What is standardization?

Table of Contents:

Introduction

1. The evolution of standardization

1.1 A brief history of the development of standardization

1.2 The emergence of international standardization

1.3 The evolution of quality standards

1.4 The evolution of standardization in Russia

1.5 Quality Management System (QMS)

2. Question: The function of a manual for the development and adoption of the system of quality meet the standard?

3. Task

Conclusion

Bibliography

Introduction

Standardization activities in the world today is aimed at implementation of the three socio-economic functions:

• ordering of objects (products, services), created in the process of scientific and technical creativity of human labor;

• establishing a normative documents on standardization of optimal organizational, technical, general engineering, technical and in-kind technical and economic standards and requirements;

• enforcement, that is, the use of and adherence to the best standards and requirements established in the regulations for standardization.

The main theme of this set of acts Evolution standardization.

The relevance of the topic due to the fact that the development of a market economy in Russia, empowerment and economic independence of business entities need to integrate Russia into the world economy has required appropriate to provide a legal framework for the formation of technical legislation, which is widely used in industrialized countries for the public regulation of the quality of products and services, providing a single mechanism for the implementation of state policy on standardization. These conditions can not be achieved without a clear knowledge of the stages of development of science and standardize the analysis of lessons learned from its use.

Adopted for the first time in our country the Russian Federation Law "On Standardization" establishes the basic provisions, principles, concepts, organization of work in the field of standardization, which are common and are mandatory for all government agencies, business entities (including individual entrepreneurs) regardless of their affiliation and ownership, as well as public organizations.

The provisions and requirements of the Act apply to the product manufacturers, vendors, providers of services (works), design, construction, transport and other organizations and businesses.

The law defines the measures of the government to protect the interests of consumers (individuals and industrial consumers), as well as the state as a whole, through the development and application of normative documents on standardization, establishing the optimal requirements for standardization objects - products, work (production processes) and services (services to the population and productive services), the order of the state control and supervision of compliance with the mandatory requirements of state standards.

The aim of this work serves the study of the evolution of standardization. Before operating the following basic tasks:

- Review and summary of the stages of evolution of science - standardization;

- The solution proposed in the task version of the problem;

- The answer to the practical question on the application of standards.

1. The evolution of standardization

1.1 A brief history of the development of standardization

Even in ancient Egypt used in the construction of permanent brick, a "standard" size, with this special officials engaged in the control of the size of bricks. Remarkable monuments of Greek architecture - the famous temples, their columns, porticos collected from a relatively small number of "standard" parts. The ancient Romans used the principles of standardization in the construction of water supply systems - pipes of the water pipes were a constant size.

In the Middle Ages, with the development of crafts standardization methods have been used more and more frequently. So, were established uniform dimensions width fabrics, the number of single strands at its core, even the uniform requirements for the raw materials used in weaving.

In 1785, French engineer LeBlanc made the party of gun locks - 50 pieces, each of which had an important quality - are interchangeable and can be used in any of the guns without first fitting. In the second half of the XIX century, the standardization work carried out on almost all industrial enterprises. Thanks to the in-plant standardization of manufactured products was made possible rationalization of production processes, the main goal, which in this case pursued entrepreneurs - obtaining higher profits. [1] Standardization has developed primarily within the individual companies and individual enterprises. However, in the future, as the development of the social division of labor, increasing the value of standardization began to acquire national and international lazhe.

In 1891 in England and later in other countries introduced a standard Whitworth thread (with inch sizes), later replaced in most countries of the metric thread. In 1846 in Germany were unified railway track width and coupling systems for cars, in 1869 there was first published reference book containing the size of standard profiles rolled iron. In 1870, a number of European countries were established standard size bricks. These are the first results of the national and international standardization had great practical importance for the development of the productive forces. However, these were only the first steps. In Germany alone, because of the presence on its territory of a large number of small states had, as Engels pointed out, as many types of weights and measures how many days per year.

The units were installed by chance: for example, "elbow" fit the length of the scepter of Henry I; widespread in many countries, a unit of length "foot" match the length of the feet of Charlemagne. The search for better decision units began long ago. So, in 1790 in France was established unit of length "meter", which is equal to a quarter of the length of the ten-millionth of a meridian. But it took 85 years before the first 17 states that participated in the International Metric Convention in 1875 in Paris, agreed to accept as a measure of the length of the meter. Metre Convention and the establishment of the International Bureau of Weights and Measures were important milestones on the road of scientific and technological progress. [2]

At the end of XIX century and early XX century, there have been major advances in the development of technology, industry and the concentration of production. In this regard, in most developed countries, developed a desire to established national standards, in most cases, culminating in the creation of national standards bodies. For example, in 1901 in England was established standards committee, whose main task was to promote the strengthening of the economic power of the British Empire through the development and implementation of standards for raw materials, industrial products, military equipment.

Reinforced the militarization of many countries in the early XX century demanded production of large quantities of arms with the necessary respect for the principle of interchangeability, this problem can be solved only by means of standardization. It is therefore not surprising that during the First World War and immediately after it was founded several national standards organizations, such as the Netherlands (1916), Germany (1917), France, Switzerland and the United States (1918) .

After World War standardization became more and more perceived as an objective economic necessity. At this time, standards organizations have been set up in Belgium and Canada (1919), Austria (1920), Italy, Japan and Hungary (1921), Australia, Sweden, Czechoslovakia (1922), Norway (1923 g), Finland and Poland (1924), Denmark (1926) and Romania (1928).

With the development of monopoly capitalism began to develop standardization and also internationally. The continuous expansion of the international exchange of goods and the need for closer cooperation in the field of science and technology led to the establishment of the International Standards Association (ISA). In 1939, the work was interrupted by the ISA World War II. [3]

In 1943, at the United Nations, the Coordinating Committee for Standardization with offices in London and New York.

In 1946, London was founded by the International Organization for Standardization (ISO), which included 33 countries. Currently, ISO is one of the largest international technical organizations (its members - 91 countries).

In addition to the ISO standardization work well under way, and in many other international and regional standards organizations. For example, in the framework of the European Coal and Steel Community was established in 1953 Coordination Commission of steel, which is mandated to develop the so-called European standards for the six countries (Germany, France. Belgium, the Netherlands, Italy and Luxembourg) are members of this association. At a meeting in Paris in March 1961 by representatives of national standards bodies of countries belonging to the European Economic Community, the European society of free trade, and to the Commission on the common market, established the Committee of European coordination of standards. The task of the Committee is to develop common standards for the countries of the European Economic Community and the European Society of free trade. As part of the Committee, there are many working groups, mainly in such industries as metallurgy, construction, textiles, shipbuilding, petroleum industry, etc.

1.2 The emergence of international standardization

Standards provide quality products and services and as a result - the quality and safety of our lives. With the development of human society continuously improved working lives. This manifested itself in the creation of various objects, tools, new working methods. In this case, people have sought to select and fix the most successful results of work with a view to their re-use. The use of the ancient world a unified system of measures building details the standard size, standard diameter water pipes - these are examples of standardization activities, which in modern scientific language is referred to as "the achievement of the optimum degree of order in a given area through the establishment of provisions for common and repeated use ... "[4].

In the Renaissance, in connection with the development of economic relations between states are beginning to be widely used methods of standardization. Thus, due to the need to build a large number of ships in the Venice began to assemble a gallery of pre-made parts and components (method was used unification).

During the transition to machine production were such impressive achievements of standardization, such as the creation of a Frenchman Le Blanc in 1785 50 gun locks, each of which was suitable for any of the guns at the same time made without first fitting (Example achieve interoperability and compatibility); in order to move to mass production in Germany at the royal arms factory has set the standard for guns, for which the latter was determined by the caliber of 13.9 mm in 1845 in England introduced a system of standardization of mounting threads, and at the same time in Germany was standardized width of railway track.

The beginning of the international standardization can be considered the adoption in 1875 by the representatives of 19 States of the International Convention for the metric and the establishment of the International Bureau of Weights and Measures. [5]

1.3 The evolution of quality standards

Having started thousands of years ago with the development of the "weights and measures" as the main characteristics of any object, the development of standards continues today, and will continue for as long as humanity will exist.

At first, standardization of quality covered only the territory of individual states, but with the development of international trade, the process spread over all the continents. Past thousand years, however, was not enough for humanity to completely shifted to a uniform system of weights and measures (feet, pounds, gallons, etc.). With the accomplishment of new scientific discoveries was sharply increase the number of used quality standards. Which began at the beginning of the last century, economic globalization is objectively demanded unification of all quality standards.

Scientific substantiation of standardization of forms of work organization brought manager Phil Taylor. His scientific work organization (MUSIC) based on the systematic study of the technical skills of the workers. That they were offered the concept of management, which includes a systematic approach, personnel management, the idea of ??the division of responsibility between the performers and managers to ensure effective and quality of the enterprise, the scientific work measurement. Principles MUSIC F. Taylor consistent quality management system of each individual product (service), as any company is interested in the maximum reduction of production of defective products or poor quality of services, as it does as the direct economic and reputational damage. In the first stage of theoretical development and practical implementation of quality control efforts have focused primarily on the final stage of production - quality control of the finished product. However, it soon became clear that it is necessary to control the quality of all processes.

The starting point in the development phase of a quality management system based on the process approach are considered works made in 1924 in the department of technical control of the company "Western Electric" (USA), Dr. Shewhart, in which he developed a method of charting now known worldwide as the "control Shewhart card. " Shewhart proposed statistical methods are given a managerial tool to focus not on the detection of unacceptable products before they are shipped to the buyer, and to increase the yield of products in the process.

U.S. scientists Edwards Deming and Joseph Juran in the 50's of last century, suggested to consider the improvement of quality as a cyclic process. The standard ISO 9001:2000 «Quality Management System. Requirements ", he is seen as a guiding principle of the quality management system. At the heart of any improvement process is a cycle PDCA (plan - planning, development processes; do - exercise, implementation processes; check - check, continuous monitoring of processes and products, and act - the action to continually improve processes). [6]

1.4 The evolution of standardization in Russia

The first mention of the standards in Russia marked the reign of Ivan the Terrible, when they were introduced to measure the standard caliber cannon - circling. Peter I, seeking to expand trade with other countries, not only introduced specifications, taking into account the increased demands of foreign markets to the quality of domestic products, but also organized a government commission brakerazhnye in St. Petersburg and Arkhangelsk. In the Commission's responsibilities included thorough quality control of exported Russian raw materials (wood, flax, hemp, etc.).

The strengthening of trade relations with neighboring peoples and market relations in the country demanded streamline Russian weights and measures. However, the Public Service of Weights and Measures was established only in 1845, after the adoption of the 1842 Regulation on weights and measures, according to which the entire country was introduced into Russian uniform system of weights and measures. Were the first samples Russian national measures - fathoms and the pound. At the same time created the first Russian metrological institution - Depot of Standard Weights and Measures, transformed in 1893 into the Main Chamber of Weights and Measures. (See Mendeleev). Its activities had two areas: metrology - to ensure the unity of action, the creation of reliable measurement methods and standards and Testing - Ensuring consistency and fidelity measures used in the country and measuring instruments. [7]

At the beginning of XX century greatly expanded the use of measuring tools, there was a complex test equipment. Home of Weights and Measures for the first time identified a rigorous procedure for the transfer of true values ??of the units of measurement standards to the measures and instruments outstanding. Cooperation with the metrological institutions of other countries contributed to the fact that in 1918 passed a Decree of the Council of People's Commissars "On the introduction of an international system of weights and measures" and the transition to a system operator International measures - as the basic units of measurement were adopted meter and kilogram.

The introduction of the metric system of weights and measures, and should be considered the beginning of the development of standardization in our country.

In 1925 he created the first central standardization body - the Committee for Standardization - the Council of Labor and Defense. The main tasks of the Committee have been guiding the work of the organization departments to develop departmental standards, as well as the approval and publication of standards. The category of standards - Standard-Union (OST). In 1926, the Committee has developed the first all-Union standards on selected varieties of wheat, iron, rolled ferrous metals and some consumer goods.

In 1940, the Central Committee of the Communist Bolshevik Party and the Soviet of People's Commissars decree of July 09, canceled the procedure for the approval of standards People's Commissariat People's Commissars of the USSR and was the All-Union Committee for Standardization. Instead of the core and a variety of industry standards has been introduced category - the all-Union State Standard (GOST). In the future, the All-Union Committee for Standardization has been transformed into the Committee of Standards, Measures and Measuring Instruments under the USSR Council of Ministers.

In 1968, in accordance with the Council of Ministers dated 01.11.1965 "On the improvement of standards in the country" for the first time in world practice has been developed and approved by the set of state standards "State Standardization System" (GHS). According to GOST 1.0-68 were introduced four categories of standards: National Standard of the USSR (GOST), the Republican standard (PCT), the industry standard (OST), Factory (STF).

A significant milestone in the development of standards was the decision of the Council of Ministers dated 07.01.1985 "On the organization of standardization work in the USSR." In that ruling, the main task of standardization has been named the development of a system of technical standards defining the progressive product requirements, regulations, ensuring its development, production and application, as well as control over the proper use of this document [8].

The decision of the Council of Ministers dated 25.12.1990 ? 1340 "On improvement of the standardization organizations" are defined tasks in the translation of the economy to the market economy and its integration into the global economy. The decree implemented the basic concept of the state system of standardization, the main idea of ??which, bringing the national standardization system in line with international practice. The main provisions of the regulations are: the establishment of standards in the two categories of product quality requirements - mandatory and recommended (refer to the mandatory requirements governing safety, environmental friendliness, interoperability and compatibility of products), and the transition to the direct application of state standards as the international and national standards of foreign countries if the requirements of such standards meet the needs of the economy.

Education in 1992, the independent states of the former Soviet Union required a search for new forms of cooperation between these countries in the field of standardization, metrology and certification. The governments - the CIS countries, recognizing the need for this in a harmonized technical policy, signed March 13, 1992 Agreement on coordinated policy in the field of standardization, metrology and certification. [9] In accordance with the Agreement was created by the Interstate Council for Standardization, Metrology and certification, the task of which included the organization of standardization (and Metrology and Certification) at the international level. The signing of the Agreement, the subsequent development of national standards of Russia marked the beginning of the formation of the Russian system of standardization.

The outstanding event in the history of standardization was the adoption in 1993 of the RF Law "On Standardization", which defined the measures of the government to protect the interests of consumers through the development and application of normative documents on standardization. With the introduction of the Act was changed from a general obligation to standards established by the legislation of the USSR, the standards contain both mandatory and recommended requirements. This trend continued after 10 years in 2003 began the transition to a fully voluntary standards.

For the period 1992-2001. characterized by the following directions of development of the Russian system of standardization: the development of the interstate standardization in accordance with the Agreement of 13.03.1992, activation of work on the harmonization of Russian and international standards in relation to the necessity to develop the international market and the preparation for accession to the WTO a priority the development of national standards for products and services subject to mandatory certification, implementation of ISO 9000 and the establishment of national quality systems that meet these standards.

The 2002-2003 period. 27.12.2002 was marked by the adoption of the Federal Law "On Technical Regulation" and its entry into force on 01.07.2003. The adoption of this law marked the beginning of the reorganization of the system of standardization, which is necessary for Russia to join the WTO, and the elimination of technical barriers to trade. [10]

1.5 Quality Management System (QMS)

In the English version - Quality Management System. Two options are available to the Russian translation of the same with a different meaning: a system of quality control and quality management system. While the first meaning is clear in the second, the inevitable question arises: quality control of what? The final product or service? Or activity of the enterprise? Assuming that the QMS - a tool for achieving a high quality of enterprise management in order to obtain the desired outcome, ie customer satisfaction quality of the manufactured product or service, then semantically correct translation would be "a system of control (management) quality . " This version includes both the achievement of quality standards for the final product satisfying the consumer, and the introduction of quality management.

The concept of "quality" in the QMS is multi-faceted. It includes the quality of economic calculation, process equipment and technology enterprise, environmental performance, social and psychological relations, ethical, legal relations, etc. In this case, the dominant, of course, is the quality of the final product. The main target of the QMS installation, built on the basis of ISO 9000 - quality assurance required by the customer, and providing it with evidence in the company's ability to do so. The basic principle of the QMS is the principle of continuous improvement, without which the system will quickly die off.

The main requirement of the QMS, established in accordance with ISO 9001, reads: "documents what you do, do what is documented." If you violate this requirement, the quality management system will cease to function, because the company is not able to confirm that actual procedures documented.

The standard requirements provide a general framework that allows to establish procedures, standards and indicators of customer satisfaction. In addition to providing assurance to the consumer, the QMS can be used for the following purposes:

· Providing a general framework for coordination and communication between departments;

· Improving the efficiency and effectiveness of processes;

· Identify problems and focus on the needs of customers;

· Achieve the desired quality and support products and services to meet the stated needs of the customer;

· The creation of a basis for improving the performance of both the individual employee and the company as a whole. [11] QMS, implemented in the company's ISO 9001 in one country and is comparable to the quality management system based on the same standard as in the other country. Such comparability brings definite advantage to enterprises.

2. Question: The function of a manual for the development and adoption of the system of quality meet the standard?

The function of a toolkit for the development and implementation of quality system fulfills the standard ISO-9000:

1) 9004

2) 9001

3) 9000

Briefly reveal the contents of ISO 9000.

MS ISO 9000-1: 94 "Total Quality management and quality assurance standards. Guidelines for selection and use."

The standard has the introduction, defines key terms, and provides an interpretation of the treaty or contractual conditions and the types of standards. ISO 9000 contains the basic principles of the policy management and quality assurance. He explains the relationship between the various concepts in the field of quality and defines the rules for the use of the three models presented in ISO 9001, ISO 9002 and ISO 9003.

The main objectives of the organization in the field of quality assurance are:

· Achievement, support, and commitment to continuous quality improvement;

· Continued satisfaction of all installed and expected requirements of customers and other stakeholders. Every enterprise (organization) has five stakeholder groups tab. 2.1

• ensuring internal management and other employees that quality requirements are performed and maintained, and that there is an improvement of quality;

· Ensuring consumer confidence, and other stakeholders in the achievement of quality requirements;

· Provide assurance that the requirements of the quality system are performed.

Table 2.1. Interested persons

Interested persons

Typical requests or queries

Consumers

Quality of products

Employees

Career and job satisfaction

Owners

Indicators of investment

Subcontractors

The possibility of continuous business

Society

Responsible management

In this case, the standard MS ISO 9000-1 provides guidelines for choosing the quality of the system, which is required, depending on the action. For example, the criteria that must be considered when choosing a system are the complexity of the design process, completion of the project (as determined by testing or use of products), the complexity of the production process (can be used to develop new processes, their number, variety, etc.) product characteristics, environmental factors, etc.

MS ISO 9001-94: "Quality systems - Model for quality assurance in design, development, production, installation and servicing."

Standard specifies requirements for a quality system, which apply if the contract is concluded by the two parties, the supplier needs to demonstrate the ability to design, develop and deliver products. This model is the most rigid of the provider.

MS ISO 9002-94 "Quality Systems. Model for quality assurance in production and installation." The standard specifies requirements for a quality system, which apply if the contract concluded between the two parties, the supplier must demonstrate their ability to delivery of the products developed by the project. This model is intermediate in terms of the requirements of the supplier.

MS ISO 9003-94 "Quality Systems. Model for quality assurance in final inspection and test."

The standard specifies the quality system requirements that apply if the contract concluded between the two parties, the supplier must demonstrate the ability to control and final test to decide on the acceptance of the final product. This model is the least hard for the supplier.

The requirements specified in ISO 9001, ISO 9002 and ISO 9003 are in addition to the technical requirements established for the products. These standards establish the requirements that determine what elements should be included in the quality system. However, not all quality system will consist of all of the proposed elements. In some situations, they can be adapted by adding or removal of certain requirements of the quality system. As the name of the ISO 9000 series, companies that implement a quality system may include in it all the stages of the product life cycle, from design (development) and ending with its operation (ISO 9001), or only some of them, such as quality control the final product (MS ISO 9003).

In other words, if the model is ISO 9003 means: "Imagine me proof that the supply meets the requirements set forth," that according to the standard ISO 9002, "Prove to me that your production machine will allow you to perform the required delivery", and ISO 9001: "Prove that you can oversee the delivery of the required since its development."

ISO 9001-9003 standards called the "contract." They are normative in nature, in contrast to the recommendation of ISO 9000-1 and 9004-1, and are intended for external goals of the enterprise.

International Organization for Standardization ISO standards stipulated revision 9000, every four years, with a view to updating them. In 1994 he published the second version of the ISO quality system for 9000-94. By this time, the number of enterprises certified their quality system to meet these standards in the world has exceeded 500 thousand

To date, the ideology of quality management ISO 1994 version no longer meets the requirements of the modern market. The basic concept of the review and preparation of ISO 9000-2000 is their convergence with the ideology of TQM, since an effective quality system to meet the present requirements of the market are integrated in this concept.

In February 1999. Technical Committee 176 (ISO TK/176) was completed the second revision, the MS ISO 9001-2000 (ISO / PSK 2 9001:2000). The official publication of the third edition of ISO 9001 to replace the second. One of the highlights of the changes is to put in order and association standards for ease of use. Will be withdrawn standards ISO 9002-94 and ISO 9003-94, due to their inclusion in a new version of the standard 9001-2000, the organization formerly used the above standards, it is recommended to use the ISO 9001-2000 "by limiting the scope, excluding certain requirements . "

Attention is drawn to the fact that the changed name of the standard 9001-94. Now, instead of "Quality Systems. Model for quality assurance in design, development, production, installation and servicing" he said, "the quality management systems. Requirements." As you can see, the name dropped the term "quality assurance". This is due to the fact that the standard sets out requirements aimed not only at ensuring that the quality of products and (or) services, but also includes the need for the organization to demonstrate its ability to achieve customer satisfaction.

MS ISO 9004-94 as revised and presented in a new version of ISO 9004-2000 "Systems of quality management. Guidelines for the implementation of improvements." Both of the above-mentioned standard designed to work together, but they can also be applied as stand-alone documents. The structure of these standards is the same, but different scope.

ISO 9001 - establishes the requirements for the quality management system, applicable as a means of ensuring conformity of production and (or) services, and can be used for certification purposes.

ISO 9004 - provides methodical assistance on all aspects of the quality management system in order to improve the overall quality performance of the enterprise (organization). However, it is not intended as a guide to compliance with ISO 9001.

3. Task

The value of dielectric strength insulating metal produced on the first plant is 4 kV / mm, the second - 5. The base value of this parameter is 6 kV / mm.

Calculate the relative indicators of quality.

The indicator of product quality - is a quantitative characteristic of one or more properties of the products that make up the quality of products, considered in relation to the specific conditions of its creation, use or consumption.

The range of consumer characteristics and indicators of the quality of products (PS and PEP) - a set of properties and parameters that determine the satisfaction of real or perceived needs. Each species has its own range of products characterized by quality indicators, which depends on the destination of the products. In this multi-purpose product range can be very large. The indicator of product quality can be expressed in different units (eg, km / h, hours between failures), points, and can also be dimensionless.

In the case of a linear dependence between the values ??of evaluation values ??and consumer indices, as indicated in the task are subject to the following formula:

Q = Pb/P1, P2 ... Pn

wherein q. - The value of the i-th evaluation of the relative quality index.

When using pre-built grading scales first determine the value of the quality index of consumer goods being valued, and then on a scale - the value of this parameter estimation and its semantic interpretation.

According to the problem we are given three values:

Basic - 6 kV / mm

The plant number 1 - 4 kV / mm

The plant number 2 - 5 kV / mm

Thus, when calculating the relative performance reference value is taken as 1. Using the above formula calculates the relative indicators of quality with respect to the base:

The plant number 1. = 4/6 = 0.7

The plant number 2 = 5/6 = 0.8

After calculating the relative quality indicators will be as follows:

Basic - 1

The plant number 1 - 0.7

The plant number 2 - 0.8

Conclusion

Many sectors of the Russian economy are forced to go through an external path that took decades in other countries. The pharmaceutical industry is no exception. However, even a very limited time can not undo the required sequence. The first step you need to take a retail link in the pharmaceutical industry is the widespread implementation of the Quality Management System based on the standards ISO 9000:2000, after which (or, at best, in parallel with it) will be possible to apply national standards of good pharmacy practice, yet to be developed.

Creating a uniform approach to the issues of quality assurance, eliminating differences and harmonization of requirements at the international level has been assigned to an international standards organization ISO. International Standards ISO 9000 appeared in the late 80s. The application of these standards on the quality system developed by the Technical Committee (ISO / TC 176), subsequently became one of the most effective ways to address the problem of ensuring the quality of products (works, services) in enterprises (organizations).

In Russia, the three standards, namely, ISO 9001, ISO 9002, ISO 9003 was adopted as the national as GOST 40.9001-88, GOST and GOST 40.9002-88 40.9003-88. (Effective from 1 January 1989). Russian State Standard Resolution of 17.07.96 ? 460 on the basis of the revised ISO standards introduced GOST R ISO 9001-96, ISO 9002-96, ISO 9003-96. Quality assurance model set out in the above standards are three distinct forms of quality system requirements, suitable to demonstrate its capabilities and supplier evaluate these opportunities outside parties. On the basis of ISO 9000 and 9004 (not received the status of national) experts developed recommendations on the application of the above standards.

Fundamental standards of ISO standards are set - ISO (9000-1, 9001, 9002, 9003, 9004-1, 8402).

MS ISO 9000-1: 94 "Total Quality management and quality assurance standards. Guidelines for the selection and application" contains the basic principles of the policy management and quality assurance, explains the relationship between the various concepts in the field of quality and defines the rules for the use of the three models shown in ISO 9001, ISO 9002 and ISO 9003. The standard provides guidance on the choice of the quality system, which is required, depending on the action.

MS ISO 9001-94: "Quality systems - Model for quality assurance in design, development, production, installation and servicing" sets the requirements for a quality system, which apply if the contract is concluded by the two parties, the supplier needs to demonstrate the ability to design, develop and supply products. MS ISO 9002-94 "Quality Systems. Model for quality assurance in production and installation" specifies requirements for a quality system, which apply if the contract concluded between the two parties, the supplier must demonstrate their ability to delivery of the products developed by the project. MS ISO 9003-94 "Quality Systems. Model for quality assurance in final inspection and test" specifies the quality system requirements that apply if the contract concluded between the two parties, the supplier must demonstrate the ability to control and final testing to address the issue of acceptance final product. In the MS ISO 9004-1-94 "Quality management and quality system elements. Guidelines" addresses all elements of the quality system.