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zicolois II, II, víass II, vincter II, zicolom II, ziculud II, vío. Kurzbeschreibung. WMP ist eine Grundierung zur Haftvermittlung zwischen. Metalluntergründen und WestWood Abdichtungs- oder. Dickschichtsystemen. Le Grosse ELF-EEFE - - - - - - Der Sie wollen die SCL-und ein Computer wird ihr Verhindeter Nr. Roboter lügen nicht Sie wollen die SOL –. Front Cover. Die von Ihnen verwendete Browser-Version wird für diese Website nicht empfohlen. Suche nach Produkten mit Embedded-Modelle erhältlich. Bree für Damen. Rangsdorf, Kienitzer Str. Ruhezustände Check this out werden genutzt, um Energie zu sparen, wenn der Prozessor 2019 ganze folge der bachelor im Leerlauf befindet. Intel-Klassifikationen 713 nur zur Information. Rangsdorf, Südringcenter View full schedule Go to station. Intel behält sich das Recht vor, den Produktionslebenszyklus, check this out Spezifikationen und die Produktbeschreibungen jederzeit ohne vorherige Ankündigung zu ändern. Bis auf check this out clipverschluss. Benötigen Sie weitere Hilfe?

The applicant shall keep the technical documentation at the disposal of the relevant national authorities throughout the service life of the subsystem.

The notified body will then decide as to whether it shall use the results of these checks or tests. The evidences gathered by the notified body shall be suitable and sufficient to show the conformity with the requirement of the relevant TSI s and that all required and appropriate checks and tests have been carried out.

The extent to which the evidence originating from other parties is taken into account by the notified body shall be justified by documented analysis using the factors listed in the following paragraph.

In all cases, the notified body keeps the responsibility of final results of the examinations, tests and checks.

The notified body shall agree with the applicant the locations where the tests will be carried out and shall agree that final subsystem tests and, whenever required in the TSI, tests under full operating conditions, are carried out by the applicant under direct supervision and attendance of the notified body.

Where the subsystem referred to in point 2 is subject to derogation, upgrade, renewal or specific case the EC certificate shall also indicate the precise reference to the TSI s or their parts to which conformity has not been examined during EC verification procedure.

Where the subsystem referred to in point 2 is subject to derogation, upgrade, renewal or specific case, the EC declaration for the subsystem shall also indicate the reference to the TSI s or their parts to which conformity has not been examined during EC verification procedure.

The technical file accompanying the EC certificate of verification shall be lodged with the applicant. A copy of the EC certificate of verification and the technical file shall be made available to the Commission, the Member States and the relevant authorities upon request.

The applicant shall keep a copy of the technical file throughout the service life of the subsystem; it shall be sent to any other Member State which so requests.

Module SH1. EC verification based on full quality management system plus design examination. EC verification based on full quality management system plus design examination is the EC verification procedure whereby the applicant fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the subsystem concerned satisfies the requirements of the relevant TSI s as well as any other regulations deriving from the Treaty that apply to it.

The design, manufacture and final subsystem inspection and testing of the subsystem concerned shall be covered by approved quality management system s as specified in point 3 and shall be subject to surveillance as specified in point 5.

The adequacy of the technical design of the subsystem shall have been examined in accordance with point 4. The quality management system shall ensure compliance of the subsystem with the requirements of the relevant TSI s that apply to it.

When the applicant operates a certified quality management system certified by an accredited certification body for the design, manufacturing and final testing of the relevant subsystem, the notified body shall take this into account in the assessment.

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant subsystem field and product technology concerned, and knowledge of the requirements of the relevant TSI s.

The applicant shall lodge an application for EC verification of the subsystem through full quality management system plus examination of the design with the notified body referred to in point 3.

The application shall make it possible to understand the design, manufacture, maintenance and operation of the subsystem, and to assess the conformity with the requirements of the TSI s that apply to it.

The technical documentation shall specify the requirements of the relevant TSI s and cover, as far as relevant for the assessment, the design and operation of the subsystem.

The supporting evidence shall include, where necessary, the results of tests including those in operational conditions carried out by the appropriate testing body of the applicant, or by another testing body on his behalf and under his responsibility.

When the subsystem referred to in point 4. The notified body shall examine the application, and where the design meets the requirements of the relevant TSI s that apply to the subsystem it shall issue an EC design examination certificate to the applicant.

The certificate shall give the name and address of the applicant, the conclusions of the examination, the conditions if any for its validity and the data necessary for identification of the approved design.

The certificate and its annexes shall contain all relevant information to allow the conformity of the subsystem with the examined design to be evaluated.

Where the subsystem referred to in point 4. Where the design does not satisfy the requirements of the relevant TSI s , the notified body shall refuse to issue an EC design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

The applicant shall keep the notified body that has issued the EC design examination certificate informed of any modification to the approved design that may affect the conformity with the requirements of the relevant TSI s or the conditions for validity of the certificate until the expiry of the validity of the certificate.

The notified body shall keep a copy of the EC design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the applicant until the expiry of the validity of the certificate.

The applicant shall keep a copy of the EC design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities throughout the service life of the subsystem.

The applicant shall, for periodic audits purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:.

The frequency of the periodic audits shall be at least once every 2 years, with at least one audit during the time period of performing the relevant activities design, manufacture, assembly or installation for the subsystem being the subject of the EC design examination referred to in point 4.

During such visits, the notified body may, if necessary, carry out subsystem tests, or have them carried out, in order to check the proper functioning of the quality management systems.

It shall provide the applicant with a visit report and, if tests have been carried out, with a test report. The EC declaration of verification shall identify the subsystem for which it has been drawn up and shall mention the number of the design examination certificate.

Module A2. Internal production control plus supervised product checks at random intervals. Module C1. Conformity to type based on internal production control plus supervised product testing.

Module C2. Conformity to type based on internal production control plus supervised product checks at random intervals.

Module D. Conformity to type based on quality assurance of the production process. Skip to main content. This document is an excerpt from the EUR-Lex website.

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Official Journal. Multilingual display. A correlation table of the modules used is attached in Annex III.

Article 2 Scope The modules shall be applicable to all TSIs which enter in force on or after the date referred to in Article 8.

Article 3 Definitions For the purposes of this Decision, the following definitions shall apply: 1. A vehicle is composed of one or more structural and functional subsystems or parts of such subsystems; 3.

This entity may be a railway undertaking, an infrastructure manager or a keeper, or the concession holder responsible for carrying out a project; 7.

Article 4 Conformity assessment procedures 1. The procedures for conformity assessment for the interoperability constituents covered by the TSIs shall be chosen among the modules set out in Annex I, in accordance with the following criteria: a whether the module concerned is appropriate to the type of interoperability constituent; b the nature of the risks entailed by the interoperability constituent and the extent to which conformity assessment corresponds to the type and degree of risk; c the need for the manufacturer to have a choice between quality management system and product certification modules set out in Annex I; d the need to avoid imposing modules which would be too burdensome in relation to the risks.

Article 5 Procedure for assessment of suitability for use Where the TSIs so require, the procedure for assessment of suitability for use of the interoperability constituents shall be done in accordance with the instructions set out in the module CV set out in Annex I.

Article 6 EC verification procedures 1. The EC verification procedures for the subsystems covered by the TSIs shall be chosen among the modules set out in Annex I, in accordance with the following criteria: a whether the module concerned is appropriate to the type of the subsystem; b the nature of the risks entailed by the subsystem and the extent to which EC verification corresponds to the type and degree of risk; c the need for the manufacturer to have a choice between quality management system and product certification modules set out in Annex I; d the need to avoid imposing modules which would be too burdensome in relation to the risks.

Article 7 Subsidiaries of and subcontracting by notified bodies 1. Article 8 Application This Decision shall apply from 1 January Done at Brussels, 9 November ANNEX I Modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability Modules for Conformity assessment of interoperability constituents Module CA.

Internal production control Module CA1. Internal production control plus product verification by individual examination Module CA2.

Internal production control plus product verification at random intervals Module CB. EC-type examination Module CC.

Conformity to type based on internal production control Module CD. Conformity to type based on quality management system of the production process Module CF.

Conformity to type based on product verification Module CH. Conformity based on full quality management system Module CH1.

Conformity based on full quality management system plus design examination Modules for Suitability for use of interoperability constituents Module CV.

EC-type examination Module SD. EC verification based on quality management system of the production process Module SF.

EC verification based on product verification Module SG. EC verification based on unit verification Module SH1. Internal production control 1.

Technical documentation The manufacturer shall establish the technical documentation. The technical documentation shall contain, wherever applicable, at least the following elements: — a general description of the interoperability constituent, — conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.

In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied, — results of design calculations made, examinations carried out, etc.

Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the interoperability constituents with the technical documentation referred to in point 2 and with the requirements of the TSI that apply to them.

EC declaration of conformity 4. Internal production control plus product verification by individual examination 1.

Product checks For each individual product manufactured, one or more tests on one or more specific aspects of the interoperability constituent shall be carried out in order to verify conformity with the type described in the technical documentation and the requirements of the TSI.

EC certificate of conformity The notified body shall issue an EC certificate of conformity in respect of the examinations and tests carried out.

EC declaration of conformity 6. Internal production control plus product verification at random intervals 1. Product checks 4. EC-type examination 1.

EC-type examination may be carried out in either of the following manners: — examination of a specimen, representative of the production envisaged, of the interoperability constituent production type , — assessment of the adequacy of the technical design of the interoperability constituent through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the interoperability constituent combination of production type and design type , — assessment of the adequacy of the technical design of the interoperability constituent through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen design type.

The application shall include: — the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well, — a written declaration that the same application has not been lodged with any other notified body, — the technical documentation.

The notified body may request further specimens if needed for carrying out the test programme, — the supporting evidence for the adequacy of the technical design solution.

The notified body shall: For the interoperability constituent: 4. For the specimen s : 4. Conformity to type based on internal production control 1.

Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the interoperability constituents with the approved type described in the EC-type examination certificate and with the requirements of the TSI that apply to them.

EC declaration of conformity 3. The certificate to be referred to is: — the EC type-examination certificate and its additions. Conformity to type based on quality management system of the production process 1.

Manufacturing The manufacturer shall operate an approved quality management system for production, final product inspection and testing of the interoperability constituents concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.

Quality management system 3. The application shall include: — the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well, — a written declaration that the same application has not been lodged with any other notified body, — all relevant information for the interoperability constituent category envisaged, — the documentation concerning the quality management system, — the technical documentation of the approved type and a copy of the EC-type examination certificate.

It shall, in particular, contain an adequate description of: — the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality, — the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used, — the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, — the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

Surveillance under the responsibility of the notified body 4. The manufacturer shall, for periodic audits purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: — the quality management system documentation, — the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

The frequency of the periodic audits shall be at least once every 2 years. EC declaration of conformity 5.

The certificates to be referred to are: — the quality management system approval indicated in point 3.

The manufacturer shall, for the period defined in the relevant TSI and, where the TSI does not define this period, for a period ending at least 10 years after the last interoperability constituent has been manufactured, keep at the disposal of the national authorities: — the documentation referred to in point 3.

Conformity to type based on product verification 1. Verification A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the interoperability constituents with the approved type described in the EC-type examination certificate and with the requirements of the TSI.

Statistical verification of conformity 5. The certificates to be referred to are: — the EC type-examination certificate and its additions, — the EC certificate of conformity referred to in point 4.

Conformity based on full quality management system 1. Manufacturing The manufacturer shall operate an approved quality management system for design, manufacture and final product inspection and testing of the interoperability constituents concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

The application shall include: — the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well, — the technical documentation for one model of each category of interoperability constituents intended to be manufactured.

The technical documentation shall, wherever applicable, contain at least the following elements: — a general description of the interoperability constituent, — conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.

The manufacturer shall, for periodic audits purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: — the quality management system documentation, — the quality records as provided for by the design part of the quality management system, such as results of analyses, calculations, tests, etc.

The certificate to be referred to is: — the quality management system approval indicated in point 3.

The manufacturer shall, for the period defined in the relevant TSI and, where the TSI does not define this period, for a period ending at least 10 years after the last interoperability constituent has been manufactured, keep at the disposal of the national authorities: — the technical documentation referred to in point 3.

Conformity based on full quality management system plus design examination 1. Manufacturing The manufacturer shall operate an approved quality management system for design, manufacture and final product inspection and testing of the interoperability constituents concerned as specified in point 3 and shall be subject to surveillance as specified in point 5.

The application shall include: — the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well, — all relevant information for the interoperability constituent category envisaged, — the documentation concerning the quality management system, and — a written declaration that the same application has not been lodged with any other notified body.

Design examination 4. It shall include: — the name and address of the manufacturer, — a written declaration that the same application has not been lodged with any other notified body, — the technical documentation.

Surveillance under the responsibility of the notified body 5. The manufacturer shall, for the period defined in the relevant TSI and, where the TSI does not define this period, for a period ending at least 10 years after the last interoperability constituent has been manufactured, keep at the disposal of the national authorities: — the documentation concerning the quality management system referred to in point 3.

Type validation by in-service experience suitability for use 1. The technical documentation shall contain the following elements: — the technical documentation specified in point 9 of Module CB or in point 4.

The programme for the validation by in-service experience shall include: — the required performance or behaviour in service of the interoperability constituent under trial, — the installation arrangements, — the duration of the programme — either time or distance, — the operating conditions and the service programme expected, — the maintenance programme, — the special in-service tests, if any, to be performed, — the batch size of the specimens — if more than one, — the inspection programme nature, number and frequency of inspections, documentation , — criteria for tolerable defects and their impact on the programme, — the information to be included in the report of the company ies operating the interoperability constituent in service see point 2, fifth indent.

Type validation by in-service experience The notified body shall: 5. EC declaration of suitability for use The certificate to be referred to is: — EC certificate of suitability for use.

The interoperability constituent may be placed on the market only after the following EC declarations have been drawn up: — EC declaration of suitability for use referred to in point EC-type examination shall be carried out by: — assessment of the adequacy of the technical design of the subsystem through examination of the technical documentation and supporting evidence referred to in point 3 design type , and — examination of a specimen, representative of the production envisaged, of the complete subsystem production type.

The application shall include: — the name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well, — a written declaration that the same application has not been lodged with any other notified body, — the technical documentation.

The notified body may request further specimens if needed for carrying out the test programme, — a specimen or specimens of a sub-assembly or assembly or a specimen of the subsystem in a pre-assembled condition shall be provided, if so required for specific test or examination methods and specified in the relevant TSI s , — the supporting evidence for the adequacy of the technical design solution.

The notified body shall For the design type: 4. For the production type: 4. EC verification based on quality management system of the production process 1.

Manufacturing The production, final subsystem inspection and testing of the subsystem concerned shall be covered by approved quality management system s as specified in point 3, and shall be subject to surveillance as specified in point 7.

The application shall include: — the name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well, — a written declaration that the same application has not been lodged with any other notified body, — the breakdown structure of the project management and the name and address of each involved entity, — all relevant information for the subsystem envisaged, — the documentation concerning the quality management system, — copy of EC ISV declaration s issued for the subsystem, if any, — the technical documentation of the approved type and a copy of the EC-type examination certificate and its annexes.

It shall, in particular, contain an adequate description of: — the quality objectives and the organisational structure, responsibilities and powers of the management with regard to subsystem quality, — the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used, — the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, — the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

If the compliance of the subsystem with the requirements of the relevant TSI s is based on more than one quality management system, the notified body shall examine in particular: — whether the relations and interfaces between the quality management systems are clearly documented, and — whether overall responsibilities and powers of the management for the compliance of the whole entire subsystem are clearly assigned to and acknowledged by each entity involved in the project.

EC verification 5. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied, — conditions for use of the subsystem restrictions of running time or distance, wear limits, etc.

Surveillance under the responsibility of the notified body 7. The applicant shall, for periodic audits purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: — the quality management system documentation, — the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

The notified body responsible for the EC verification of the subsystem, if not carrying out the surveillance of all the quality management systems concerned as under point 3, shall coordinate the surveillance activities of any other notified bodies responsible for that task, in order: — to be ensured that correct management of interfaces between the different quality management systems relating to subsystem integration has been performed, — to collect, in liaison with the applicant, the necessary elements for the assessment to guarantee the consistency and the overall supervision of the different quality management systems.

This coordination includes the right of the notified body: — to receive all documentation approval and surveillance , issued by the other notified body ies , — to witness the surveillance audits as in point 7.

EC certificate of verification and EC declaration of verification 8. The applicant shall, throughout the service life of the subsystem, keep at the disposal of the national authorities: — the documentation referred to in point 3.

EC verification based on product verification 1. Manufacturing The manufacturing process and its monitoring shall ensure conformity of the manufactured subsystem with the approved type described in the EC-type examination certificate and with the requirements of the relevant TSI s that apply to it.

The application shall include: — name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well, — the technical documentation, regarding the approved type, including the EC type examination certificate and its annexes, as issued after completion of the procedure defined in module SB.

EC verification 4. EC declaration of verification 5. EC verification based on unit verification 1. The application shall include: — name and address of the applicant and, if the application is lodged by the authorised representative, his name and address as well, and — the technical documentation.

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Carin Helena Järne , född i Helsingfors. Adolf Fredrik son av Henrik, Tab. Ordinarie Pastoralexamen Kyrkoherde i Pyttis pastorat Tillträdde Prost Ordinarie kontraktsprost The manufacturer shall present his products in the form of homogeneous lots and shall take all measures necessary in order that the manufacturing process ensures the homogeneity of each lot produced.

All interoperability constituents shall be available for verification in the form of homogeneous lots. A random sample shall be drawn from each lot.

All interoperability constituents in a sample shall be individually examined and appropriate tests shall be carried out to ensure the product conformity with the type described in the technical documentation and the requirements of the TSI that apply to it and to determine whether the lot is accepted or rejected.

Module CB. EC-type examination. EC-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an interoperability constituent and verifies and attests that the technical design of the interoperability constituent meets the requirements of the technical specification for interoperability TSI that apply to it.

The manufacturer shall lodge an application for EC-type examination with a notified body of his choice. The notified body may request further specimens if needed for carrying out the test programme,.

The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes.

Where the type meets the requirements of the TSI that apply to the interoperability constituent concerned, the notified body shall issue an EC-type examination certificate to the manufacturer.

The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions if any for its validity and the necessary data for identification of the approved type.

The certificate may have one or more annexes attached. The certificate and its annexes shall contain all relevant information to allow the conformity of interoperability constituents with the examined type to be evaluated.

Where the type does not satisfy the requirements of the TSI, the notified body shall refuse to issue an EC-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EC-type examination certificate of all modifications to the approved type that may affect the conformity of the interoperability constituent with the requirements of the TSI or the conditions for validity of the certificate.

Such modifications shall require additional approval in the form of an addition to the original EC-type examination certificate.

Only those examinations and tests that are relevant and necessary to the changes shall be performed. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EC-type examination certificate, its annexes and additions, including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

The manufacturer shall keep a copy of the EC-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.

Module CC. Conformity to type based on internal production control. Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares on his sole responsibility that the interoperability constituents concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the technical specification for interoperability TSI that apply to them.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the interoperability constituents with the approved type described in the EC-type examination certificate and with the requirements of the TSI that apply to them.

The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.

Module CD. Conformity to type based on quality management system of the production process. Conformity to type based on quality management system of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the interoperability constituent concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the technical specification for interoperability TSI that apply to it.

The manufacturer shall operate an approved quality management system for production, final product inspection and testing of the interoperability constituents concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.

The manufacturer shall lodge an application for assessment of his quality management system with the notified body of his choice, for the interoperability constituents concerned.

The quality management system shall ensure that the interoperability constituents are in conformity with the type described in the EC-type examination certificate and comply with the requirements of the TSI that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.

The quality management system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

The notified body shall assess the quality management system to determine whether it satisfies the requirements referred to in point 3.

When the manufacturer operates a certified quality management system certified by an accredited certification body, for the manufacturing of the relevant interoperability constituent, the notified body shall take this into account in the assessment.

In this case, the notified body will make a detailed assessment of quality management system specific documents and records of the interoperability constituent only.

The notified body shall not assess again the entire quality manual and all the procedures already assessed by the quality management system certification body.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant interoperability constituent field and product technology concerned, and knowledge of the requirements of the TSI.

The auditing team shall review the technical documentation referred to in point 3. The decision shall be notified to the manufacturer.

The notification shall contain the conclusions of the audit and the reasoned assessment decision. Where the assessment of the quality management system provided satisfying evidence that the requirements referred to in point 3.

The manufacturer shall undertake to fulfil the obligations arising out of the quality management system as approved and to maintain it so that it remains adequate and efficient.

The manufacturer shall keep the notified body that has approved the quality management system informed of any intended change to the quality management system having impact on the interoperability constituent, including changes of quality management system certificate.

The notified body shall evaluate any proposed changes and decide whether the modified quality management system will continue to satisfy the requirements referred to in point 3.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality management system.

The manufacturer shall, for periodic audits purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:.

The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality management system and shall provide the manufacturer with an audit report.

When the manufacturer operates a certified quality management system, the notified body shall take this into account during the periodic audits.

In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out interoperability constituent tests, or have them carried out, in order to verify that the quality management system is functioning correctly.

The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

The manufacturer shall, for the period defined in the relevant TSI and, where the TSI does not define this period, for a period ending at least 10 years after the last interoperability constituent has been manufactured, keep at the disposal of the national authorities:.

Each notified body shall inform its notifying authorities of quality management system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality management system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality management system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality management system approvals which it has issued.

Module CF. Conformity to type based on product verification. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 5.

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the interoperability constituents with the approved type described in the EC-type examination certificate and with the requirements of the TSI.

The examinations and tests to check the conformity of the interoperability constituents with the requirements of the TSI shall be carried out, at the choice of the manufacturer either by examination and testing of every interoperability constituent as specified in point 4 or by examination and testing of the interoperability constituents on a statistical basis as specified in point 5.

Verification of conformity by examination and testing of every interoperability constituent. When a test is not set out in the TSI, harmonised standard s and technical specification s , the appropriate tests to be carried out shall be decided between the manufacturer and the notified body concerned.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his interoperability constituents for verification in the form of homogeneous lots.

A random sample shall be taken from each lot according to the requirements of the TSI. If a lot is accepted, all interoperability constituents of the lot shall be considered approved, except for those interoperability constituents from the sample that have been found not to satisfy the tests.

The notified body shall issue an EC certificate of conformity in respect to the examinations and tests carried out.

The manufacturer shall keep the EC certificates of conformity at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.

If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot is being placed on the market.

In the event of the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.

The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it at the disposal of the national authorities, for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.

Module CH. Conformity based on full quality management system. Conformity based on full quality management system is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the interoperability constituents concerned satisfy the requirements of the technical specification for interoperability TSI that apply to them.

The manufacturer shall operate an approved quality management system for design, manufacture and final product inspection and testing of the interoperability constituents concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

The technical documentation shall, wherever applicable, contain at least the following elements:.

The quality management system shall ensure compliance of the interoperability constituents with the requirements of the TSI that apply to them.

When the manufacturer operates a certified quality management system certified by an accredited certification body, for the design and manufacturing of the relevant interoperability constituent, the notified body shall take this into account in the assessment.

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant interoperability constituent field and product technology concerned, and knowledge of the requirements of the TSI.

The manufacturer or his authorised representative shall be notified of the decision. The manufacturer shall, for periodic audits purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:.

During such visits, the notified body may, if necessary, carry out interoperability constituent tests, or have them carried out, in order to check the proper functioning of the quality management system.

It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Each notified body shall inform the other notified bodies of quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality management system approvals which it has issued.

Module CH1. Conformity based on full quality management system plus design examination. Conformity based on full quality management system plus design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the interoperability constituents concerned satisfy the requirements of the technical specification for interoperability TSI that apply to them.

The manufacturer shall operate an approved quality management system for design, manufacture and final product inspection and testing of the interoperability constituents concerned as specified in point 3 and shall be subject to surveillance as specified in point 5.

The adequacy of the technical design of the interoperability constituents shall have been examined in accordance with point 4.

The manufacturer shall lodge an application for examination of the design with the notified body referred to in point 3.

The application shall make it possible to understand the design, manufacture, maintenance and operation of the interoperability constituent, and to assess the conformity with the requirements of the TSI that apply to it.

It shall include:. The technical documentation shall specify the requirements and cover, as far as relevant for the assessment, the design and operation of the interoperability constituent.

The notified body shall examine the application, and where the design meets the requirements of the TSI that apply to the interoperability constituent it shall issue an EC design examination certificate to the manufacturer.

The certificate and its annexes shall contain all relevant information to allow the conformity of interoperability constituent s with the examined design to be evaluated.

Where the design does not satisfy the requirements of the TSI, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

The manufacturer shall keep the notified body that has issued the EC design examination certificate informed of any modification to the approved design that may affect the conformity with the requirements of the TSI or the conditions for validity of the certificate until the expiry of the validity of the certificate.

Such modifications shall require additional approval — from the notified body that issued the EC design examination certificate — in the form of an addition to the original EC design examination certificate.

On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EC design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate.

The manufacturer shall keep a copy of the EC design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.

The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up and shall mention the number of the design examination certificate.

Module CV. Type validation by in-service experience suitability for use. Type validation by in-service experience is the part of assessment procedure in which a notified body ascertains and attests that a specimen, representative of the production envisaged meets the requirements for suitability for use of the technical specification for interoperability TSI that apply to it.

The manufacturer shall lodge an application for type validation by in-service experience with a notified body of his choice.

A type may cover several versions of the interoperability constituent provided that the differences between the versions are all covered by EC certificates as mentioned above.

The notified body may request further specimens if needed for carrying out the validation by in-service experience. The technical documentation shall cover the design, manufacturing, maintenance and operation of the interoperability constituent.

If the TSI requires further information for the technical documentation, this shall be included. Where the type meets the requirements of the TSI that apply to the interoperability constituent concerned, the notified body shall issue an EC certificate of suitability for use to the manufacturer.

The certificate shall contain the name and address of the manufacturer, the conclusions of the validation, the conditions if any for its validity and the necessary data for identification of the approved type.

A list of the relevant parts of the technical documentation shall be annexed to the EC certificate of suitability for use and a copy kept by the notified body.

Where the type does not satisfy the requirements of the TSI, the notified body shall refuse to issue an EC certificate of suitability for use and shall inform the applicant accordingly, giving detailed reasons for its refusal.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EC certificate of suitability for use of all modifications to the approved type that may affect the suitability for use of the interoperability constituent or the conditions for validity of the certificate.

Such modifications shall require additional approval in the form of an addition to the original EC certificate of suitability for use.

The notified body shall keep a copy of the EC certificate of suitability for use, its annexes and additions, until the expiry of the validity of the certificate.

The manufacturer shall draw up a written EC declaration of suitability for use for an interoperability constituent and keep it at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.

The EC declaration of suitability for use shall identify the interoperability constituent for which it has been drawn up.

A copy of the EC declaration of suitability for use shall be made available to the relevant authorities upon request.

The interoperability constituent may be placed on the market only after the following EC declarations have been drawn up:.

Module SB. EC-type examination is the part of an EC verification procedure whereby a notified body examines the technical design of a subsystem and verifies and attests that the technical design of the subsystem meets the requirements of the relevant TSI s as well as any other regulations deriving from the Treaty that apply to it.

A type may cover several versions of the subsystem provided that the differences between the versions do not affect the provisions of the relevant TSI s.

The applicant shall lodge an application for EC-type examination with a notified body of his choice. The technical documentation shall specify the requirements of the relevant TSI s and cover, as far as relevant for the EC-type examination procedure, the design, manufacture and operation of the subsystem.

The technical documentation shall contain the following elements:. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate testing body of the applicant, or by another testing body on his behalf and under his responsibility.

The applicant shall also provide the notified body with a precise reference to the TSI s or their parts for which the derogation is requested.

The applicant shall communicate to the notified body the outcome of the derogation procedure. Where the type meets the requirements of the relevant TSI s that apply to the subsystem concerned, the notified body shall issue an EC-type examination certificate to the applicant.

The certificate shall contain the name and address of the applicant, the conclusions of the examination, the conditions if any for its validity and the necessary data for identification of the approved type.

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems with the examined type to be evaluated.

Where the type does not satisfy the requirements of the relevant TSI s , the notified body shall refuse to issue an EC-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

Where the subsystem referred to in point 3 is subject to derogation, upgrade, renewal or specific case, the EC-type examination certificate shall also indicate the precise reference to the TSI s or their parts to which conformity has not been examined during EC verification procedure.

The applicant shall inform the notified body that holds the technical documentation relating to the EC-type examination certificate of all modifications to the approved type that may affect the conformity of the subsystem with the requirements of the relevant TSI s or the conditions for validity of the certificate.

The notified body shall keep a copy of the EC-type examination certificate, its annexes and additions, including the documentation intended for the technical file submitted by the applicant, until the expiry of the validity of the certificate.

The applicant shall keep a copy of the EC-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities throughout the service life of the subsystem.

Module SD. EC verification based on quality management system of the production process. EC verification based on quality management system of the production process is the part of a EC verification procedure whereby the applicant fulfils the obligations laid down in points 2 and 8, and ensures and declares on his sole responsibility that the subsystem concerned is in conformity with the type described in the EC-type examination certificate and satisfies the requirements of the relevant TSI s as well as any other regulations deriving from the Treaty that apply to it.

The production, final subsystem inspection and testing of the subsystem concerned shall be covered by approved quality management system s as specified in point 3, and shall be subject to surveillance as specified in point 7.

The applicant shall lodge an application for assessment of the quality management system with the notified body of his choice, for the subsystem concerned.

The quality management system shall ensure that the subsystem is in conformity with the type described in the EC-type examination certificate and comply with the requirements of the relevant TSI s that apply to it.

All the elements, requirements and provisions adopted by the applicant shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.

If the compliance of the subsystem with the requirements of the relevant TSI s is based on more than one quality management system, the notified body shall examine in particular:.

The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of the applicant to the subsystem.

When the applicant operates a certified quality management system certified by an accredited certification body, for the manufacturing and final testing of the relevant subsystem, the notified body shall take this into account in the assessment.

In this case, the notified body will make a detailed assessment of quality management system specific documents and records of the subsystem only.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant subsystem field and product technology concerned, and knowledge of the requirements of the relevant TSI s.

The audit shall include an assessment visit to the premises of the relevant entities concerned. The decision shall be notified to the applicant.

The applicant shall undertake to fulfil the obligations arising out of the quality management system as approved and to maintain it so that it remains adequate and efficient.

The applicant shall keep the notified body that has approved the quality management system informed of any intended change to the quality management system having impact on the subsystem design, manufacture and final inspection, testing and operation, as well as of any changes of quality management system certificate.

It shall notify the applicant of its decision. The applicant shall lodge an application for the EC verification of the subsystem with a notified body of his choice.

The notified body chosen by the applicant shall first examine the application concerning the validity of the EC type examination certificate and its annexes.

If the notified body considers the EC type examination certificate no longer remains valid or is not appropriate and that a new EC type examination is necessary, the notified body shall refuse to assess the quality management system of the applicant and shall justify its refusal.

When the subsystem referred to in point 5. The purpose of surveillance is to make sure that the applicant duly fulfils the obligations arising out of the approved quality management system.

The applicant shall, for periodic audits purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:.

The notified body shall carry out periodic audits to make sure that the applicant maintains and applies the quality management system and shall provide the applicant with an audit report.

When the applicant operates a certified quality management system, the notified body shall take this into account during the periodic audits.

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4 thoughts on “713

  1. Sie sind absolut recht. Darin ist etwas auch mir scheint es die ausgezeichnete Idee. Ich bin mit Ihnen einverstanden.

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