality of a product or service. (2) These standards have been formulated by people who are conversant with the problems or failures which occur in industries. (3) ISO : 9000 standard series tells suppliers and manufactures what is requires of quality oriented working system. (4) It defines the basic concepts and species the procedures and criteria to ensure that the outgoing product meet the customers requirements. (5) There are no dictatorial clauses in the standards. In most cases it requires a company to establish its own procedures.

(6) The standards are designed to be user friendly. They are generic in nature, and follow a logical, easily understood format. They are applicable to every product, let it be a tooth brush or nuclear reactor.

Benefits by becoming an ISO : 9000 company

(1) ISO : 9000 series of standards enable to meet the requirements of an internationally uniform quality system. (2) If Indian industry adopts the ISO : 9000 standards, it would enhance foreign exchange. So it is important for the Indian industry to adopt ISO : 9000 to compete in the international market. (3) It enables the company to build customer confidence that it is capable of delivering the products or services of desired quality. (4) It reduces the need for assessment by multiple buyers. It thus avoids time and money spent on multiple inspection of products for conformance. (5) In our country some concessions for import have been given a per Export and Import policy of 1992-97 to the companies adopting ISO 9000 standard. (6) To adopt ISO : 9000 standards it is necessary to establish and maintain sound quality assurance system. This results in improvement in efficiency, and reduction in inspection; scrap and network. (7) Adoption of ISO : 9000 helps to enhance quality image of the company and gives a competitive edge over the other companies which do not have ISO : 9000 quality system. (8) Motivates the employees and develops pride in them for achieving excellence. (9) The suppliers not having registered ISO : 9000 quality system may be required to pay higher insurance premium or insurance coverage may be denied to them in some countries. (10) ISO : 9000 helps the company to :

-- Define clearly the need of the company. -- Specify the right components, processes, tools and equipments for the job. -- Distribute information to right people and at the right times. -- Achieve a system of management and control.

Disadvantages :
There are few disadvantages of ISO : 9000 series of standards. These are : (1) The implementation of ISO : 9000 series of standards is very much demanding on resources. The formulating and documenting of system is time consuming, and may involve considerable clerical expenses. (2) Assessment and registration are also expensive. (3) Unless carefully interpreted and planned, the system can become burdensome and expensive, quite often impending normal operations. (4) The need to change attitudes and accept new working practice may strain the management capabilities of the company beyond its ability to cope.

Steps to Registration
ISO standards are adopted by national standard Bodies of the individual countries. These bodies if mutually recognized by the countries, are the certifying or registering bodies. The following steps may be followed for ISO : 9000/IS : 14000 Registration. (1) Management commitment : The top management decision to start the implementation of ISO : 9000 standard in the company (considering the benefit that would be obtained) is the prime requirement. (2) Prepare the workmen for change (make sure about the workmen participation). It would be beneficial to arrange training, seminars/workshops on standards for the workers and also take their views and suggestions. This will help to ensure all employee participation and minimize the resistance to changr. (3) Selection of appropriate Model : The next step would be to study the models 9001 to 9003 and select the model which is applicable to the organization. The selection of the

model will depend upon the type of organization and the stage at which quality is to be achieved. (4) Study the selected model. Study each clause of the selected model carefully. List down the various elements required to be practiced to satisfy the clause. Study should be undertaken by atleast two experts having sufficient experience. (5) Set up Steering (Co-ordination) Group and subgroups. Obtaining ISO:9000 certification is the project with which every person working in the organization is concerned. The management may appoint different groups (2 to 4 members each)to identify the activities to be done and also to carry out the survey of the existing practice of quality assurance system. (6) Arrange training of Leaders and Co-ordinators. Training courses in the ISO:9000 standards would be necessary for the coordinators and group leaders in order to appraise them of their role and the contribution in the entire projects success. (7) Prepare a Check List. Prepare the check list analyzing the documents and categories the elements which are already in practice, which are in practice and need some changes and which are not in practice. (8) Prepare Corporate Quality Manual. Prepare a quality manual and other documents incorporating all the elements of the selected model, under each model to carry out actions, deligation of power and authority. (9) Prepare procedure manuals, operation manuals/work instructions. Prepare procedure manuals, operation manuals and work instructions in short, simple sentenceswith unambiguous words so that they are easily understood by all employes. (10) Update all drawings and specifications. All obsolete and irrelevant drawings should be withdrawn from the departments and vendors. All specifications must be thoroughly reviewed revised in the lighlt of market feedback to meet international standards and customer requirements. (11) Prepare schedule of training program and educate employees. An initial appreciation course regarding ISO: 9000 is a must for all employees. This will enable them about their important role and contribution in the entire project success. (12) Provide Tooling, Equipments, Facilities etc to meet standards. Prepare the list of tools, equipments, jigs, fixtures and other facilities required. Indicate the existing equipment which may be modified to meet the quality standards.

(13) Carry out Internal Audit. The next step is to carry out self audit to evaluate companys documented quality system, and also to ensure that all practices are followed and documents are available. (14) Take Corrective Action. Based on internal audit , correction regarding procedural requirement to meet the standards are made and the procedure is finalized and documented. (15) Apply for Trial/External audit. The next step is to apply to Bureau of Indian Standards or any other certifying body for a trial audit and get their recommendations. (16) Implement Recommendations. Implement the recommendations in any given by certifying body and include them in quality manual and audit check list. (17) Apply for registration. Once the trial audits result is positive, the organization is in position to apply for registration to BIS/ or any other internationally recognized body. Once the application has been accepted, the documented quality system will be examined by certifying agency to verify the conformance to the relevant standard. Discrepancies if any, will have to be corrected by the applicant. (18) Grant for License. The corrective action taken by the firm on the discrepancies observed during assessment will have to be verified by the BIS. Based on the findings of assessment team and satisfactory report, license will be granted to the firm by BIS/ISO to use the certification mark in letter heads, quality certificates etc. The certificate awarded is normally valid for 3 years. During the period of validity surveillance audits are conducted to ensure that the documented quality system is being effectively maintained. The certificate is to be renewed for a further period of 3 years if requirements are adhered to continuously.

India and ISO:9000

The Indian economy is progressively developing towards a free market-oriented economy. Indian industries have recognized the importance of the aspect like productivity, efficiency, quality and competitiveness for long term survival and entry in the global market. India has launched vigorous program for implementation of ISO:9000 in Indian organization, both in industrial and service sector. As a first step it adopted ISO:9000 series in 1989 (initially as IS:14000 series). During the last five years a considerable progress has been made, over 550 organization in the field of engineering, chemical, textile, food processing industries, testing laboratories, service organization and financial institutions have already obtained ISO:9000 certification. The government initiative to support and promote the quality programmes and encourage manufacturers exports to attain internationally accepted standards of quality for their products includes: (1) Quality Awareness Campaign: The government is assisting trade and industry associations to conduct a nationwide program on quality awareness and to promote the concept of TQM and ISO:9000. (2) Rewards and Benefits: The manufacturers who have acquired the IS/ISO:9000 or any other internationally accepted equivalent certification on quality systems are eligible for special import license in promotion to the value of the export. (3) Incentives for Small Scale Industries: The government of India has introduced in 1993-94 a scheme to encourage small industries to go for ISO:9000 certification. The scheme provides a monetory incentives of Rs 75000/- for small scale industries for getting ISO:9000 certification. (4) Upgradation of Testing Facilities: The central government assists the laboratories in their modernization to bring them upto international standards and to adopt ISO:9000 certification. In our country the following standard bodies provide guidance and consultancy in connection with adoption of ISO:9000 series standards: (1) Bureau of Indian Standards (BIS) (2) Confederation of Indian Industry (CII) (3) National Productivity Council (4) National Centre for Quality Management.

Statistical Quality Control by M. Mahajan Industrial Engineering and Management by Banga Sharma