Concerning the issue of quality management, an initial model has to be accepted. This model divides the management cycle into a sequence of activities performed according to the structure called Deming's Circle, after its author E.W. Deming.

The set-up divides the cycle called PDCA into several stages: plan, do, check and act. The first stage determines new targets and new tasks for the employers. The second stage ensures resources for the completion of the planned tasks. The third stage consists in controlling the tasks realized according to the plan. The last stage incorporates necessary corrections made if the tasks have not been completed in accordance with the plan. The PDCA cycle ends with the achievement of the assumed goals and it begins anew by the specification of new targets at the same time.

ISO 9000

The most popular ISO management standard is the ISO 9001 quality management system. The third revision of the ISO 9000 series of standards appeared in Poland in Sept. 2001. This version was based on a translation of the European EN ISO norms which are identical with the international ISO standards. It was introduced precisely 270 days after the European Committee for Standardization (CEN) accepted the standard as European.

The process of establishing the standards proceeded as follows:

ISO International Organization for Standardization - ISO 9001:1987,
ISO 9001:1994 (9002, 9003), ISO 9001:2000

CEN European Committee for Standardization - EN 29001:1987, EN ISO 9001:1994 (9002, 9003), EN ISO 9001:2000

PKN Polish Committee for Standardization - PN-EN 29001:1993, PN-ISO 9001:1996 (9002, 9003), PN-EN ISO 9001:2001

Along with the PN-EN ISO 9001:2001, specifying the requirements concerning the quality management system, the PN-EN 9000:2001 standard was introduced in order to comply with the requirements of customers and to increase their satisfaction. It has replaced the PN-ISO 8402:1996 standard. ISO 9000 describes the basics of quality management systems and specifies the terminology concerning quality management systems.

Another standard available, which was issued by PKN a little later than ISO 9000:2000 and ISO 9001:2000, is ISO 9004:2000. Its aim is to improve an organization's functioning and to ensure the satisfaction of customers and other interested parties.
Before this, activities were based on the 20 requirements of the PN-ISO 9001:1996 standard, for which proper procedures were established. They described the systems functioning in companies in a relatively detailed way, but did not take mutual interrelations into account. The current amendment of ISO 9001:2000 encourages companies to accept a process approach when establishing, introducing and improving the quality management system to increase customer satisfaction.

To function efficiently, an organization should identify processes and manage them. One benefit of such an approach is the fact that it ensures constant control over connections between particular processes and over their combination and mutual interaction.

In addition to the ISO 9001 quality management system, other systems are also becoming increasingly popular, which stems not only from current trends.

ISO 14000

The standards of the 14000 series, incorporating requirements concerning environmental management systems, were published in 1996.
The formulation of the requirements was similar to that implemented in the case of ISO 9000. The management methods and techniques are similar and only the goal has changed.

The most significant elements stressed by ISO 14001 include the obligations of constant improvement, consistency with legal regulations in force, internal management concerning environmental protection, preventing pollution in all areas of the natural environment such as air emissions, sewage discharge to the water, waste disposal, soil contamination, natural resource utilization, impact on society and other environmental issues.

The ISO 14001 standard consists of five basic requirements. These include general requirements, environmental policy, planning, introduction and functioning, checking and correcting as well as control by the management. The standard can be applied by all kinds of organizational units: production, service and trade units. They include city administration offices, county offices, schools, institutes, transport-logistic companies, sewage and water utilities, heat generation utilities, sewage plants and hospitals. Moreover, ISO 14001 is proactive, which means that its main purpose is to prevent negative impact on the environment through predicting hazards. The purpose of the environmental management system is also to constantly improve the efficiency of activities performed for the sake of the environment.

A less popular system connected with environmental management are the EMAS requirements, similar to ISO 14001, which function in the European Union.

PN-N 18000

Work safety and hygiene (BHP) can be defined as the state of working conditions and the organization of work, as well as workers' behavior which prevent dangers occurring in the work environment. The purpose of the PN-N 18000 standard is to support activities promoting improvement in BHP. The BHP management system is a subsystem of the organization's management system. It incorporates aims, structure, principles of procedure, responsibility and processes, describing them and the methods and tools necessary for
introducing and sustaining the system.

The PN-N 18001 standard issued in 1999 describes a BHP management system consistent with Polish regulations. The model is designed on the basis of the British BS 8800 standard, as an international standard has not yet been established. Analyzing its requirements, one should consult the Labor Code, detailed regulations and EU directives. The structure of this standard is very similar to that of the ISO 14001 environmental management system.

BS 8800

In 1996 the British Institute for Standardization published the standard BS 8800 "Guide to occupational health and safety management systems," incorporating directives for systems managing health protection and work safety. These are meant to help organizations establish an approach towards health and safety management which would protect employees and others from a company's harmful activities. The directives incorporated in the standard are based on the general principles of good management and were established in such a way as to make the integration of health and safety management with the general management system easier.

As in the case of EMAS environmental management, other systems can also be distinguished in health and safety management, like OHSAS, fulfilling the British requirements of BS 8800 or the German safety management system based on the requirements of the Safety Certificate Contractors (SCC) list identical with the requirements of PN-N 18001. These requirements are also a basis for conducting certifying audits.

GMP

The Good Manufacturing Practice (GMP) standard makes use of experiences gathered in the domain of storage, processing and consumption of food, supported by scientific research. The current requirements connected with GMP concern every factor which may influence the hygiene and safety of a product in the process of manufacturing, and thus also influence the quality of the ready-made food product. The requirements are first of all connected with:

-the construction of production facilities and other buildings and structures
-the equipment, machines and other production devices
-the quality of the raw material, intermediate products and additives
-the production technology
-the personnel's qualifications and training
-the implemented methods of quality control

The GMP principles were formulated in the early 1970s for the needs of the pharmaceutical industry and later the food industry in the United States. The requirements were acknowledged by the American Food and Drug Administration (FDA). They were also written into the Codex Alimentarius, established by FAO/WHO. The codex incorporates general requirements of hygiene and safety of food products. In Western countries, numerous commercial contracts are signed with regard to the provisions of Codex Alimentarius. Products not complying with the minimum requirements set by the codex usually are not accepted for the market.

HACCP

Depending on individual needs, we have three (very similar) HACCP standards. These are:

-Codex Alimentarius Annex to CAC/RCP1-1969 Rev. 3 (1997) Amd. 1999
-the Dutch standard called Criteria voor het toesten van een operationeel HACCP-systeem: CCvD-HACCP September 1998
-the Danish DS 3027 E:1997 standard entitled "Ensuring food safety in accordance with HACCP-the requirements that have to be fulfilled by food manufacturers and their suppliers".

The Hazard Analysis Critical Control Point (HACCP) system constitutes a supplement of the GMP method, mainly during the manufacturing process. It is a preventive system. The critical control points are those in the manufacturing process which may, in case control over them is lost, cause the risk of danger to health.

The HACCP system was introduced in the 1960s in the U.S. in the course of work on the design and production of food for astronauts, due to the cooperation of institutions such as The Pillsbury Co., NASA (National Aeronautics and Space Administration) and the U.S. Army Research Laboratory. The aim was to obtain food entirely free from pathogenic microorganisms. The HACCP method was presented for the first time in public in 1971 by Pillsbury Co. at a conference devoted to food protection. Soon after, the provisions of HACCP were used by the American Food and Drug Administration (FDA) to specify the conditions for the production of low acidity food. With time, the HACCP standards were introduced in many sectors of the food industry.

The principles of a system of danger analysis and critical points control in the processes of product manufacturing, were formulated under the patronage of the Federal Safety and Inspection Service (FSIS) for the meat and poultry industries, and under the patronage of the National Marine Fisheries Service for the fish processing industry.

The HACCP system, due to its significance and efficiency, quickly became popular throughout the world. In the U.S. it was acknowledged as the obligatory system. In Europe it was recommended for implementation in 1994 by a special directive of the European Communities (EEC directive 93/94) concerning the hygiene of food products. From 1995 all food companies functioning in the area of the European Community have been obliged to introduce the system.

GLP

The Good Laboratory Practice (GLP) is a consequence of the realization of the Good Manufacturing Practice program. A food manufacturer, without reliable and regular research carried out by a company laboratory, is unable to realize the reasons for shortcomings connected with the quality of food and cannot be sure that the manufacturing process is proceeding correctly with respect to technology and quality. The operation of the laboratory, according to Good Laboratory Practice, concerns not only the control of food products and process supervision, but also the examination and control of raw materials.

The principles of Good Laboratory Practice were established by a group of experts (chemists and biochemists) working for the Organization for Economic Cooperation and Development (OECD). Representatives of many countries and experts representing the European Communities' Commission, the World Health Organization and the International Organization for Standardization participated in the formulation of the basis of Good Laboratory Practice.

Laboratories operating in accordance with GLP principles can obtain proper accreditation, thanks to which the results of their research will be acknowledged internationally. The accreditation can be granted only to a laboratory which, apart from obeying the GLP principles, operates in compliance with the general criteria of the operation of laboratories specified by the EN-45001 European standard.

QS 9000

The requirements of the QS 9000 quality system were established and introduced by truck manufacturers. Quality System Requirements QS-9000 have been formulated on the basis of the ISO 9001 standard issued in 1994, supplemented with additional requirements specific to the automotive market and to the characteristic features of the requirements' authors, i.e. the Big Three car manufacturers-Chrysler, Ford and General Motors.

QS 9000 is applicable to all internal and external suppliers (manufacturing materials, elements used in the process of manufacturing or in services, application of metallic layers, heat treatment, painting, application of chromium layers and other kinds of surface treatment) of units of the mentioned corporations as well as other companies which will accept the standards as the foundation of their quality management systems. There are also specific requirements concerning the suppliers of tools, machines and other equipment.

ISO/TS 16949

After a longer period of efforts, an international standardization of the requirements towards suppliers in the automotive market has been accomplished. On the basis of the QS 9000 standard, a new set of requirements has been established which also takes into account the requirements of the following qualification standards for automotive industry suppliers-EAQF (France), VDA 6.1 (Germany) and AVSQ (Italy).

According to ISO representatives, the new standard called ISO/TS 16949 "Quality systems for suppliers of the automotive market" is a significant step in the unification of requirements connected with quality management in one of the most powerful industries. The system was established at the initiative of the IATF, which decided to charge the technical group ISO/TC 176-the International Organization for Standardization with the task of formulating the requirements. The standard was acknowledged in 1999 as the first ISO standard of its type to concern a particular sector of the economy.

The main purpose of setting the new standard was to establish a uniform platform of requirements in the automotive market and to have it acknowledged both in the European market and by the three American manufacturers: Chrysler, Ford and General Motors.

EN 46000

In 1996 the standards called EN 46001 and EN 46002 were established by a joint coordinating team of CEN/CENELEC in cooperation with CEN/TC 205 "Inactive medical products", CENELEC/TC 62 "Electrical devices used in medicine", CEN/TC 140 "In vitro diagnostics" and the "Joint Working Group for implantable active medical products."
The standards of the EN 46000 series include detailed requirements concerning suppliers of medical products and they supplement the general standards of the ISO 9000 series. They should be applied only together with these standards. Only then do they fully determine the requirements posed towards quality systems with regard to medical products. They incorporate all the principles of Good Manufacturing Practice (GMP) which are usually followed in the manufacturing process of medical products.

TL 9000

In the U.S. in 1996, at the initiative of the main operators active in the North American telecommunications market, a voluntary association of representatives of operators and suppliers of equipment and services was formed under the name Quality Excellence for Suppliers of Telecommunication (QuEST) Leadership Forum, in order to modify the ISO 9001 standard to the needs of the sector. The first effect of the activity of the representatives of various
areas (operators, equipment and service providers and cooperating organizations) was the issuing of a new standard called TL (Telecommunication Leadership) 9000 towards the end of 1999, as well as the issuing of 2.5, Quality System Requirements-Book 1 and Quality System Metrics-Book 2. A complete novelty in the TL 9000 (TL 9000 Quality System Metrics-Book 2, Release 2.5) model in comparison with ISO 9001 is the fact that the model has specified metrics concerning the products supplied, divided into hardware metrics, software metrics and services metrics.

The TL 9000 (TL 9000 Quality System Requirements, Book 1, Release 2.5) set of requirements is based on the complete ISO 9001 set of requirements. The QuEST Forum, as the author and publisher, has supplemented each paragraph of the ISO 9001 standard (there were 20 paragraphs in the 1994 edition) with additional requirements in order to make it fully useful to the sector. In addition, the authors of TL have added one more element entitled "Quality Improvement and Customer Satisfaction". There are several possibilities of certification/registration of companies fulfilling the TL 9000 requirements, depending on the range of the company's operation in the market, including:

-TL 9000-H Hardware Quality System Requirements & Hardware Metrics
-TL 9000-S Software Quality System Requirements & Software Metrics
-TL 9000-V Services Quality System Requirements & Services Metrics
or any combination of these items.

Complying with the requirements and metrics, including the obligation to report to the UTD (University of Texas, Dallas), is a necessary condition for certification/registration by certifying/registering units accredited by the QuEST Forum. At the beginning of 2001, the QuEST Forum issued the TL 9000 Release 3.0 edition based on the new edition of the ISO 9001:2000 standard.

TQM

An increasing interest in TQM, though still largely in the form of a subject discussed at conferences, seminars and in publications, can be observed, which means that there is a growing awareness of the fact that the success of a company or organization depends on lasting customer satisfaction.

What is TQM? There is not a single commonly used description for Total Quality Management, which is called management through quality, comprehensive quality management, total quality management etc. Noriaki Kano, a Japanese expert, defines TQM as a systematic recognition of customers' demands as being very important, based on scientific grounds and concerning the whole company. Another way of describing TQM is through its five principles, including the engagement of managers (leadership), focusing on customers and employees, concentrating on facts, constant improvement and general involvement.

Total Quality Management is a management system directed towards people, aimed at continually improving customer satisfaction while constantly reducing real costs. TQM is a comprehensive systemic approach and an integral part of high-level strategy, rather than a selected area or program. The system operates horizontally across functional units and departments, engaging all employees, and it spreads in both directions outside the company, in order to include the company's chain of supplies and distribution. TQM stresses training and adaptation to a process of constant change as key to an organization's success.

The Total Quality Management attitude is philosophical in character. It is also a scientific method. TQM concerns systems, methods and tools. The system allows for changes, but the philosophy remains unchanged. TQM is also based on qualities emphasizing the dignity of the individual and the power of joint activity.

It is difficult to provide an explicit definition of TQM and to classify the definition-say whether it is a method, a tool, a concept, a management system or a philosophy. It will also be hard to determine whether someone has already implemented TQM. Thus, it is best to refrain from analyzing various management concepts while talking about TQM , as it is perceived as a whole range of principles and methods. The best advice is to draw models from the place where TQM was born, i.e. Japan, and from its authors-W.E. Deming and J. Juran.

Professor Stanisław Tkaczyk
Bogdan Malinowski, M.Sc.

Orgmasz- The Institute of Organization and Management in Industry