Standardization of quality requirements.

Levels of standardization and types of standards.

Standards are developed and used due to the fact that the relevant circles of society (manufacturers, consumers, trade) face problems that require common solutions. Standards are based on generally recognized results of science, technology and experience.

A standard is a document issued and approved by an official body for permanent use, containing guidelines, rules or specifications aimed at ensuring optimum results.
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Classification of standards in accordance with the levels of standardization.

Standardization (development, approval, adoption and publication of standards) is carried out at the following levels:

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  Companies (enterprise standard).
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  Groups of companies (standard of concern).
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  Ministries (industry standard).
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  National (for example, the national standard of Ukraine DSTU).
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  Regional (for example, European standard EN).
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  Interstate (for example, within the CIS).
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  International (international standard ISO).

Standardization at the level of companies, groups of companies applies only to products manufactured in a particular enterprise or group of enterprises. The standard is developed by an enterprise with the following objectives:

1. 
   Installation and declaration of increased requirements compared with the requirements adopted by competitors.
2. 
   Regulation of internal requirements, streamlining processes and operations.
3. 
   Guarantees to consumers.

^ National and industry standards. National standards are developed by national standardization bodies (in Ukraine Gosstandart), Industry standards are developed by relevant ministries and departments. Industry standards are developed for products in the absence of state standards or, if necessary, establishing requirements that exceed or supplement the requirements of national standards. Standardization at the national and sectoral levels is carried out with the following objectives:

1. 
   Meeting the needs of society in development through the adoption of uniform requirements based on the latest achievements of science and technology.
2. 
   Protection of consumers ' health and life, environmental protection , protection of domestic producers.
3. 
   Acceptance of international requirements to eliminate technical barriers to trade.

^ International and regional standards are adopted respectively by international and regional standardization organizations. International standardization is aimed at facilitating trade and industrial relations in the world, which is especially important when global international markets are emerging, such as the Single European market, the North American market, and the Asia-Pacific market. Regional standardization is aimed at protecting the interests of a particular region. In particular, standardization in Europe (regional standardization) is aimed at meeting the needs of the European Single Market.

Within the state, only national standards are in circulation. An international or regional standard is not required to be included in the national standards compendium. Each country decides on the adoption of an international or regional standard as a national one.

^ A harmonized standard is a national standard that conforms to a standard developed by an international or regional standardization organization.
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Standards of mandatory and voluntary use

There are standards of mandatory and voluntary use.

Standards for mandatory use contain mandatory requirements regulated by law. Health and safety of consumers, labor safety in the production process, environmental protection, product compatibility depend on the compliance of entrepreneurs with the mandatory requirements of standards. In addition, the requirements of mandatory standards protect consumers from poor quality products in cases where there are no competing offers on the market. Obligatory requirements of standards are subject to unconditional implementation by the executive state authorities, all enterprises, their associations, institutions, organizations and citizens - business entities whose activities are subject to the standards.

Mandatory requirements include:

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  Requirements that ensure the safety of products for the life, health and property of citizens, environmental protection.
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  Requirements that ensure compatibility and interchangeability of products and requirements for methods for measuring these indicators.
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  Safety and occupational health and safety requirements in accordance with current sanitary norms and rules.
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  Metrological norms, rules, requirements and regulations that ensure accuracy and uniformity of measurements.
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  Provisions that ensure technical unity during the development, manufacture, operation of products.

Standards of voluntary use contain requirements of a recommendatory nature. The statement of compliance with the manufacturer’s standards of voluntary use is used to achieve the following objectives:

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  Increased confidence in product quality and market expansion.
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  Eliminating competition from manufacturers who use standards with lower requirements.
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  Supporting the image of the company, providing advertising and increasing sales.

If the manufacturer has decided to manufacture products (provide services) in accordance with the requirements of the standard of voluntary use, then after a corresponding declaration, standards of voluntary use become mandatory for use. The requirement to apply standards of voluntary use can be negotiated. Deviations from the standards stipulated by the contract lead to a break in the contractual relationship, loss of reputation in the market. Thus, the recommended requirements of standards are subject to unconditional implementation if:

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  Manufacturer / supplier / products made a statement about the compliance of products with these standards;
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  These requirements are included in the contracts for the development, manufacture and supply of products;
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  This is provided for by current legislation .

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International standardization.

The issues of development, adoption and publication of international standards are dealt with by international standardization organizations. There are two equal international standardization organizations, differing by area of ​​activity:

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  ISO - International Organization for Standardization (International Standard Organization)
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  IEC - International Electrotechnical Commission (International Electrotechnical Commission).

The International Electrotechnical Commission (IEC) was established in 1906 in London at a conference of representatives from 13 countries. The prototype of an international organization for standardization (ISO) - the international federation of national associations of standardization was established in 1926. The federation was transformed into a UN standards coordination committee in 1944, and then into a modern ISO in 1946. With the creation of ISO, IEC joined the ISO on autonomous rights, maintaining independence in financial and organizational matters and cooperating on a voluntary basis. In 1993, changes were made in the structure and organization of ISO work aimed at accelerating the development of international standards and improving the organization’s activities due to radical changes in economic and political spheres, as well as increasing requirements for international standardization from the market.

International standardization organizations are civil law associations under Swiss law. Territorially, the IEC and ISO secretariats are located in the same building in Geneva. On the general issues of standardization, ISO and IEC are consistent. The interests of each individual country in the field of standardization are expressed through its official representative.

Detailed information on ISO activities, international standards in various fields can be obtained via the Internet at http://www.iso.ch/.
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International Organization for Standardization

The main objective of ISO is to develop international standards and actively promote their voluntary adoption and use to achieve the highest possible level of industry and trade efficiency throughout the world.
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The main activities of ISO.

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  Development and publication of international standards in all areas of technical and economic activities (with the exception of electrical engineering and electronics).
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  Promotion of the adoption of international standards by national standardization systems.
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  The international cooperation.

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Composition ISO:

At present, 120 countries are members of ISO, and its activities are connected with 500 international organizations. Some of the CIS countries, including Belarus, Ukraine, Turkmenistan and Uzbekistan, are among the new members of ISO. ISO has 185 technical committees. The main ISO bodies are the General Assembly, the Council and the Executive Bureau (committee). In Fig. Figure 1 shows the ISO structure and the color highlighted ISO committees, in which Ukraine is represented by Gosstandart .

The Council (see Fig. 1) consists of 18 representatives of member committees. Five of them are assigned automatically from among those who occupy the first five places in the ranking of the ISO. Now it is DIN (Germany), AFNOR (France), ANSI (USA), BSI (United Kingdom), JISC (Japan). The remaining 13 Council members are elected at the ISO General Assembly for a term of 2 years. The secretariats of ISO technical bodies are 34 countries (Germany - 20% of the secretariat, Great Britain - 18%, the United States and France, 13% each).

Leading firms seek to have secretariats in their field, regardless of financial costs, which allows them to transform their national standards into international ones with the requirements that these firms have already mastered and, thus, profitable for them to participate in the international division of labor.



Fig. 1 ISO structure
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International Electrotechnical Commission (IEC)

The main objective of IEC is to develop international standards in the field of electrical engineering and electronics and actively promote their voluntary adoption and use.
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Composition IEC:

Members of the IEC are 41 national committees. These national committees are national standards organizations. These are mainly industrialized countries, as well as a number of developing countries. In these countries, 80% of the world's population lives, *** consuming 95% of world electricity production and using almost 90% of all electronics and electrical products.

The structure of IEC technical bodies is the same as ISO, that is, technical committees (TC), subcommittees (PCs), working groups (WGs). In IEC there are more than 85 TC, 114 PCs and more than 600 WG. An average of 15 to 25 countries participate in the activities of each TC.

The vast majority of TCs and PCs are headed by European countries and, above all, France, Germany, the United Kingdom, members of the European Union (EU), which has an important technical, commercial and economic advantage for these countries.
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European standardization

Objectives of European standardization:

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  Coordination of national standards in the member countries of the European Union;
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  Unified adoption by EU member states of international standards;
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  Development of common European standards in areas where international standards are not adopted.

The solution of issues of standardization within the EU is carried out by equal European standards organizations, differing in the field of activity:

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  CEN - European Committee for Standardization (Comite europeen de normalization);
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  CENELEC - European Committee for Standardization in Electrical Engineering (Comite europeen de normalization en electrotechnique).

European standardization organizations, like the relevant international standardization organizations, are civil law associations according to Belgian or French law . Each country has only one official representative who expresses all the interests of this country in the field of standardization. When coordinated at the European level (especially when adopting European standards), representatives have votes weighted according to their economic level. The number of votes of each country of the European Union is presented in Table. one . The European Union countries have the same number of votes in the Council of Ministers of the European Union - the EU legislature. The prescriptions of the Council of Ministers of the European Union are equivalent to the laws of the partner states. It also includes one representative from each of the 18 governments.

Tab. 1 The number of votes of the member states of the European Union taken into account when coordinating issues at the European level.

The functioning of the internal European market is largely based on European standards.

^ The policy of European rationing commissions is the adoption of international standards as a basis (mostly unchanged) when developing European standards.

European standards according to the regulations of the European Commissions should be translated into national collections of standards of the European Union Member States without changes. In doing so, differing national standards are abolished .
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European Committee for Standardization (CEN)

The European Committee for Standardization was established in Paris on March 25, 1961. In 1970, compulsory development of European standards (EN) was introduced.
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Composition CEN.

CEN members are national standards organizations of 18 countries. This is a closed organization. CEN member countries recognize the priority of international standardization within ISO and IEC.
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Area of ​​activity.

The work of standardization in CEN is based largely on or complements the results achieved in ISO. In addition to European standards, CEN also reviews and adopts harmonization documents and preliminary standards. Harmonization documents are the easiest form of removing technical barriers to trade between these countries. They differ from European standards in that they reflect the essence of administrative and legal norms that may hinder the development of trade relations. These documents also differ in the procedure for their adoption by CEN members. Their main purpose is to ensure uniformity of application of international standards (ISO) in the EU countries. Preliminary standards are developed in cases when the level of innovation is high, technologies change quickly, rapid changes in indicators and requirements are possible, and also when a long period is required for approvals and adoption of standards. Such standards have a limited duration - up to 3 years.

Administrative work is performed by the Central Secretariat, which is located in Brussels, and, according to Belgian law, is designed as a scientific and technical non-profit organization.
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Европейский комитет по стандартизации в электротехнике (CENELEC)

Европейский комитет по стандартизации в электротехнике создан в 1972 г. Членами CENELEC являются Национальные электротехнические комитеты 17 европейских государств. Все они являются одновременно членами IEC. Высшим органом CENELEC является Генеральная ассамблея, в которой представлены национальные организации по стандартизации, правительственные органы стран-членов Европейского Союза, Европейское экономическое сообщество, Европейская ассоциация свободной торговли. Функции структур, ответственных за стандартизацию, такие же, как в СЕN. Центральный секретариат находится в Брюсселе, в одном здании в СЕN. Официальные языки – английский, французский и немецкий.
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Европейская и международная стандартизация – отличительные особенности.

Наиболее высокие уровни стандартизации – международный и европейский. Они направлены на решение глобальных задач: устранение технических барьеров в торговле, облегчение взаимного обмена передовыми технологиями, межгосударственное экономическое сотрудничество. В это же время задачи европейской стандартизации сфокусированы на достижение конкретных целей, связанных с объединением Европы. Отличительные особенности международной и европейской стандартизации представлены в Табл. 2