Cabinet of Ministers Regulations No. 212 in 2016 (12 April. No 17 6. §) means of measurement and metrological requirements to metrological control order Issued in accordance with the law "on conformity assessment" 7. the first and second subparagraphs and the law "on a uniformity of measurements" 6. the second paragraph of article 1 General questions 1. determines the essential metrological requirements subject to the state metrological control of measuring instruments, meters of water consumption, 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) – so they can be placed on the market and put into use, as well as the means of measurement and of metrological control and supervision of the market. 2. The terms used in the following terms: 2.1 measurement tool – a device which is intended to perform measurements independently or together with additional devices; 2.2. additional device-measuring means assistive device that functions independently and connect the measuring instrument to the other device or measuring; 2.3. the applicable document-a document which defines the means of measuring the technical specifications approved by the international legal metrology organisation; 2.4. market-economic activities to supply the means for measuring whether or not for consideration for distribution or use within the Union; 2.5. the placing on the market-the first time offer for use in the European Union market of measuring means; 2.6. commissioning – the end user for the first-time measuring the use of it for the purposes intended; 2.7. the manufacturer – natural or legal person who manufactures means of measuring or measuring tasks features are designed or manufactured and placed on the market in the measurement features, under his name or trademark; 2.8. the authorised representative established in the European Union – natural or legal person who has received a written mandate from a manufacturer to act on his behalf in specific tasks; 2.9. the importer established in the European Union – natural or legal person who places on the market a measuring tools from third countries; 2.10. distributor – natural or legal persons established in, which provides a means of measuring the market and not the manufacturer or the importer; 2.11. the persons involved – the manufacturer, the authorised representative, the importer and the Distributor; 2.12. technical specification-a document that lays down the technical requirements which correspond to the measuring means; 2.13. the notified body – accredited by the national accreditation bodies of the conformity assessment bodies of the funds, which have been notified to the Commission in accordance with the laws and regulations on the procedures for the notification of the Commission creates, as well as the order in which the Commission takes a decision and shall notify the European Commission of conformity assessment bodies performing conformity assessment of regulated sphere, or another Member State of the European Union or European economic area measuring products notified conformity assessment body; 2.14. withdrawal – any measures to ensure that measuring be returned funds that have already been delivered to the end user; 2.15. withdrawal – any measures to prevent the supply chain existing means of measuring the placing on the market; 2.16. the CE conformity marking-marking, by which the manufacturer indicates that the measuring instrument complies with the applicable requirements, which are defined in the regulations, which provides for the marking of products with this mark. 3. The person involved or may be placed on the market and putting into service or use only the 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 perform the evaluation of conformity (annex 1) and marked with the CE marking and papildmarķējum. 4. 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. 5. means of measurement, which complies with the applicable standards or parts thereof, or of the applicable document or part of the requirements, references to which have been published in the official journal of the European Union, considers appropriate that provision listed in annex 2 essential requirements covered by these standards, the applicable documents or parts thereof. 6. The national standardisation body shall publish in its tīmekļvietn the list of applicable standards, adapted to the status of national standards, and the national metrology body shall publish the list in its tīmekļvietn with the applicable documents. 2. obligations of the parties concerned 7. Involved following the market surveillance authority shall provide information on the means of measurement, including: 7.1 all persons concerned that they have supplied measuring means; 7.2. all parties that they have supplied the means of measurement. 8. Parties ensure that paragraph 7 contains the availability of information to the supervisory authority of the market 10 years after they delivered or supplied the means for measuring them. 2.1. The manufacturer's obligations 9. the meaning of these rules importer and distributor shall be considered a manufacturer and has the responsibilities laid down in this chapter, if it is placed on the market for measuring features under his name or trademark or modifies a measurement marketed products that may affect the conformity of the means of measuring this provision in annex 2 to these essential requirements. 10. The placing on the market of measuring tools, the manufacturer shall ensure that they are designed and produced according to the rules referred to in annex 2 of the essential requirements. 11. the manufacturer shall draw up the rules for the metering feature Chapter 4 technical documentation referred to in this provision and referred to in annex 1. the conformity assessment procedures or ensuring that it is carried out. 12. where the conformity assessment procedure has been demonstrated that the measuring instrument complies with the essential requirements, the manufacturer shall draw up a declaration of conformity and affix to the measuring instrument with the CE conformity marking and supplementary metrology marking. 13. the manufacturer shall keep the technical documentation and Declaration of conformity for a period of 10 years after the release of the metering market. 14. when the measuring tool is produced in series, producer establish control procedures, to ensure compliance with the means of measuring the requirements of this regulation, and shall take due account of changes in the construction of measurement or characteristics, as well as the applicable standards or other technical specifications on the basis of which attests the conformity of the means of measuring the requirements of this regulation. 15. where necessary to assess the risk of measurement, the manufacturer of measuring instruments on the market for testing and examination, the complainant maintained the non-compliance and recall from the market of means of measurement records, as well as inform distributors of the operations. 16. The manufacturer shall ensure that the means of measuring the market label contains a type, batch or serial number or other identification elements they are. When measuring the size of the funds does not allow it, the manufacturer shall indicate this information measurement in a document accompanying the product and on the packaging, if any. 17. the manufacturer of the measuring points to their name or registered trade mark and the address where you can contact the manufacturer. If it is not possible to specify the means of measurement, this information indicates the measurement in a document accompanying the product and on the packaging, if any. 18. The manufacturer shall ensure that measuring instruments are added to the Declaration of conformity, instructions and annex 2 of this rule 20 and 22 in the national language. Instructions for use and the provisions of annex 2 in paragraph 20 and 22 above, as well as other information on the means of measuring the information is clear and understandable. 19. the manufacturer who believes or has reason to believe that measuring means which it has placed on the market do not meet the requirements of these regulations, shall immediately take the corrective action, to ensure compliance with the means of measuring the requirements of this regulation or, if necessary, to recall or withdraw them from the market. If the means of measuring risk, manufacturers shall immediately inform the market surveillance authority, giving details, in particular, of the non-compliance and of the corrective actions taken. 20. After the market surveillance the request of the authority, the manufacturer shall provide it with all necessary information and documentation in the national language, to demonstrate compliance with the measurement requirements of this regulation. 21. the market surveillance authorities shall cooperate with the request of the manufacturer, the market surveillance authority to prevent the means of measuring the market risks. 2.2. The authorised representative of the manufacturer with 22 written mandate can appoint an authorized agent. The mandate does not include this provision in paragraphs 10 and 11 above. 23. Authorized Representative shall take at least the following: 23.1.10 years after measuring the placing on the market of the products stored in the market available to the supervisory authority a declaration of conformity and the technical documentation; 23.2. upon reasoned request, the market surveillance authorities shall provide all the information and documentation necessary to demonstrate the conformity of the measuring means; 23.3. the market surveillance authorities on request, subject to the authorisation, shall cooperate with the market surveillance authority, to prevent the risk of measurement. 2.3. the importer's obligations 24. Importer placed on the market according to the requirements of these regulations for measuring tools. 25. Before the measurement of the placing on the market and putting into the importer shall ensure that the manufacturer has made the rule referred to in Chapter 3 of the relevant conformity assessment procedure, prepared by the appropriate technical documentation, added the Declaration of conformity of the measuring instrument with the labelled CE conformity marking and supplementary metrology marking, add the required documentation, as well as the provisions met the 16 and 17 the obligations referred to in paragraph 1. 26. importers who consider or have reason to believe that the measurement tools do not meet this provision listed in annex 2 of the essential requirements, it shall not be placed on the market or put into service until such time as the person involved is not made for conformity with the rules referred to in annex 2 of the essential requirements. If the means of measurement presents a risk, the importer shall inform the manufacturer and the market surveillance authorities. 27. the importer on the measuring instrument indicates their name or registered trade mark and the address where you can contact the importer. If it is not possible to specify the means of measurement, this information indicates the measurement in a document accompanying the product and on the packaging, if any. 28. The importer shall ensure that the measurement feature is added to a manual and annex 2 to these regulations 20 and 22 in the national language. 29. importers shall ensure that, at a time when it is responsible for the measurement, storage or transport conditions do not adversely affect their compliance with the rules referred to in annex 2 of the essential requirements. 30. If necessary the means of measurement to assess the risks, the importer of consumer health, safety and the protection of interests test and assess the market offered the means of measurement, register complaints and information on appropriate means of measurement and measuring withdrawn from the market means, as well as inform distributors of the operations. 31. importers who consider or have reason to believe that measuring means which it has placed on the market do not meet the requirements of these regulations, shall immediately take the corrective action, to ensure compliance with the means of measuring the requirements of this regulation or, if necessary, to recall or withdraw them from the market. If the means of measuring risk, importers shall immediately inform the market surveillance authority, giving details, in particular, of the non-compliance and of the corrective actions taken. 32. The importer 10 years after measuring the placing on the market of the products stored in the market surveillance authorities available a copy of the Declaration of conformity, as well as the market surveillance authority shall ensure the availability of technical documentation. 33. the market surveillance authorities on request, the importer shall provide it with all necessary information and documentation in the national language, to demonstrate compliance with the measurement requirements of this regulation. 34. the market surveillance authorities shall cooperate with the request of the importer, the market surveillance authority to prevent the means of measuring the market risks. 2.4. obligations of Distributors offering 35. measuring features on the market, distributors shall act with appropriate diligence to comply with the requirements of this regulation. 36. Before the measurement tools on the market, distributors shall ensure that measurement tools are marked with the CE conformity marking and supplementary metrology marking, they are added to the Declaration of conformity and the required documentation, instructions for use and the provisions of annex 2 to 20 and 22 in the national language, as well as the manufacturer has noticed this rules 16 and 17 of the type referred to in paragraph 1, while the importer – this provision is referred to in paragraph 27. 37. distributors who consider or have reason to believe that the measurement tools do not meet this provision listed in annex 2 of the essential requirements, it is not offered on the market and put into service in until the person involved has not been made for conformity with the rules referred to in annex 2 of the essential requirements. If the means of measuring risk, the distributor shall inform the manufacturer or the importer and the market surveillance authorities. 38. The distributor shall ensure that, while it is responsible for the measurement, storage or transport conditions do not adversely affect their compliance with the rules referred to in annex 2 of the essential requirements. 39. distributors who consider or have reason to believe that measuring means which it has offered on the market or put into service does not comply with the requirements of this regulation, ensure that the necessary remedial action to ensure compliance with the means of measuring the requirements of this regulation or, if necessary, to recall or withdraw them from the market. If the means of measuring risk, distributors shall immediately inform the market surveillance authority, giving details, in particular, of the non-compliance and corrective actions taken. 40. the market surveillance authorities on request the Distributor it provides all necessary information and documentation in the national language, to demonstrate compliance with the measurement requirements of this regulation. 41. the market surveillance authorities on request, the distributor shall cooperate with the market surveillance authority to prevent the means of measuring the market risks. 3. The conformity assessment procedures 42. measurement of conformity 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 of metrological requirements measuring specific feature (annex 1). 43. In measuring compliance of a manufacturer may choose to use any technical solution that complies with the rules in Appendix 2 requirements and with the essential requirements laid down in the laws on the metrological requirements for a particular measurement feature, while respecting the applicable standards and requirements of the applicable document. 44. If the testing is performed in accordance with the applicable standards and requirements, of the applicable document testing results must show that the means of measurement, the 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) strength specifications. 45. This provision is referred to in annex 1. conformity assessment procedures (module A2 and C2 module) can make a separate manufacturer's internal structure, which does not participate in the measuring instruments evaluated in the design, manufacture, supply, installation, use or maintenance and are clearly separated from the operating activities of the manufacturer, if it meets the following requirements: 45.1. the Department is accredited by the accreditation body of the national appropriate legislation on assessment of conformity assessment bodies, accreditation and surveillance; 45.2. the Department and its employees are organisational identifiable and has developed reporting methods that ensure impartiality; 45.3. the Department and its employees are not responsible for the estimated measurement means the design, manufacture, supply, installation, use or maintenance, and they are not involved in any activities that could conflict with their independence of the decision or the integrity of the evaluation activities; 28.2. the Department provides services only and only for the manufacturer, which is part of this unit. 46. Information on 45 of these regulations the departments referred to in the notification of the Accreditation Commission on request from the manufacturer, which is part of the Department, or the national accreditation body. 47. measurement and enhancement of their conformity assessment can be performed separately, if it provides a measure of the metrological requirements for a specific measurement feature. 48. the documents relating to this chapter, the following conformity assessment procedures, prepare its national Edition, which will be carried out the conformity assessment procedure, or in a language acceptable to the notified body. 4. Technical documentation 49. Technical documentation contains information about the measurement of the design, manufacture, installation and operation, to perform the conformity assessment. 50. The technical documentation shall be sufficiently detailed to ensure: 50.1. metrological characteristics; 50.2. measuring features made metrological performance reproducibility when correctly adjusted, using the means provided for that purpose; 50.3. measuring the uptime. 51. 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: 51.1. measuring features general description; 51.2. design sketches, production drawings, component deployment plans and schemes; 51.3. the manufacturing procedures to ensure consistent production; 51.4. If necessary, a description of the electronic devices with drawings, diagrams, software information traceability schemes, which explains the equipment specification and operation; 51.5. descriptions and explanations necessary for the understanding of the measurement activities; 51.6. fully or partly applicable standards used, as well as the applicable document list; 32.1. the solutions used and their descriptions, to comply with the requirements of this regulation if applicable standards and applicable documents are not used; 32.2. the structural calculations and results of checks; 51.9. test results, where necessary, to demonstrate that the measurement tool and type: 51.9.1. certain operating and environmental conditions meet the requirements of these regulations and laws on the metrological requirements for a particular feature of measurement; 51.9.2. meet the gas and water meters, heat meter and measuring system for liquids (except water) the durability specifications; EU type assessment 51.10. certificates or certificate of EU project containing parts identical to those in the design. 52. The technical documentation the manufacturer specifies the timestamp and marking the location. 53. If necessary, the manufacturer indicates the interface (the interface) and the enhancement of interoperability conditions. 5. Declaration of conformity declaration of conformity 54. points out that it is a proven means of measuring compliance with the rules referred to in annex 2 of the essential requirements. 55. The Declaration of conformity shall be drawn up in accordance with annex 3 to these regulations, accompanied by the necessary information under the relevant conformity assessment procedures, and regularly updated. The Declaration of conformity with the European Union in the language or languages of the Member State in which the means of measurement are placed or offered on the market. 56. Where the measuring instruments subject to several laws that require Declaration of conformity is established in a single declaration of conformity to all applicable laws and regulations. Declaration of conformity indicates the relevant laws, rules and references to their publications. 57. in drawing up a declaration of conformity, the manufacturer takes responsibility for the conformity of the measuring instruments to the requirements in these rules. 6. Marking of measuring instruments 58. compliance with the requirements of this regulation indicates the "CE" marking and the supplementary metrology marking. 59. The CE conformity marking and the supplementary metrology marking shall apply mutatis mutandis subject to the General principles, the European Parliament and of the Council of 9 July 2008. Regulation (EC) no 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (hereinafter Regulation No 765/2008), article 30. 60. the metrological papildmarķējum uses a capital letter "M" and the affixing of the CE the last two digits of the year that are located inside of the rectangle. The height of the rectangle is equal to the height of the CE conformity marking. 61. The CE conformity marking and supplementary metrology marking shall be displayed on each metering features or on the information plate clearly visible, legible and indelible manner. 62. when a measuring instrument is too small or too sensitive to put on it of the CE marking and supplementary metrology marking, it shall be indicated on the packaging, if any, and these rules and laws on the metrological requirements for a particular measurement feature accompanying documents required. 63. If the measurement tool consists of devices that do not have additional devices, and work together with them, marking of measuring instruments placed on the main unit. 64. Measuring features marked with the CE marking and supplementary metrology marking before placing on the market or the production of measurement progresses, if justified. 65. the supplementary metrology marking shall immediately follow the placing of the CE conformity marking. 66. the CE conformity marking and supplementary papildmarķējum deploys in the notified body (or bodies) identification number, which was involved in these rules referred to in annex 1 the means of measuring the conformity assessment procedure in the production stage. Notified body identification number imposed itself upon the institution or its instructions, the manufacturer or his authorised representative. Notified body identification number is permanently marked with or one that cannot be changed, without damaging it. 67. the CE conformity marking, metrological and papildmarķējum notified body identification number can be deployed to other labelling indicating the information on specific risks or use. 7. the notified body 68. The notified body shall meet the following requirements: 68.1. the institution has legal personality, and it acts as a third party that is independent of the economic operator (associations), which evaluate the measuring means; 68.2. the institution has demonstrated independence and absence of conflict of interest, if it is a member of the Association or Foundation (member), associated with the measurement tools being evaluated the design, manufacture, supply, installation, use or maintenance; 68.3. institutions managers and employees who are responsible for the conformity assessment of measuring instruments to be assessed has neither the designer, manufacturer, supplier, Installer, purchaser, owner, user or attendant or their authorized representatives. This does not prevent them from using estimated means of measuring the conformity assessment bodies in action, or to use them for personal purposes; 68.4. the institution's management and employee responsible for conformity assessment, is not directly related to this means of measuring design, manufacture or construction, the marketing, installation, use, or service and do not represent the parties engaged in these activities; 68.5. institutions managers and employees do not engage in any activity (particularly in consulting), which may conflict with their independence and fairness of the decision in relation to the institution for evaluation activities; 68.6. the institution shall ensure that its affiliates and subcontractors do not affect the operation of conformity assessment confidentiality, objectivity and impartiality; 68.7. the institution and its staff in the conformity assessment shall be carried out in good faith and is a professional, technically competent. The staff in decision making and in the assessment of conformity are free from any influences (especially financial) and from persons or groups of persons with an interest in the impact of this activity; 68.8. the institution is able to carry out all the conformity assessment tasks for which it has fixed this in the annex of the rules and for which it has been notified, whether these tasks are carried out by the same body or are made on its behalf, under the responsibility of the authority; 42.8. the institution of the appropriate action that conformity assessment procedures and categories of means of measurement, for which it has been notified, is: 68.9.1. necessary personnel with technical knowledge and relevant experience, to perform the necessary conformity assessment activities; 68.9.2. Description of the procedures, in accordance with which conformity assessment carried out, ensuring the transparency and the ability to repeat this procedure. The institution is designed according to the policies and procedures to the tasks it carries out as a notified body is separated from the other activities; 68.9.3. developed the procedures take into account the economic size of the offender, the sector in which it operates, its structure, the manufacture of measuring technology complexity and the mass or serial nature of the production process; 68.10. institution has the necessary means to enable it to perform properly the technical and administrative tasks connected with conformity assessment activities, and have access to all the necessary equipment and facilities; 68.11. conformity assessment activities the staff responsible are: 68.11.1. provide technical and professional training for the relevant conformity assessment activities; 68.11.2. knowledge and permission, to comply with the requirements relating to the activities of conformity assessment activities; 68.11.3. knowledge and understanding of the rules referred to in annex 2 of the essential requirements and regulations of metrological requirements measuring specific product requirements, applicable standards and applicable documents; 68.11.4. skills needed to prepare certificates, records and reports to the conformity assessment; No 68.12. institutions is ensured by its management and employees, making the impartiality of the conformity assessment activities; 68.13. Management and institution staff carrying out the conformity assessment activities, the remuneration shall not depend on the number of assessments carried out or on the results; No 68.14. body is to insure civil liability in respect of the activities that it is entitled to make; 68.15. institutions employees observe professional confidentiality with regard to all information gained in carrying out the conformity assessment activities, with the exception of information that is provided to the market surveillance authorities; the institution participates in standardization 68.16. activities organized by the European Commission and notified bodies in the working groups on measurement devices, or to ensure that information on these activities is available to its employees. The institution in its activities as guidelines used by the notified body working groups prepare for decisions and documents. 69. If a notified body certifies its compliance with the criteria laid down in the relevant applicable standards or parts thereof, the references to which have been published in the official journal of the European Union, it is deemed appropriate that provision in paragraph 68 above requirements, to the extent applicable standards cover those requirements. 70. If a notified body shall conclude a contract with the subcontractor on the specific conformity assessment tasks or pass this task to a branch, it shall ensure that the subcontractor and the branch meets this rule 68. the requirements laid down in paragraph 1 and shall inform the Commission of the notification that is created in accordance with the laws and regulations on the procedures for the notification of the Commission creates, as well as the order in which the Commission takes a decision and shall notify the European Commission of conformity assessment bodies carrying out the assessment of conformity with the regulated sphere. The notified body shall assume full responsibility for the subcontractors and affiliates activity. 71. The notified body shall transfer a specific conformity assessment activity or branch subcontractors only with the consent of the customer. 72. The notified body shall keep the documents for subcontractors and affiliates and their competence evaluation carried out the conformity assessment activities and the availability of this document provides notification to the Commission. 73. The notified body shall carry out conformity assessments in accordance with the rules referred to in annex 1 of the conformity assessment procedures. 74. the notified body in the conformity assessment shall be carried out in a proportionate, avoiding unnecessary burdens for the persons involved, taking account of the sector in which it operates, the organisational structure, the means of measuring the degree of complexity of technology and mass production process or the nature of the series, however, have a toughness and level of protection required for measuring features meet the requirements of this regulation. 75. If a notified body finds that the manufacturer has not adhered to these rules in annex 2 and the essential requirements laid down in the laws on the metrological requirements for measuring specific product requirements or according to the applicable standard, the applicable document or other technical specifications referred to the essential requirements, it shall require the manufacturer to take appropriate measures to remedy the non-compliance, and issue a certificate. 76. If the means of measuring, monitoring compliance with the requirements of these regulations upon issuance of the certificate, a notified body finds that the measurement tools no longer meets the requirements of these regulations and laws on the metrological requirements for a particular measurement feature, it shall request the manufacturer to take appropriate measures to prevent non-compliance and, if there is a risk to consumer health, safety and the interests of, suspend or revoke the certificate. 77. If corrective action is not taken or it does not produce the desired results, the notified body accordingly, limit, suspend or revoke the certificate. 78. The notified body shall inform the Ministry of economy on: 78.1. each certificate of refusal, restriction, suspension or withdrawal; 78.2. any circumstances affecting the scope of the notice and conditions; 78.3. any market surveillance authorities requesting information regarding conformity assessment activities; 78.4. carried out conformity assessment activities notify sphere and other transactions, including cross-border activities and subcontracting (upon request). 79. The notified body shall provide the relevant information concerning the negative and, on request, positive conformity assessment results to the other notified bodies which carry out similar conformity assessment activities covering the same means of measurement. 8. market supervision 80. Measuring market supervision of consumer protection Center that the meaning of these provisions constitute a market supervisory authority. 81. the means of measurement of market surveillance in the applicable Regulation No 765/2008 article 15, paragraph 3, and article 16-29. 82. the manufacturer and importer to market surveillance authorities to request the technical documentation or a translation of the portion of the national language. The market surveillance authority, requiring the submission of technical documentation, as well as part of the translation determines the time-limit of 30 days, unless it is necessary to set a shorter deadline for finding a serious and immediate risk. 83. The notified body by the market surveillance authority shall provide information on the certificates which it has granted, refused or withdrawn, including providing test reports and technical documentation. 84. the interested party concerned have the responsibility of market surveillance authorities within a certain reasonable and objectively necessary to prevent non-compliance with the time limit, if the market surveillance authority finds that any of the following administrative irregularities: 84.1. CE conformity marking and the supplementary metrology marking do not satisfy this provision in Chapter 6 above requirements; 52.3. the "CE" marking and the supplementary metrology marking is not imposed; 84.3. not imposed or are not imposed these rules 17 and paragraph 27 of the label; not imposed on 84.4. the notified body identification number, which was involved in the production phase of the conformity assessment procedures or that are not subject to this provision in Chapter 6, the above requirements; 84.5. not attached is not prepared or is preparing a declaration of conformity; 84.6. technical documentation is not available or it is incomplete; 84.7. not satisfied any other this provision 2.1. and 2.3. subheading of an administrative nature referred to in the claim. 85. where the market surveillance authority finds that a means of measuring the risk to the public, it shall take the appropriate means of measurement and assessment, taking into account the risks referred to in those rules and covering all the requirements laid down. Involved parties have an obligation to cooperate with the market surveillance authorities in that assessment. 86. the person Involved by the market surveillance authorities and the prescribed time limit, which is proportionate to the risks of non-compliance, are obliged to take all the necessary corrective measures to ensure compliance with the measurement requirements of this regulation or, if necessary, withdraw, or withdraw it from the market, as well as to inform the relevant authorities notified, if this provision is referred to in paragraph 85 of the assessment, measuring the market surveillance authority finds one of the following situations : 86.1. a measuring feature does not comply with these rules and laws on the metrological requirements for measuring specific product requirements; 86.2. measuring instrument complies with these rules and laws on the metrological requirements for measuring specific product requirements, but nevertheless constitute a risk to the public. 87. If the person involved in the market surveillance authorities do not resolve this within the time limit set in paragraph 84 of the rules of the irrelevance or 86. these provisions the obligations referred to in paragraph 1, the market surveillance authority shall take a decision in accordance with the laws of unity of measurements, to prohibit the placing of a measurement or the placing on the market or, if necessary, revoke or withdraw it from the market. 9. cooperation with the European Commission and the Member States of the European Union 9.1. This provision is inadequate for measuring features 88. Where the market surveillance authority has reason to believe that the measuring tool, which made this provision, paragraph 85 rating and found that it does not comply with these rules and regulations on metrological requirements for measuring specific product requirements, are also offered in other Member States of the European Union, the market surveillance authority after obtaining all necessary information shall immediately inform the European Commission and the other Member States of the European Union on the results of the assessment, and market surveillance authorities laid down measures to be taken, specifying all the necessary details, including: the identification of measurement be. the information required; 88.2. details of the origin of the measuring means; 88.3. nature and non-compliance risks; 88.4. information about the specific nature of the measures to be taken and the duration, as well as relevant stakeholders explanations and arguments; 88.5. information on whether the measuring instrument does not meet the requirements of these regulations and laws on the metrological requirements for a particular product or the applicable measurement standards and the applicable documents. 89. If, within three months after this provision in paragraph 88 of the information given in any Member State of the European Union or the European Commission has not objected to the market surveillance authorities laid down measures to be taken, it is considered reasonable. 90. If the European Commission decides that market surveillance authorities the measures are unjustified, they are irrevocable. 91. where the market surveillance authority receives this provision the information referred to in paragraph 88 of the other Member State of the European Union, it shall immediately inform the European Commission and the other Member States of the European Union on the measures taken and give the information about the means of measuring non-compliance, as well as inform on their objections, if it does not agree with the other European Union market surveillance authorities laid down measures to be taken. 9.2. the requirements of this regulation according to the means of measuring the risk of 92. Where the market surveillance authority has reason to believe that the measuring tool, which made this provision, paragraph 85 rating and found that it meets the requirements of these regulations and laws on the metrological requirements for a particular measurement feature, but the risk to the public, the market surveillance authority after obtaining all necessary information shall immediately inform the European Commission and the other Member States of the European Union, indicating all available information, including the : 57.2. measurement features for identification of the necessary information; 92.2. details of the origin of the measuring means; 92.3. nature and non-compliance risks; 92.4. information about the nature of the measures to be taken and the duration, as well as relevant stakeholders explanations and arguments. 93. If the European Commission, the rules get the information referred to in paragraph 92, adopt a decision that the market surveillance authorities the measures are unjustified, they are irrevocable. 10. final 94 issues. To declare unenforceable in the Cabinet of 22 august 2006 Regulation No 673 "provision on metrological requirements measuring instruments" (Latvian journal, 2006, nr. 137.; 2007, no. 72). 95. Measuring features that are placed on the market until the date of entry into force of the provisions, may be placed on the market and put into use if it meets the Cabinet of 22 august 2006 no. 673 of the provisions of the "rules for the metrological requirements measuring instruments". 96. certificates issued in accordance with the Cabinet of Ministers on 22 august 2006, regulations no 673 "provision on metrological requirements measuring instruments", shall be valid until the expiry of the period specified therein. 97. the provisions shall enter into force on 20 April 2016. Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 26 February 2014 2014 of the directive/32/EU on the harmonization of the laws of the Member States relating to the availability of the measuring instruments on the market; 2) European Commission 2014 delegated Directive of 13 October (EU) 2015/13, amending directives by 2014/32/EU Annex III in relation to the water meter flow rate range. Prime Minister Māris kučinskis Deputy Prime Minister, Minister of economy of 1. Ašeraden Arvil annex Cabinet 2016 April 12 regulations No 212 conformity assessment procedures i. conformity based on internal production control (module A) 1. Conformity based on internal production control is the conformity assessment procedure in accordance with the manufacturer complies with those rules and regulations on requirements for specific features of measurement (hereinafter referred to as the regulations) requirements and certifying that the measurement tool meets these requirements. 2. the manufacturer shall perform the following obligations: 2.1 establish technical documentation. The technical documentation provides the opportunity to assess the means of measuring compliance with the requirements of this regulation, including risk analysis and assessment. The technical documentation shall specify the applicable requirements and, to the extent necessary, for the evaluation of measurement means it covers the design, manufacture and operation; 2.2. take all necessary measures to ensure the conformity of the manufactured instruments of measurement rules and relevant regulatory requirements; 2.3. each measuring instrument that satisfies the requirements of this regulation, shall be marked with the CE conformity marking and supplementary metrology marking; 2.4. for each type of measurement means declaration of conformity shall be drawn up and made available to the supervisory authority of the market 10 years after measuring the placing on the market of the product. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 3. the authorised representative of the manufacturer can perform this annex 2.3 and 2.4. the obligations referred to in, if they are specified in the mandate. II. Conformity based on internal production control and measuring instruments for checking at random intervals (A2 module) 4. Conformity based on internal production control and measuring instruments for checking at random intervals method is the conformity assessment procedure in accordance with the manufacturer complies with these rules and the relevant legislation requirements and certify that the measuring tool meets these requirements. 5. the manufacturer shall perform the following obligations 5.1 establish technical documentation. The technical documentation provides the opportunity to assess the adequacy of the means of measuring the requirements of this regulation, including risk analysis and assessment. The technical documentation shall specify the applicable requirements and, to the extent necessary, for the evaluation of measurement means it covers the design, manufacture and operation; 5.2. take all necessary measures to ensure the conformity of the manufactured instruments of measurement rules and relevant regulatory requirements; 5.3. each measuring instrument that satisfies the requirements of this regulation, shall be marked with the CE conformity marking and supplementary metrology marking, as well as the identification number of the notified body, if it carries out the procedures referred to in paragraph 6; 5.4. each measurement type of Declaration of conformity shall be drawn up and made available to the supervisory authority of the market 10 years after measuring the placing on the market of the product. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 6. Conformity assessment procedure the manufacturer chooses one notified body or that rule 45, paragraph unit that performs the following: 6.1. taking into account the features of measuring technological complexity and the volume of production, determines the frequency of the periodic inspection and perform or shall ensure that the products are carried out checks on the means of measuring internal quality checks; 6.2. before placing the product on the market and also the final test sample in accordance with the applicable standards and requirements of the applicable document or perform equivalent tests laid down in other relevant technical specifications in order to assess the conformity of the measuring instruments in the EU type-examination certificate and to the type as described in the requirements of this regulation; 6.3. If under the applicable standards or the applicable documents are not available, shall take a decision on the tests to be carried out; 6.4. If, in accordance with the results of testing the product does not meet the requirements of this regulation, shall take appropriate measures. 7. The manufacturer's authorised representative can perform 5.3 and 5.4 of this annex. the obligations referred to in, if they are specified in the mandate. III. the EU type-examination (module B) 8. EU type examination is the conformity assessment procedure, which is part of the conformity assessment procedures in accordance with notified body examines the technical design of the measuring and certifying that it complies with the regulations laid down in the requirements. 9. the EU type examination shall be carried out using one of the following methods: 9.1. completed the planned means of measuring the sample testing; 9.2. technical means of measuring the project's conformity assessment, the evaluation of this annex, paragraph 10 of the technical documentation and supporting evidence and checking one or more of the essential ingredients of representative samples of the production (production type and design type combination); 9.3. means of measurement of technical project evaluation of conformity assessment of this annex, paragraph 10 of the technical documentation and supporting evidence, but not taking the sample test (project type). A decision on the most appropriate method and then the models adopted required the notified body. 10. the application of the EU type-examination shall be submitted in one producer reported institution of their choice. The application shall contain the following information and documentation: 10.1. name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address; 10.2. a written declaration that the same application has not been lodged with any other notified body; 10.3. the technical documentation that provides the opportunity to assess the means of measuring compliance with the requirements of this regulation and which include risk analysis and assessment. The technical documentation shall specify the applicable requirements and, to the extent necessary, for the evaluation of measurement means it covers the design, manufacture and operation; 10.4. If possible, the application shall include at least the following elements: 10.4.1. notified body the required planned measurement or its ingredients samples; 10.4.2. the attestations of conformity to technical design solutions, which specify all used documents, especially if not applied fully in the applicable standard or applicable documentation, and, if necessary, submit to the laboratory of the manufacturer or on his behalf and on behalf of other laboratory testing results. 11. The notified body shall perform the following obligations: 11.1 in accordance with this annex 9.1. method referred to: 11.1.1 examine the technical documentation and supporting evidence; 11.1.2. check that the model is manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable standards or applicable requirements, as well as document elements, designed in accordance with other relevant technical specifications; 11.1.3. make the appropriate checks and tests or ensure, to assess whether the manufacturer has used the solutions in accordance with the applicable standards or the requirements of the applicable document; 11.1.4. make the appropriate checks and tests or ensure to assess, or when it is not used in the relevant applicable standards or the applicable documents specific solutions, technical solutions chosen by the manufacturer to comply with the relevant legislation; 11.1.5. agree with the applicant the location where the examinations and tests carried out; 11.2. in accordance with the method referred to in point 9.2. inspection of the technical documentation and supporting evidence to assess the means of measuring compliance with the technical part of the project. 11.3. pursuant to this annex referred to in point 9.3 method checks the technical documentation to ensure that the manufacturer has adequate means to ensure consistent production. 12. the notified body shall draw up an assessment report indicating the measures taken in accordance with paragraph 11 of the annex, and the results of such measures. Without prejudice to its obligations against the notifying authorities, the notified body only with the consent of the manufacturer, wholly or in part the content of that report disclosed. 13. Where the type meets the requirements of these provisions, which apply to specific means of measurement, the notified body shall issue a manufacturer the EU type-examination certificate. The certificate shall contain the name and address of the manufacturer, conclusions of the examination, the conditions for validity of the certificate, if any, and for identification of the approved type the necessary information. 14. the EU type-examination certificate can have one or more annexes. The EU type-examination certificate and its annexes shall contain all relevant information allowing an evaluation to be made of the conformity of measuring instruments to the type of test and inspection during use. 15. certificates and annexes shall include all information necessary to evaluate the features of measuring compliance with the approved type: 15.1 measuring type metrological characteristics; 15.2. the measures the integrity of measurement (for example, sealing, identification of software); 15.3. information on other elements necessary for the identification of the means of measurement and Visual inspection of conformity; 15.4. any particular information required in measuring product characteristics made for inspection; 15.5. to ensure compatibility with additional devices or other measuring instruments, if any. 16. the EU type examination certificate is issued for 10 years, and can be repeated several times to extend for 10 years. 17. If the type does not conform to the requirements of these provisions, which apply to specific means of measurement, the notified body shall refuse to issue an EU type-examination certificate and shall inform the applicant accordingly, indicating the reasons for such refusal. 18. the notified body shall identify the common standard changes, which indicate that the approved type may no longer continue meeting the requirements of this regulation, and shall determine whether such changes require further study. If necessary, the notified body shall inform the manufacturer. 19. The manufacturer shall inform the notified body that holds the technical documentation concerning the EU type-examination certificate of all modifications to the approved type that may affect the conformity of the means of measuring this provision with the essential requirements or the conditions for validity of the certificate in the. Such modifications require additional approval, added an addition to the original EU type-examination certificate. 20. The notified body once every quarter or, upon request, inform the Ministry of the economy of the EU type-examination certificate and any additions which it has issued or withdrawn, and shall submit the certificates and their additions for a list of rejected certificate and certificates which have been abolished or otherwise limited. 21. at the request of the European Commission and the Member States may receive technical documentation and reported the results of the inspections carried out by the institution. The notified body shall keep the EU type-examination certificate, its annexes and additions, technical documentation, and a copy of the documentation provided by the manufacturer for the remainder of that certificate expires. 22. the manufacturer shall provide the EU type-examination certificate, its annexes and additions and a copy of the technical documentation available to the supervisory authority of the market 10 years after taking the products on the market. 23. The manufacturer's authorised representative may lodge the application referred to in paragraph 10 of this annex and the 19 and 22 the obligations, if they are specified in the mandate. IV. Conformity to type based on internal production control (module C) 24. Conformity to type based on internal production control is the conformity assessment procedure whereby the manufacturer fulfils the legislation requirements, ensures and declares that the measuring tools correspond to the EU type-examination certificate and to the type as described in the requirements of this regulation. 25. the manufacturer shall fulfil the following obligations: 25.1. take all necessary measures to ensure the conformity of the measuring instruments manufactured in the EU type-examination certificate and to the type as described in the requirements of this regulation; 25.2. each measuring instrument that satisfies the EU type-examination certificate referred to in type and requirements of these provisions, shall be marked with the CE conformity marking and supplementary metrology marking; 25.3. each measurement type of Declaration of conformity shall be drawn up and made available to the supervisory authority of the market 10 years after measuring the placing on the market of the product. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 26. The manufacturer's authorised representative may hereto 25.2 and 25.3.. obligations referred to, if they are specified in the mandate. V. conformity to type based on internal production control and measuring instruments for checking at random intervals method (module C2) 27. Conformity to type based on internal production control and measuring instruments for checking at random intervals, the method is the part of a conformity assessment procedure whereby the manufacturer fulfils the legislation requirements, and ensures and declares that the measuring instrument complies with the EU type-examination certificate and to the type as described in the requirements of this regulation. 28. the manufacturer shall fulfil the following obligations: 28.1. take all the necessary measures to ensure the conformity of the measuring instruments manufactured in the EU type-examination certificate and to the type as described in the requirements of this regulation; 28.2. each measuring instrument that satisfies the EU type-examination certificate and to the type as described in the requirements of this regulation, shall be marked with "CE" marking and the supplementary metrology marking as well as notified body identification number, yes it makes the procedure specified in paragraph 29; 28.3. for each type of measurement a declaration of conformity shall be drawn up and made available to the supervisory authority of the market 10 years after measuring the placing on the market of the product. The Declaration identifies the appropriate measuring tool. Each measuring instrument that is placed on the market, accompanied by a copy of the Declaration. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 29. The conformity assessment procedure, the manufacturer shall select one notified body or that rule 45, paragraph Department to fulfil the following obligations: 29.1. taking into account the features of measuring technological complexity and the volume of production, determines the frequency of the periodic inspection and perform or shall ensure that the products are carried out checks on the means of measuring internal quality checks; 29.2. before placing the product on the market and also the final test sample in accordance with the applicable standards and requirements of the applicable document or perform equivalent tests laid down in other relevant technical specifications in order to assess the conformity of the measuring instruments in the EU type-examination certificate and to the type as described in the requirements of this regulation; 3. where, in accordance with the results of testing the product does not meet the requirements of this regulation, take appropriate measures; 29.4. sampling procedure is carried out to determine whether the means of measuring the production process takes place in accordance with quality, and provide the means of measuring compliance with the requirements of this regulation. 30. The manufacturer's authorised representative may hereto 28.2 and 28.3. the obligations referred to in, if they are specified in the mandate. Vi. Conformity to type based on quality assurance of the production process (module D) 31. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the 32, 42, 43 and 44. the obligations laid down in point, as well as on his own responsibility, and declares that the measuring tools correspond to the EU type-examination certificate and to the type as described in the requirements of this regulation that apply to them. 32. the manufacturer shall use the approved quality assurance system for the production of the means of measurement, final product inspection and testing as specified in paragraph 33 of the present annex, and the producer is subject to this annex, 42, 43 and 44 in the specific paragraph. monitoring. 33. The manufacturer shall submit the application to evaluate the means of measuring the quality system in one of the notified body of his choice. The application shall include: 33.1. name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address; 33.2. written declaration that the same application has not been lodged with any other notified body; 33.3. any relevant information about the expected measuring tools category. 33.4. the quality assurance system documentation; 33.5. technical documentation relating to the approved type and the EU type-examination certificate. 34. the quality system shall ensure compliance of the measuring instruments in the EU type-examination certificate and to the type as described in the requirements of this regulation. 35. All adopted elements of the quality system, requirements and conditions the manufacturer systematically and adequately documented in writing, developing policies, procedures and instructions. The quality system documentation allows a consistent interpretation of the quality programmes, plans, manuals and documentation, and include the following information: according to the described 21.8. the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality; 35.2. manufacturing, quality control and quality assurance techniques, processes and systematic actions; 35.3. the examinations and tests that will be carried out before the process, during and after its completion, as well as the frequency of the conduct; 35.4. the quality records, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned; 22.1. the resources required for achieving product quality surveillance and quality assurance for the efficient operation of the system. 36. The notified body shall assess the quality system to determine whether it meets this annex and paragraph 33.35. These requirements match these elements of the quality system that comply with the relevant applicable standard specifications. 37. At least one audit group member in addition to experience in quality assurance systems must be an assessor in the product areas of measurement and product technology concerned, and knowledge of the rules and relevant regulatory requirements of the Act. 38. Audit includes assessment visit to the manufacturer's premises. Audit Group look 20.8. this annex referred to in the technical documentation to verify the manufacturer's ability to identify the relevant requirements of these regulations and to carry out the necessary checks to ensure the means of measuring compliance with those requirements. The decision is notified to the manufacturer. The notification shall contain the conclusions of the audit and the assessment of justification. 39. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to uphold it so that it remains adequate and efficient. 40. the manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. 41. The notified body shall evaluate any proposed changes and decide whether the amended quality system will still meet the requirements referred to in this annex, and paragraph 33.35, or you need a revaluation. The notified body shall communicate its decision to the manufacturer. The notification shall contain the conclusions of the examination and assessment. 42. The notified body for the purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 43. the purpose of the evaluation the manufacturer provides the notified body access to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular: 43.1. the quality assurance system documentation; 43.2. the quality records, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned. 44. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. Notified body representatives may attend at the manufacturer without notice. During such visits the notified body may, if necessary, carry out product tests, or providing it to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if tests have been carried out in the test report. 45. Each measuring instrument that satisfies the EU type-examination certificate and to the type as described in the requirements of this regulation, the manufacturer shall be marked with the CE conformity marking and supplementary metrology marking, as well as to this annex referred to in paragraph 33 of the notified body responsible for the label adds its identification number. 46. the manufacturer shall draw up a written instrument of measuring each declaration of conformity and ensure its availability to the supervisory authority of the market 10 years after measuring the placing on the market of the product. In the Declaration of conformity shall identify the means of measurement model, for which it was prepared. A copy of the Declaration of conformity shall be made available on request to the authorities. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 47. the manufacturer 10 years after measuring the placing on the market of the products ensures market supervisory authority access to information relating to the evaluation of the quality assurance system referred to in paragraph 33 of the present annex, activities and information of the approved changes to the quality system, as well as information on the notified bodies and the reports in connection with the audits relating to the manufacturer's quality system. 48. The notified body once every quarter or, upon request, inform the Ministry of the economy of all issued or withdrawn approval of the quality system and shall provide the quality system approval list of approval and rejected approvals, the transaction is aborted or otherwise limited. 49. The manufacturer's authorised representative may hereto 33, 40, 41, 45, 46 and 47. producer referred to the obligations and responsibilities on behalf of the manufacturer, if they are specified in the mandate. VI. Conformity based on quality assurance of the production process (module D1) 50. quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the 40, 51, 53 and 54. the obligations set out in point and, on his own responsibility, and declares that the measuring instruments comply with this provision and the relevant legislative requirements that apply to them. 51. the manufacturer shall establish the technical documentation that provides the opportunity to assess the means of measuring compliance with this provision and the relevant legislative requirements, including risk analysis and assessment. The technical documentation shall specify the applicable requirements and, to the extent necessary, for the evaluation of measurement means it covers the design, manufacture and operation. 52. the manufacturer shall provide the technical documentation available to the supervisory authority of the market 10 years after taking the products on the market. 53. the manufacturer shall use the approved quality assurance system for the production of the means of measurement, final product inspection and testing as specified in paragraph 54 of this annex, and the producer is subject to this annex, 63, 64 and 65. above. monitoring. 54. The manufacturer shall submit the application to evaluate the means of measuring the quality system in one of the notified body of his choice. The application shall include: 54.1. the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address; 54.2. written declaration that the same application has not been lodged with any other notified body; 54.3. all relevant information about the expected measuring tools category. 54.4. the quality assurance system documentation; 54.5. the technical documentation referred to in paragraph 51 of this annex. 55. the quality system shall ensure compliance of the means of measuring this provision and the relevant legislative requirements of the Act. 56. All of the manufacturer's quality system adopted by the elements, requirements, and conditions documents systematically and adequately in writing, developing policies, procedures and instructions. The quality system documentation allows a consistent interpretation of the quality programmes, plans, manuals and documentation, and include appropriate to describe the following information: 56.1. the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality; 56.2. manufacturing, quality control and quality assurance techniques, processes and systematic actions; 56.3. the examinations and tests that will be carried out before the process, during and after its completion, as well as the frequency of the conduct; 56.4. quality records, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned; 56.5. resources required for achieving product quality surveillance and quality assurance for the efficient operation of the system. 57. The notified body shall assess the quality system to determine whether it satisfies 55. of this annex and paragraph 56. These requirements match these elements of the quality system that comply with the relevant applicable standard specifications. 58. At least one audit group member in addition to experience in quality assurance systems must be an assessor in the product areas of measurement and product technology concerned, and knowledge of the rules and relevant regulatory requirements of the Act. 59. Audit includes assessment visit to the manufacturer's premises. The audit team examined 51. this annex documentation referred to in point, to verify the manufacturer's ability to identify the relevant requirements of these regulations and to carry out the necessary checks to ensure the means of measuring compliance with those requirements. The decision is notified to the manufacturer. The notification shall contain the conclusions of the audit and the assessment of justification. 60. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure its proper and effective work. 61. the manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. 62. The notified body shall evaluate any proposed changes and decide whether the amended quality system will still meet the requirements referred to in this annex, paragraph 55 and 56., or need a revaluation. The notified body shall communicate its decision to the manufacturer. The notification shall contain the conclusions of the examination and assessment. 63. The notified body for the purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 64. the purpose of the evaluation the manufacturer provides the notified body access to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular: 64.1. the quality assurance system documentation; 64.2.51. this annex technical documentation referred to in paragraph 1; 64.3. data about quality, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned. 65. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. Notified body representatives may attend at the manufacturer without notice. During such visits the notified body may, if necessary, carry out product tests, or providing it to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if tests have been carried out, the test message. 66. Each measuring instrument that satisfies the requirements of this regulation, the manufacturer shall be marked with the CE conformity marking and supplementary metrology marking, as well as to this annex referred to in paragraph 54 of the notified body responsible for the label adds its identification number. 67. the manufacturer shall draw up a written instrument of measuring each declaration of conformity and ensure its availability to the supervisory authority of the market 10 years after measuring the placing on the market of the product. In the Declaration of conformity shall identify the means of measurement model, for which it was prepared. A copy of the Declaration of conformity shall be made available on request to the authorities. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 68. the manufacturer 10 years after measuring the placing on the market of the products ensures market supervisory authority access to information relating to the evaluation of the quality assurance system referred to in paragraph 54 of the present annex, activities and information of the approved changes to the quality system, as well as information on the notified bodies and the reports in connection with the audits relating to the manufacturer's quality system. 69. The notified body once every quarter or, upon request, inform the Ministry of the economy of all issued or withdrawn approval of the quality system and shall provide the quality system approval list of approvals and rejected approvals, the transaction is aborted or otherwise limited. 70. The manufacturer's authorised representative may hereto 52, 54, 61, 66, 67, and referred to in paragraph 68 manufacturer's obligations and responsibilities on behalf of the manufacturer, if they are specified in the mandate. VIII. Conformity to type based on quality assurance of final product inspection and testing (module E) 71. Conformity to type based on quality assurance of final product inspection and testing is the conformity assessment procedure whereby the manufacturer fulfils the requirements laid down in this annex for measuring production and on his own responsibility, and declares that the measuring tools correspond to the EU type-examination certificate to the type described in these rules and, as well as the legislative instrument that apply to them. 72. the manufacturer shall use the approved quality assurance system for the production of the means of measurement, final product inspection and testing as specified in this annex, 73, 74, 75 and 76., and the producer is subject to this annex, 82, 83 and 84 paragraph specific. monitoring. 73. The manufacturer shall submit the application to evaluate the means of measuring the quality system in one of the notified body of his choice. The application shall include the following: 73.1. the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address; 73.2. written declaration that the same application has not been lodged with any other notified body; 73.3. all relevant information about the expected measuring tools category. 45.6. the quality assurance system documentation; 73.5. technical documentation relating to the approved type and the EU type-examination certificate. 74. the quality system shall ensure compliance of the measuring instruments in the EU type-examination certificate and to the type as described in the requirements of this regulation. 75. All of the manufacturer's quality system adopted by the elements, requirements, and conditions documents systematically and adequately in writing, developing policies, procedures and instructions. The quality system documentation allows a consistent interpretation of the quality programmes, plans, manuals and documentation, and include appropriate to describe the following information: 75.1. the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality; 75.2. the examinations and tests carried out after the production process; 75.3. the quality records, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned; 75.4. features of the required product quality and the monitoring of achievement of quality assurance for the efficient operation of the system. 76. The notified body shall assess the quality system to determine whether it meets this annex and paragraph 74.75. These requirements match these elements of the quality system that comply with the relevant applicable standard specifications. 77. At least one audit group member in addition to experience in quality assurance systems must be an assessor in the product areas of measurement and product technology concerned, and knowledge of the rules and relevant regulatory requirements of the Act. 78. The Audit includes assessment visit to the manufacturer's premises. The audit team examined 73.5. this annex referred to in the technical documentation to verify the manufacturer's ability to identify the relevant requirements of these regulations and to carry out the necessary checks to ensure the means of measuring compliance with those requirements. The decision is notified to the manufacturer. The notification shall contain the conclusions of the audit and the assessment of justification. 79. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure its proper and effective work. 80. the manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. 81. The notified body shall evaluate any proposed changes and decide whether the amended quality system will still meet the requirements referred to in this annex, paragraph 72 and 73., or need a revaluation. The notified body shall communicate its decision to the manufacturer. The notification shall contain the conclusions of the examination and assessment. 82. The notified body for the purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 83. the purpose of the evaluation the manufacturer provides the notified body access to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular: 83.1. the quality assurance system documentation; 51.7. data on the quality, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned. 84. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. Notified body representatives may attend at the manufacturer without notice. During such visits the notified body may, if necessary, carry out product tests, or providing it to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if tests have been carried out, the test message. 85. Each measuring instrument that satisfies the EU type-examination certificate and to the type as described in the requirements of this regulation, the manufacturer shall be marked with the CE conformity marking and supplementary metrology marking, as well as to this annex referred to in paragraph 54 of the notified body responsible for the label adds its identification number. 86. the manufacturer shall draw up a written instrument of measuring each declaration of conformity and ensure its availability to the supervisory authority of the market 10 years after measuring the placing on the market of the product. In the Declaration of conformity shall identify the means of measurement model, for which it was prepared. A copy of the Declaration of conformity shall be made available on request to the authorities. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 87. the manufacturer 10 years after measuring the placing on the market of the products ensures market supervisory authority access to information relating to the evaluation of the quality assurance system referred to in paragraph 73 of this annex, the information about the actions and approved changes to the quality system, as well as information on the notified bodies and the reports in connection with the audits relating to the manufacturer's quality system. 88. The notified body once every quarter or, upon request, inform the Ministry of the economy of all issued or withdrawn approval of the quality system and shall provide the quality system approval list of approvals and rejected approvals, the transaction is aborted or otherwise limited. 89. The manufacturer's authorised representative may hereto 73, 80, 86 and 87. producer referred to obligations and responsibilities on behalf of the manufacturer, if they are specified in the mandate. IX. Conformity based on quality assurance of measurement surveys and testing (module E1) 90. Conformity based on quality assurance of measuring and testing, testing is the conformity assessment procedure whereby the manufacturer fulfils the 90, 93.106.107. points, and obligations, as well as provides and declares on his sole responsibility that the measuring instruments concerned satisfy the rules and the relevant legislative requirements that apply to them. 91. the manufacturer shall establish the technical documentation that provides the opportunity to assess the means of measuring compliance with this provision and the relevant legislative requirements, including risk analysis and assessment. The technical documentation shall specify the applicable requirements and, to the extent necessary, for the evaluation of measurement means it covers the design, manufacture and operation. 92. the manufacturer shall provide the technical documentation available to the supervisory authority of the market 10 years after measuring the placing on the market of the product. 93. the manufacturer shall use the approved quality assurance system for the measurement of production, final product inspection and testing, as specified in this annex, 94, 95, 96, 97, 98 and 99..., and the producer is subject to this annex, 104 and 105 103. monitoring laid down in paragraph. 94. The manufacturer shall submit the application to evaluate the means of measuring the quality system in one of the notified body of his choice. The application shall include the following: 94.1. name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address; 94.2. written declaration that the same application has not been lodged with any other notified body; 58.6. all relevant information about the expected measuring tools category. 94.4. the quality assurance system documentation; 91. this annex 94.5 points specified in the technical documentation. 95. the quality system shall ensure compliance of the means of measuring this provision and the relevant legislative requirements of the Act. 96. All of the manufacturer's quality system adopted by the elements, requirements, and conditions documents systematically and adequately in writing, developing policies, procedures and instructions. The quality system documentation allows a consistent interpretation of the quality programmes, plans, manuals and documentation, and include appropriate to describe the following information: 96.1. the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality; 96.2. the examinations and tests carried out after the production process; 96.3. quality records, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned; 59.9. resources required for achieving product quality surveillance and quality assurance for the efficient operation of the system. 97. The notified body shall assess the quality system to determine whether it meets the 95 and 96 of this annex. requirements. These requirements match these elements of the quality system that comply with the relevant applicable standard specifications. 98. At least one audit group member in addition to experience in quality assurance systems must be an assessor in the the measurement and product technology concerned, and knowledge of the rules and relevant regulatory requirements of the Act. 99. Audit includes assessment visit to the manufacturer's premises. The audit team examined this Annex 91. documentation referred to in point, to verify the manufacturer's ability to identify the relevant requirements of these regulations and to carry out the necessary checks to ensure the means of measuring compliance with those requirements. The decision is notified to the manufacturer. The notification shall contain the conclusions of the audit and the assessment of justification. 100. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure its proper and effective work. 101. the manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. 102. The notified body shall evaluate any proposed changes and decide whether the amended quality system will still meet the requirements referred to in this annex and paragraph 95.96, or need a revaluation. The notified body shall communicate its decision to the manufacturer. The notification shall contain the conclusions of the examination and assessment. 103. The notified body for the purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 104. the purpose of the evaluation the manufacturer provides the notified body access to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular: 104.1. the quality assurance system documentation; 104.2.91. this annex technical documentation referred to in paragraph 1; 104.3. data on the quality, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned. 105. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. Notified body representatives may attend at the manufacturer without notice. During such visits the notified body may, if necessary, carry out product tests, or providing it to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if tests have been carried out, the test message. 106. Each measuring tool that meets the requirements of this regulation, the manufacturer shall be marked with the CE conformity marking and supplementary metrology marking, as well as to this annex referred to in paragraph 94 of the notified body responsible for the marking shall be accompanied by the identification number of the manufacturer shall draw up a written 107. each measurement of the Declaration of conformity and ensure its availability to the supervisory authority of the market 10 years after measuring the placing on the market of the product. In the Declaration of conformity shall identify the means of measurement model, for which it was prepared. A copy of the Declaration of conformity shall be made available on request to the authorities. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 108. the manufacturer 10 years after measuring the placing on the market of the products ensures market supervisory authority access to information relating to the evaluation of the quality assurance system referred to in paragraph 94 of this annex, the information about the actions and approved changes to the quality system, as well as information on the notified bodies and the reports in connection with the audits relating to the manufacturer's quality system. 109. The notified body once every quarter or, upon request, inform the Ministry of the economy of all issued or withdrawn approval of the quality system and shall provide the quality system approval list of approvals and rejected approvals, the transaction is aborted or otherwise limited. 110. The manufacturer's authorised representative may hereto, 94, 92, 101, 102, 107 and 106.108. producers referred to the obligations and responsibilities on behalf of the manufacturer, if they are specified in the mandate. X. conformity to type based on product verification (module F) 111. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the 112, 119, 123 and 124. the obligations laid down in point and, on his own responsibility, and declares that the measuring tools correspond to the EU type-examination certificate and to the type described in these rules and the relevant legislative requirements that apply to them. 112. The manufacturer shall take all measures necessary in order that the manufacturing process and its monitoring ensure conformity of the manufactured instruments of measurement in the EU type-examination certificate and the approved type described in this provision and the relevant legislative requirements of the Act. 113. a notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to verify the conformity of the measuring instrument in the EU type-examination certificate and to the type described in these rules and relevant regulatory requirements of the Act. 114. The examinations and tests that will let you check the means of measuring compliance with the relevant requirements, perform one of the following methods: chosen by the manufacturer of each means of measuring 114.1. verification; 114.2. statistical verification. 115. in the verification of measuring instruments for measuring each feature check and then performs the appropriate tests defined in the relevant applicable standards or the applicable documents, as well as perform equivalent tests to assess the conformity of the measuring instruments in the EU type-examination certificate and to the type described in these rules and relevant regulatory requirements of the Act. If the proper documentation is not available, the notified body shall take a decision on the tests to be carried out. 116. the notified body shall, on the basis of paragraph 115 of this annex, the checks carried out and issue a certificate of conformity and affix its identification number to the measuring instruments approved or, on his own responsibility, to charge it. 117. the manufacturer shall ensure the availability of the certificate of conformity market surveillance authority 10 years after measuring the placing on the market of the product. 118. the statistical verification, provides: 118.1. quality level with a 95 percent probability that the match is not the appropriate means of measurement is less than one percent; 118.2. quality levels with a five-percent probability that does not match the appropriate means of measurement is less than seven percent. 119. the manufacturer shall take all measures necessary in order that the manufacturing process and its monitoring ensure the measuring instruments manufactured batch uniformity, and ensure that a verification for a batch is uniform. 120. Statistical verification on a random sample is taken from each batch in accordance with paragraph 118 of this annex to the requirements of, and all the means of measuring a random sample check separately by performing appropriate tests defined in the relevant applicable standards and the applicable documents, or equivalent tests, to determine the appropriate technical specifications to ensure that the selected means of measuring compliance with the type as described in the EU type-examination certificate and the relevant provisions and legislative requirements. If the documents are not available, the notified body shall take a decision on the tests to be carried out. 121. at paragraph 120 of this annex, the procedures taken in the notified body shall decide whether the lot is accepted or rejected is. 122. If the batch is accepted, the means of measuring the lot shall be considered approved, except for measuring features that did not meet the criteria for testing. The notified body shall issue a certificate of conformity and affix its identification number to each approved product or measuring, on his own responsibility, to charge it. If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of the party. If similar cases recur repeatedly notified body repealed the statistical verification and take appropriate measures. 123. Each measuring instrument that satisfies the EU type-examination certificate and to the type as described in the requirements of this regulation, the manufacturer shall be marked with the CE conformity marking and supplementary metrology marking, as well as to this annex referred to in paragraph 113 of the notified body responsible for the label adds its identification number. 124. the manufacturer shall draw up a written instrument of measuring each declaration of conformity and ensure its availability to the supervisory authority of the market 10 years after measuring the placing on the market of the product. In the Declaration of conformity shall identify the means of measurement model, for which it was prepared. A copy of the Declaration of conformity shall be made available on request to the authorities. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 125. If this annex referred to in paragraph 113 of the notified body agree, the responsibility of the manufacturer of the measuring instruments can be imposed also notified body identification number. 126. If it is agreed to this annex referred to in paragraph 113 of notified body, the manufacturer may impose the means of measuring the notified body's identification number during the manufacturing, taking responsibility for it. 127. The manufacturer's authorised representative may fulfil the obligations of the manufacturer the manufacturer's task and responsibility, with the exception of this annex 112. and in paragraph 119 above if they are specified in the mandate. XI. the conformity based on product verification (module F1) 128. Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils the 129, 131, 137, 143, 144 and 145... the obligations laid down in point and, on his own responsibility, and declares that the measuring instruments comply with this provision and the relevant legislative requirements that apply to them. 129. the manufacturer shall establish the technical documentation that provides the opportunity to assess the means of measuring compliance with the requirements of this regulation, including risk analysis and assessment. The technical documentation shall specify the applicable requirements and, to the extent necessary, for the evaluation of measurement means it covers the design, manufacture and operation. 130. the manufacturer shall provide the technical documentation available to the supervisory authority of the market 10 years after measuring the placing on the market of the product. 131. The manufacturer shall take all measures necessary in order that the manufacturing process and its monitoring ensure conformity of the manufactured instruments of measurement of this provision and the relevant legislative requirements of the Act. 132. a notified body chosen by the manufacturer shall carry out the appropriate examinations and tests in order to verify the conformity of the measuring instruments and of the provisions, where these legislative requirements. 133. The examinations and tests that will let you check compliance of the means of measuring the relevant requirements, perform one of the following methods: chosen by the manufacturer of each means of measuring 133.1. verification; 133.2. statistical verification. 134. in the verification of measuring instruments for measuring each feature check and then performs the appropriate tests defined in the relevant applicable standards or the applicable documents, as well as perform equivalent tests to assess the adequacy of the means of measuring this provision and the relevant legislative requirements of the Act. If the proper documentation is not available, the notified body shall take a decision on the tests to be carried out. 135. the notified body shall, on the basis of paragraph 134 of this annex, the checks carried out and issue a certificate of conformity and affix its identification number to the measuring instruments approved or, on his own responsibility, to charge it. 136. the manufacturer shall ensure the availability of the certificate of conformity market surveillance authority 10 years after measuring the placing on the market of the product. 137. the manufacturer shall take all measures necessary in order that the manufacturing process and its monitoring ensure the means of measurement produced uniformity of the party and ensure that a verification for a batch is uniform. 138. the statistical verification, provides: the level of quality with the 138.1.95 percent probability that the match is not the appropriate means of measurement is less than one percent; 138.2. quality levels with a five-percent probability that does not match the appropriate means of measurement is less than seven percent. 139. Statistical verification on a random sample is taken from each batch in accordance with paragraph 138 of this annex to the requirements of, and all the means of measuring a random sample check separately by performing appropriate tests defined in the relevant applicable standards and the applicable documents, or equivalent tests, to determine the appropriate technical specifications to ensure that the selected means of measuring compliance with this provision and the relevant legislative requirements of the Act. If the documents are not available, the notified body shall take a decision on the tests to be carried out. 140. After paragraph 139 of this annex, the procedures taken in the notified body shall decide whether the lot is accepted or rejected. 141. If a lot is accepted, this means of measurement of the Party shall be considered approved, except for measuring features that did not meet the criteria for testing. The notified body shall issue a certificate of conformity and affix its identification number to each approved product or measuring, on his own responsibility, to charge it. 142. If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the market of the party. If similar cases recur repeatedly notified body repealed the statistical verification and take appropriate measures. 143. Each measuring instrument that complies with the applicable rules and the legislative requirements, the manufacturer shall be marked with the CE conformity marking and supplementary metrology marking, as well as to this annex referred to in paragraph 132 of the notified body responsible for the label adds its identification number. 144. the manufacturer shall draw up a written instrument of measuring each declaration of conformity and ensure its availability to the supervisory authority of the market 10 years after measuring the placing on the market of the product. In the Declaration of conformity shall identify the means of measurement model, for which it was prepared. A copy of the Declaration of conformity shall be made available on request to the authorities. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 145. If this annex referred to in paragraph 132 of the notified body, the manufacturer shall agree on means of measuring the liability can be imposed also notified body identification number. 146. If it is agreed with the 132. the notified body referred to in paragraph 1, the manufacturer may impose the means of measuring the notified body's identification number during the manufacturing, taking responsibility for it. 147. The manufacturer's authorised representative may fulfil the obligations of the manufacturer the manufacturer's task and responsibility, with the exception of this annex, and 129 131.137. the obligations referred to in paragraph 1, if they are specified in the mandate. XII. Conformity based on unit verification (module G) 148. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the 149, 150, 151, 155.., 156 and 157. the obligations laid down in point and, on his own responsibility, and declares that the measuring instruments comply with this provision and the relevant legislative requirements that apply to them. 149. the manufacturer shall establish the technical documentation that provides the opportunity to assess the means of measuring compliance with this provision and the relevant legislative requirements of the Act and make it available to this annex referred to in paragraph 152. notified body. The technical documentation shall include risk analysis, assessment and requirements applicable, and, to the extent necessary, for the evaluation of measurement means it covers the design, manufacture and operation. 150. the manufacturer shall provide the technical documentation available to the supervisory authority of the market 10 years after taking the products on the market. 151. The manufacturer shall take all measures necessary in order that the manufacturing process and its monitoring ensure conformity of the manufactured instruments of measurement apply to this provision and the relevant legislative requirements of the Act. 152. the notified body chosen by the manufacturer shall carry out the necessary inspections and tests laid down in the relevant applicable standards or the applicable documents or equivalent tests laid down in other relevant technical specifications in order to verify the conformity of the measuring instruments applicable to this provision and the relevant legislative requirements, or provide it. If according to the applicable standards or the applicable documents are not available, the notified body shall take a decision on the tests to be carried out. 153. the notified body shall, on the basis of the checks carried out and issue a certificate of conformity and affix its identification number to the measuring instruments approved or, on his own responsibility, to charge it. 154. the manufacturer shall ensure the availability of the certificate of conformity market surveillance authority 10 years after measuring the placing on the market of the product. 155. Each measuring instrument that complies with these rules and the relevant legislative requirements, the manufacturer shall be marked with the CE conformity marking and supplementary metrology marking, as well as to this annex referred to in paragraph 132 of the notified body responsible for the label adds its identification number. 156. the manufacturer of the product for each measurement shall draw up a written declaration of conformity and ensure its availability to the supervisory authority of the market 10 years after measuring the placing on the market of the product. In the Declaration of conformity shall identify the means of measurement model, for which it was prepared. A copy of the Declaration of conformity accompanied by the instrument. 157. a copy of the Declaration of conformity shall be made available on request to the competent authorities. 158. The manufacturer's authorised representative can perform 149. of this annex, 155.156.157., and producers referred to the obligations of the manufacturer and, if the responsibility they are specified in the mandate. XIII. Conformity based on full quality assurance (module H) 159. Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the legislation requirements and certifying that the measurement features, meeting the requirements of this regulation. 160. the manufacturer shall use the approved quality assurance system for the measurement of media design, production, final product inspection and testing as specified in this annex, 161, 162, 163, 164, 165.., 166, 167 and 168..., and the producer is subject to this annex, 170, 171, 172 and 172.. monitoring provided for in point. 161. The manufacturer shall submit the application to evaluate the means of measuring the quality system in one of the notified body of his choice. The application shall include: 161.1. name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address; 161.2. technical documentation that provides the opportunity to assess the means of measuring compliance with the requirements of this regulation, including risk analysis and assessment. The technical documentation shall specify the applicable requirements and, to the extent necessary, for the evaluation of measurement means it covers the design, manufacture and operation; 161.3. the quality assurance system documentation; 161.4. written declaration that the same application has not been lodged with any other notified body. 162. the quality system shall ensure compliance of the means of measuring these rules and the applicable regulatory requirements. 163. All of the manufacturer's quality system adopted by the elements, requirements, and conditions documents systematically and adequately in writing, developing policies, procedures and instructions. The quality system documentation allows a consistent interpretation of the quality programmes, plans, manuals and documentation, and include appropriate to describe the following information: 163.1. the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality; 163.2. design specifications, applicable standards and the applicable documents or, if not used in the relevant applicable standards or the applicable documents specific solutions, the manufacturer or the technical solutions chosen, suitable to meet the requirements of this regulation, including other relevant technical specifications listing; 163.3. the design control and design verification techniques, processes and systematic actions that will be used in developing the category of measuring means; 163.4. design control and design verification techniques, processes and systematic measures in the design of the measuring instrument; 163.5. the examinations and tests that will be carried out before the process, during and after its completion, as well as the frequency of the conduct; 163.6. quality records, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned; 163.7. the means necessary for achieving product quality surveillance and quality assurance for the efficient operation of the system. 164. The notified body shall assess the quality system to determine whether it meets this annex and paragraph 163 162. requirements. These requirements match these elements of the quality system that comply with the relevant applicable standard specifications. 165. At least one audit group member in addition to experience in quality assurance systems must be an assessor in the product areas of measurement and product technology concerned, and knowledge of the rules and relevant regulatory requirements of the Act. 166. Audit includes assessment visit to the manufacturer's premises. The audit team examined 161.2. this annex referred to in the technical documentation to verify the manufacturer's ability to identify the relevant requirements of these regulations and to carry out the necessary checks to ensure the means of measuring compliance with those requirements. The decision is notified to the manufacturer. The notification shall contain the conclusions of the audit and the assessment of justification. 167. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure its proper and effective work. 168. the manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. 169. The notified body shall evaluate any proposed changes and decide whether the amended quality system will still meet the requirements referred to in this annex, and in paragraph 162.163, or need a revaluation. The notified body shall communicate its decision to the manufacturer. The notification shall contain the conclusions of the examination and assessment. 170. The notified body for the purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 171. the purpose of the evaluation the manufacturer provides the notified body access to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular: 171.1. the quality assurance system documentation; 171.2. data about quality, such as results of analyses, calculations, tests, as provided for in the design of quality assurance systems; 171.3. data about quality, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned. 172. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. Notified body representatives may attend at the manufacturer without notice. During such visits the notified body may, if necessary, carry out product tests, or providing it to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if tests have been carried out, the test message. 173. Measuring features that meet the requirements of this regulation, the manufacturer shall be marked with the CE conformity marking and supplementary metrology marking, as well as to this annex referred to in paragraph 161 of the notified body responsible for the label adds its identification number. 174. the manufacturer shall draw up a written instrument of measuring each declaration of conformity and ensure its availability to the supervisory authority of the market 10 years after measuring the placing on the market of the product. In the Declaration of conformity shall identify the means of measurement model, for which it was prepared. A copy of the Declaration of conformity shall be made available on request to the authorities. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 175. the manufacturer 10 years after measuring the placing on the market of the products ensures market supervisory authority access to information relating to the evaluation of the quality assurance system referred to in paragraph 161 of this annex, the information about the actions and approved changes to the quality system, as well as information on the notified bodies and the reports in connection with the audits relating to the manufacturer's quality system. 176. The notified body once every quarter or, upon request, inform the Ministry of the economy of all issued or withdrawn approval of the quality system and shall provide the quality system approval list of approvals and rejected approvals, the transaction is aborted or otherwise limited. 177. The manufacturer's authorised representative may hereto 161, 168.173.174, 175, and the producers referred to in paragraph duties and responsibilities on behalf of the manufacturer, if they are specified in the mandate. XIV. Conformity based on full quality assurance, supplemented by an evaluation of the project (module H1) 178. Conformity based on full quality assurance, supplemented by an evaluation of the project, is the conformity assessment procedure whereby the manufacturer fulfils the legislation requirements and declares that the measuring means for meeting the requirements of this regulation. 179. the manufacturer shall use the approved quality assurance system for the measurement of media design, production, final product inspection and testing as specified in this annex, 181, 182, 183, 184.., 185, 186, 187 and 188., and the producer is subject to this annex, 203 and 204 202. monitoring laid down in paragraph. 180. the means of measuring compliance with the technical requirements of the project in accordance with this annex, 191, 192, 193.., 194, 195, 196.., 197 and 198 paragraph. 181. The manufacturer shall submit the application to evaluate the means of measuring the quality system in one of the notified body of his choice. The application shall include: 181.1. name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address; 181.2. all the relevant information about the means of measuring the expected category; 181.3. the quality assurance system documentation; 181.4. a written declaration that the same application has not been lodged with any other notified body. 182. the quality system shall ensure compliance of the means of measuring these rules and relevant regulatory requirements. 183. All of the manufacturer's quality system adopted by the elements, requirements, and conditions documents systematically and adequately in writing, developing policies, procedures and instructions. The quality system documentation allows a consistent interpretation of the quality programmes, plans, manuals and documentation, and include appropriate to describe the following information: 183.1. the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality; 183.2. design specifications, applicable standards and the applicable documents, or, if not used in the relevant applicable standards or the applicable documents specific solutions, the manufacturer or the technical solutions chosen, suitable to meet the requirements of this regulation, including other relevant technical specifications listing; 183.3. the design control and design verification techniques, processes and systematic actions that will be used in developing the category of measuring means; 183.4. design control and design verification techniques, processes and systematic measures in the design of the measuring instrument; 183.5. the examinations and tests that will be carried out before the process, during and after its completion, as well as the frequency of the conduct; 183.6. quality records, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned; 183.7. features of the required product quality and the monitoring of achievement of quality assurance for the efficient operation of the system. 184. The notified body shall assess the quality system to determine whether it meets this annex and paragraph 182.183. These requirements match these elements of the quality system that comply with the relevant applicable standard specifications. 185. At least one audit group member in addition to experience in quality assurance systems must be an assessor in the product areas of measurement and product technology concerned, and knowledge of the rules and relevant regulatory requirements of the Act. 186. Audit includes assessment visit to the manufacturer's premises. The decision is notified to the manufacturer. The notification shall contain the conclusions of the audit and the assessment of justification. 187. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure its proper and effective work. 188. the manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system. 189. The notified body shall evaluate any proposed changes and decide whether the amended quality system will still meet the requirements referred to in this annex and paragraph 182.183, or need a revaluation. The notified body shall communicate its decision to the manufacturer. The notification shall contain the conclusions of the examination and assessment. 190. The notified body once every quarter or, upon request, inform the Ministry of the economy of all issued or withdrawn approval of the quality system and shall provide the quality system approval list of approvals and rejected approvals, the transaction is aborted or otherwise limited. 191. the manufacturer shall submit to the verification of this annex referred to in paragraph 181. notified body. The application provides a means of measuring the awareness project, the manufacture and the activities and provide the ability to assess compliance with the requirements of these provisions, which apply to it. The application shall include the following: 191.1. the name and address of the manufacturer; 191.2. a written declaration that the same application has not been lodged with any other notified body; 191.3. technical documentation that provides the opportunity to assess the adequacy of the means of measuring this provision and the relevant legislative requirements of the Act and that includes risk analysis and assessment. The technical documentation shall specify the applicable requirements and, to the extent necessary, for the evaluation of measurement means it covers the design, manufacture and operation; 191.4. supporting evidence for the adequacy of the technical design, including any documents used, in particular, if not fully appropriate for the standards applicable to them or the applicable documents and, if necessary, provide test results in accordance with other relevant technical specifications in the manufacturer has taken adequate laboratory or other test laboratory on behalf of the producer and on his responsibility. 192. The notified body shall examine the application specified in paragraph 191, and the manufacturer is issued a certificate of inspection of the EU project, if a project meets the relevant legislative requirements. The said certificate shall contain the name and address of the manufacturer, conclusions of the examination, the conditions for validity of the certificate (if any) and for identification of the approved project the necessary data. This certificate can be one or more attachments. 193.192. To this annex referred to in paragraph 1 the certificate and its annexes shall contain all the information needed to assess the conformity of the manufactured instruments for measuring the project checked and tested in use. To make it possible to assess the compliance of the manufactured products of the measuring check the project regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, indicate the following information: 193.1. measuring features of the metrological characteristics of the project; 193.2. the measures necessary for the integrity of measurement (sealing, identification of software); 193.3. information on other elements necessary for the identification of the instruments and to check their Visual external conformity to the design; 193.4. any specific information needed for measuring the characteristics of the manufactured products for testing; 193.5. If it is part of the complex, all the information necessary to ensure its compatibility with other sub-assemblies or measuring instruments. 194. Without prejudice to their obligations toward the notifying authorities, the notified body only with the consent of the manufacturer, wholly or partly gets the project inspection report content. 195. the EU project certificate is valid for 10 years from the date of its issue, and may be extended repeatedly for 10 years. 196. If a project does not comply with these rules and relevant regulatory requirements, the notified body shall issue the EU project not examination certificate and shall inform the applicant, specifying the reasons for such refusal. 197. the notified body shall identify the common standard changes, which indicate that the approved project further would not meet the applicable requirements of these regulations, and shall determine whether such changes require further study. If necessary, the notified body shall inform the manufacturer. 198. The manufacturer shall inform the notified body which issued the EU design-examination certificate of all modifications to the approved design changes that may affect its compliance with the requirements of this regulation or that the conditions for validity of the certificate. Such modifications require additional approval, added an addition to the original EU draft examination certificate. 199. The notified body once every quarter or, upon request, inform the Ministry of the economy of all issued or withdrawn an EU project examination certificates and submitted to the EU project certificate approval a list of rejected certificates and certificates, which have been suspended or otherwise restricted. 200. at the request of the European Commission and the Member States may receive EU design examination certificates and their additions for a copy of the technical documentation and reported the results of the inspections carried out by the institution. The notified body shall keep the EU project examination certificate, its annexes and additions, technical documentation, and a copy of the documentation provided by the manufacturer for the remainder of that certificate expires. 201. the manufacturer shall provide the EU type-examination certificate, its annexes and additions and a copy of the technical documentation available to the supervisory authority of the market 10 years after taking the products on the market. 202. The notified body for the purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 203. the purpose of the evaluation the manufacturer provides the notified body access to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular: 203.1. the quality assurance system documentation; 203.2. data about quality, such as results of analyses, calculations, tests, as provided for in the design of quality assurance systems; 203.3. data on the quality, such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned. 204. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. Notified body representatives may attend at the manufacturer without notice. During such visits the notified body may, if necessary, carry out product tests, or providing it to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if tests have been carried out, the test message. 205. Every measuring instrument that meets the requirements of this regulation, the manufacturer shall be marked with the CE conformity marking and supplementary metrology marking, as well as to this annex referred to in paragraph 181 of the notified body responsible for the label adds its identification number. 206. the manufacturer shall draw up a written instrument of measuring each declaration of conformity and ensure its availability to the supervisory authority of the market 10 years after measuring the placing on the market of the product. In the Declaration of conformity shall identify the means of measurement model, for which it was prepared. A copy of the Declaration of conformity shall be made available on request to the authorities. If one user supplied a large batch of measuring instruments, measuring instruments of the party concerned or to add one mailing a copy of the Declaration. 207. the manufacturer 10 years after measuring the placing on the market of the products ensures market supervisory authority access to information relating to the evaluation of the quality assurance system referred to in paragraph 181 of this annex, the information about the actions and approved changes to the quality system, as well as information on the notified bodies and the reports in connection with the audits relating to the manufacturer's quality system. 208. The manufacturer's authorised representative may hereto 181, 188, 191, 198, 201, 205.., 206.207. as referred to in paragraph 1 and the manufacturer's obligations and responsibilities on behalf of the manufacturer, if they are specified in the mandate. Deputy Prime Minister, Minister of economy of Ašeraden of Arvil annex 2 Cabinet 2016 April 12 regulations No 212 essential requirements of measurement feature 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 following terms used in the Annex: 2.1.-specific measured quantity value, which is the object of measurement; 2.2.-size-size that is not measured, but who can influence the measurement results; 2.3. specific operating conditions, – the use of measurement conditions, under which the measured size and size values are affecting the limits; 2.4. nuisance--that the 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; 2.5. the critical change value, in which-the results of measurements of changes are considered undesirable; 2.6. direct sales — sales that: 2.6.1. based on the results of the measurement, you determine the price; 2.6.2. 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; 2.6.3. all persons involved in the transaction at the time and place of the measurement results is recognised; 2.7. climatic environment, circumstances in which you can use the measuring means; 2.8. the public service – a service that covers electricity, gas, heat or water supply; 2.9. 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 with the maximum permissible errors. 2.10. repeatability – carried out in 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. 3. measuring instruments ensure adequate 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. 4. selecting the essential requirements taken into account solutions for measuring the use of resources and its possible wrong use. 5. subject to certain operating conditions, if there is no interference, the measurement error must not exceed the value of the maximum permissible errors laid down in the laws on the metrological requirements for a particular measurement feature. If the normative unless otherwise specified in the Act, it is expressed as the reciprocal of the deviation from the true measurement value. 6. Measuring feature must comply with the laws on the metrological requirements for a particular measurement feature, if the specified operating conditions and take into account possible disturbance. 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 error. 7. 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, as defined by the laws on the metrological requirements for a particular measurement feature. 8. the manufacturer shall specify the upper and lower temperature limit values according to table 1 of this annex, if the regulations of metrological requirements measuring specific feature is not otherwise specified, and indicates whether the measuring tool is designed to work with or without moisture condensation, and 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 9. Motor environment are divided into the following classes, depending on the size of possible influencing (vibration and mechanical shock) intensity: 9.1. class M1 apply to measuring instruments used in locations with low intensity vibration and shock; 9.2. M2 class apply to measuring instruments used in locations with significant or high levels of vibration and shock; 9.3 M3 class apply to measuring instruments used in locations with high and very high levels of vibration and shock. 10. 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 measurement feature otherwise: 10.1. class E1 applied measuring features use in locations with electromagnetic disturbances that occur in residential, commercial and light industrial buildings; 10.2. 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; 10.3. E3 class apply to measuring instruments, which are the source of energy used for the vehicle's battery. They must meet the E2 class requirements and in addition must be resistant to: 10.3.1. voltage, caused by internal combustion engine starter chain; 10.3.2. the temporary loss of load emissions by the transition process, if discharged battery disconnect, but the engine continues to run. 11. If necessary, also take account of the following uncertainties: 11.1. voltage fluctuations; 11.2. main frequency fluctuations; 11.3. power frequency magnetic fields; 11.4. any other sizes, which could significantly affect the accuracy of the measurement. 12. in carrying out the tests laid down in these rules, the following requirements shall be met: 12.1. examine each relevant influencing size defined in this annex, paragraph 5 and 6. 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, the consequences, while the rest of the impact factors remain unchanged the reference value; 12.2. 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; 12.3. 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. 13. measurement tool designed to ensure that: 13.1 the metrological characteristics specified by the manufacturer according to the stability period, subject to the appropriate installation, maintenance and use, in accordance with the manufacturer's instructions for its intended environmental conditions; 13.2. where possible, reduce exposure to a fault that could cause an inaccurate measurement result, unless the presence of such a defect is obvious. 14. The measuring instrument must not be the characteristics that contribute to its fraudulent use, and the need to reduce as far as possible the means of measuring a random wrong. 15. The measuring tool is suitable for: 15.1 the use, in the light of actual working conditions. It is not permissible to impose unreasonable requirements for the user to get the correct measurement results; 15.2. resistant and construction materials are suitable for conditions of use; 15.3. designed to allow 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 described in the user guide; 15.4. the sensitivity and the sensitivity threshold is low enough for the intended measurement task. 16. when the measuring tool is used for utility accounting, its error should not unduly digress, one way or another, if the flow or current is outside the mērdiapazon boundaries set. 17. If the measuring tool designed for such measurements is that the measured size remains constant over time, the measuring instrument does not affect large measured size fluktuācij or measuring tool to react accordingly to them. 18. If the measuring instrument is equipped with software that performs without measuring other features, the software the metrological characteristics critical to be identified is not acceptable means of measuring the dependence of the associated software. 19. A measuring feature provides protection against such damage: 19.1. 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; 19.2. hardware components that can significantly affect the measurements of the metrological characteristics shall be designed so that it is secure and any interference would be identified; 19.3. the software, which significantly affect the metrological characteristics shall be labelled accordingly, and it must be protected; 19.4. the means of measuring software is easily identifiable; 19.5. the evidence on interventions are available for a sufficiently long period; 12.2. measurement data, software essential metrological characteristics metrological characteristics and significance that is stored or transmitted, are protected against accidental or deliberate damage; 19.7. If the measuring tool designed for utilities, it shows the total show, in the quantity supplied or from those you might compute the total quantity to be delivered, or display in whole or in part, serve as the basis for payment. Readings may not terminate the use of the measurement time. 20. the measuring instruments are the following: 20.1. manufacturer's mark or name; 20.2. information about its accuracy; 20.3. If necessary, information on the conditions of use, measurement capabilities and mērdiapazon, identification marks, the EU type-examination certificate or certificate of EU evaluation of the project and information on whether the additional devices providing metrological results comply with the requirements of these provisions and laws on the metrological requirements for a particular measurement feature. 21. Dimensionāl measurement instruments that are too small or with great sensitivity, allowed important information to add to the packaging, if any, and the accompanying documentation prescribed in these provisions. 22. Measuring features adds information about the entry (except measurement features whose use is simple and unambiguous). Information is easily understood and include: 22.1. under certain operating conditions; 22.2. mechanical and electromagnetic environment classes; 22.3. the upper and lower temperature limit, as well as the likelihood of condensation or operating environment (outdoor or indoor); 22.4. installation, maintenance and repair instructions, as well as the permissible adjustments; 22.5. instructions for proper use and any special conditions of use; 22.6. the conditions for compatibility with interfaces, additional devices or other means of measurement. 23. If the same place 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. 24. where these rules and laws on the metrological requirements for measuring specific feature does not provide otherwise, the value of the scale interval is 1 x 10n, 2 x 10n or 5 x 10n, where n is any integer or zero. A unit of measurement or its symbol is listed close to the numeric value. 25. the tangible measures indicate the nominal value or a scale, together with a unit of measure used. 26. the units of measurement Used and their symbols shall conform to the requirements of the legislation on units of measurement and their symbols. 27. all marks and inscriptions are clear, indelible, unambiguous and non-replaceable. 28. The measurement readings are read under the following conditions: 28.1. the results of the readings read from the display or print; 28.2. the results of any display is clear and unambiguous, supplemented with the required marks and signs to inform the user about the significance of the results. In normal conditions of use, to ensure easy reading of the results. Additional readings can be displayed, if it is not to be confused with the metrologically controlled indications; 17.6. If the results of the readings available in print, the print or record shall be clearly legible and indelible; 28.4. the measuring tool for use at the point of sale is 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; 28.5. regardless of whether a measuring instrument for the measurement of the utilities provided with long-range reading device or not, it shall 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. 29. 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 result is stored persistently along with information on the specific transaction. 30. The continued evidence of stored measurement results and information about specific transactions is available upon request from the completion of the measurement. 31. Measuring features design provides the ability to perform the assessment of conformity with the corresponding requirements of this regulation and the laws on the metrological requirements for a particular measurement feature. Deputy Prime Minister, Minister of economy of 3. Ašeraden Arvil annex Cabinet 2016 April 12 regulations no declaration of conformity 1 212. measurement of the model, product, type, batch or serial number. 2. the manufacturer and, if appropriate, his authorised representative, the name and address. 3. A statement that the Declaration of conformity is issued only to the manufacturer's responsibility. 4. object of the Declaration of conformity (product identification of measurement that provides traceability, if necessary, the measurements for the identification of the measuring instrument can be added). 5. A statement that the measuring tool complies with the relevant laws and regulations. 6. References of applicable standards and the applicable document or reference other technical specifications in relation to which conformity is declared. 7. information on the notified body involved, stating the name and number of institution, the institution of the conformity assessment activities and issued certificates. 8. Additional information. 9. information on preparation of the Declaration of conformity: 9.1 the place and date of issue; 9.2. name, surname, position and signature. Deputy Prime Minister, Minister of economy of Ašeraden of Arvil