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12 Standartizavimas


Literatūra: http://www.wssn.net1. Standards and standardization1.1 What is a standard?1.1.1 Definition of a standard

ISO/IEC Guide 2:1996 defines a standard as a document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.

1.1.2 Content of a standard

Standards are varied in character, subject and medium. They:

cover several disciplines: dealing with all technical, economic and social aspects of human activity and covering all basic disciplines such as language, mathematics, physics, etc.;

are coherent and consistent: standards are developed by technical committees which are coordinated by a specialized body, and ensure that barriers between different areas of activity and different trades are overcome;

result from participation: standards reflect the results of joint work involving all competent parties concerned and are validated by consensus to represent all relevant interests: producers, users, laboratories, public authorities, consumers, etc.;

are a living process: standards are based on actual experience and lead to material results in practice (products – both goods and services, test methods, etc.); they establish a compromise between the state of the art and the economic constraints of the time;

are up to date: standards are reviewed periodically or as dictated by circumstance to ensure their currency, and therefore evolve together with technological and social progress;

have a reference status: in commercial contracts and in court in the event of a dispute;

have national or international recognition: standards are documents which are recognized as valid – nationally, regionally or internationally, as appropriate;

are available to everyone: standards may be consulted and purchased without restriction.

As a general rule, standards are not mandatory, but are for voluntary application. In certain cases, implementation may be obligatory (such as in fields connected with safety, electrical installations, in relation to public contracts, etc.).

1.1.3 The role of standards

A standard represents a level of know-how and technology which renders the presence of industry to its preparation indispensable. A standard is never neutral.

It is a reference document used in particular in the context of public contracts or in that of international trade and on which the majority of commercial contracts rely.

It is used by industrialists as the indisputable reference, simplifying and clarifying the contractual relations between economic partners.

It is a document that is being used more and more by jurisprudence.

For the economic players, the standard is:

a factor for rationalization of production: the standard makes it possible to master the technical characteristics, to satisfy the customer, to validate the manufacturing methods, to increase productivity and gives operators and installation technicians a feeling of security;

a factor for clarification of transactions: faced with overabundant product or service offers which may have extremely different practical values, the existence of systems of reference enables one to better assess the offers and to reduce uncertainties, to aid in the definition of the needs, to optimize supplier relations, to do without additional testing;

a factor for innovating and developing products: to participate in standardization work enables one to anticipate and therefore to make one’s products progress simultaneously. Standards play a favourable role for innovation thanks to transferral of knowledge;

a factor for transferral of new technologies: standardization facilitates and accelerates the transferral of technologies in fields which are essential for both companies and individuals (new materials, information systems, biotechnology, electronics, computer-integrated manufacturing (CIM), etc.);

a factor for strategic choice for companies: to participate in standardization signifies introducing solutions adapted to the competence of one’s company and equipping oneself to compete within competitive economic environments. It signifies acting on standardization, not enduring it.

1.1.4 Types of standards

Four major types of standards can be cited:

  • fundamental standards which concern terminology, metrology, conventions, signs and symbols, etc.;
  • test methods and analysis standards which measure characteristics;
  • define the characteristics of a product (product standard) or of a specification standards which service (service activities standard) and the performance thresholds to be reached (fitness for use, interface and interchangeability, health, safety, environmental protection, standard contracts, documentation accompanying products or services, etc.);
  • organization standards which deal with the description of the functions of the company and with their relationships, as well as with the modelling of the activities (quality management and assurance, maintenance, value analysis, logistics, quality management, project or systems management, production management, etc.).
1.1.5 Life cycle

A standard generally comprises seven major phases:

Identification of the needs of the partners: analysis per sector of the appropriateness and of the technical-economic feasibility of normative work on the basis of two determining questions: will a standard provide a technical and economic "plus" to the sector? Is the necessary knowledge required for the drawing-up of a standard available?

Collective programming: reflection on the basis of the needs identified and the priorities defined by all of the partners, then decision to register in the work programme of the organization involved;

Drawing up of the draft standard by the interested parties, represented by experts (including producers, distributors, users, consumers, administrations, laboratories, etc. as relevant), gathered together within standardization committees;

Consensus of the experts concerning the draft standard;

Validation: wide consultation, at international and/or national level as appropriate, in the form of a public enquiry, involving all of the economic partners in order to make certain that the draft standard conforms to the general interest and does not give rise to any major objection. Examination of the results and of the comments received. Finalization of the definitive text of the draft standard;

Approval of the text for publication as a standard;

Review: the application of all standards forms the subject of a regular assessment of its relevance by the standardizing body, which makes it possible to detect the time when a standard must be adapted to new needs. Following review, a standard may be confirmed without change, go forward for revision, or be withdrawn.

1.1.6 Copyright and right to useNational standards:

The standard is a collective work. The national standard is programmed and studied under the authority of the national standards body. It is published by the latter. It is therefore protected, as early as at the draft standard stage, by a copyright belonging to the national body.

International standards:

From the stage of Committee Draft (CD), international standards are protected by the copyright of the international standards body (ISO, IEC). The exploitation right of this copyright is automatically transferred to the national standards bodies which comprise the membership of ISO or IEC, for the purpose of drawing up national standards. The national standards body is under obligation to take all appropriate measures in order to protect the intellectual property of ISO and IEC on the national territory. Each draft International Standard and each published International Standard bears a copyright statement with the international copyright symbol, the publisher’s name and the year of publication.

Reproduction of standards

Unless otherwise specified, no standard or part of a standard may be reproduced, recorded or transmitted in any form or by any means, electronic or mechanical, including photocopying and microfilm, without the written consent of the national or international standards body concerned.

Use of public networks, including Internet

At all levels – national, regional or international – the national standards body must be consulted prior to the opening up of any public or private electronic network (Internet, Intranet or similar) aimed at disseminating, transmitting or exchanging texts or parts of texts of standards, within the framework or not of standardization work. Whatever the case, there is a strict obligation to follow the recommendations of the international or national body concerned whenever public or private networks are used.

1.2 Regarding standardization1.2.1 The role of standardization

Standardization is today recognized as being an essential discipline for all players within the economy, who must strive to master its motivating forces and implications. 20 years ago, it was the reserved field of a few specialists. Today, companies have integrated standardization as a major technical and commercial element. They are aware that they must play an active role in this field, or be prepared to accept standardization which is established without them, or without consideration of their interests. Various factors have combined to produce this trend:

The economic integration of Europe

The march towards European economic integration and the choice of the Commission of the European Communities to put on standards a decisive value concerning the free movement of goods and services within the Union, have led to the normative tool playing a key role. Increased competition and the specialization to which it leads, will result in a major development of the exchanges within the single market. These exchanges must comply with certain rules. The Commission was able to limit its role to the affirmation of objectives – the "essential requirements" – leaving it to the economic players who draw up the standards to specify the ways and means of attaining them.

The quality requirement

Born in the 50s, the quality requirement has taken on an increasing importance and asserts itself more and more as a determining factor of competitiveness. While today it is easy to compare prices, it is much more complex to compare levels of quality. The existence of a unanimously recognized quality system of reference, constitutes a very precious clarification tool. The standard plays precisely this role.

The technical and technological evolution

Another very positive factor for the expansion of standardization is the emergence of new techniques and technologies. All the techniques which concern information, its processing and its remote transmission (data processing, telecommunications, information highways, etc.). involve the setting up of networks. As for other network-based techniques (electronic transmission), their development depends on acceptance by the users of common rules which facilitate interoperability. In the economy of developed countries, these techniques play a considerable role, as is attested by, for example, the increasing expansion of Electronic Data Interchange (EDI).

1.2.2 International, regional and national standardization

Standards are drawn up at international, regional and national level. The coordination of the work at these three levels is ensured by common structures and cooperation agreements.

International standardization

ISO, International Organization for Standardization

Founded in 1947, ISO is a worldwide federation of national standards bodies, currently comprising some 145 members, one per country. The mission of ISO is to encourage the development of standardization and related activities in the world in order to facilitate international exchanges of goods and services and to achieve a mutual entente in the intellectual, scientific, technical and economic fields. Its work concerns all the fields of standardization, except electrical and electronic engineering standards, which fall within the scope of the IEC.

ISO counts over 2 900 technical work bodies (technical committees, subcommittees, working groups and ad hoc groups). To date, ISO has published over 13 700 International Standards.

IEC, International Electrotechnical Commission

Founded in 1906, the IEC is responsible for international standardization in the fields of electricity, electronics and related technologies. Its charter embraces all electrotechnologies including electronics, magnetics and electromagnetics, electroacoustics, telecommunication, and energy production and distribution, as well as associated general disciplines such as terminology and symbols, measurement and performance, dependability, design and development, and safety and the environment. IEC's members, which currently number over 60, are national committees, one for each country, which are required to be fully representative of all electrotechnical interests in the country concerned. National committees obtain a large measure of support from industry and are mostly recognized by their governments.

The IEC has published over 5 000 standards.

Both ISO and the IEC have their central offices in Geneva, Switzerland, and operate according to similar rules. The transposal of ISO and/or IEC standards into the national collections is voluntary: It may be complete or partial.

ITU, International Telecommunications Union

The birth of the ITU can be traced back to 1865. A specialized agency of the United Nations since 1947, ITU membership currently includes almost 190 member States and over 650 sector members. ITU international recommendations are developed in the fields of both telecommunications and radiocommunications.

ITU headquarters are located in Geneva, Switzerland.

Other International standardizing bodies

A large number of international organizations are in liaison with ISO and IEC and participate to varying degrees in their work. Several of these organizations have themselves standardization activities in their own area of interest, which are recognized at international level. In a number of cases, the results of the standardization work of these organizations are fed directly into the ISO/IEC system and appear in International Standards published by ISO or by IEC. However, some of these organizations themselves publish normative documents, and these must be taken into account in any review of international standardization.

Regional standardizationin Europe

CEN, European Committee for Standardization

Founded in 1961, CEN draws up European standards and regroups 22 European standards institutes. CEN has witnessed strong development with the construction of the European Union. Its headquarters is located in Brussels, Belgium.

A Technical Board is in charge of the coordination, planning and programming of the work which is conducted within the work bodies (technical committees, subcommittees, working groups), the secretariats of which are decentralized in the different EU member states. CEN, which counts over 270 technical committees, has published some 8 300 European standards and approved documents. Over 6000 documents are under study.

CENELEC, European Committee for Electrotechnical Standardization

Founded in 1959 and also located in Brussels, Belgium, CENELEC fulfils within the electrotechnical sector the same functions as CEN.

ETSI, European Telecommunications Standards Institute

ETSI develops European standards in the telecommunications field (ETS, European Telecom Standard). Its headquarters are at Sophia Antipolis, France.

ETSI regroups over 750 members (administrations, operators, research bodies, industrialists, users) representing some 55 countries (EU, EFTA, Eastern Europe).

in the Americas

COPANT, Pan American Standards Commission

COPANT is a civil, non-profit association. It has complete operational autonomy and unlimited duration. The basic objectives of COPANT are to promote the development of technical standardization and related activities in its member countries with the aim of promoting their industrial, scientific and technological development in benefit of an exchange of goods and the provision of services, while facilitating cooperation in the intellectual, scientific and social fields.

The Commission coordinates the activities of all institutes of standardization in the Latin American countries. The Commission develops all types of product standards, standardized test methods, terminology and related matters. COPANT's legal seat is in Buenos Areas, Argentina.

MERCOSUR, the Common Market of the South

Known by either its Spanish acronym MERCOSUR, or its Portuguese acronym MERCOSUL. MERCOSUR is a common market made up of the economies of Argentina, Brazil, Paraguay and Uruguay. Its principal objectives are to improve the economies of its member countries by making them more efficient and competitive and by enlarging their markets and accelerating their economic development by means of more efficient use of available resources; to preserve the environment; to improve communications; to coordinate macroeconomic policies; to harmonize the different sectors of their economies.

MERCOSUR's permanent headquarters are in the city of Montevideo, Uruguay.

National standardization

Each country possesses its own national standardization system. The central or most representative national standards body participates within the regional or international bodies.

1.2.3 The standardization processes

At national level, the standardization work is conducted by standards committees which can obtain assistance from groups of experts. These committees or working groups are made up of qualified representatives of the industrial circles, research institutes, public authorities, consumer or professional bodies.

At regional or international level, the work is conducted by technical committees for the secretariats of which, responsibility is assumed by the national standards bodies. These technical committees are created by the technical management boards of the relevant regional or international bodies. All national members are entitled to be represented within the international or regional committee dealing with a specific subject matter.

1.2.4 Standardization and the WTO (World Trade Organization)

The last negotiations of the GATT (General Agreement on Tariffs and Trade) Uruguay Round, gave birth to the WTO, which was established on 1 January 1995. As of 5 February 2003, there were 145 members and observers. The Agreement on Technical Barriers to Trade (WTO TBT) is one of the 29 individual legal texts of the WTO Agreement which obliges members to ensure that technical regulations, voluntary standards and conformity assessment procedures do not create unnecessary obstacles to trade. Annex 3 of the TBT Agreement is the Code of Good Practice for the Preparation, Adoption and Application of Standards. In accepting the TBT Agreement, WTO Members agree to ensure that their central government standardizing bodies accept and comply with this Code of Good Practice and agree also to take reasonable measures to ensure that local government, non-governmental and regional standardizing bodies do the same. The Code is therefore open to acceptance by all such bodies.

The TBT Agreement recognizes the important contribution that international standards and conformity assessment systems can make to improving efficiency of production and facilitating international trade. Where international standards exist or their completion is imminent, therefore, the Code of Good Practice says that standardizing bodies should use them, or the relevant parts of them, as a basis for standards they develop. It also aims at the harmonization of standards on as wide a basis as possible, encouraging all standardizing bodies to play as full a part as resources allow in the preparation of international standards by the relevant international bodies.

In the interest of transparency, the Code requires that standardizing bodies that have accepted its terms notify this fact to the ISO/IEC Information Centre located at the ISO Central Secretariat in Geneva, either directly or through the relevant national/international member of ISONET (ISO Information Network). Contact information for all ISONET members is given in the ISONET Directory. At least once every six months, standardizing bodies must publish their work programmes and also notify the existence of their work programmes to the ISO/IEC Information Centre. Other important provisions relate to the preparation, adoption and application of standards. The WTO TBT Standards Code Directory, lists standardizing bodies that have notified acceptance of the WTO TBT Code of Good Practice for the Preparation, Adoption and Application of Standards. The Directory also contains the addresses of these standardizing bodies and information related to the availability of their work programmes. It is published annually.

1.3 Management system standards

Recent years have seen the development and application of what are known as "generic management system standards", where "generic" means that the standards' requirements can be applied to any organization, regardless of the product it makes (or whether the "product" is actually a service activity), and "management system" refers to what the organization does to manage its processes. Two of the most widely known series of international standards falling into this category are almost certainly the ISO 9000 series for managing quality systems, and the ISO 14000 series for environmental management systems. Wide ranging information and assistance related to these standards and their application is available from the ISO members, many of which give extensive information through their Web sites, and from the ISO site.

2 Certification of conformity to standards and quality assurance2.1 Certification2.1.1 Definition of certification

Certification is a procedure by which a third party gives written assurance that a product, process or service conforms to specified requirements. (Definition: ISO/IEC Guide 2:1996)

It is distinct from the other systems of proof of conformity such as supplier declarations, laboratory test reports or inspection body reports. Certification is based on the results of tests, inspections and audits and gives confidence to the customer on account of the systematic intervention of a competent third body.

2.1.2 The role of certification

Certification is an asset and an advantage, both for the producer and for the purchaser, consumer or distributor. It gives an incontestable added value to the product or service bearing its mark.

For the manufacturer or service provider, it valorizes the goods or service, it opens up markets and simplifies relations.

For the user, it provides assurance that the product purchased meets defined characteristics or that an organization's processes meets specified requirements. Certain product certification marks may represent an assurance of safety and quality. Certification enables one to distinguish apparently identical products or services; it offers to everyone a possibility of appeal in the event of dissatisfaction.

2.1.3 Types of certification

Product certification attests that a product complies with the safety, fitness for use and/or interchangeability characteristics defined in standard(s), and in specification(s) supplementary to standards where they are requested by the market.

Organization certification demonstrates the conformity of, for example, an organization's quality or environmental management system to the relevant model of the ISO 9000 or ISO 14000 series of management system standards. The different systems of reference are not attached to the performance level of a product.

2.2 Accredited testing laboratories

Manufacturers may need the technical help of independent testing laboratories either for developing new products or at the marketing and export stage. Many industrialized countries have made substantial attempts to develop laboratory networks that provide assurance of the quality of testing services (mainly in terms of the quality of results on which they base their decisions).

At international level, this activity falls within the scope of the International Laboratory Accreditation Cooperation (ILAC). One of the objectives of this coordination is to provide companies with better access to the services of those laboratories which are most likely to meet their testing needs and optimize the use of these means.

At national level, there are a number of laboratory networks. The national standards bodies may be contacted for information relative to their countries.

3. Access to standards and standardization services

Each national standards body manages its own collection of standards and has access to the collections of other institutes. It places this collection at the disposal of the economic players and proposes a range of services. These may include:

  • free information tools or services for identifying standards or for announcing new standards: catalogues, newsletters, Web servers, etc.;
  • chargeable services for access to the normative texts in different forms: subscription, hardcopy form, CD-ROM, online;
  • notification or subscription services for regular information;
  • technical assistance, including to exporters.
Members of WSSN

To facilitate access to standards information and services, WSSN maintains direct links to the Web sites of organizations in the following categories:

A geographical listing of the above sites by region and by country is also provided.

In turn, the national members of ISO and IEC maintain links to related national organizations and, where applicable, to national standards-related networks, such as NSSN (a resource for US, international and regional standards information in the USA, accessible through the Web site of ANSI – American National Standards Institute), SISC (Standards Information Service of Canada, accessible through the Web site of SCC – Standards Council of Canada), etc.

The WSSN structured index provides a means of easy access to specific pages of the Web sites of WSSN members, such as contact information, catalogues, etc.

Non-members of WSSN

Information about organizations falling into the above categories which do not have Web sites may be obtained as follows:

  • International standardizing bodies – the ISO/IEC Directory of international standardizing bodies contains information on some 45 international bodies with recognized standardization activities. Available from national members of ISO.
Other sources of information

ISONET: the information centres of a number of national standards bodies, regional standardizing bodies and international standardizing bodies cooperate within the framework of ISONET, the ISO Information Network. ISONET is an agreement btween standardizing bodies to combine their efforts in order to make information on standards, technical regulations and related matters readily available whenever it is required. ISONET members agree to share experience and exchange information as required with each other, enabling information about foreign national standards and regulations to be obtained through the local ISONET member. Contact information for ISONET members and information on the services they provide is given in the ISONET Directory.

WTO TBT and WTO SPS enquiry points: these WTO Agreements* foresee the establishment of national enquiry points to provide information and assistance about relevant technical regulations, standards and conformity assessment procedures. For countries where there is an ISONET member, contact information for relevant WTO TBT and WTO SPS national enquiry points is included in the ISONET Directory. Complete listings of WTO TBT and WTO SPS national enquiry points are maintained by the WTO. The listings are also made available from the ISONET Directory.

* WTO TBT: World Trade Organization Agreement on Technical Barriers to Trade;
WTO SPS: World Trade Organization Agreement on Sanitary Phyto-Sanitary

Free versus chargeable information services

Depending on the type of information being sought, the response provided may be free or may enter into the framework of a chargeable service.

As a rule, information on standardization and certification systems, the identification of information concerning the standards, products and services offered by each member of WSSN will be free. Similarly, the catalogue service of WSSN members, allowing identification of the references of standards in force in each country and the document ordering service will also usually be offered free of charge.

The publications of the standards bodies (standards, handbooks, hardcopy catalogues, etc.) are chargeable, and each body has its own tariffs.

The document services (databank, normative watch service in hardcopy form, CD-ROM and online services, added-value services) will also be chargeable.

Some tools

ICS, International Classification for Standards

Inasmuch as an ever-growing number of standards catalogues are structured in accordance with the ICS, the users of standards benefit from a common access key to many of the standards collections of the world. Users have a more comprehensive view over their fields of interest thanks to a multiple classification of the standards and are better guided in their search. ICS comprises 40 fields, subdivided into some 390 groups, themselves subdivided into some 895 subgroups.

 

Atnaujinta: 2007.04.18

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