WELMEC 8.
8 Issue 1
WELMEC
European cooperation in legal metrology
General and Administrative Aspects of the Voluntary System of Modular Evaluation of Measuring instruments under the MID
December 2008
WELMEC
European cooperation in legal metrology
WELMEC is a co-operation between the legal metrology services of the Member States of the European Union and EFTA. This document is the introduction to WELMEC. WELMEC is publishing a number of Guides to provide guidance to manufacturers of measuring instruments and to notified bodies responsible for conformity assessment of their products. The Guides are purely advisory and do not themselves impose any restrictions or additional technical requirements beyond those contained in relevant EC Directives. Alternative approaches may be acceptable, but the guidance provided in these documents are representing the considered view of WELMEC as to the best practice to be followed.
Published by: WELMEC Secretariat BEV Bundesamt fr Eich- und Vermessungswesen Schiffamtsgasse 1-3 A-1025 Vienna
CONTENTS
1 2 3 4
5 6
INTRODUCTION SCOPE AND BORDERS DEFINITIONS AND ABBREVIATIONS GENERAL PRINCIPLE 4.1 Evaluation of a part of a complete measuring instrument 4.2 Application for the measuring instrument or sub-assembly 4.3 Evaluation of the measuring instrument or sub-assembly TECHNICAL ASPECTS REFERENCE DOCUMENTS
4 4 4 7 7 8 9 9 9
INTRODUCTION The Measuring Instruments Directive (MID) aims to harmonise within the European Union the legal requirements for Measuring Instruments. MID includes provisions to deal with sub-assemblies but only for some categories of measuring instruments, as specified in the Annexes MI-002 and MI-004. Nevertheless in practice measuring instruments or sub-assemblies often consist of an assembly of parts produced by different OEMs (Original Equipment Manufacturers), in this document referred to as producers. In that case the MID responsible Manufacturer builds the several parts together into a measuring instrument or sub-assembly with the objective of placing such a measuring instrument or sub-assembly on the market or into use for his own purposes.
If such a part performs a specific/defined function inside the design of the measuring instrument, it can be evaluated separately with respect to its specific function as part of the complete design. When such a part fulfils prescribed functional aspects of a measuring instrument or sub-assembly, conforms to the applicable harmonised standard or normative document or WELMEC guide, a document illustrating such compliance can be issued. Although this is not a procedure which follows from the MID, it is however common practice in metrology. In order to accommodate this (cost efficient) practice and without prejudice of the possibility for the manufacturer to use the MID article 10 point 3 g) h), i) and j), the following procedure of modular evaluation is considered to be appropriate by WELMEC. It is reminded that in any case the application concerning the complete instrument or sub-assembly still has to be delivered to a notified body under MID. 2 SCOPE AND BORDERS This document describes for the notified bodies, manufacturers and producers and all other interested parties (like notified bodies under modules F and D, the notifying authorities and the Market surveillance authorities) the conditions for a harmonised procedure for a voluntary system of modular evaluation of measuring instruments and sub-assemblies mentioned as such in the specific annexes under conformity assessment module B of the MID. This document is limited to the general and administrative aspects of such an approach, leaving instrument specific and technical aspects to be specified by the applicable Welmec Working Groups. It is reminded that it is the responsibility of the manufacturer of each complete instrument to be able to demonstrate the conformity of the measuring instrument or sub assembly to all applicable requirements of the MID even when he uses the modular evaluation. The manufacturer should therefore ensure that the producer of the parts he uses in his measuring instrument or sub-assembly take his responsibility with respect to compliance to type and to compliance to the requirements against which the parts have been tested. Even if he uses this modular evaluation, in any case a manufacturer shall apply for an EC typeexamination certificate for the complete instrument or in some categories of measuring instruments for sub-assemblies as required according to the MID. The manufacturer of the measuring instrument or the sub-assembly shall make available the technical documentation as described in Article 10 of the MID, including the documentation on the parts which are evaluated in the modular evaluation. The documentation shall enable assessment of the conformity of the instrument with the appropriate requirements of this Directive. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the instrument and compatibility of parts when reference is made to this guide and the relevant technical guide. The part may bear the CE marking according to directives other than MID but it cannot bear the supplementary marking and notified body number related to MID. Only a complete measuring instrument or a sub assembly can bear the supplementary marking and notified body number related to conformity to MID. 3 DEFINITIONS AND ABBREVIATIONS
In this document, in addition to the definitions from the reference documents (see Chapter 6), the following abbreviations and definitions are applied: Part A part of a measuring instrument or a sub-assembly, which performs a specific function and can be evaluated separately. This also includes peripherals, for example but not limited to: printers, data storage devices and (personal) computers. Producer The Original Equipment Manufacturer that produces the part. Manufacturer A natural or legal person responsible for the conformity of the measuring instrument or sub-assembly with the MID with a view to either placing it on the market under his own name and/or putting it into use for his own purposes. Testing An activity during which the applicable performance tests are carried out and deviations / errors of the equipment under tests are determined, in comparison with reference values. As a result of testing, a Test Report can be issued. Examination An activity during which: the documentation is confirmed to be in accordance with the applicable requirements, and the equipment under test is confirmed to be constructed in accordance with the documentation, and the equipment under test is confirmed to be in accordance with the applicable requirements, in particular when applicable, to be equipped with a clearly readable display, properly operating software, checking facilities, markings, etc. Typically a checklist shall be filled out as a result of an examination being part of an evaluation report. Evaluation An activity where it is confirmed that the equipment under test submitted for evaluation meets the applicable requirements. Evaluation can include the study of examination results and/or the study of test results. Upon successful completion of an evaluation a "statement of conformity" (e.g. Certificate, Type / Pattern Approval Certificate, OIML Certificate) can be issued. Modular Evaluation An activity where it is confirmed that a part of a measuring instrument meets the relevant, applicable requirements. Approval (VIML) Decision of legal relevance, based on the evaluation report, stating that the type of a measuring instrument complies with the relevant statutory requirements and is suitable for use in the regulated area in such a way that it is expected to provide reliable measurement results over a defined period of time. Note: Evaluation and Approval are often used in combination with the word Type or Pattern. For the purpose of this document, Type and Pattern have the same meaning. OIML Pattern Evaluation Report (OIML PER) A document presenting a record of a (modular) evaluation, performed in-line with an OIML Recommendation. Please note that, under OIML, the word "Pattern" can be used for both a complete measuring instrument / measuring system and for a part of a complete measuring instrument / measuring system. Evaluation Report (ER) A document presenting a record of a (modular) evaluation, performed in-line with a harmonised standard or a normative document or a WELMEC guide.
Evaluation Certificate (EC) A document describing the metrologically relevant characteristics of a part of a measuring instrument, including its compatibility with other devices. An Evaluation Certificate is accompanied by a set of documentation that allows the conformity to be checked of the physical part and the metrologically relevant characteristics not covered by the description in the Evaluation Certificate. This set of documentation is either given by the producer of the part to the manufacturer of the complete measuring instrument or these documents are kept by the Notified Body that has issued the Evaluation Certificate. After permission of the holder of the EC of the part the set of documentation can be sent to other Notified Bodies in the cause of a conformity assessment procedure. However, the holder of the Evaluation Certificate agrees a priori, with the application, that copies of the technical documentation, test reports and certificates shall always be made available on request to the competent authorities of the Member States.
Note: Parts with only an Evaluation Certificate are not eligible for general acceptance in the EC type examination certificate. Parts Certificate (PC) A document describing the metrologically relevant characteristics of a part of a measuring instrument, including its compatibility with other devices. A Parts Certificate is accompanied by a set of documentation that allows the conformity to be checked of the physical part and the metrologically relevant characteristics not covered by the description in the Parts Certificate. These documents are kept by the Notified Body that has issued the Parts Certificate. Parts Certificates are free to use by manufacturers of complete measuring instruments. The holder of the Parts Certificate agrees a priori (with the application for a Parts Certificate) with the free use of his certificate and that copies of the technical documentation, test reports and certificates shall be made available on request to other Notified Bodies and the competent authorities of the Member States.
Note: Parts with a Parts Certificate are eligible (under the responsibility of the notified body involved in the evaluation of the complete instrument or sub assembly) for general acceptance in an EC type examination certificate.
Note:
OIML PER's, ER's, PCs and EC's for use under MID may only be issued by Notified Bodies designated under the MID for Conformity Assessment Annex B, for that particular measuring instrument. In the case of OIML PER's, the Notified Body must also be an OIML Issuing Authority for that particular OIML Recommendation.
GENERAL PRINCIPLE Below, in chronological order, the general (administrative) principle of the voluntary system of modular evaluation is described.
4.1
Evaluation of a part of a complete measuring instrument A producer of a part of a complete measuring instrument or part of a sub-assembly (with relevancy to the MID) may request a Notified Body to evaluate (test and examination) with reference to this guide that particular part of a measuring instrument or sub-assembly against the normative documents or harmonised standards or WELMEC guides. Together with its application he shall provide documentation in line with article 10 of the MID and the relevant documents mentioned above. The producer shall indicate that he is aware of the fact that this documentation shall be issued to the competent authorities of the member states when they request it; the evaluation report (test and examination results) will be if requested given by the notified body to the competent authorities of the member states; he has to provide the manufacturer of measuring instruments using one of its part with the necessary individual technical data for the compatibility as foreseen in the relevant OIML Recommendation, standard or technical WELMEC guide; he has to ensure that each individual part he provides with reference to the certificate obtained is in conformity with the model certified; he shall inform the notified body of any evolution in the part so that a revision of the certificate is provided and he shall inform the manufacturers using its parts in due time; he cannot affix the supplementary marking and notified body number according to MID on the part and he cannot deliver any general statement of conformity to MID based on the document he will get from the notified body.
The Notified Body shall then examine if the technical documentation for the part fulfils the requirements of article 10 of the MID. examine the information provided to ensure that compatibility with other parts, modules or sub-assemblies can be established. When completed with a positive result, the Notified Body may issue one of the following documents depending on the request of the applicant: an Evaluation Certificate or a Parts Certificate The certificate, whether it is an EC or PC, shall include all relevant documentation describing the device's appearance, applicability, functionality and the conditions which have to be satisfied in order to guarantee the compatibility with other devices, together with an OIML Pattern Evaluation Report or an Evaluation Report, describing the performed tests, examinations and their results. An EC or a PC can only be issued if an OIML PER or ER is issued, references to the OIML PER or ER must be included in the EC or PC to identify that they belong together. The EC, PC, PER, ER and any paper related to the part and issued by the notified body cannot bear the reference of the notified body as this is not a notified body activity and cannot contain any statement of conformity to the MID.
The Notified Body that issues the ECs or PCs of parts of a measuring instrument or a sub-assembly keeps the technical documentation based on article 10 of the MID. Parts Certificates are free to use by manufacturers of complete measuring instruments. The holder of the Parts Certificate agrees a priori (with the application for a Parts Certificate) with the free use of his certificates and that copies of the technical documentation, test reports and certificates shall be made available on request to other Notified Bodies and the competent authorities of the Member States. Parts with a Parts Certificate are eligible for general acceptance in an EC type examination certificate because availability of the underlying documents is covered. Parts with only an Evaluation Certificate are not eligible for general acceptance in the EC type examination certificate. The set of documentation is either given by the producer of the part to the manufacturer of the complete measuring instrument or these documents are kept by the Notified Body that has issued the Evaluation Certificate. After permission of the holder of the EC of the part the set of documentation can be sent to other Notified Bodies in the cause of a conformity assessment procedure. However, the holder of the Evaluation Certificate agrees a priori, with the application, that copies of the technical documentation, test reports and certificates shall always be made available on request to the competent authorities of the Member States.
4.2
Application for the measuring instrument or sub-assembly The application concerning the complete instrument or sub assembly has to be delivered to a notified body under MID. The giving of an EC, PC, PER, ER for a part by another notified body doesn't prejudge full responsibility of the notified body responsible for the complete instrument or sub assembly. A manufacturer of a measuring instrument can apply for the EC type examination certificate of the measuring instrument or sub-assembly with any Notified Body (not systematically the one who has evaluated the parts) . The application can (partly) be supported by OIML PER's, ER's and EC's or PCs of the parts, indicating the conformity of those parts with the relevant requirements. If the application is supported by PCs then the Notified Body can request the manufacturer to provides the PC together with the OIML PER or ER and the underlying documents through the Notified Body that has issued the PCs. If the application is supported by OIML PERs, ER, and or ECs then the manufacturer should supply the Notified Body either with a copy of the EC and the underlying documents and or the OIML PERs or ERs or the Notified Body can request the manufacturer to provides the EC together with the OIML PER or ER and the underlying documents through the Notified Body that has issued the ECs.. Without a copy of the documents, the EC and or OIML PERs and or ER can not be included in the application. The application shall include the technical documentation as described in Article 10. In the case of a part with a PC, the technical documentation of the used parts should be made available. A Notified Body can request the manufacturer to provide these documents through the Notified Body that has issued the PC. In the case of a part with an EC, the technical documentation of the part should be given to the Notified Body. Without this information the EC can not be included in the application.
4.3
Evaluation of the measuring instrument or sub-assembly The Notified Body, within its sole responsibility, judges if the application and documents attached thereto are complete and do satisfy all relevant terms and conditions needed, prior to issue an EC type examination certificate for the measuring instrument or sub-assembly indicated in the application. Additional tests and examinations may be required. When fully satisfied, an EC type examination certificate is issued in the name of the manufacturer of the instrument. In the EC type examination certificate the necessary information for the conformity of the parts is included. In particular, to allow the conformity of manufactured instruments to be evaluated with the examined type regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, the content shall be compatible with annex 3: Example for a model of certificate of WELMEC guide 8.3 and include in particular: the metrological characteristics of the type of instrument and its parts; measures required for ensuring the integrity of the instruments and its parts (sealing, identification of software, etc.); information on other elements necessary for the identification of the instruments and its parts and to check their visual external conformity to type; if appropriate, any specific information necessary to verify the characteristics of manufactured instruments and its parts; all necessary information to ensure the compatibility with other parts, modules or sub-assemblies of measuring instruments.
TECHNICAL ASPECTS The relevant Welmec Working Groups are to identify for which parts of the measuring instruments or sub-assembly modular evaluation is possible under which conditions and what evaluations should be carried out. Until then it is presumed that parts identified by OIML Recommendations for separate pattern approval, can be subject to the voluntary system of modular evaluation under the conditions stated in the OIML Recommendation. The relevant Welmec Working Groups should also define the relevant documentation describing the device's appearance, applicability, functionality and the conditions which have to be satisfied in order to guarantee the compatibility with other devices that has to be in the EC or PC. The relevant Welmec Working Groups are also to define under which conditions parts are included in the EC type examination certificate1.
REFERENCE DOCUMENTS DIRECTIVE 2004/22/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on measuring instruments (Measuring Instruments Directive MID). OIML International Vocabulary of Terms in Legal Metrology, edition 2000. Welmec Guide 2.5, edition September 2000 (general principle thereof, taking MID and the Welmec WG8 terminology into account).
For example:
some critical parts may not be eligible for general acceptance in an EC type examination certificate.
