Handbook of Healthcare Quality & Patient Safety Girdhar J Gyani, Alexander Thomas
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1Introduction to Healthcare Quality Management
CHAPTER 1 Fundamentals of Quality
CHAPTER 2 Evolution and Journey of Quality in Healthcare
CHAPTER 3 Quality-driven Strategy: Role of Leadership

Fundamentals of QualityChapter 1

Girdhar Gyani,
Suresh Lulla


It has never been easy to define quality. It is more of perception, which can vary from person to person and from one context to another. For many, it is ART and for others it is SCIENCE or may be it is mix of the both. Today, Quality drives the strategy of many business houses. It is a subject which is taught from school to undergraduate and at postgraduate level. There are large number of doctoral level dissertations, which show the kind of interest in the subject of QUALITY. We attribute quality to product, process, system, organization or even to a nation. The chapter covers this complex subject starting from evolution to where we have reached.
The term “Quality” means different things to different people. For technical people, they would like to evaluate quality by way of conformance to the specified requirements as provided in a given standard or as specified by client organization. Quality on the other hand when viewed by customer or user is more of perception. One may go to a restaurant and like the food. On next visit, even if restaurant serves the same quality food, he/she may say that food served on last visit was of better quality. This kind of perception gave birth to definition, which says—Quality means, satisfying customer on continuous basis. This means quality cannot be static. It is dynamic and should keep on improving on continuous basis. Quality, at times, is also defined as Value for Money. Here again it is linked with the perception of an individual, but at the same time it brings important aspect of cost or affordability. Definition by Dr Juran, which says—Quality means fitness for purpose. For example, a car which is designed to be robust is quality car for road full of potholes, whereas a sophisticated/low floor car will not serve the purpose on such roads and hence not a quality car.
The International Organization for Standardization (ISO) 9000:2000 standards define quality as “degree to which a set of inherent characteristics fulfils requirements”. The requirements in this definition could be specified by the supplier, by the customer, or may also be legal. Looking from the customer's perspective, this definition simply means that a product must have features, which meet customer's needs and thereby provide customer satisfaction. Yet 4another simpler definition says—Quality means, satisfying/delighting customers on a continuous basis. Here onus has been put entirely on the supplier to keep on assessing the customer's needs (which are dynamic) and make sure that products/services take care of such needs. Mere conformance to specifications may not match the customer needs and hence quality departments cannot relax by declaring that their products conform to the specifications. They need to continuously lookout and assess the varying needs or aspirations of the customers and incorporate them in their products.
Quality can be attributed to a product, a process, or even to an organization. A quality organization will have an established network of quality processes to deliver the quality products. Even within an organization, every process will have a supplier and a customer, which are termed as internal supplier and internal customer. Likewise it may have external suppliers and external customers.
An organization can be broadly viewed as the process shown in the Fig. 1.1. An organization consists of departments/functions. One department receives goods/services from another department and similarly it feeds its output to another department, before it finally goes to external customer. A quality organization is one, where internal supplier/ customer relationship is treated at par with what is done with external supplier/ customer. The process shown in the central block is designed based on the requirements projected by the internal/external customer.
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Figure 1.1: Customers, suppliers and process relationship
Quality can be qualitative, quantitative or both, and hence it is described on the basis of domain under consideration. For example, a quality health care would mean correct diagnoses, good communication, informed consent, respect for patient's rights and finally patient's safety. An airline service would require on-time performance as basic criteria. Similarly a catering service would need to demonstrate hygiene followed by courtesy. A good academic institution would need to demonstrate effective teaching-learning process capable of delivering competency based education.
As a step towards achieving external customer delight, all companies should know the names of their principal external customers. Their purchase departments are likely to be the focal points for material, component and product purchases. But do we know who else within these businesses might assess your performance as a supplier? If the business is quality driven then their quality team might be monitoring the quality of the goods we supply to them, or the response times for service calls. If they are dissatisfied with our performance, they are likely to look for another supplier. Their goods inwards department may have needs about when and how goods should be delivered. Their production department may have needs relating to interchangeability of items. Their finance department will have needs concerning the address and content of our invoice. Liaison with their marketing team might even yield an opportunity for the joint development of products to our mutual advantage. Each of these customers 5may influence the decision to purchase goods or services from us. It is important to understand the needs of all the groups within our customer's organization that influence its purchasing decisions. Only then will we be able to try and satisfy their needs.
Meeting the external customer's needs requires two major steps:
  • Identify the external customer's needs
  • Ensure that internal processes result in meeting external customer needs at minimum cost.
This can be accomplished by using the quality planning process—quality function deployment (QFD). QFD is a planning process as opposed to a tool for problem solving or analysis. The customers' wants and needs are the inputs to the matrix (Fig. 1.2, Quality Map 1). QFD essentially forces an organization to get in touch with the people who use its products.
There is a complete linkage running from every customer, through the needs of that customer, the features of the product to meet those needs, the process features required to deliver that product, and the controls used to ensure performance as planned.
Customer needs may be divided into two categories:
  • Hard needs—Those needs which must be met by the delivered product or service. They are often specified in the contract, and may include size, weight, color, texture, functions, reliability, packaging, labeling, delivery times, cost and payment arrangements, customer support required, response time to failure, etc. These are the basic needs for each product or service. They are the minimum customer needs which must be met if a product is to be considered satisfactory.
  • Soft needs—These relate to the perception given to the customer of the sort of company they are doing business with. These factors convey a message to customers about whether they are welcome or just a nuisance. Are they kept waiting? This indicates to customers that you believe your time is more valuable than theirs! It is the little things that show you really care for your customers, and the effort you make will generally be well received. Examples of factors which may influence this impression may include telephone response, reception and lift area, building maintenance, correspondence, on-time meetings, speedy admissions, etc. These are customer needs that are often overlooked, but which can make a lasting impression.
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    Figure 1.2: Quality map 1Source: Quality planning and analysis
    Every individual within the organization who makes any contact with people outside the organization creates an impression of the organization. The business has to demonstrate that it is committed to quality and customer satisfaction.
A reputed international hotel chain had, over the years, built a loyal customer base through successfully meeting the soft needs of its customers. Amongst the several soft needs were “warm welcome” and “fond farewell”, in the technical language of the hotel. A few years ago, a new management team set about creating extraordinary efficiencies in their hotel chain operations. This entailed measuring cycle times for reservations, check-in, check-out, room service, laundry service and so on. Other hard needs were also addressed, with remarkable results, but at the cost of not meeting the soft needs that had originally built a reputation for the chain. A recent customer survey at its New Delhi property revealed that loyal customers missed the “warm welcome” during check-in. They valued the friendship of the hotel more than the seconds saved in check-in time. As a result, these customers are now, actually, fence-sitters. The hotel chain is acting on the lessons learned.
In another example, customer service training at the Sheraton is not just for the company's guest service attendants (GSAs). Sheraton trains everyone—from room attendants to internal staff members—to believe that when colleagues treat each other as customers they will have the energy and momentum to treat external customers well. They obviously believe that customer focus is the basis for quality leadership.
Quality is a timeless concept. It has been an inherent part of the human society, right from their creation. Somewhere down the line, we began to identify quality only with the manufacturing sector and accordingly link the quality evolution with the industry. Today, the clock has taken a full turn and quality is an inseparable entity in everything we do, and hence it has truly become a way of life. Going by the literature, the quality movement originated with the work of artisans and craftsmen. The goods made by them were priced on the basis of their quality or the reputation of the individual artisan/craftsman who created it. The competition among them soon resulted into formation of craftsmen unions called guilds. During the late 13th century, these guilds began to formally look into establishing specifications for the finished products as well as evolving the appropriate methods for their inspection and testing.
Quality through inspection: The industrial revolution began in Europe during the mid-eighteenth century and gave birth to factories that soon outperformed the artisans and the guilds. The craftsmen became factory workers, and the quality was managed through the skills of craftsmen, and supplemented by in-house supervisory inspection which is 7termed as ‘first party inspection’. Late in the nineteenth century, the United States broke the European tradition and adopted the concept of Taylor system of scientific management by separating planning from execution. The emphasis on productivity had a negative effect on quality. To restore the balance, a central inspection department came into being. For example, the Hawthorns Works of the Western Electric Company employed 40,000 people in year 1928, out of which 5,200 people were in the Inspection Department.
Emergence of Quality Management: During World War–II, the European and American industry was faced with the added burden of producing enormous quantities of military products meeting their stringent requirements of time and quality. It saw emergence of new concepts in organizational management, including “Quality Management”. Some of the pioneering work done in “Statistical Quality Control” in 1920s by Bell Telephone Laboratories (Dr Shewart) and within Hawthorn Works of Western Electric Company (Dr Deming and Dr Juran) got immense boost during and after World War-II and this led to the formation of American Society for Quality Control (ASQC). The post-World War-II period witnessed dramatic developments of quality management tools and their applications in different organizations. Most of companies converted their Inspection Departments to the Departments of “Quality Control”, or “Quality Engineering”, or “Quality Assurance”, which provided for planned and systematic actions required to ensure adequate confidence to a customer that a product or service would satisfy the given quality requirements.
Cost of Poor Quality
Car makers and television manufacturers, banks and hospitals, airlines and couriers, electricity boards and municipalities—they all afflict us with poor quality. We add to this by our own frequent failures to do things right the first time in our personal lives. The burden that poor quality imposes on society is probably incalculable. When companies are asked what poor quality costs them, they guess around 3% or 5% of sales. But when they actually calculate their costs they find it more like 20 to 30%.
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Figure 1.3: Costs of poor quality elements
  • Costs of poor quality (COPQ) consist of:
    • failure costs
    • appraisal costs
    • prevention costs
  • COPQ = 20% of sales (conservative estimate)
  • Profit = 10% of sales (optimistic estimate)
  • Strategic Goal: Double profit by halving COPQ, with no capital investment.
According to Dr Juran, costs of poor quality can be generally classified into four broad categories (Fig. 1.3).
  • Internal failure costs: Scrap, rework, failure analysis, re-inspection, retesting, avoidable process losses, downgrading
  • External failure costs: Warranty charges, complaint adjustment, returned material and concessions
  • Appraisal costs: Incoming inspection and testing, in-process inspection and testing, final inspection and testing, product 8quality audits, maintaining accuracy of testing equipment and evaluation of stocks
  • Prevention costs: Quality planning, new-product review, process control, quality audits, supplier quality evaluation, and training.
Prevention costs are incurred to keep failure and appraisal costs to a minimum.
The quality initiative in India was originally in the hands of artisans, until the independence. During the post-independence period, especially during the 1960s, the departments of space, atomic energy, and many public sector undertakings (PSUs) started quality initiatives in the form of inspection and quality assurance activities. The PSUs, which had collaboration with Japanese companies, imported some of the Japanese quality management concepts, such as quality circles, quality plans, and verification activities for assuring product quality. Such industries realized that the quality had to be built into at the design stage and inspection alone of the final product was just not good enough. At an institutional level, the Quality Circle Forum of India was perhaps one of the first institutions set up in the 1980s, where quality circle competitions were organized. The International Quality Circle Convention, headquartered in Japan, also recognized the Quality Circle Forum of India.
Quality Initiatives by the Manufacturing Sector: The quality initiatives largely originated in the manufacturing sector in India during early 1980s. These efforts got boost through various industrial associations, viz., Confederation of Indian Industry (CII), Associated Chambers of Commerce (ASSOCHAM), and Federation of Indian Chambers of Commerce and Industry (FICCI). Quality movement at CII owes its origin to activities undertaken by a group of industrialists at Nashik to carry forward the agenda on productivity and quality. They formed a study circle to understand Ishikawa's 7-steps of problem-solving process. This exercise resulted into a number of success stories. In the mid-1980s, the Nashik group organized a number of seminars to publicize the initiative taken by them, wherein Carbon Corporation played a major role. Hindustan Aeronautics Limited, located at Ojhar (Nashik), lend active support to the quality initiatives of the group, besides formalizing the same within its own complex, involving manufacturing and overhauling of MIG series of military airplanes.
Creation of Total Quality Management Cell at CII: Bharat Heavy Electricals Ltd (Hyderabad) took major initiatives on quality in their plant, which resulted in formation of Quality Circle Forum of India in April 1982, with its headquarters at Hyderabad. The forum played a key role in creating country-wide awareness on Quality among people at the shop floor level in the industry. This caught the attention of organizations like the Steel Authority of India Limited (SAIL), Maruti Udyog Limited (MUL) and Confederation of Indian Industries (CII). During April 1986, Prof Ishikawa was invited by the CII to address a gathering of industrialists, wherein he advised them to develop the Indian way of total quality management (TQM), just as there was a Japanese way. This resulted in a decision to set up a TQM division in CII in 1988. Impressed by Prof Ishikawa, Sundaram Clayton initiated a long-term collaborative program with the Japanese Union of Scientists and Engineers (JUSE), implemented TQM in the organization, and finally claimed the Deming Prize in 1998.
After the creation of TQM division in CII 1988, twenty founder companies launched the TQM programs in their organizations. 9However, at that time the environment was still highly protected and companies did not see great merits in making a change toward a “fact and data-based management approach” that was propagated as the key characteristic of TQM. Prof Miyauchi and Prof Washio from JUSE conducted a 2-week seminar on “Train the Trainer” in 1991, where about fifteen Indian companies participated. This seminar provided adequate competence to the companies on seven steps of problem solving, use of statistical methods, application of TQM in all functions including materials, production, pre-production planning, design, marketing, and market research. Some of the lessons learnt from this program triggered many success stories.
Quality and Economic Reforms: The year 1991 proved to be a major milestone for giving the requisite push to quality movement in India. This year marked the formation of European Union with twelve European nations joining hands in business. The erstwhile USSR, which was an important trade partner of India, disintegrated during the same year. This year also witnessed the crisis of economic breakdown in terms of balance of payment, an important event. This brought in the era of economic reforms by way of liberalization and opening of economy. These three events pushed the Indian industry to have a serious look at quality as one of the key business parameters. Industries made big leap from protected environment to open environment, driven by the market competitiveness.
The Role of ASSOCHAM: The Associated Chambers of Commerce and Industry of India (ASSOCHAM), one of the oldest apex level chambers of commerce body in India, started quality initiatives in a formal manner in the year 1992. A separate TQM division was formed with the responsibility of creating awareness on quality among its members. Initially, their activities were limited to implementation of ISO 9000, but soon the activities in the emerging areas like Lean Manufacturing and Six Sigma, etc. were also introduced. The TQM division was responsible to conduct range of activities like awareness programs, seminars, workshops, and specialized training programs related to various aspects of quality. In order to raise the quality performance of small scale industries this division also engaged in conducting special programs through the support of Government agencies. The TQM division of ASSOCHAM offered expert services to various industries to launch, develop, enhance, implement, and maintain quality initiatives and management of change. It also assists various companies to improve their performance through a wide range of quality-related programs (like lean manufacturing, Six Sigma, etc.) to ensure that their products and processes meet international standards.
The Role of FICCI: The Federation of Indian Chambers of Commerce and Industry (FICCI) came into being in 1927 on the advice of Mahatma Gandhi. The history of FICCI is very closely interwoven with that of the India's freedom movement. FICCI inspired economic nationalism as a political tool to fight against discriminatory economic policies. That commitment, drive, and mission continued in the ever-changing economic landscape of India. In the knowledge-driven globalized economy, FICCI worked for quality, competitiveness, transparency, accountability, and business-government-civil society partnership to spread ethics-based business practices and to enhance the quality of life of the common man. FICCI established Quality Forum in 1991 to assist the Indian industry to attain world standards through consultancy and training. 10FICCI Quality Forum has close collaboration with many International agencies on various quality-related matters, which include:
  • Indo-Norwegian Project sponsored by The Norwegian Agency for Development Cooperation for promotion of the concept of QMS in Small Scale Industries (SSI) in India.
  • Asia Invest Program of European Union for implementation of food safety system with the application of Hazard Analysis Critical Control Points principles.
  • The United Nations Industrial Development Organization (UNIDO) Project for training and development in the area of environment
  • The United Nations Industrial Development Organization (UNIDO)- Government of India (GOI)-The Federation of Indian Chambers of Commerce and Industry (FICCI) Joint Business Program for the development of selected sectors with respect to quality management
  • FICCI Quality Forum's partnership with American Society of Quality for certification of the quality professionals.
The Role of National Productivity Council of India: National Productivity Council of India (NPC), established as an autonomous body under the Societies Registration Act, 1958, had a tripartite character, which is reflected in the 75-member council and 25-member governing body, where Government, industry and labor have equal representation. The NPC, with its headquarters at New Delhi, has twelve regional directorates, two regional offices and two training institutes. It provides training, consultancy, research and information in the areas of productivity, industrial engineering, pollution prevention and control, human resource development and various other related fields including quality. NPC established TQM division in early 1990s with a mandate to provide consultancy and training in various aspects of quality including QMS (ISO 9000), 5S, Kaizen, quality circles, and Seven QC tools, etc. India is a founder member of the Asian Productivity Organization, Tokyo and NPC was nominated by the Government to coordinate its programs in India. These include workshops, surveys, seminars and training.
Establishment of Indian Institute of Quality Management: Year 1993 marked the launch of Indian Institute of Quality Management (IIQM) under the standardization, testing, and quality certification (STQC) program of the Government of India under support from GTZ. STQC and GTZ collaboration which came around in the year 1982, with the setting up of a network of regional test laboratories in the country to provide test and calibration support to the Industry. Under this program numbers of scientists were trained on TQM at UK during the period 1988–1992. This expertise was transferred to IIQM which provided training on quality management standards (ISO 9000, ISO 14000, OHSAS 18000), laboratory quality systems (ISO 17025), and quality technology (Statistical process control, Six Sigma), etc. to about 1500 engineers/managers every year. The institute also trained assessors for the laboratory accreditation program of National Accreditation Board for Testing and Calibration Laboratories (NABL). The institute, in collaboration with BITS, Pilani, launched MS program in QM, which was partly conducted through distance learning. Over the years IIQM came to be known as center of excellence in imparting training in all the areas of quality management and quality technology.
Adoption of ISO 9000 Series of Standards: ISO 9000 series of quality assurance standards were released in the year 1987. This series of standards were developed with the participation of more than a 100 countries 11through a consensus-based approach, leading to a much wider acceptance amongst the trading partners. The European Union, with a view to become a ‘single common market’, evolved a consensus to use these standards as non-tariff barriers for imports into Europe. These barriers, along with the Government of India's thrust on exports, provided an impetus to the Indian manufacturers to widely adopt ISO 9000 series standards. Even if it did not act as a significant deterrent, many companies reported to have gained advantages in entering the export market after getting certified to ISO 9000.
Creation of Quality Council of India (QCI): Quality Council of India (QCI) was created in the year 1997 as an autonomous non-profit organization to establish the National Accreditation Structure, jointly by the Government of India and the Indian Industry, represented by the three premier industry associations, Associated Chambers of Commerce and Industry of India (ASSOCHAM), Confederation of Indian Industry (CII) and Federation of Indian Chambers of Commerce and Industry (FICCI). It was a landmark event as accreditation was needed to facilitate international trade, by overcoming non-tariff barriers on account of technical regulations, standards and procedures for conformity assessment.
In addition, QCI was mandated, among others:
  • To promote, coordinate and implement a national quality initiative for building confidence in products and services and for improving competitiveness of Indian industries
  • To raise quality consciousness in the country through national quality campaigns, conducting seminars and other forms of promotion; and by promoting business excellence through, e.g. quality award schemes, holding competitions, etc.
In short QCI is perceived to facilitate in building quality culture in all walks of life. QCI has launched series of initiatives to improve and institutionalize Quality in Public Services, Health and Education. These initiatives, in time to come, will have bearing on national quality.
Quality on the National Agenda: Looking at the impact of quality and conformity assessment, the Planning Commission, Government of India, for the first time constituted a working group on Quality, Certification and Conformity Assessment with QCI holding the secretariat of the group. Quality was formally on the national agenda of the eleventh Five-Year Plan (2007–2012) drafted by the Planning Commission, Government of India.
In the present globally competitive environment, it is not just sufficient to achieve quality at any cost; it is necessary to achieve quality at a competitive cost to sustain the market forces. In this context, establishment of quality management system (QMS) provides a right framework for the organizations to harness their capabilities, direct their efforts to achieve the intended business results, and provide a basis for long-term growth and survival. The QMS is commensurate with the benefit, cost, and risk considerations of an organization. The key objectives of QMS are to have effective management of internal processes to:
  • Enhance customer/stakeholder satisfaction
  • Sustain business competitiveness, and
  • Increase bottomline results and profitability with optimum use of resources.
The approach to develop and implement a QMS consists of several steps, as shown in the Fig. 1.4.
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Figure 1.4: Implementation of quality management system
The need to have structured approach in managing system for quality resulted in development of an international set of standards, which came to be known as ISO 9000 series of standards.
Quality by Second Party Inspection: During World War-II, the United Kingdom faced a serious problem of accidental detonations in weapon factories that supplied ammunitions to the armed forces. To handle this problem, the UK's Ministry of Defence evolved guidelines, wherein it was essential that the supplier writes down the procedures for making a product, ensure that their workers strictly follow these procedures, and carry out internal inspection of their work. Finally, the complete method of working was inspected by a Government representative from the Ministry of Defence to ensure that only a quality product comes out of the factory for supplying to the forces. This was a small beginning for the evolution of the concept of control and inspection, which ensured that the quality is maintained and the products meet the desired specifications. This method of control was designed to ensure consistency of output. Quality became associated with “conformance” and “quality assurance”, and implied that the conformance has been assured through inspection.
MIL-Standards (USA) and DEF Standards (UK): Development of quality standards reflected the desire to shift the burden of inspection by the Government inspectors (second-party inspection) to quality assurance guaranteed by the supplier. In 1959, the United States developed “Quality Program Requirements”, their first quality standard (Mil-Q-9858a) for military procurement, which laid down what the suppliers had to do to achieve conformance. By 1962, the NASA Space Program also developed “quality system requirements” for their suppliers. In 1968, NATO adopted the Allied Quality Assurance Procedures (AQAP) specifications, the standards for procurement of NATO equipment. British Ministry of Defence released the Standards as ‘DEF–STAN 05–20 series in 1969. By this time, the idea of quality assurance had spread beyond the military domain. In 1969, the UK's Central Electricity Generating Board and Canadian Ontario Hydroelectric Organization developed their own quality assurance standards for their suppliers.
In 1966, the UK Government led the first national campaign for quality and reliability and evolved a slogan “quality is everybody's business”. At this time, suppliers were being assessed by their customer, 13which was thought to be a wasteful effort, as it unnecessarily consumed resources. In 1969, Colonel GW Raby chaired a committee to prepare a report on the inspection and assessment of the UK's military quality systems. This committee's report reinforced the idea that suppliers should take the responsibility for quality assurance and recommended that their methods should be assessed against the generic standards of quality assurance. This opened the door to the “third-party inspection”, which also led to the creation of assessing organizations and made many Government (second-party) assessors redundant.
British Standards for Quality Assurance: In response to many problems that were occurring in their new electronics industry, the British Standards Institute (BSI) published their first Quality Assurance Standards—BS 9000 in 1971, A Guide to Quality Assurance—BS 4891 in 1972 and, Guidelines for Quality Assurance—BS 5179 in 1974. These early documents were only guidelines and hence were not suitable for specifying the customer's requirements or for the assessment of a supplier's quality system. This led to major purchasing organization producing their own contractually binding versions of quality assurance measures. Such multiple assessments led to the demand for a single national standards and thus the BS 5750 – series of Quality System Standards were evolved in 1979. The key industrial bodies agreed to drop their standards and instead use BS 5750 standards, which provided a common contractual document to control their industrial production.
ISO 9000 Series of Standards: Following the lead taken by the UK, many national quality system standards were introduced in various parts of the world. Many of these standards were copies of the British Standards, with certain modifications. Increase in the global interest in “Quality Management Systems” resulted in the ISO developing and publishing the ISO 9000—Series of International Standards on Quality Management System in 1987.
The International Organization for Standardization
The Geneva-based International Organization for Standardization (ISO) is a worldwide federation of national standards of bodies, comprising approximately 130 countries. The role of this organization is to promote the standardization-related activities to facilitate the international exchange of goods and services. Initially, it started its activities in the electromechanical field and its forerunner was the International Electrotechnical Commission (IEC), which was created in 1906. In addition, the International Federation of the National Standardizing Associations (ISA), which was created in 1962, undertook other pioneering work, primarily in the field of mechanical engineering. The World War-II interrupted their work. Subsequent to a meeting of 25 countries in 1946, a new international organization was created with the objective of facilitation of the international coordination and unification of industrial standards. ISO was duly formed and started functioning from February 23, 1947, as a non–government organization to develop cooperation in the spheres of intellectual, scientific, technological, and economic activities. Based on the consensus among the member countries, this organization publishes the international standards.
Quality Standards ISO 9000:1987
Initially, the Quality Standard ISO 9000:1987 (1987 version) had the same structure as that of 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. This document 14heavily drew from numerous documents in use all over the world. Although these standards have now gone through two more iterations, resulting in some radical changes, all the core prevention-oriented quality assurance requirements are same as those present in the 1987 document. The first version of the standard was influenced by the then existing US and other Defence Military Standards (MIL SPECS) and hence it was more accessible to manufacturing sector, and well-suited to the demands of a rigorous, stable, factory-floor manufacturing process (Fig. 1.5). With its structure of twenty 'elements' of requirements, the emphasis was on conformance with procedures rather than the overall process of management, which was the actual intent.
Quality Standards ISO 9000:1994: The Standard ISO 9000:1994 (the 1994 version) was an attempt to break away from certain practices, which had somewhat corrupted the use of the ISO 9000: 1987 Standards. It also emphasized quality assurance via preventive actions, and continued to acquire evidence of compliance with documented procedures. Unfortunately, the earlier companies implemented its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy.
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Figure 1.5: Evolution of ISO 9000 series of standards
Quality Standard ISO 9000:2000
The Standards ISO 9000:2000 (the 2000 version) made a radical change in thinking by including the concept of “process management”. Documents produced by the ISO Technical Committee, which drafted the 2000 version of standards, made it clear that they did not see any change in the essential goals of the standards, which had always been about “a documented system” not a “system of documents”. The goal was always to have management system effectiveness via process performance metrics. The third version made this more visible and thus reduced the emphasis on having documented procedures, if sufficient evidence could be presented to show that the process was working well. Expectations of continual process improvement and tracking customer satisfaction were made explicit in this revision. Unfortunately, too many organizations continued to produce reams of unnecessary documents and to write quality systems around the paragraph structures of ISO 9001 rather than analyzing their business processes and building systems around the process flow of the organization.
The ISO 9000:2000 series of standards provide sound base for total quality management. The quality management approach in these Standards encourages organizations to analyze the customer's requirements and define the processes that contribute to the achievement of a product that is acceptable to the customer. It calls for transition away from managing procedures toward process management and in organization that must answer the following questions:
  • Whether they have clearly defined what the organization's objectives are and how they will measure and review the success of achieving these objectives?
  • Whether they have evaluated the impact of these objectives on the interested parties, the stakeholders?
  • Whether they have designed the critical, end-to-end processes necessary to deliver the objectives?
  • Whether they have assessed and provided the resources, skills and competence to make the processes work?
The model of process approach illustrates generic Quality Management System, on which ISO 9000: 2000 series of Standards, works. The model recognizes that the customers play a significant role during the process of defining requirements. Satisfaction measures are used as feedback to evaluate and validate whether requirements have been met.
Structure of ISO 9000:2000 Series of Standards
The ISO 9000:2000 series of Quality Standards basically comprise the following three Standards:
  • ISO 9000: 2000 Quality Management Systems—Fundamentals and Vocabulary
  • ISO 9001:2000 Quality Management Systems—Requirements
  • ISO 9004:2000 Quality Management Systems—Guidelines for Performance Improvements
The ISO 9000:2000 Standard defines the principles and fundamental concepts and terms used in the ISO 9000 series of standards; ISO 9001:2000 defines the requirements where an organization needs to demonstrate its ability to provide products and services that meet customer and regulatory requirements and aims to enhance the customer satisfaction. ISO 9004:2000 provides guidelines for improving the performance of organization and enables them to satisfy all the interested parties. Of these only ISO 9001:2000 is being used for contractual and certification purposes. There is yet another related standard, which is taken as a member of the extended family of ISO 9000 series, i.e. ISO 19011:2002. This standard provides guidelines for quality and/or environment management systems auditing.
The ISO 9000:2000 standard has now been revised and published as ISO 9000:2005 document. This has been done to align with the terminology relating to audit used in ISO 19011:2002.
These are the Standards, which the desiring organizations should implement for their “certification”. About 250 requirements of the ISO 9001 can be condensed into the following 5 linked requirements. ISO 9001 basically requires the organization to:
  • Determine the needs and expectations of customers and other interested parties
  • Establish policies, objectives and a work environment necessary to motivate the organization to satisfy these needs
  • Design, resource and manage a system of interconnected processes necessary to implement the policy and attain the objectives
  • Measure and analyze the adequacy, efficiency, and effectiveness of each process in fulfilling its purpose and objective
  • Pursue the continual improvement of the system from an objective evaluation of its performance.
The focus, therefore, is on the results and the processes that produce these results. This means that there has to be a link between the needs of the interested parties, the organization's objectives, the processes for achieving these objectives and the results being produced.
The ISO 9000 series standards are re-visited and revised every 4–6 years. Present version in use is ISO 9000:2008.