Provisions On Metrological Requirements Measuring Instruments

Original Language Title: Noteikumi par metroloģiskajām prasībām mērīšanas līdzekļiem

Read the untranslated law here: https://www.vestnesis.lv/ta/id/142379

Cabinet of Ministers Regulations No. 673 in Riga august 22, 2006 (pr. Nr. 43. § 12) the provisions on metrological requirements measuring instruments Issued in accordance with the law "on conformity assessment" and article 7 of the law "on a uniformity of measurements" 6. the second paragraph of article i. General questions 1. metrological requirements determine the state metrological control of measuring instruments subject to water consumption meters, gas consumption meters and volume conversion devices, active electrical energy meters, heat meters, measuring systems for liquids (except water), automatic weighing instruments, taximeters , tangible measures, dimensionāl and measuring the exhaust gas analyser (hereinafter referred to as the means of measurement) to put them on the market and put into use, as well as their metrological control and supervision of the market.
2. under the terms of This auxiliary device is measuring the assistive device that functions independently and connect the measuring instrument to the other device or measuring tool.
3. Insert the market and put in use can only measuring instruments and additional devices, which comply with the requirements of this Regulation as well as the laws on the metrological requirements for a particular feature of measurement and regulations on electromagnetic compatibility, if the measuring instruments and additional devices carried out conformity assessment (chapter II) and marked with the CE marking and papildmarķējum (chapter III).
4. Measuring features meet the requirements of these regulations and laws on the metrological requirements for a particular measurement feature, if they meet the applicable standards and the international organization of legal metrology requirements document. This information is available in the limited liability company "Latvian National Metrology Centre" website.
5. If the measuring instrument does not meet the requirements of these regulations and laws on the metrological requirements for a particular measurement feature, it may not restrict the display at trade fairs, shows and fairs where it is marked with an indication that it may not be placed on the market, as well as put in use, until compliance with the requirements of the rules and regulations of metrological requirements for a particular measurement feature.
6. Essential requirements means of measurement defined in annex 1 of these provisions, the specific requirements laid down in the Act, regulations on the metrological requirements for a particular measurement feature. The means of measuring the conformity assessment shall be carried out in accordance with the provisions of chapter II.
7. Measuring features of conformity assessment shall be carried out: 7.1. conformity assessment bodies accredited national agency "Latvian National Accreditation Bureau" according to the following standards: 7.1.1 LVS EN ISO/IEC 17020:2005 "the main criteria for the different types of institutions that conduct inspections" and EN ISO/IEC17025: EN 2005 "the competence of testing and calibration laboratories-General requirements", to carry out conformity assessment according to the requirements of module A1;
7.1.2. Lvs EN 45011:2004 "General requirements for bodies dealing with product certification systems" and EN ISO/IEC17025: EN 2005 "the competence of testing and calibration laboratories-General requirements", to carry out conformity assessment to the requirements of module B;
7.1.3. Lvs EN ISO/IEC 17020:2005 "the main criteria for the different types of institutions that conduct inspections" and EN ISO/IEC17025: EN 2005 "the competence of testing and calibration laboratories-General requirements", to carry out conformity assessment according to the requirements of module C1;
7.1.4. EN EN 45012:2004 "General requirements quality system assessment and certification/registration bodies", to carry out conformity assessment according to the requirements of module D;
7.1.5. EN EN 45012:2004 "General requirements quality system assessment and certification/registration bodies", to carry out conformity assessment according to the requirements of module D1;
7.1.6. EN EN 45012:2004 "General requirements quality system assessment and certification/registration bodies", to carry out conformity assessment according to the requirements of module E;
7.1.7. EN EN 45012:2004 "General requirements quality system assessment and certification/registration bodies", to carry out conformity assessment according to the requirements of module E;
7.1.8. Lvs EN ISO/IEC 17020:2005 "the main criteria for the different types of institutions that conduct inspections" and EN ISO/IEC17025: EN 2005 "the competence of testing and calibration laboratories-General requirements", to carry out conformity assessment according to the requirements of module F;
7.1.9. Lvs EN ISO/IEC 17020:2005 "the main criteria for the different types of institutions that conduct inspections" and EN ISO/IEC17025: EN 2005 "the competence of testing and calibration laboratories-General requirements", to carry out the assessment of conformity with the corresponding requirements of the F1 module;
7.1.10. Lvs EN 45011:2004 "General requirements for bodies dealing with product certification systems" and EN ISO/IEC17025: EN 2005 "the competence of testing and calibration laboratories-General requirements", to carry out conformity assessment according to the requirements of module G;
7.1.11. EN EN 45012:2004 "General requirements quality system assessment and certification/registration bodies", to carry out conformity assessment according to the requirements of module H;
7.1.12. EN EN 45011:2004 "General requirements for bodies dealing with product certification systems", EN EN 45012:2004 "General requirements quality system assessment and certification/registration bodies" and EN ISO/IEC17025: EN 2005 "the competence of testing and calibration laboratories-General requirements", to carry out conformity assessment according to the requirements of module H1;
7.2. other Member States of the European Union or the European economic area countries that have notified authorities of civil liability and apdrošinājuš for the which the Economy Ministry published a notice in the newspaper "Gazette" (hereinafter referred to as the notified body).
8. The Ministry of economy in cooperation with the Technical Committee for Standardization recommends that the limited liability company "Latvian standards", reliance and the newspaper "Latvian journal" published a list of the standards.
9. Limited liability company "Latvian standards" submit for publication in the newspaper "journal" national list of the standards that apply to these rules and laws on the metrological requirements for a particular feature of measurement (hereinafter referred to as the applicable standards). State Agency "Latvian National Metrology Centre" submitted for publication in the newspaper "journal" for the international organization of legal metrology list of documents shall apply these rules and laws on the metrological requirements for a particular measurement feature.
II. Evaluation of conformity 10. measuring of the compliance with the essential requirements by the choice of the manufacturer assessed under one of the modules of conformity assessment procedures set out in the Act, regulations on the metrological requirements for a particular measurement instrument (annex 2).
11. Test results demonstrate that the measuring tool, its type or the measuring instrument and the type meets the requirements of these regulations and laws on the metrological requirements for a particular measurement feature, as well as gas, water and heat consumption meter and measuring system for liquids (except water) endurance specifications, if the testing is performed in accordance with the applicable standards and the international organization of legal metrology requirements document.
12. the means of Measuring compliance producer can choose any technical solution that complies with these rules 1. the requirements set out in the annex and with the essential requirements laid down in the laws on the metrological requirements for a particular measurement feature, while the applicable standards to be followed and the international organization of legal metrology requirements document.
13. measurement and enhancement of the conformity assessment can be performed separately, if it provides a measure of the metrological requirements for a particular measurement feature.
14. Technical documentation contains information about the measurement of the design, manufacture, installation and operation, to perform the conformity assessment.
15. The technical documentation shall be sufficiently detailed to ensure: 15.1. metrological characteristics;
15.2. features of the manufactured measuring performance reproducibility of the metrological, if they are correctly adjusted, using the means provided for that purpose;
15.3. the means of measuring integrity.
16. The technical documentation shall include all necessary information, in so far as it relates to the means of measurement, as well as the assessment and identification of the type: measuring the 16.1. General description;
16.2. design sketches, production drawings, component deployment plans and schemes;

16.3. manufacturing procedures to ensure consistent production;
16.4. If necessary, a description of the electronic devices with drawings, diagrams, software information traceability schemes, which explains the equipment specification and operation;
16.5. the descriptions and explanations necessary for the understanding of the measurement activities;
16.6. the fully or partly applicable standards used, as well as the international organization of legal metrology in the list;
16.7. solutions used to comply with the essential requirements and descriptions, if applicable standards are used, as well as the international organization of legal metrology;
16.8. the design calculation, test results;
16.9. test results, where necessary, to demonstrate that the measurement tool and type: 16.9.1. specific operating conditions and environmental disturbances meet the requirements of the rules and regulations of metrological requirements measuring specific feature;
16.9.2. meet the gas and water meters, heat meter and measuring system for liquids (except water) the durability specifications;
16.10. the European Community (hereinafter the EC) type assessment certificates or EC design assessment certificates for measuring products containing identical parts used in construction.
17. Conformity assessment document in annex 1 of these rules or regulations in the Act for specific metrological requirements measuring feature that documents and correspondence are conducted in its Member State of the European Union or European economic area national language, in which the notified body, which shall carry out specific conformity assessment of measuring instruments, or the language accepted by the notified body. Metrological requirements for proper measuring instrument provides national language.
18. The technical documentation the manufacturer specifies the timestamp and marking the location.
19. If necessary, the manufacturer indicates the interface (the interface) and the enhancement of interoperability conditions.
III. The CE marking and measuring tools papildmarķējum 20. compliance with the requirements of these regulations and laws on the metrological requirements for a particular measurement feature attest to the CE marking (annex 3) and papildmarķējum, which must be affixed by the manufacturer or his authorised representative, on their own responsibility.
21. the Papildmarķējum consist of a rectangular frame placed a large letter "M" and the affixing of the CE year's last two digits. The height of the rectangle is equal to the height of the CE conformity marking. Papildmarķējum applied immediately behind the CE conformity marking.
22. The notified body identification number indicates the CE marking and the papildmarķējum Gorge, where it is intended for conformity assessment procedures.
23. the CE marking and papildmarķējum, as well as the notified body identification number must be clearly visible, easily legible, indelible and protected against removal.
24. where a measuring instrument complies with the other requirements of the law, which provides a means of measuring the affixing of the CE marking, this should be stated on the label.
25. If the measurement tool consists of devices that do not have additional devices, and work together with them, marking must be affixed to the main features of measuring devices.
26. where a measuring instrument is too small or too sensitive to attach the CE marking and papildmarķējum, mark indicated on the packaging, if any, or in these regulations and laws on the metrological requirements for a particular measurement feature accompanying documents required.
27. the measuring tool can be attached to another label if it does not interfere with the CE marking and the visibility and legibility of the papildmarķējum.
28. the measuring instruments must not deploy label, which can be confused with CE marking or papildmarķējum.
IV. Market monitoring 29. These rules and laws on the metrological requirements for a particular measurement feature for the state metrological control procedures and market surveillance is undertaken by the consumer protection centre.
30. The consumer protection centre 31. these provisions referred to measures to ensure that measuring instruments are subject to metrological control regulated, but which do not comply with these rules and laws on the metrological requirements for a particular measurement feature requirements are not placed on the market or put into service.
31. If the consumer rights protection Centre finds that all or part of certain types of measuring instruments marked with the CE mark and papildmarķējum, correctly installed and used in accordance with the manufacturer's instructions, does not meet the requirements of these regulations and laws on the metrological requirements for a particular measurement feature, it makes up of administrative acts and take appropriate measures to remove them from the market, prohibit or restrict its further placing on the market and use of as well as inform the Ministry of economy of the measures taken.
32. If the information about a specific non-compliance is received, systematically, the Ministry of economy shall inform the European Commission of the consumer rights protection centre the measures taken, specifying the validity of the decision.
33. If the European Commission approves the rule referred to in paragraph 30 of the decision, the consumer protection centre is a fine person who affixed the mark and shall inform the Ministry of the economy. The Ministry of economy shall inform the European Commission and the other Member States of the European Union in the official representation of the measures taken.
34. If the European Commission finds that decision taken pursuant to this provision, paragraph 30, and the measures taken by the consumer rights protection centre, is not justified, it shall inform the Ministry of the economy. The Ministry of economy shall inform the state metrological inspection and the manufacturer or his authorised representative.
35. If the consumer rights protection Centre establishes that the CE marking has been affixed papildmarķējum and improperly, the manufacturer or his authorised representative shall be obliged: 21.8. ensure compliance with the measurement requirements under which affixed the CE marking and the papildmarķējum;
35.2. prevent consumer protection Centre identified irregularities.
36. If the violation is not corrected, the consumer rights protection centre 31. these provisions referred to measures to limit or prohibit certain measuring instruments into the market or ensure that it is withdrawn from the market, or prohibit or restrict its further use, indicating the validity of the decision and informing the manufacturer or his authorised representative.
37. The consumer protection centre, carrying out market surveillance, cooperating with other European Union Member States ' market surveillance authorities.
38. The consumer protection centre with the other European Union Member States ' market surveillance authorities the information shall relate to the following: 38.1. information about measuring means tested compliance with the requirements of these regulations and laws on the metrological requirements for a particular feature of measurement;
38.2. information on notified body EC type assessment issued by the EC design assessment certificates and their annexes, as well as additions, amendments and nullification of certificates issued previously;
23.8. information on the notified bodies of quality system approvals issued, refused or nullification;
23.9. information on notified bodies assessment reports prepared, if requested by the other institutions.
39. The consumer protection centre shall ensure that the notified bodies are available all the necessary information relating to the certificates and quality system approvals.
V. concluding questions 40. Measuring features for which type-approval was issued until the date of entry into force of the rules, allowed to put on the market and measurement of features that made the first verification, allowed to pass until they use the type approval expiration date, but if it is not set, the-by 2016 of 30 October.
41. the rules shall enter into force on 30 October 2006.
Informative reference to European Union Directive provisions included in the law arising from the European Parliament and of the Council of 31 March 2004, Directive 2004/22/EC on measuring instruments.
Prime Minister a. Halloween economic Minister a. Štokenberg Editorial Note: the entry into force of the provisions by 30 October 2006.
 
1. the annex to Cabinet of 22 august 2006 Regulation No. 673 of the essential requirements set out in this annex 1 essential requirements of measurement feature. If the measuring tool for special requirements set out in other laws on the metrological requirements for a particular measurement feature, they must comply with the requirements of this annex, with the essential requirements.
2. the means of measurement provides the appropriate metrological security level to involved parties can trust the results of measurements and can be designed and manufactured according to high quality requirements, taking into account the measurement technology and data security.

3. the essential requirements taken into account solutions for measuring the use of resources and its possible wrong use.
4. for the purposes of this Annex: 4.1 measured quantity has a size, which is the object of measurement;
4.2.-the size is size, which is not measured, but who can influence the measurement results;
4.3. specific operating conditions of the measuring conditions of use under which the measured size and size values are affecting the limits;
4.4. the disorder is affecting that value is within the limits, but does not include the means of measuring a given operating conditions. -The size is considered a nuisance if it is not specified in the operating conditions;
4.5. the critical change value is the value with which the change in the measurement result is considered undesirable;
4.6. the direct marketing is a trade deal if: 4.6.1. based on the results of the measurement, you determine the price;
4.6.2. at least one of the parties involved in the transaction related to measurement is a consumer or those of any other person who needs an equivalent level of protection;
4.6.3. all persons involved in the transaction at the time, and instead recognise the measurement results;
4.7. climatic environments are the conditions that you can use the measuring means;
4.8 utility service is a service that covers electricity, gas, heat or water supply.
5. Allowable error: 5.1. taking under certain operating conditions, if there is no interference, the measurement error must not exceed the maximum permissible error (MPE) value as laid down in the laws on the metrological requirements for a particular measurement feature. If the maximum permissible error in the laws on the metrological requirements for measuring specific product is not established otherwise, it is expressed as the reciprocal of the deviation from the true measurement value;
5.2. subject to certain operational conditions and disturbance measurement feature must comply with the laws on the metrological requirements for a particular measurement feature. If the measuring instrument is intended to be permanent and constant effort laid down in electromagnetic field measurement results produced by the test of amplitude modulated electromagnetic field must not exceed the maximum permissible errors.
5.3. the manufacturer shall specify the climatic, mechanical and electromagnetic environments in which is intended for use in measuring tool as well as a source of energy supply capacity and other influencing sizes, which could affect the accuracy of measurement defined in the laws on the metrological requirements for a particular measurement feature.
6. Climatic environment-the manufacturer shall specify the upper and lower temperature limit values according to table 1 of this annex, if specified in the laws on the metrological requirements for a particular measurement feature is not otherwise specified, indicates whether the measuring tool is designed to work with or without moisture condensation, indicates the action of the measuring location (indoors or outdoors).
table 1 temperature robeždiapazon in the upper temperature limit of + 30 ° C + 40 ° C + 55 ° C + 70 ° C lower temperature limit + 5 ° C to 10 ° C – 25 ° C – 40 ° C 7. Mechanical environment are divided into the following classes, depending on the size of possible influencing (vibration and mechanical shock) intensity: 7.1 M1 class apply to measuring instruments used in locations with low intensity vibration and shock;
7.2 M2 class apply to measuring instruments used in locations with significant or high levels of vibration and shock;
7.3. M3 class apply to measuring instruments used in locations with high and very high levels of vibration and shock.
8. Electromagnetic environment are divided into the following classes, depending on the size of the effects (voltage interruption, temporary voltage drops in the power supply line voltage transition or signal transmission lines, electrostatic discharge, radio frequency electromagnetic fields, transmission radio frequency electromagnetic field power supply lines of transition or signal transmission lines, as well as the supply line or signal transmission line pārspriegojum), if the laws on the metrological requirements for a particular feature of measurement unless otherwise specified: class E1 apply 8.1 measuring features use in locations with electromagnetic disturbances that occur in residential, commercial and light industrial buildings;
8.2. the E2 class apply to measuring instruments used in locations with electromagnetic disturbances, which are found in industrial buildings that are not the light industrial buildings;
8.3. E3 class apply to measuring instruments, which are the source of energy used for the vehicle's battery. They must meet the E2 class and the following additional requirements: 8.3.1. voltage decrease, caused by internal combustion engine starter chain;
8.3.2. the temporary loss of the load caused the transition process if the discharged battery disconnect, but the engine continues to run.
9. If necessary, also take account of the following uncertainties: 9.1 voltage fluctuations;
9.2. the main frequency fluctuations;
9.3. power frequency magnetic fields;
9.4. any other sizes, which could affect the accuracy of the measurement.
10. When testing the measurement features: 10.1 checks every relevant influencing size set in this annex 5.1 and 5.2 above. If the laws on the metrological requirements for a particular feature of measurement unless otherwise specified, the essential requirements shall apply when evaluating each individual-size and assessing its impact, while the rest of the effects of influence factors remain unchanged the reference value;
10.2. the metrological tests shall be carried out in influencing size during or after exposure to it, if the conditions for normal work of means of measurement mode when the normal effects affecting size;
10.3. depending on the climatic environment, which is expected to operate the measuring instrument, humidity and heat cycle test at a constant temperature (condensation) or damp heat cyclic (condensing occurs). Testing damp heat cyclic, if condensation is essential or promote the penetration of steam aspiration. When moisture condensation occurs, the condition is appropriate.
11. the reproducibility of measurement results, coincidentally, the same mērlielum using different locations or different users, if all other conditions are unchanged. The difference between the results of measuring are small compared to the maximum permissible error.
12. Repeatability – perform a sequence of the same size to be measured measurement reproducibility of the results, if the measuring conditions are unchanged. The difference between the results of measuring are small compared to the maximum permissible error.
13. the sensitivity and the sensitivity threshold – measuring instrument shall be sufficiently sensitive and the sensitivity threshold should be low enough for the intended measurement task.
14. Strength-measuring product must be designed to ensure the appropriate metrological characteristics of stability within the period specified by the manufacturer, subject to the appropriate installation, maintenance and use, in accordance with the manufacturer's instructions for its intended environmental conditions.
15. Safety – measuring product must be designed in such a way that it is possible, reduce exposure to a fault that could cause an inaccurate measurement result, unless the presence of such a defect is obvious.
16. Fitness: 16.1 measuring feature may not be the characteristics that promote the use of unfair, and to reduce the chance of abuse;
16.2. a measuring instrument shall be suitable for the intended use, taking into account the actual conditions of employment, not to impose unreasonable requirements for the user to get the correct measurement results;
16.3. the means of measurement errors that are used in the public utility accounting, excessive digress, one way or another, if the flow or current is outside the boundaries of the mērdiapazon laid down;
16.4. If the measuring tool designed for such measurements is that the measured size remains constant over time, the measuring instrument shall be insensitive to small in size to be measured or the fluktuācij to respond to them;
16.5. the measuring instrument must be strong, and its materials of construction shall be appropriate for the conditions of use;
16.6. the measuring instrument shall be designed to enable the measurement of progress in check after it placed on the market and put into use. If necessary, in order to ensure verification of the measuring instrument is equipped with special equipment or software. The test procedure must be described in the user manual.
10.4. If the measuring instrument is equipped with software that performs without measuring other features, the software the metrological characteristics critical to be identifiable and not allowed its dependence on related software.

17. protection against damage: 17.1. measuring instrument metrological characteristics should not unduly affect other equipment or any other device that fall within a certain distance of the measuring means and is connected with it;
17.2. hardware components that can significantly affect the metrological characteristics of measuring instruments must be designed so that it is secure and any interference would be identified;
17.3. software, which significantly affect the metrological characteristics shall be labelled accordingly, and it must be protected;
17.4. the software identification must be protected with the same measuring feature;
17.5. the evidence of tampering should be available to a reasonably long period;
10.9. measurement data, software essential metrological characteristics metrological characteristics and significance that is stored or transmitted shall be adequately protected against accidental or deliberate damage;
17.7. If means of measurement for utilities, the display must show the total quantity supplied or the displays must be presented from which you may compute the total quantity to be delivered, and display all or part of which serves as the basis for payment. Readings may not terminate the use of the measurement time.
18. measurement feature plug-in information: 18.1. on measuring feature must include the following information: 18.1.1. the manufacturer's mark or name;
18.1.2. information about its accuracy;
18.1.3. where appropriate, information on the conditions of use, measurement ability, mērdiapazon, identification marks, the EC type assessment or EC design assessment certificate number, and information about whether additional devices providing metrological results comply with the requirements of these provisions and laws on the metrological requirements for a particular feature of measurement;
18.2. dimensionāl measurement instruments that are too small or with great sensitivity, allowed important information onto the packaging, if any, and the accompanying documentation;
18.3. measuring features adds information about the entry (except measurement features whose use is simple and unambiguous). The information must be easily understood and include: 18.3.1. certain operating conditions;
18.3.2. mechanical and electromagnetic environment classes;
18.3.3. upper and lower temperature limit, as well as the likelihood of condensation or operating environment (outdoor or indoor);
18.3.4. installation, maintenance and repair instructions, as well as the permissible adjustments;
18.3.5. instructions for proper use and any special conditions of use;
18.3.6. conditions for compatibility with interfaces, additional devices or other measuring instruments;
18.4. If the same site or utilities are used for measurement of a number of identical measuring features for each of them there is no need to add a separate instruction manual;
18.5. where these rules and laws on the metrological requirements for measuring specific feature does not provide otherwise, the value of the scale divisions must be 10n, 2 1 ´ ´ 10n or 5 ´ 10n, where n is any integer or zero. The unit or its symbol must be close to a numerical value;
18.6. the material to be measured indicates the nominal value or a scale, together with the unit of measure used;
11.6. used units and with their symbols must correspond to the requirements of the legislation on units of measurement and their symbols;
12.8. all markings and inscriptions must be clear, indelible, unambiguous and non-replaceable.
19. the measurement result display: 19.1. results measurements read from the display or print;
19.2. any reading results should be clear and unambiguous, accompanied by such marks and inscriptions necessary to inform the user about the significance of the results. Under normal conditions of use to ensure easy reading of the results. Additional readings may be shown if it is not to be confused with the metrologically controlled indications;
19.3. If the results of the readings available in print to print or records must be clearly legible and indelible;
19.4. feature of measurement for use in trade must be designed to display the results after you have access to both parties involved in the transaction. Direct sales is essential to all receipts, which the consumer receives from the accessories which do not satisfy the requirements of the rules and regulations of metrological requirements for a particular feature of measurement, indication of the limits of the information obtained;
19.5. regardless of whether a measuring instrument for the measurement of the utilities provided with long-range reading device or not, it must be fitted with a metrologically controlled indications device available to the consumer without the use of additional resources. Means of measurement readings on the indicating device is the result of measurement, which serves as the basis for the charges.
20. further processing of data trade deal: 20.1. If the measuring instrument is not used for utility records and is usually intended for use, present one of the parties to the transaction, and it is not possible to repeat a measurement, the measurement results to be stored persistently along with information about a particular transaction;
20.2. the continued evidence of stored measurement results and information on the specific transaction must be available on request from the completion of the measurement.
21. the measuring instruments must provide the ability to make its assessment of conformity with the corresponding requirements of this regulation and the laws on the metrological requirements for a particular measurement feature.
Economic Minister a. Štokenberg presented the Ministry of Economics in annex 2 versions of the Cabinet of Ministers of 22 august 2006 Regulation No. 673 of the conformity assessment procedures the conformity assessment procedures module manufacturer's liability obligations of notified bodies authorized representative module A-declaration of conformity based on internal production control-the conformity assessment procedure whereby the manufacturer fulfils the obligations which are defined in these regulations and its annexes, as well as regulations on the requirements of certain measuring instruments and declares that they satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer shall draw up technical documentation in accordance with this provision, 15, 16, 17, 18 and 19 of the requirements to the extent that enables you to assess the compliance of the means of measuring this provision and its annex, as well as on the requirements of the laws and specific features of measurement requirements, including measurement of the design, manufacture and operation.
-The manufacturer maintains the technical documentation for 10 years after the last measuring instrument manufacturing and make it available, upon request, the consumer rights protection centre.
-The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments of measurement rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer shall affix the "CE" marking and in addition the metrological measurement of each feature that complies with this regulation and its annexes, as well as on the requirements of the laws and specific means of measuring requirements.
-Draw up a declaration of conformity for a product model and measuring it upon request make available to the consumer rights protection centre, 10 years after the last measuring instrument manufacturing. The Declaration must identify a measuring tool for which it has been drawn up.
Each measuring feature that inserts on the market equipped with a copy of the Declaration of conformity. If one user supplied a large batch of measuring instruments, it issued only one copy of the Declaration of conformity, which includes all the features of measuring a lot.
 
-The manufacturer's obligations are described in paragraph 3 of these regulations, and in paragraph 5.2 it may be authorized representative.
If the manufacturer or his representative is not in the European Community countries, the obligations of this provision is described in paragraph 3 and in paragraph 5.2, assume the person who places the measuring instrument on the market.
Module A1-declaration of conformity based on internal production control and topped with bodies notified product testing — the conformity assessment procedure whereby the manufacturer fulfils the obligations which are defined in these regulations and its annexes, as well as regulations on the requirements of certain measuring instruments and declares that they satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer shall draw up technical documentation according to these noteikumu15, 16, 17, 18 and 19 of the requirements to the extent that enables you to assess the compliance of the means of measuring this provision and its annex, as well as on the requirements of the laws and specific features of measurement requirements, including measurement of the design, manufacture and operation.

-The manufacturer maintains the technical documentation for 10 years after the last measuring instrument manufacturing and make it available, upon request, the consumer rights protection centre.
-The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments of measurement rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer shall affix the "CE" marking and in addition the metrological measurement of each feature that complies with this regulation and its annexes, as well as on the requirements of the laws and specific means of measuring requirements.
-Draw up a declaration of conformity for a product model and measuring it upon request make available to the consumer rights protection centre, 10 years after the last measuring instrument manufacturing. The Declaration must identify a measuring tool for which it has been drawn up.
Each measuring feature that inserts on the market equipped with a copy of the Declaration of conformity. If one user supplied a large batch of measuring instruments, it issued only one copy of the Declaration of conformity, which includes all the features of measuring a lot.
-The notified body chosen by the manufacturer, its specific intervals out product checks or have present at the inspection of products in order to verify the quality of the internal checks of the product, subject to the means of measuring the technological complexity and the volume of production. Before inserting the product on the market, the notified body shall examine and test the final product, also an adequate quantity of samples as identified in the relevant documentation and the corresponding provisions of the requirements of paragraph 11, or equivalent tests, in order to assess the conformity of the measuring means this rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements. If proper documentation is not available, the notified body shall take a decision on the tests you need to perform.
In cases where the quantity of sample to confirm compliance with the permissible level, the notified body shall take appropriate measures.
-The manufacturer's obligations are described in paragraph 3 of these regulations, and in paragraph 5.2 it may be authorized representative.
If the manufacturer or his representative is not in the European Community countries, the obligations of this provision is described in paragraph 3 and in paragraph 5.2, assume the person who places the measuring instrument on the market.
B-Type assessment module-part of a conformity assessment procedure whereby a notified body examines the technical design of the measuring instrument, ensures and declares that the technical design meets the rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-Type of assessment carried out in accordance with one of the following methods:-the measuring range, representative of the production envisaged, of the test sample;
-measuring instrument, representative of the production envisaged, of one or more of the critical components of the examination, supplemented by means of measuring the adequacy of other components of the evaluation, using the technical documentation and supporting evidence to the test, according to paragraph 3 of these rules;
-measurement of the technical evaluation of the project, using the technical documentation and supporting evidence verification of compliance with these provisions, according to paragraph 3, without examination of the sample.
The notified body shall take a decision on the most appropriate method, and for this purpose the necessary samples.
 
-The manufacturer shall submit the application to the evaluation of the type announced institution of their choice. The application shall include:-the name and address of the manufacturer, but if the application is lodged by the authorised representative of the manufacturer, then even more to his name and address;
-a written declaration that the same application has not been filed yet another notified body;
-the technical documentation as required by this rule 15, 16, 17, 18 and 19 (documentation must allow assessment of the measuring according to these rules and its annex, as well as on the requirements of the laws and specific requirements of measuring instruments to the extent that this is necessary to assess the means of measuring the design, manufacture and operation);
-measuring instruments or their components, samples from the production, according to the notified body in the request;
-supportive evidence for the measurement of the technical components of the project, for which no request for samples (receipts must be references to documents that were used, t.sk. This provision of the document referred to in point 15, if not fully used; supporting receipts must include, if necessary, laboratory or its producer; and on behalf of other laboratory testing results).
-The manufacturer shall inform the notified body that holds the EC type assessment certificate-related technical documentation for all measurement features modifications which may affect the measurement of conformity with the essential requirements or the conditions for validity of the certificate. This modification requires approval of the extraordinary as a supplement to the original EC type assessment certificate.
-The manufacturer maintains EC type assessment, a copy of the certificate, its annexes and additions with the technical documentation for 10 years after the manufacture of the measuring means.
 
For models:-the notified body shall examine the technical dossier;
-Verify the samples that are made in accordance with the documentation and identify the elements which have been designed in accordance with the provisions set out in paragraph 15 of the document;
-identify the elements which have been designed without this document.
-the notified body shall carry out appropriate checks and testing or are present at the tests in order to assess whether the manufacturer has used the solutions, in accordance with the provisions referred to in paragraph 15 of the document, and whether those documents are used correctly.
-the notified body shall carry out appropriate checks and testing or are present at the tests in order to evaluate the results obtained without these rules referred to in paragraph 15 of the document and get solutions to meet the requirements of these regulations.
-the notified body shall agree with the applicant the location where the examinations and tests carried out.
For other means of measuring components of the notified body shall examine the technical documentation and supporting evidence to assess the adequacy of the technical design for the rest of the components of the measuring means.
On the production process of the notified body shall examine the technical documentation to ensure that the manufacturer has adequate means to ensure consistent production.
-The notified body shall draw up an evaluation report that is recorded in this provision laid down in paragraph 4, the activities and the results obtained. To publish the contents of the report in part or in full to the notified body may only with the manufacturer's consent.
-Where the technical design meets the rules and its annex, as well as on the requirements of the laws and specific requirements of measuring instruments, the notified body issues an EC type assessment certificate.
Shown on the certificate the name and address of the manufacturer or his authorized representative, if any, of the examination, the conditions of validity of the certificate and identification of the means of measuring the data you need. The certificate, you can add one or more attachments.
Certificate and include conformity assessment annexes and the related controls in the appropriate information. Such monitoring may include:-measuring type metrological characteristics;
-measures necessary for measuring the integrity of (sealing, identification of software, URu.tml);
-information on other elements necessary for the identification of the means of measurement and Visual inspection of conformity;
-If necessary, any specific information necessary to verify the characteristics of the manufactured measuring instruments;
-all the information you need to ensure compatibility with additional devices or other measuring instruments, if any.
-the notified body shall draw up a report for the evaluation and ensure that it is available on the consumer rights protection centre on request.
-The notified body shall immediately inform the consumer centres on:-the EC type assessment issued certificates and their annexes;
-additions and amendments relating to certificates already issued;
-withdrawn EC type assessment certificates.
Notified body keeps the register of technical, including the documentation provided by the manufacturer until the end of the period of validity of the certificate.
-The manufacturer's authorised representative may lodge the provisions referred to in paragraph 3, the application of these provisions and to take the 6 and 8 commitments. If the manufacturer is not established in any of the countries in the European Union and he is also not a representation in one of the European Union countries, the responsibility for the preparation of the technical documentation and access the person who is meant by the manufacturer.
 

Module c-Declaration of conformity to type based on internal production control-the conformity assessment procedure whereby the manufacturer fulfils the obligations which are laid down in this annex ensures and declares that the measuring instruments concerned are in conformity with the type as is formulated in EC type assessment certificate and satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments for measuring type, as is formulated in EC type assessment certificate and meet the provisions of this annex and, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer shall affix the "CE" marking and in addition the metrological measurement for each product that matches the type as is formulated in EC type assessment certificate and satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-Declaration of conformity is drawn up for each of the measurement model and it must be maintained for a period of 10 years after the last measuring instrument manufacturing and make it available, upon request, the consumer rights protection centre. The Declaration must identify the means of measurement model for which it has been drawn up.
Each measuring instrument that is placed on the market must be provided with a copy of the Declaration. If one user supplied a large batch of measuring instruments, it issued only one copy of the Declaration of conformity, which includes all the features of measuring a lot.
 
-The manufacturer's obligations are described in point 3.2 of these regulations, may perform the authorized representative.
If the manufacturer or his representative is not in the European Community countries, the obligations of this provision is described in point 3.2, assume the person who places the measuring instrument on the market.
Module C1-Declaration of conformity to type based on internal production control and topped with bodies notified product testing — the conformity assessment procedure whereby the manufacturer fulfils the obligations which are laid down in this annex ensures and declares that the measuring instruments concerned are in conformity with the type as is formulated in EC type assessment certificate and satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments for measuring type, as is formulated in EC type assessment certificate and meet the provisions of this annex and, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer shall affix the "CE" marking and in addition the metrological basis of notified body rating, as defined in paragraph 3 of this rule, and indicate the institution identification number to each measuring instrument that is in conformity with the type as defined in the EC type assessment certificate and satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-Declaration of conformity is drawn up for each of the measurement model and it must be maintained for a period of 10 years after the last measuring instrument manufacturing and make it available, upon request, the consumer rights protection centre. The Declaration must identify the means of measurement model for which it has been drawn up.
Each measuring instrument that is placed on the market must be provided with a copy of the Declaration. If one user supplied a large batch of measuring instruments, it issued only one copy of the Declaration of conformity, which includes all the features of measuring a lot.
-The notified body chosen by the manufacturer, its specific intervals out product checks or have present at the tests in order to verify the quality of the internal checks of the product, subject to the means of measuring the technological complexity and the volume of production. Before inserting the product on the market, the notified body shall examine and test the final product, also an adequate quantity of samples as identified in the relevant documentation, under this rule, the requirements of paragraph 11, or equivalent tests, in order to assess the features of measuring compliance with the relevant requirements of this regulation. If proper documentation is not available, the notified body shall take a decision on the tests to be carried out.
In cases where the quantity of sample to confirm compliance with the permissible level, the notified body shall take appropriate measures.
-The manufacturer's obligations set out in this provision in subparagraph 4.2, you can execute the authorized representative.
If the manufacturer or his representative is not in the European Community countries, the obligations of this provision is described in point 4.2, assume the person who places the measuring instrument on the market.
Module d-Declaration of conformity to type that is based on quality assurance of the production process-the conformity assessment procedure whereby the manufacturer fulfils the obligations which are laid down in this annex ensures and declares that the measuring instruments concerned are in conformity with the type as is formulated in EC type assessment certificate and satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer must run an approved quality system for production, final product inspection and testing of measuring instruments concerned as provided for in paragraph 3 of this rule, and this system should be subject to monitoring as specified in point 4 of these rules.
 
-The notified body the manufacturer shall lodge an application for assessment of the quality system. The application shall include:-all relevant information for the planned means of measurement categories;
-the documentation concerning the quality system;
-documentation of the approved type the EC type certificate and a copy of the assessment.
-Quality system provides a means of measuring compliance with the type as it is defined in the EC type certificate and assessment of these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
All system elements, requirements, and conditions that are imposed by the manufacturer, are documented in a systematic way: policies, procedures and instructions.
The quality system documentation shall ensure appropriate quality programmes, plans, hand book and the interpretation of the Protocol.
Documentation dial, special attention is paid to aspects such as:-the quality objectives, the organisational structure, responsibilities and powers of the management with regard to product quality;
-production process, quality control and quality assurance techniques, processes and systematic measures used;
-the examinations and test that will be carried out before and after the production, the production process, as well as the frequency of these checks;
-quality Protocol (such as inspection reports, test and calibration data, personnel qualifications);
-product quality monitoring and effective quality management system.
-The manufacturer assumes obligations arising out of the approved quality system adequate and efficacious and keep at it.
-The manufacturer shall inform the notified body which approved the quality system informed of any proposed change in the quality system.
-The manufacturer shall allow the notified body access to all production, inspection, testing and storage sites for the purposes of the inspection, provide all necessary information, in particular such as:-the quality system documentation;
-quality protocols (such as inspection reports, test and calibration data, qualification of the personnel concerned, etc.).
-The manufacturer shall affix the "CE" marking and in addition the metrological, as well as in accordance with the provisions of section 3.1, the notified body's identification number to each measuring instrument that is in conformity with the type as defined in the EC type certificate and satisfy the assessment that the relevant requirements.
-Declaration of conformity is drawn up for each of the measurement model and it must be maintained for a period of 10 years after the last measuring instrument manufacturing and make it available, upon request, the consumer rights protection centre. The Declaration must identify the means of measurement model for which it has been drawn up.
Each measuring instrument that is placed on the market must be provided with a copy of the Declaration. If one user supplied a large batch of measuring instruments, it issued only one copy of the Declaration of conformity, which includes all the features of measuring a lot.
-Manufacturer of 10 years after the last measuring instrument manufacturing ensures that the consumer rights protection Centre has the following information on:-the documentation referred to in point 3.1 of these regulations;
-information about the changes that are listed in point 3.5 of these rules;
-notified body decisions and statements referred to in this provision 3.5, 4.3 and 4.4.
-The notified body shall assess the quality system to determine whether it satisfies the requirements of any of these terms are defined in point 3.2. It shall also assess the quality system compliance with the applicable standards.

Audit Group in addition to the qualifications of the quality management system, has the experience and the appropriate means of measurement of metrology technology, knowledge of the rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements. The assessment procedure includes the inspection visit to the manufacturer's plant.
Notified body of their decision on the results of inspection shall notify the manufacturer. Decision research conclusions and reasons for the decision.
-The notified body must assess the modifications proposed and decide whether the changed quality system will still satisfy the rule formulated in paragraph 3.2, or a reassessment is required. This decision should be the manufacturer and should include research findings and results of the evaluation.
-The notified body shall carry out regular monitoring of the quality system, the purpose of which is to make sure whether the manufacturer fulfils the obligations arising out of the approved quality system.
-The notified body carries out periodic audits to make sure that the manufacturer maintains and applies the quality system. This audit report shall be submitted to the manufacturer.
-In addition to regular audits, notified body may make unannounced inspections of the manufacturer. These audits notified body, if necessary, may make the product testing or be an observer of the testing carried out by the producer, to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if tests have been made, then the test report.
-Notified body provides consumer protection Center to access list with a quality system approvals or denials and must promptly inform it of a quality system approval.
 
-The manufacturer's obligations are described in this rule 3.1, 3.5, 5.2 and 6 under, you can execute the authorized representative.
 
 
Module D1-Declaration of conformity, which is based on quality assurance of the production process-the conformity assessment procedure whereby the manufacturer fulfils the obligations which are defined in these regulations and its annexes, as well as on the requirements of the laws and specific means of measurement, and declares that they satisfy these rules and its annex, as well as on the requirements of the laws and specific requirements of measuring instruments-manufacturer develop technical documentation according to 15 of these rules. , 16, 17, 18 and 19 of the requirements to the extent that enables you to assess the compliance of the means of measuring this provision and its annex, as well as on the requirements of the laws and specific features of measurement requirements, including measurement of the design, manufacture and operation.
-The manufacturer maintains the technical documentation for 10 years after the last measuring instrument manufacturing and make it available, upon request, the consumer rights protection centre.
-Manufacturer run by the approved quality system for production, final product inspection and testing of measuring instruments concerned as specified in point 5 of these regulations, and this system is subject to monitoring as specified in point 6 of these rules.
-The notified body the manufacturer shall lodge an application for assessment of the quality system. The application shall include:-all relevant information for the planned means of measurement categories;
-the documentation concerning the quality system;
-the technical documentation provided for in paragraph 2 of these regulations;
-quality system provides a means of measuring compliance with the type as it is formulated in these regulations and its annexes, as well as the laws and regulations on the requirements of specific measurement tools.
All system elements, requirements, and conditions that are imposed by the manufacturer, are documented in a systematic way the policies, procedures and instructions. The quality system documentation shall ensure a proper quality programmes, plans, hand book and the interpretation of the Protocol.
Documentation dial, special attention is paid to aspects such as:-the quality objectives, the organisational structure, responsibilities and powers of the management with regard to product quality;
-production process, quality control and quality assurance methods;
-the examinations and test that will be carried out before and after the production, the production process, as well as the frequency of these checks;
-quality Protocol (such as inspection reports, test and calibration data, personnel qualifications);
-product quality monitoring and effective quality management system.
-The manufacturer assumes obligations arising out of the approved quality system adequate and efficacious and keep at it.
-The manufacturer shall inform the notified body which approved the quality system informed of any proposed change in the quality system.
-The manufacturer shall allow the notified body access to all production, inspection, testing and storage sites for the purposes of the inspection, provide it with all necessary information, in particular such as:-the quality system documentation;
-the technical documentation required by paragraph 2 of these regulations;
-quality protocols (such as inspection reports, test and calibration data, qualification of the personnel concerned, etc.).
-The manufacturer shall affix, in accordance with the provisions of section 5.1, "CE", and in addition to the metrological markings and the notified body responsible for the identification number to each measuring instrument that complies with these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-Declaration of conformity is drawn up for each of the measurement model and it must be maintained for a period of 10 years after the last measuring instrument manufacturing and make it available, upon request, the consumer rights protection centre. The Declaration must identify the means of measurement model for which it has been drawn up.
Each measuring instrument that is placed on the market must be provided with a copy of the Declaration. If one user supplied a large batch of measuring instruments, it issued only one copy of the Declaration of conformity, which includes all the features of measuring a lot.
-Manufacturer of 10 years after the last measuring instrument manufacturing ensures that the consumer rights protection Centre has the following information on:-the documentation referred to in point 5.1 of these rules;
-information about the changes that are in accordance with the provisions of paragraph 5.1;
-notified body decisions and statements referred to in that rule 5.5., 6.3 and 6.4.
-The notified body shall assess the quality system to determine whether it satisfies the requirements of this provision is formulated in point 5.2. It shall also assess the quality system compliance with the applicable standards.
Audit Group in addition to the qualifications of the quality management system, has the experience and the appropriate means of measurement of metrology technology, knowledge of the rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements. The assessment procedure includes the inspection visit to the manufacturer's plant.
Notified body of their decision on the results of inspection shall notify the manufacturer. Decision research conclusions and reasons for the decision.
-The notified body shall evaluate the modifications proposed by the producers and decide whether the changed quality system will still satisfy the rule formulated in paragraph 5.2 requirements or need re-evaluation. This decision shall be communicated to the manufacturer and it includes research findings and results of the evaluation.
-The notified body shall carry out regular monitoring of the quality system, the purpose of which is to make sure that the manufacturer fulfils the obligations arising out of the approved quality system.
-The notified body carries out periodic audits to make sure that the manufacturer maintains and applies the quality system. This audit reports must provide the manufacturer with a notified body.
-In addition to regular audits, notified body may make unannounced inspections of the manufacturer. These audits notified body, if necessary, may make the product testing or be an observer to the testing performed by the manufacturer to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with a visit of this report, but, when testing, the test report.
-Notified body provides consumer protection Center to access list with a quality system approvals or denials and must promptly inform it of a quality system approval.
-The manufacturer's obligations are described in this provision, paragraph 3 and 8, 5.1 and 7.2, you can execute the authorized representative.
 
Module e-Declaration of conformity to type based on quality assurance of the finished product inspection and testing

-The part of a conformity assessment procedure whereby the manufacturer fulfils the obligations which are laid down in this annex ensures and declares that the measuring instruments concerned are in conformity with the type as is formulated in EC type assessment certificate and satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
 
-Manufacturer run by the approved quality system, the specific means of measuring the final product inspection and testing as specified in point 3 of this provision, and this system is subject to monitoring as specified in point 4 of these rules.
-The notified body the manufacturer shall lodge an application for assessment of the quality system. The application must include:-all relevant information for the planned means of measurement categories;
-the documentation concerning the quality system;
-documentation for the approved type the EC type certificate and a copy of the assessment.
-Quality system provides a means of measuring compliance with the type as it is defined in the EC type certificate and assessment according to the requirements of these regulations.
All system elements, requirements, and conditions that are imposed by the manufacturer, are documented in a systematic way the policies, procedures and instructions. The quality system documentation shall ensure appropriate quality programmes, plans, hand book and the interpretation of the Protocol.
Documentation dial, special attention is paid to aspects such as:-the quality objectives, the organisational structure, responsibilities and powers of the management with regard to product quality;
-the examinations and test that will be carried out before and after the production, the production process, as well as the frequency of these checks;
-the quality records, such as inspection reports, test and calibration data, personnel qualifications;
-product quality monitoring and effective quality management system.
-The manufacturer assumes obligations arising out of the approved quality system adequate and efficacious and keep at it.
-The manufacturer shall inform the notified body which approved the quality system informed of any proposed change in the quality system.
-The manufacturer shall allow the notified body access to all production, inspection, testing and storage sites for the purposes of the inspection, provide all necessary information, in particular such as:-the quality system documentation;
-quality protocols (such as inspection reports, test and calibration data, qualification of the personnel concerned, etc.).
-The manufacturer, in accordance with the provisions of point 3.1 of the requirements, shall affix the "CE" marking and in addition the metrological and responsible notified body identification number to each measuring instrument that is in conformity with the type as defined in the EC type certificate and satisfy the assessment that the relevant requirements.
-Declaration of conformity is drawn up for each of the measurement model and it must be maintained for a period of 10 years after the last measuring instrument manufacturing and make it available, upon request, the consumer rights protection centre. The Declaration must identify the means of measurement model for which it has been drawn up.
Each measuring instrument that is placed on the market must be provided with a copy of the Declaration. If one user supplied a large batch of measuring instruments, it issued only one copy of the Declaration of conformity, which includes all the features of measuring a lot.
-Manufacturer of 10 years after the last measuring instrument manufacturing ensures that the consumer rights protection Centre has the following information on:-the documentation referred to in point 3.1 of these regulations;
-information about the changes that are listed in point 3.5 of these rules;
-notified body decisions and statements referred to in this provision 3.5, 4.3 and 4.4.
-The notified body shall assess the quality system to determine whether it satisfies the requirements of any of these terms are defined in point 3.2. It shall also assess the quality system compliance with the applicable standards.
Audit Group in addition to the qualifications of the quality management system, has the experience and the appropriate means of measurement of metrology technology, knowledge of the requirements of this regulation. The assessment procedure includes the inspection visit to the manufacturer's plant.
-The notified body of their decision on the results of inspection shall notify the manufacturer. Decision research conclusions and reasons for the decision.
-The notified body shall evaluate the modifications proposed and decide whether the changed quality system will still satisfy the rule formulated in paragraph 3.2, or a reassessment is required. This decision shall be communicated to the manufacturer and it includes research findings and results of the evaluation.
-The notified body shall carry out regular monitoring of the quality system, the purpose of which is to make sure whether the manufacturer fulfils the obligations arising out of the approved quality system.
-The notified body carries out periodic audits to make sure that the manufacturer maintains and applies the quality system. This audit report shall be submitted to the manufacturer.
-In addition to regular audits, the notified body may make unannounced inspections of the manufacturer. These audits notified body, if necessary, may make the product testing or be an observer of the testing carried out by the producer, to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with a visit of this report, but, when testing, the test report.
-Notified body consumer protection Center provides access to the list of quality system approvals or denials and immediately informed of quality system approval.
 
-The manufacturer's obligations are described in this rule 3.1, 3.5, 5.2 and 6 under, you can execute the authorized representative.
 
Module E1-Declaration of conformity, which is based on quality assurance of final product inspection and testing-the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations which are laid down in this annex ensures and declares that the measuring instruments concerned satisfy the rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
 
 
-The manufacturer shall draw up technical documentation in accordance with this provision, 15, 16, 17, 18 and 19 of the requirements to the extent that they provide the ability to assess the conformity of the measuring instruments and of the provisions of this annex to the requirements, including the means of measuring the design, manufacture and operation.
-The manufacturer maintains the technical documentation for 10 years after the last measuring instrument manufacturing and make it available, upon request, the consumer rights protection centre.
-Manufacturer run by the approved quality system, the specific means of measuring the final product inspection and testing as specified in point 5 of these rules and this system should be subject to monitoring as specified in point 6 of these rules.
-The notified body the manufacturer shall lodge an application for assessment of the quality system. The application shall include:-all relevant information for the planned means of measurement categories;
-the documentation concerning the quality system;
-the technical documentation that is requested in paragraph 2 of this rule.
-the quality system shall ensure compliance of the measuring instruments with the requirements of these regulations.
All system elements, requirements, and conditions that are imposed by the manufacturer, are documented in a systematic way the policies, procedures and instructions. The quality system documentation shall ensure appropriate quality programmes, plans, hand book and the interpretation of the Protocol.
Documentation dial, special attention is paid to aspects such as:-the quality objectives, the organisational structure, responsibilities and powers of the management with regard to product quality;
-the examinations and test that will be carried out before and after the production, the production process, as well as the frequency of these checks;
-quality Protocol (such as inspection reports, test and calibration data, personnel qualifications);
-product quality monitoring and effective quality management system.
-The manufacturer assumes obligations arising out of the approved quality system adequate and efficacious and keep at it.
-The manufacturer shall inform the notified body which approved the quality system informed of any proposed change in the quality system.
-The manufacturer shall allow the notified body access to all production, inspection, testing and storage sites for the purposes of inspection, give all necessary information, in particular such as:-the quality system documentation;
-the technical documentation required by paragraph 2 of these regulations;
-the quality records, such as inspection reports, test and calibration data, qualification of the personnel involved.
-The manufacturer, in accordance with the provisions of point 5.1 shall be according to the "CE" marking and in addition the metrological and notified body responsible identification number to each measuring instrument that is in conformity with the requirements of these provisions.

-Declaration of conformity is drawn up for each of the measurement model and it must be maintained for a period of 10 years after the last measuring instrument manufacturing and make it available, upon request, the consumer rights protection centre. The Declaration must identify the means of measurement model for which it has been drawn up.
Each measuring instrument that is placed on the market must be provided with a copy of the Declaration. If one user supplied a large batch of measuring instruments, it issued only one copy of the Declaration of conformity, which includes all the features of measuring a lot.
-Manufacturer of 10 years after the last measuring instrument manufacturing ensures that the consumer rights protection Centre has the following information on:-the documentation referred to in point 5.1 of these rules;
-information about the changes that are in accordance with the provisions of paragraph 5.1;
-notified body decisions and statements referred to in that rule 5.5., 6.3 and 6.4.
-The notified body shall assess the quality system to determine whether it satisfies the requirements of one of these provisions is defined in paragraph 5.2. It shall also assess the quality system compliance with the applicable standards.
Audit Group in addition to the qualifications of the quality management system, has the experience and the appropriate means of measurement of metrology technology, knowledge of the requirements of this regulation. The assessment procedure includes the inspection visit to the manufacturer's plant.
Notified body of their decision on the results of inspection shall notify the manufacturer. Decision research conclusions and reasons for the decision.
-The notified body shall evaluate the modifications proposed by the manufacturer and shall decide whether the changed quality system will still satisfy the rule formulated in paragraph 3.2, or a reassessment is required. This decision shall be communicated to the manufacturer and it includes research findings and results of the evaluation.
-The notified body shall carry out regular monitoring of the quality system, the purpose of which is to make sure whether the manufacturer fulfils the obligations arising out of the approved quality system.
-The notified body carries out periodic audits to make sure that the manufacturer maintains and applies the quality system. This audit report shall be submitted to the manufacturer.
-In addition to regular audits, notified body may make unannounced inspections of the manufacturer. These audits notified body, if necessary, may make the product testing or be an observer of the testing carried out by the producer, to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with a visit of this report, but, when testing, the test report.
-Notified body consumer protection Center provides access to the list of quality system approvals or denials and must promptly inform it of a quality system approval.
 
 
-The manufacturer's obligations are described in this provision, paragraph 3 and 8, 5.1 and 7.2, you can execute the authorized representative.
 
 
Module f-Declaration of conformity to type based on product verification,-the conformity assessment procedure whereby the manufacturer fulfils the obligations which are laid down in this annex ensures and declares that the measuring instruments have met the conditions of paragraph 3 of the rules, in conformity with the type as is formulated in EC type assessment certificate and satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer must take all measures necessary to ensure that the manufactured and type approved as it is defined in the EC type certificate, the assessment of compliance with the provisions of this instrument and its annexes, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer maintains certificates of conformity for a period of 10 years after the last measuring instrument certification and shall make it available, upon request, the consumer rights protection centre.
-The metrological characteristics of the statistical verification of conformity.
-The manufacturer shall take all the necessary measures, which are necessary for the production process ensure the uniformity of each batch produced and must be presented for verification tools in the form of homogeneous lots.
-The manufacturer maintains certificates of conformity for a period of 10 years after the last instrument certification and ensure availability of the consumer rights protection centre.
-The manufacturer shall affix the "CE" marking and in addition the metrological measurement of each feature, which corresponds to the type approved and satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-Draw up a declaration of conformity pattern of instrument and maintained for a period of 10 years after the last instrument has been manufactured and made available to the consumer protection centre. The Declaration identifies the instruments to which it has been drawn up.
Each measuring instrument that is placed on the market is provided with a copy of the Declaration. If a large batch of instruments is delivered to any user with a copy of the Declaration is sufficient to supply the entire batch or consignment instruments.
If the manufacturer has an agreement with the notified body according to the provisions of paragraph 3, the manufacturer notified body shall be affixed in the means of measuring the Authority also notified body identification number.
-The notified body the manufacturer may affix the Authority notified body identification number already measuring in the production process.
-The notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or take part in such inspection and testing by the manufacturer in order to check the conformity of the instruments with the type as it is defined in the EC type certificate and the assessment of the requirements of these regulations.
Inspection and testing compliance with metrological characteristics is carried out at the choice of the manufacturer or as each instrument inspection and testing as specified in point 4 of these rules, or the inspection and testing of the instruments on a statistical basis as specified in point 5 of these rules.
-The metrological characteristics of the compliance verification, for each inspection and testing of the instrument.
-Each instrument examined and appropriate tests on an individual basis as defined in the relevant documents referred to in this provision in paragraph 5.9., or equivalent tests carried out their metrological characteristics with which this instrument is applied. If the proper documentation is not available, the appropriate tests shall adopt the notified body involved.
-The examinations and test the notified body shall issue a certificate of conformity and affix the identification number to each approved instrument or empowered to do any of the other institutions.
-Samples from each batch of chosen at random according to this provision the requirements of paragraph 5.3. In order to determine whether the lot is accepted or rejected all the instruments examine and sample appropriate tests on an individual basis as defined in the relevant documents referred to in this provision in paragraph 5.9., or equivalent tests carried out to compliance with metrological characteristics that are suitable for this instrument. If the proper documentation is not available, the appropriate tests shall adopt the notified body involved.
-The statistical procedure shall meet the following requirements:-the quality criteria corresponding to the 95% probability of acceptance with a less than 1% of non-compliance;
-quality criteria corresponding to a 50% probability of acceptance with irregularities less than 7%.
-If a lot is accepted, all instruments of the lot shall be considered approved, except for those instruments from the sample that did not pass testing criteria.
The notified body shall issue a certificate of conformity and affix the identification number to each approved instrument or empowered to do any of the other institutions.
-If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of the party. When rejection of the party becomes a frequent phenomenon, the notified body shall abolish the statistical verification and take appropriate measures.
-The manufacturer's obligations may be fulfilled by the authorized representative, except for the obligations of this provision is described in paragraph 2 and in paragraph 5.1.
Module F1-Declaration of conformity based on product verification-the conformity assessment procedure whereby the manufacturer fulfils the obligations which are laid down in this annex ensures and declares that the measuring instruments have met this provision, paragraph 5 satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
 
-The manufacturer shall draw up technical documentation (as described in article 10). Documentation shall enable the conformity of the measuring instrument to evaluate these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements. The documentation covers the need for evaluation of such means of measuring design, production and operation.

-The manufacturer maintains the technical documentation for 10 years after the last measuring instrument manufacturing and ensure its availability of consumer protection Center.
-The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments of measurement rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer maintains a certificate of conformity for a period of 10 years after the last measuring instrument certification and, if necessary, make it available to the consumer rights protection centre.
-The metrological characteristics of the statistical verification of conformity.
-The manufacturer shall take all necessary measures that are needed to ensure the production process each batch produced uniformity and presented for verification of measuring means the form of homogeneous lots.
-The manufacturer must maintain certificates of conformity for a period of 10 years after the last measuring instrument certification and, if necessary, shall make them available to the consumer rights protection centre.
-The manufacturer shall affix the "CE" marking and in addition the metrological measurement of each feature that satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-Draw up a declaration of conformity pattern of instrument and maintained for a period of 10 years after the last instrument has been manufactured, and, if necessary, make it available to the consumer rights protection centre. The Declaration identifies the instruments to which it has been drawn up.
Each measuring instrument that is placed on the market is provided with a copy of the Declaration. If a lot of instruments is delivered to any user with a copy of the Declaration is sufficient, the entire batch.
If the manufacturer has an agreement with the notified body, in accordance with paragraph 5 of these regulations, the manufacturer notified body shall be affixed in the means of measuring the Authority also notified body identification number.
-The notified body of the manufacturer may affix the Authority notified body identification number to the measuring instruments already in the production process.
-The notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or take part in such inspection and testing by the manufacturer in order to check the conformity of the provisions of the instrument.
Inspection and testing compliance with metrological characteristics shall be carried out at the choice of the manufacturer or as each instrument inspection and testing as specified in point 6 of these rules, or the inspection and testing of the instruments on a statistical basis as specified in section 7 of these regulations.
-The metrological characteristics of the compliance verification by examination and testing of the instrument.
-Each instrument examined and appropriate tests on an individual basis, as defined in the relevant documents referred to in this provision in paragraph 5.9., or equivalent tests carried out their metrological characteristics with which this instrument is applied. If the proper documentation is not available, the appropriate tests shall adopt the notified body involved.
-The examinations and test the notified body shall issue a certificate of conformity and affix the identification number to each approved instrument or empowered to do any of the other institutions.
-Samples from each batch of chosen at random according to this provision the requirements of point 7.3. In order to determine whether the lot is accepted or rejected all the instruments examine and sample appropriate tests on an individual basis as defined in the relevant documents referred to in this provision in paragraph 5.9., or equivalent tests carried out their metrological characteristics with which this instrument is applied. If the proper documentation is not available, the appropriate tests decision notified body.
-The statistical procedure shall meet the following requirements:-the quality criteria corresponding to the 95% probability of acceptance with a less than 1% of non-compliance;
-quality criteria corresponding to a 50% probability of acceptance with irregularities less than 7%.
-If a lot is accepted, all instruments of the lot shall be considered approved, except for those instruments from the sample that did not pass testing criteria.
The notified body shall issue a certificate of conformity and affix the identification number to each approved instrument or empowered to do this to any other institution.
-If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of the party. When rejection of the party becomes a frequent phenomenon, the notified body shall abolish the statistical verification and take appropriate measures.
-The manufacturer's obligations may be fulfilled by the authorized representative, except for the obligations of this provision is described in paragraph 4 and 7.1.
 
Module g-Declaration of conformity based on unit verification-the conformity assessment procedure whereby the manufacturer fulfils the obligations which are laid down in this annex ensures and declares that the measuring instruments have met this provision, paragraph 4 this provision met and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer shall draw up the technical documentation as described in these rules 15, 16, 17, 18 and 19 points and provides access to the notified body, as set out in paragraph 4 of these rules. Documentation shall enable to evaluate the compliance of these provisions of the instrument and its annexes, as well as on the requirements of the laws and specific means of measuring requirements. The documentation covers as necessary for such assessment, cover the design, manufacture of tools and operation.
The manufacturer maintains the technical documentation for 10 years and ensure that it is available to the consumer protection centre.
-The manufacturer shall take all measures necessary to ensure conformity of the manufactured instruments this regulation and its annexes, as well as on the requirements of the laws and specific means of measuring requirements.
-The manufacturer maintains certificates of conformity for a period of 10 years after the last instrument certification and, if necessary, the consumer protection Center provides them access.
-The manufacturer shall affix the "CE" marking and in addition the metrological measurement of each feature of the mandate by the notified body as defined in point 4 of these rules, as well as affix the notified body's identification number to each measuring instrument that satisfies this rule and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-A declaration of conformity for 10 years after the instrument has been manufactured and made available to the consumer protection centre. The Declaration identifies the instruments to which it has been drawn up.
The measuring instrument must be fitted with a copy of the Declaration of conformity.
-To check the conformity of the instrument requirements of these provisions, the notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or take part in such inspection and testing by the manufacturer, as it is stated in paragraph 11 of these rules mentioned in the documents, or equivalent tests are carried out. If the proper documentation is not available, the appropriate tests decision notified body.
About the examinations and testing of the notified body shall issue a certificate of conformity and affix the identification number to each approved instrument or empowered to do any of the other institutions.
-Manufacturer's obligations referred to in paragraph 2 of this rule and in subparagraph 4.2, you can execute the authorized representative.
Module h-Declaration of conformity based on full quality assurance-the conformity assessment procedure whereby the manufacturer fulfils the obligations which are laid down in this annex ensures and declares that the measuring features satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
 
 
-Manufacturer run by approved quality system for design, manufacture and final product inspection and testing of measuring instruments concerned as laid down in paragraph 3 of this rule, and this system is subject to monitoring as specified in point 4 of these rules.
-The manufacturer shall submit the application to the notified body for assessment of the quality system. Application shall contain:-all relevant information for the instrument category envisaged;
-the documentation concerning the quality system.
-the quality system shall ensure compliance of the instruments with the type as it is formulated in these regulations and its annexes, as well as regulations on the requirements of specific measurement tools.
All system elements, requirements, and conditions that are imposed by the manufacturer, are documented in a systematic way the policies, procedures and instructions. The quality system documentation shall ensure appropriate quality programmes, plans, hand book and the interpretation of the Protocol.
Documentation dial, special attention is paid to aspects such as:-the quality objectives, the organisational structure, responsibilities and powers of the management with regard to design and product quality;

-the technical design specifications, applicable standards and cases where these rules 15, 16, 17, 18 and 19 the documents referred to in paragraph 1 may not be used in whole or in part, the provisions of the relevant funds for enforcement;
-the design control and design verification techniques, processes and systematic actions for the design of the instrument;
-According to the production process, quality control and quality assurance techniques, processes and systematic measures used;
-the examinations and test that will be carried out before and after the production, the production process, as well as the frequency of these checks;
-the quality records, such as inspection reports, test and calibration data, personnel qualifications;
-the means of monitoring the required design and product quality, efficient quality management system.
-Manufacturer of bound by the obligations arising from the approved quality system and to maintain adequate and effective.
-The manufacturer shall inform the notified body which approved the quality system informed of any proposed change in the quality system. In turn, the notified body shall evaluate the modifications proposed and decide whether the changed quality system, which must comply with that defined in paragraph 3.2 of the rules, or a reassessment is required. This decision shall be communicated to the manufacturer and it includes research findings and results of the evaluation.
-The manufacturer shall allow the notified body access for inspection purposes to all manufacturing, inspection, testing and storage locations and supply all the necessary information, in particular:-the quality system documentation;
-quality protocols that provide quality system design section, such as results of analyses, calculations and test results;
-quality protocols, which provides production quality system section, such as inspection reports, test and calibration data, qualification of the personnel involved.
-The manufacturer shall affix the "CE" marking and in addition the metrological, as defined in point 3.1 of these regulations, and the identification of the notified body responsible for the number, to each measuring instrument that complies with these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
-A declaration of conformity shall be drawn up for each instrument model and maintained for a period of 10 years after the last instrument has been manufactured, as well as the availability of consumer protection Center. The Declaration identifies the model of the instrument for which it has been drawn up.
Each measuring instrument that is placed on the market must be provided with a copy of the Declaration. If the instrument is delivered to one party, one copy of the Declaration to all instruments of the lot.
-Manufacturer of 10 years after the last instrument has been manufactured provides affordable consumer centres:-the documentation referred to in point 3.1 of these regulations;
-information about the changes that are listed in paragraph 5.5 of these rules;
-notified body decisions and statements referred to in this provision 3.5, 4.3 and 4.4.
-Each notified body consumer protection Center provides access to the list of quality system approvals or denials and immediately inform the consumer rights protection centre of quality system approval.
-The notified body shall assess the quality system to determine whether it this provision the requirements of point 3.2. It shall also assess the quality system compliance with the applicable standards.
Audit Group in addition to the qualifications of the quality management system, have experience relevant metrology and instrument technology, knowledge of the rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements. The assessment procedure includes the inspection visit to the manufacturer's plant.
The notified body shall be notified of the decision of the manufacturer. Decision research conclusions and reasons for the decision.
-The purpose of surveillance is to make sure whether the manufacturer fulfils the obligations arising out of the approved quality system.
-The notified body carries out periodic audits to make sure that the manufacturer maintains and applies the quality system. This audit report shall be submitted to the manufacturer.
-In addition to regular audits, the notified body may make unannounced visits to the manufacturer. Such visits the notified body may, if necessary, carry out product tests, or have been made by the manufacturer as an observer for testing, to verify whether the quality system is functioning correctly. The notified body must provide the manufacturer with a visit of this report but, when testing, the test report.
 
 
-The manufacturer's obligations set out in this rule 3.1, 3.5, 5.2 and 6 under, can accomplish his responsibility of authorized representative.
 
 
Module H1-Declaration of conformity based on full quality assurance with design and evaluation — the conformity assessment procedure whereby the manufacturer fulfils the obligations which are laid down in this annex ensures and declares that the measuring features satisfy these rules and its annex, as well as on the requirements of the laws and specific means of measuring requirements.
 
 
 
 
-Manufacturer run by approved quality system for design, manufacture and final product inspection and testing of measuring instruments concerned as laid down in paragraph 3 of this rule, and this system is subject to monitoring as specified in point 5 of these rules. The technical design of the measuring test in accordance with paragraph 4 of this rule.
-The notified body the manufacturer shall lodge an application for assessment of the quality system. Application shall contain:-all relevant information for the instrument category envisaged;
-the documentation concerning the quality system.
-the quality system shall ensure compliance of the instruments with the type as it is defined in these regulations.
All system elements, requirements, and conditions that are imposed by the manufacturer, are documented in a systematic way the policies, procedures and instructions. The quality system documentation shall ensure appropriate quality programmes, plans, hand book and the interpretation of the Protocol.
Documentation dial, special attention is paid to aspects such as:-the quality objectives, the organisational structure, responsibilities and powers of the management with regard to design and product quality;
-the technical design specifications (including applicable standards and cases where these rules 15, 16, 17, 18 and 19 the documents referred to in paragraph 1 may not be used in whole or in part, the provisions of the relevant funds requirements;-the design control and design verification techniques, processes and systematic actions for the design of tools;-adequate production process, quality control and quality assurance techniques, processes and systematic measures used;-inspection and testing to be taken before and after the production, the production process, as well as the frequency of these checks;
-the quality records, such as inspection reports, test and calibration data, personnel qualifications;
-the means of monitoring the required design and product quality, efficient quality management system.
-The notified body shall assess the quality system to determine whether it satisfies the requirements laid down in point 3.2 of these regulations. It shall also assess the quality system compliance with the applicable standards.
Audit Group in addition to the qualifications of the quality management system is the assessment of experience in the relevant instruments metrology and technology, knowledge of the requirements of this regulation. The assessment procedure includes the inspection visit to the manufacturer's plant.
The notified body shall communicate its decision to the manufacturer. Decision research conclusions and reasons for the decision.
-The manufacturer assumes obligations arising out of the approved quality system and to maintain adequate and effective.
-The manufacturer shall inform the notified body which approved the quality system informed of any proposed change in the quality system. In turn, the notified body shall evaluate the modifications proposed and decide whether the changed quality system will still satisfy the requirements of point 3.2 of the rules, or a reassessment is required. This decision shall be communicated to the manufacturer and it includes research findings and results of the evaluation.
-The manufacturer submits an application for the institution of the project notified.
-Application gives you the opportunity to understand the design of the instrument, the production and operation, as well as allow the evaluation of conformity to the relevant requirements of these rules. The application contains the following information:-the name and address of the manufacturer and, if the application is lodged by the authorised representative of the manufacturer, then the addition of his name and address;
-a written declaration that the same application has not been lodged with another notified body;

-the technical documentation as required by this rule 15, 16, 17, 18 and 19; documentation must enable the conformity assessment of the instrument and its annexes to these regulations as well as regulations on the requirements specific to the requirements of the measuring means and it should cover as necessary instruments for evaluation, design, production and operation;
-technical project of the supportive assurance; supportive statements must be given to the references to documents that were used especially for this rule 15, 16, 17, 18 and 19 above, if they are not fully used; supporting evidence, where appropriate, include the manufacturer's laboratory or on its behalf and on behalf of other laboratory testing results.
-The manufacturer shall inform the notified body that has issued the EC design certificate of assessment of any major modifications to the approved design. Modifications to the approved project receives an additional approval from the notified body that has issued the EC design assessment certificate where such changes may affect conformity with the essential requirements of the rules, the conditions for validity of the certificate and the proposed conditions of use of the instrument. Additional approval is given in the form of an addition to the original EC design assessment certificate.
-The manufacturer or his authorised representative shall maintain the EC design assessment, copies of the certificates, the annexes and additions with the technical documentation for 10 years after the last measuring instrument manufacturing.
If the manufacturer or his representative is not in the country of the European Community, the obligation to produce technical documentation on request to persons who are authorized by the manufacturer.
-The manufacturer shall allow the notified body access for inspection purposes to all design, manufacture, inspection, testing and storage sites, provide all necessary information, in particular:-the quality system documentation;
-quality protocols that provide quality system design section, such as results of analyses, calculations and test results;
-quality protocols, which provides production quality system section, such as inspection reports, test and calibration data, qualification of the personnel involved.
-The manufacturer shall affix the "CE" marking and in addition the metrological and responsible notified body identification number to each measuring instrument that complies with these rules and its annex, as well as on the requirements of the laws and specific requirements of measuring means, according to this rule 3.1.
-A declaration of conformity shall be drawn up for each instrument model and maintained for a period of 10 years after the last instrument has been manufactured, as well as ensure its availability for the consumer protection centre. The Declaration identifies the model of the instrument for which it has been drawn up and noted the EC design assessment certificate number.
Each measurement tools that are placed on the market shall provide a copy of the Declaration. If a large batch of instruments is delivered to any user with a copy of the Declaration is sufficient to supply the entire batch or consignment instruments.
-Manufacturer for 10 years after the last instrument has been manufactured since provides consumer protection Center available for the following information:-the documentation referred to in point 3.1 of these regulations;
-information about the changes that are listed in point 3.5 of these rules;
-notified body decisions and statements referred to in this provision 3.5, 5.3 and 5.4.
-Each notified body provides consumer protection Center to access list with a quality system approvals or denials and immediately inform the consumer rights protection centre of quality system approval.
-The notified body shall examine the application and, if the project met the requirements of the rules for measuring feature, issue to the manufacturer an EC design assessment certificate. The certificate shall bear the name and address of the manufacturer, conclusions of the examination, any conditions that apply to the certificate's validity and the necessary data for identification of the approved instrument.
-All the relevant parts of the technical documentation shall be annexed to the certificate.
-The certificate and its annexes provide all the details for conformity assessment and monitoring management.
If the instrument is set up correctly, this documentation enables you to check the manufactured instruments to assess the compliance of the project with regard to the reproducibility of the metrological performances, including:-the metrological characteristics of the project;
-measures required for ensuring the integrity of the instruments (sealing, identification of software);
-the information necessary for the measurement of another element identification and verify project Visual compliance;
-If applicable, any specific information necessary for the verification of measuring instruments;
-where is the auxiliary units, all the information necessary to ensure compatibility with them or other means of measurement.
-The results of the notified body assessment report summarizes and provides access to the consumer rights protection centre. The notified body shall publish the contents of the report in whole or in part, only with the consent of the manufacturer.
The period of validity of the certificate is 10 years from the date of issue and the validity of each row can be restored in the next ten years.
If the manufacturer design assessment certificate is rejected, the notified body provides detailed grounds for refusal.
-Each notified body consumer protection Center provides access to:-the EC design assessment certificates and their annexes;
-additions and corrections to certificates issued.
Each notified body shall immediately inform the consumer rights protection centre on voided the EC design assessment certificates.
-The notified body for the purpose of surveillance is to make sure whether the manufacturer fulfils the obligations arising out of the approved quality system.
-The notified body carries out periodic audits to make sure that the manufacturer maintains and applies the quality system. This audit report shall be submitted to the manufacturer.
-In addition to regular audits, notified body may make unannounced visits to the manufacturer. Such visits the notified body may, if necessary, carry out product tests, or have been made by the manufacturer as an observer for testing, to verify whether the quality system is functioning correctly. Notified body for this visit to provide the manufacturer with a report, but when testing, the test report.
 
 
 
-The manufacturer's obligations are described in this clause 3.1., 3.5., and in paragraph 6.2 and point 7, you can execute the authorized representative.
 
 
 
 
Economic Minister a. Štokenberg in annex 3 of the Cabinet of Ministers of 22 august 2006 Regulation No. 673 of the CE marking 1. CE marking consists of the capital letters "CE" in the form: 2. the CE marking of vertical size may not be less than 5 mm. 3. If the size of the CE marking is reduced or enlarged, the proportions in the sample.
Economic Minister a. Štokenberg in