Lecture
Certification in Russia is organized and carried out in accordance with the national laws of the Russian Federation: «On Protection of Consumer Rights», «On Certification of Products and Services», «On Standardization»; laws of the Russian Federation relating to specific industries; legal acts of the Russian Federation aimed at addressing individual socio-economic problems; decrees of the President and acts of the Government.
According to Article 41 of the Law, for violations of certification rules by certification bodies and testing laboratories (centers), a fine is established in the amount of twice the cost of certification work. If goods are sold in violation of certification rules, then a fine is imposed on the manufacturers (sellers) in the amount of the cost of the goods sold. Managers of manufacturing enterprises and of certification bodies also bear responsibility for such violations. In a broader sense, the legal basis for mandatory and voluntary certification is established by the RF Law «On Certification of Products and Services», adopted in 1993. The Law establishes the objectives of certification, defines the national certification body — the State Committee of the Russian Federation for Standardization, Metrology and Certification (Gosstandart of Russia), defines the main directions of its certification activities, as well as the objects, forms and duties of participants in mandatory certification, sources of financing, control and liability for violation of the provisions of the Law.
The first Russian mandatory certification system was the GOST R System — the largest in Russia. It covers all types of products that are subject to certification in accordance with the Law «On Protection of Consumer Rights» and other legislative acts concerning individual types of products. On the basis of the rules and principles of the GOST R system, the operating certification infrastructure in Russia, as well as in the CIS countries, has been formed. The central body of the System is Gosstandart and Gosstroy of the RF. The functions of the system's participants are established by the Law «On Certification of Products and Services». The fundamental principle of the system is that it is built on the basis of certification systems for homogeneous products, so the GOST RF system is their aggregate, united by common rules and principles. These systems are formed on the basis of the «Rules for Conducting Certification in the RF». Each certification system for homogeneous products is approved by Gosstandart of Russia and registered in the State Register.
Gosstandart of the RF maintains the State Register, which contains basic certification information: on issued certificates; accredited bodies and testing laboratories; approval of certification systems; certified expert auditors, etc. The official language of the GOST R System is Russian. But by agreement of the parties, documentation may also be drawn up in another language. The main principles and rules of the System are established by a set of documents comprising four groups of provisions: general system provisions, product certification, service certification, and certification of production quality systems. Each group of documents contains fundamental documents and specifying provisions.
The SovAsK System, developed in 1992, registered and put into effect from 1993, is one of the first voluntary certification systems in Russia. This organization is an International Association (IA), whose members are organizations and enterprises of all forms of ownership from CIS countries, and the objects of certification include many types of products, services, processes, quality assurance systems, and production systems. The System has the right to accredit testing laboratories in the RF and beyond its borders, as well as auditors for the assessment of quality systems and the certification of production.
The development of SovAsK was based on ISO developments, ISO/IEC guides, and the European standards EN45000. Unlike GOST R, where inspections are carried out by expert auditors, the SovAsK System separates the duties of the expert and the auditor. Highly qualified specialists working in a specific industry and possessing knowledge of certification are invited as experts. Several dozen auditors are accredited in the register of the SovAsK System. An auditor is a specialist in conducting inspections of quality systems and certification of production. Experts, on the other hand, are invited as needed and are included in the composition of auditor groups. In addition to the experts who have passed the certification commission of the SovAsK Steering Committee, there are also corresponding members — candidates for expert status.
More than 40 voluntary certification systems are registered in the State Register of Certification (for example, measurement systems, the Metrological Academy, etc.). Interest in voluntary certification is connected with its broad possibilities for confirming compliance with the requirements that are of interest to the consumer and declared by the customer of the certification.
Certification of quality assurance systems for compliance with the ISO 9000 series of standards is a guarantee of the reliability and stability of an enterprise, a pledge of its success in domestic and foreign markets. It is part of the Russian GOST R system and is called the «Quality Systems Register». The main directions of its activity are certification of quality systems, certification of production, inspection control over certified quality systems and production, and international cooperation in the interests of mutual recognition of certificates for quality systems.
The International Organization for Standardization ISO is called ISO in all languages. Its main activity in the field of certification is organizational and methodological support. In the area of certification, ISO deals exclusively with methodological problems.
The International Electrotechnical Commission (IEC), in the field of certification of electrical engineering products, created the IECEE certification system — the IEC System for Conformity Testing of Electrical Equipment to safety standards for the certification of electrical engineering products. The goal of this system is to promote international trade in electrical equipment operated by ordinary consumers rather than by specialists in electrical engineering. The result of the joint activity of ISO and IEC is a series of guides, which have been adopted as fundamental documents by all countries in resolving such issues as assessing the level of work of a testing laboratory, determining technical competence and scope of activity, assessing the effectiveness of the testing methods used, accreditation of laboratories, etc.
To protect the European market from American competitors, within the framework of CENELEC in the late 1960s, the CECC certification system for electronic engineering products was created as a closed regional system for the member countries of the EU and EFTA. Regional certification of electronic engineering products for compliance with European standards stimulated governmental decisions by Western European countries in favor of purchasing certified products.
The RF Law «On Ensuring the Uniformity of Measurements», adopted in 1993, laid the foundation for legislative metrology of the RF. The objectives of the Law are as follows:
The Law establishes and legislatively enshrines the following important definitions: uniformity of measurements, measuring instrument, unit-of-quantity standard, state unit-of-quantity standard, regulatory documents for ensuring the uniformity of measurements, metrological service, metrological control and supervision, verification and calibration of measuring instruments, certificate of approval of the type of measuring instruments, accreditation for the right to verify measuring instruments, calibration certificate.
State Metrological Service of Russia (SMS) is a combination of state metrological bodies and is created to manage activities for ensuring the uniformity of measurements. Overall management of the SMS is carried out by Gosstandart of the RF. The SMS includes seven state scientific metrological centers, the All-Russian Scientific Research Institute of Metrological Service (VNIIMS) and about 100 centers for standardization and metrology. The scientific centers are the custodians of state standards (more than 120 of them), and also conduct research on the theory of measurements, the principles and methods of high-precision measurements, and the development of scientific and methodological foundations for improving the Russian measurement system.
Along with the SMS, issues of ensuring the uniformity of measurements are also dealt with by: the State Service of Time, Frequency and Determination of Earth Rotation Parameters (SSTF); the State Service of Standard Reference Materials for the Composition and Properties of Substances and Materials (SSRM); the State Service of Standard Reference Data on Physical Constants and Properties of Substances and Materials (SSRD). The activity of these services is also directed by Gosstandart of the RF, which coordinates their work with the work of the SMS on the basis of a unified technical policy.
In many state administrative bodies, metrological services are created that operate in accordance with the «Regulation on the Metrological Service», which is subject to approval by Gosstandart of the RF. The main tasks, rights and duties of such services of state administrative bodies and legal entities, regardless of the form of ownership, are defined in the Metrology Rules PR 50-732-93 «GSI. Standard Regulation on the Metrological Service of State Administrative Bodies and Legal Entities». This document provides for the introduction of metrological units into the structure of administrative bodies: the position of chief metrologist is created in the Central Office, lead and base metrological services in the industries, and calibration laboratories and units for the repair of measuring instruments in enterprises and organizations.
Metrological services of state administrative bodies and legal entities organize their activities on the basis of the provisions of the laws «On Ensuring the Uniformity of Measurements», «On Standardization», «On Certification of Products and Services», as well as resolutions of the Government of the RF, administrative acts of the subjects of the Federation, regions and cities, regulatory documents of the State System for Ensuring the Uniformity of Measurements, and resolutions of Gosstandart of the RF.
In accordance with the current legislation, the main tasks of the metrological services include ensuring the uniformity and required accuracy of measurements, raising the level of metrological support of production, and carrying out metrological control and supervision. Within concerns, joint-stock companies, associations, and inter-branch associations, a similar structure of the metrological service is created and operates by decision of their governing bodies. The metrological services of enterprises and organizations may include independent calibration laboratories, as well as structural units for the repair of measuring instruments.
Lead and base organizations of the metrological service are subject to accreditation, which is carried out by state administrative bodies with the involvement of SMS specialists. Scientific and methodological guidance of the work on accreditation of lead and base organizations is provided by VNIIMS — the main center of the metrological service, which, based on accreditation materials, keeps a register of lead and base organizations of the metrological service of state administrative bodies and associations of legal entities.
The metrological services of enterprises may be accredited for the right to calibrate measuring instruments on the basis of agreements concluded with state scientific metrological centers or SMS bodies. Interested metrological services of enterprises of any departmental affiliation and form of ownership may, on their own initiative, be accredited for technical competence in the field of ensuring the uniformity of measurements and the required degree of measurement accuracy. This activity may also be defined as a metrological service rendered to legal entities and individuals. The Law «On Ensuring the Uniformity of Measurements» establishes the following procedures of state metrological control: approval of the type of measuring instruments, verification of measuring instruments, including standards, and licensing of the activities of legal entities and individuals for the right to manufacture, repair, sell and lease measuring instruments.
The testing program for measuring instruments may also provide only for the determination of the metrological characteristics of specific samples of measuring instruments and the experimental testing of the verification procedure, which, in terms of the amount of work, is equivalent to the metrological attestation carried out before the adoption of the Law. In both of the cases considered, Gosstandart of Russia approves the type of measuring instrument, registers it in the State Register, and issues the applicant a certificate of type approval.
Verification of measuring instruments — a set of operations performed by SMS bodies or other authorized bodies and organizations for the purpose of determining and confirming the compliance of measuring instruments with established technical requirements. It is carried out when measuring instruments are released from production or repair, upon import, and during operation. Verification of measuring instruments is carried out by SMS bodies, state scientific metrological centers (SSMC), as well as accredited metrological services of legal entities and individuals certified as verifiers in accordance with PR 50.2.012—94. The result of verification is the issuance of a «Verification Certificate» and (or) an imprint of the verification stamp, and, in the event of a negative result, a «Notice of Unsuitability» is issued, or a corresponding entry is made in the technical documentation for the MI. In Russia, the following types of verification of measuring instruments are applied: primary, periodic, extraordinary, inspection and expert.
Licensing, in the general case, refers to the mandatory procedure of issuing a license to a legal entity or individual to carry out activities that are not prohibited by current legislation and are subject to mandatory licensing. In the field of metrology, a license — is a permit issued upon application by a body of the State Metrological Service, within the territory assigned to it, to a legal entity or individual (the licensee) to carry out activities in the manufacture, repair, sale and rental of MI within the territory of the RF. A license to manufacture a measuring instrument gives the licensee the right to repair, sell and rent that measuring instrument. A license is issued for a term of no more than five years. The amount and procedure for paying the license fee are established by Gosstandart of Russia.
Measurement procedures (MP) — a set of operations and rules that ensure the obtaining of measurement results with a known error. With the entry into force of GOST R 8.563—96 «GSI. Measurement Procedures», it became necessary to revise all existing documents on MPs, to carry out the attestation and standardization of MPs, and to train enterprise specialists who will carry out the attestation of MPs, etc.
Attestation of an MP is the procedure for establishing and confirming the compliance of an MP with the metrological requirements imposed on it. Attestation of an MP is carried out by means of metrological examination of documentation, or theoretical or experimental studies of the MP. The choice of attestation method is determined by the complexity of the MP and experience in attesting similar MPs. MPs used in areas subject to state metrological control and supervision, as well as for monitoring the condition of complex technical systems, are subject to mandatory attestation. When exercising state metrological supervision, the existence of lists of documents on MPs, and the existence of plans (schedules) for the cancellation and revision of documents on MPs that do not meet the requirements of this standard, are checked.
State metrological supervision (SMS) includes verifying compliance with metrological rules and norms, the requirements of the Law and the regulatory documents of the GSI system, in effect both before and after the Law was adopted. The objects of SMS include: certified measurement technique procedures (MVI), certification certificates, and certification reports. It also supervises violations of metrological rules and norms in various trade operations, and supervises compliance with the metrological requirements applicable to lots of packaged goods. This type of supervision is based on a quantitative assessment of short-weighing of goods in packages by the method of statistical examination of the contents of packaged goods.
Calibration of measuring instruments — a set of operations performed for the purpose of determining and confirming the actual values of the metrological characteristics and (or) the fitness for use of measuring instruments not subject to state metrological control and supervision. The fitness of a measuring instrument means that its metrological characteristics conform to previously established technical requirements, which may be contained in a regulatory document or determined by the customer. Unlike verification, which is carried out by the bodies of the State Metrological Service (GMS), calibration — is a voluntary operation and may be carried out by any metrological service (or individual) provided that proper conditions exist for the qualified performance of this work.
The Russian Calibration System (RSK) is based on such principles as voluntary participation, mandatory transfer of the size of units from state measurement standards to working measuring instruments, professionalism and technical competence of RSK participants, and self-sufficiency. Coordination of the activities of RSK participants is carried out by Gosstandart of Russia, while organizational, methodological and informational support — is provided by VNIIMS.
The legal basis for the calibration of measuring instruments is defined by Article 23 of the Law of the Russian Federation «On Ensuring the Uniformity of Measurements». The procedure for accrediting the metrological services of legal entities is established by Gosstandart of Russia and set out in the document: «GSI. Procedure for Accrediting the Metrological Services of Legal Entities for the Right to Perform Calibration Work».
Inter-calibration interval — is the calendar period of time after which a measuring instrument must be sent for calibration regardless of its technical condition. Four methods of verification (calibration) of measuring instruments are permitted: direct comparison with a measurement standard, comparison using a comparator, and direct and indirect measurements of the quantity.
Verification schemes establish the metrological subordination of the state measurement standard, secondary standards and working measuring instruments, and serve to correctly transfer the sizes of measurement units from the standard to the working measuring instruments.
State verification schemes are developed by the scientific research institutes of Gosstandart of the Russian Federation and approved by Gosstandart of Russia, while local ones are developed by departmental metrological services or the management of the enterprise. Strict adherence to verification schemes and timely verification of secondary standards are necessary conditions for transferring reliable sizes of measurement units to working measuring instruments.
By reference materials are meant samples of substances or materials whose chemical composition or physical properties are typical of a given group of substances (materials), determined with the necessary accuracy, distinguished by high stability, and certified by a certificate. They are used for calibration, verification and calibration of the chemical composition and various properties of materials (mechanical, thermophysical, optical, etc.). Reference materials, as a measure with an established error (accuracy class), are used directly for quality control of raw materials and industrial products by comparison. In essence, reference materials serve to maintain the uniformity of measurements, i.e., they are measuring instruments.
The category of reference materials is of great importance for establishing the purity of substances. The concept of «especially pure substances» is associated with the production of many materials for modern technology, medicine, etc. Reference materials undergo special tests, based on the results of which they receive certificates and are entered into the state register of reference materials, which in turn is an integral part (section) of the State Register of Measuring Instruments. The certificate of a reference material must indicate a shelf life, since practically all substances and materials change over time due to the effects of environmental factors on their properties. And the reliability of measurement results depends on this. To date, data on more than 3.5 million substances and materials have been published, which characterizes the significance of such a measuring instrument as reference materials of the composition and properties of substances and materials.
Russia has a State Service for Reference Materials (GSSO) as part of the NPO «VNIIM named after D.I. Mendeleev». The main goal of this service is to provide any organization that needs to control the quality of its products using reference materials, with samples, and to manufacture new samples upon request from interested legal entities.
The State Service of Standard Reference Data (GSSSD), as an integral part of the State Metrological Service, is a specialized nationwide system that, on the basis of unified scientific, methodological and organizational provisions, ensures work in the field of data on physical constants and properties of substances (materials). The Service collects, processes, evaluates, stores and standardizes this data, and also provides reference and information services to consumers in the relevant fields of science and production. It publishes reference books, bibliographic indexes, and reviews that facilitate the prompt use of verified, unified information on the values of physical constants and the properties of materials and substances by interested organizations. Reference data are classified into standard, recommended and informational.
The problems of maintaining the uniformity of measurements in areas not subject to state metrological control and supervision have made it necessary to create a voluntary Certification System for Measuring Instruments for conformity with metrological norms and rules. The methodological basis for building this system is the regulatory documents of ISO, IEC, ILAC, the GOST R Certification System and the OIML Certificate System. The organizational structure of the Certification System for Measuring Instruments is formed by: the Central Body of the System — the Metrology Directorate of Gosstandart of Russia; the Coordination Council, the Appeals Committee; the scientific and methodological center of the System — VNIIMS; and the certification bodies — testing laboratories (centers) for measuring instruments.
The System provides free access for manufacturers, public organizations, certification bodies, testing laboratories, as well as all other interested enterprises, organizations and individuals to information (except information constituting a trade secret) about the activities within the System, its rules, participants, and the results of accreditation and certification.
Certification of measuring instruments is carried out by accredited measuring-instrument certification bodies, taking into account the results of tests conducted by centers accredited for technical competence and independence. Accreditation of certification bodies and inspection control over their work is carried out by the Central Body of the System. The introduction of the Certification System for Measuring Instruments is based on the relevant recommendations on the procedure for carrying out the work, the accreditation of certification bodies, and the System Register (MI 2277—93 — MI 2279—93).
The International Bureau of Weights and Measures Organization (IOWM) was created to promote the practical dissemination of the metric system of measures on an international scale, to keep the international prototypes of the standards of the meter, the kilogram and other units of measurement, to research them and compare national standards against them, and to carry out scientific work to improve the metric system.
The highest international body for establishing units, their definitions and methods of reproduction is the General Conference on Weights and Measures, in whose work representatives of all 47 states that have joined the Convention participate. The General Conference elects the International Committee for Weights and Measures (CIPM), which directs the work of the entire organization between General Conferences.
In accordance with the Convention, a scientific laboratory has been established and operates — the International Bureau of Weights and Measures (BIPM), located in the city of Sevres (France). The goals of the BIPM are to keep and maintain the international standards of various units of measurement and to compare national standards against them. The activities of the BIPM are directed by the International Committee for Weights and Measures. The use, through the BIPM, of averaged data from the international time scale allows Russia to maintain the specified accuracy of the state primary standard of time and frequency and of the entire system for transmitting reference frequencies and secondary standards at a much lower cost. The high measurement accuracy achieved at the BIPM's reference facilities makes it possible to use them to obtain new scientific data and conduct unique research.
The International Organization of Legal Metrology (OIML) establishes metrological characteristics of measuring instruments that are uniform for standardization methods, the procedure for verification and calibration of verification equipment, methods for comparing and verifying reference, model and working measuring instruments, ensures the use in countries of units of measurement unified on an international scale; develops optimal forms of organization of metrological services and ensures the uniformity of state regulations on their conduct; provides scientific and technical assistance to developing countries in creating and organizing the work of metrological services and equipping them with the necessary technical means; establishes uniform principles for training personnel in metrology at various levels of qualification. This organization periodically revises adopted international recommendations and documents, which is due to scientific and technical progress in each individual field of metrology, at the proposal of one of the OIML member countries, but no later than five years after their approval by the conference. The OIML program includes more than 200 topics covering many types of measurements carried out in industry, trade, agriculture, and medicine.
To achieve the uniformity of measurements in practice on an international scale, international organizations develop corresponding regulatory documents and norms and rules in the field of metrology that are introduced into national systems. International regulatory documents, in terms of content and scope of application, cover four components of metrological practice: terminology in the field of metrology; units of quantities, their names, designations and definitions; requirements for the metrological characteristics of measuring instruments; and methods for expressing the errors of measurement results of quantities.
In the field of terminology, the most important document is the International Vocabulary of Basic and General Terms in Metrology, which was published in its second edition in 1993. Specialists appointed by seven international organizations, including ISO, IEC, OIML and BIPM, took part in preparing the vocabulary. This vocabulary is published by the International Organization of Legal Metrology.
In the field of units of physical quantities, the main document is the International System of Units SI — this is the basis for unifying the units of measurement used to ensure the uniformity of measurements. Attaching special importance to systematizing all materials on improving the International System of Units, the BIPM published the collection «The International System of Units SI», which is the most important fundamental international regulatory document on metrology.
International documents containing requirements for the metrological characteristics of measuring instruments include: specifications for standards developed by the BIPM; the Regulation on the International Temperature Scale of 1990 (ITS-90); the International Recommendations of the OIML and the international standards of ISO and IEC on the technical requirements for measuring instruments and methods for their verification.
An analysis of the information models of the measuring channels of information-measuring systems (IMS) showed that, when built on the basis of the direct conversion method, only five structure variants are possible, while when using measurement methods with feedback (compensation) conversion of information — 20.
In most cases (especially when building an IMS for remote objects), the generalized information model of the measuring channel (MC) of the IMS has the form shown in Fig. 1.13, and the most widespread are the analog-discrete branches 0-1-2-32-42 and0-2-32-42. As can be seen, for the indicated branches the number of information conversion levels in the MC does not exceed three.
Since the nodes house the technical means that carry out the conversion of information, then, taking into account the limited number of conversion levels, they can be combined into three groups. This will make it possible, when developing the MC of the IMS, to select the technical means needed to implement one structure or another.
The group of technical means of the node includes the entire set of primary measuring transducers, as well as unifying (normalizing) measuring transducers (UMT) that perform scaling, linearization, power conversion, etc.; test-forming units and reference measures.
In node 2 where analog-discrete branches are present, another group of measuring instruments is located: analog-to-digital converters (ADC), commutators (KM), which serve to connect the corresponding information source to the MC or to the processing device, as well as communication channels (CC).
The third group (node 3) combines code converters (PC), digital-to-analog converters (DAC) and delay lines (DL).
Thus, the information model of the MC of the IMS makes it possible to move to its structure according to the diagram, which for the branch 0-1-2-32-42 has the form shown in Fig. 1.14.
The structure of the MC shown, which implements the direct measurement method, is shown without the connections controlling the operation of the switching element and the ADC. It is a standard one, and most multichannel IMS, especially long-range IMS, are built on its basis.
Fig. 1.14. Block diagram of the measuring channel of the IMS:
PT — primary transducer;PC — code converter;Kl — key element of the control commutatorKM
+Of interest are the methods of calculating the MC for the various information models discussed above. A strict mathematical calculation is not possible, but by using simplified approaches to determining the components of the resulting error, the parameters and distribution laws, setting a value of confidence probability and taking into account the correlation relationships between them, it is possible to compile and calculate a simplified mathematical model of a real measuring channel. Examples of calculating the error of channels with analog and digital recorders are considered in the works of P.V. Novitsky.
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