Guide to the implementation of directives based on the New ...

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5. Conformity assessment procedure Conformity assessment according <strong>to</strong> <strong>the</strong> modules is ei<strong>the</strong>r <strong>based</strong> on <strong>the</strong> intervention <strong>of</strong> a first party (manufacturer) or a third ● Conformity assessment is subdivided in<strong>to</strong> modules, which party (notified body) ( 91 ), and relates <strong>to</strong> <strong>the</strong> design phase <strong>of</strong> products, <strong>to</strong> <strong>the</strong>ir production phase or both (see Tables 5/1 <strong>to</strong> 5/3). <strong>to</strong> <strong>the</strong> widest range <strong>of</strong> products. comprise a limited number <strong>of</strong> different procedures applicable Should a manufacturer subcontract design ● The modules relate <strong>to</strong> <strong>the</strong> design phase <strong>of</strong> products, <strong>the</strong>ir or production, he still remains responsible production phase or both. The eight basic modules and <strong>the</strong>ir for <strong>the</strong> execution <strong>of</strong> conformity assessment eight possible variants can be combined with each o<strong>the</strong>r in a for both phases ( 92 ). variety <strong>of</strong> ways in order <strong>to</strong> establish complete conformity The modules give <strong>the</strong> legisla<strong>to</strong>r, in relation <strong>to</strong> <strong>the</strong> type <strong>of</strong> products and hazards assessment procedures. ● As a general rule, a product is subject <strong>to</strong> conformity assessment according <strong>to</strong> a module during <strong>the</strong> design as well as <strong>the</strong> involved, <strong>the</strong> means <strong>to</strong> set up <strong>the</strong> appropriate procedures for manufacturers <strong>to</strong> demonstrate product conformity against production phase. <strong>the</strong> provisions <strong>of</strong> <strong>the</strong> directive. In setting <strong>the</strong> ● Each New Approach directive describes <strong>the</strong> range and contents <strong>of</strong> possible conformity assessment procedures, which range <strong>of</strong> possible modules, <strong>directives</strong> take in<strong>to</strong> consideration, according <strong>to</strong> <strong>the</strong> principle <strong>of</strong> proportionality in particular, such <strong>directives</strong> also set out <strong>the</strong> criteria governing <strong>the</strong> conditions are considered <strong>to</strong> give <strong>the</strong> necessary level <strong>of</strong> protection. The issues as <strong>the</strong> type <strong>of</strong> products, <strong>the</strong> nature <strong>of</strong> under which <strong>the</strong> manufacturer can make a choice, if more than <strong>the</strong> risks involved, <strong>the</strong> economic infrastructures <strong>of</strong> <strong>the</strong> given sec<strong>to</strong>r (such as <strong>the</strong> exis- one option is provided for. tence or non-existence <strong>of</strong> third parties), <strong>the</strong> types and importance <strong>of</strong> production <strong>to</strong> ensure a high degree between two or more conformity assessment procedures <strong>of</strong> protection as defined in Article 95(3) <strong>of</strong> <strong>the</strong> EC Treaty. for <strong>the</strong> same product may, for instance, be justified, where Additionally, <strong>the</strong> conformity assessment procedures under different certification infrastructures have developed in <strong>the</strong> a specific directive must provide in an equivalent way, Member States as a result <strong>of</strong> different legislation. Still, <strong>the</strong> although <strong>the</strong> procedures are not identical, sufficient confidence as regards <strong>the</strong> conformity <strong>of</strong> products <strong>to</strong> <strong>the</strong> relevant Member States must transpose in<strong>to</strong> <strong>the</strong>ir national legislation all <strong>the</strong> conformity assessment procedures established essential requirements. The principle <strong>of</strong> proportionality also under a directive and <strong>the</strong>y must guarantee <strong>the</strong> free movement <strong>of</strong> all products, which have been subject <strong>to</strong> a con- requires that <strong>the</strong> <strong>directives</strong> should not include unnecessary procedures, which are <strong>to</strong>o onerous relative <strong>to</strong> <strong>the</strong> objectives, in particular as laid down in <strong>the</strong> essential requireformity assessment procedure according <strong>to</strong> <strong>the</strong> directive in question. The choice <strong>of</strong> modules may also be justified ments. The fac<strong>to</strong>rs that have been taken in<strong>to</strong> account when where a product is subject <strong>to</strong> <strong>the</strong> provisions <strong>of</strong> more than setting <strong>the</strong> range <strong>of</strong> possible procedures are described in one directive. In such cases <strong>the</strong> objective is <strong>to</strong> provide <strong>the</strong> <strong>the</strong> <strong>directives</strong>. manufacturer with a common procedure contained in all <strong>the</strong> New Approach <strong>directives</strong> establish different procedures, according <strong>to</strong> <strong>the</strong> categories <strong>of</strong> products covered, by relevant <strong>directives</strong> or at least with compatible procedures. Finally, a choice may also be justified on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> ei<strong>the</strong>r leaving manufacturers no choice or by giving <strong>the</strong>m infrastructure <strong>of</strong> <strong>the</strong> branch <strong>of</strong> industry concerned, <strong>to</strong> <strong>the</strong> freedom <strong>of</strong> choice within <strong>the</strong> same category <strong>of</strong> products. Alternatively, <strong>the</strong> <strong>directives</strong> can also establish, for all nomic procedure. enable manufacturers <strong>to</strong> choose <strong>the</strong> most suitable and eco- <strong>the</strong> products covered by <strong>the</strong> scope, a range <strong>of</strong> procedures Certain <strong>directives</strong> provide for <strong>the</strong> possibility <strong>of</strong> using from which <strong>the</strong> manufacturer shall choose. Fur<strong>the</strong>r, each procedures <strong>based</strong> on quality assurance techniques. In <strong>the</strong>se New Approach directive determines <strong>the</strong> contents <strong>of</strong> <strong>the</strong> cases <strong>the</strong> manufacturer also usually has recourse <strong>to</strong> a procedure or a combination <strong>of</strong> procedures not using such tech- applicable conformity assessment procedure, which may differ from <strong>the</strong> models set up by <strong>the</strong> modules ( 93 ). niques, except where compliance with <strong>the</strong> requirements Providing a choice under a New Approach directive demands <strong>the</strong> exclusive application <strong>of</strong> a certain procedure. 5.1. The modules ( 90 ) for which <strong>the</strong>re is nei<strong>the</strong>r a harmonised standard, a recognised national standard, nor a mandate for a harmonised standard, and <strong>to</strong> products which differ significantly from harmonised or recognised national standards) and <strong>to</strong> pressure equipment (<strong>the</strong> European approval may be granted <strong>to</strong> materials which are not covered by any harmonised standard and which are intended for repeated use in <strong>the</strong> manufacture <strong>of</strong> pressure equipment). ( 86 ) See, for instance, Directives relating <strong>to</strong> construction products, electromagnetic compatibility and gas appliances. ( 87 ) In addition, <strong>the</strong> Directive relating <strong>to</strong> radio and telecommunications terminal equipment provides a possibility for <strong>the</strong> Commission, in <strong>the</strong> case <strong>of</strong> shortcomings <strong>of</strong> harmonised standards, <strong>to</strong> publish in <strong>the</strong> Official Journal guidelines <strong>to</strong> <strong>the</strong> interpretation <strong>of</strong> harmonised standards, or <strong>the</strong> conditions under which compliance is possible. ( 88 ) Only national standards, which may give a presumption <strong>of</strong> conformity according <strong>to</strong> certain <strong>directives</strong> as a transitional measure before <strong>the</strong> area is covered by a harmonised standard, are subject <strong>to</strong> a verification procedure (see Section 4.3). ( 89 ) Under <strong>the</strong> terms <strong>of</strong> <strong>the</strong>ir internal regulations or rules <strong>of</strong> procedure, <strong>the</strong> European standards organisations review <strong>the</strong>ir standards – whe<strong>the</strong>r or not <strong>based</strong> on a mandate – at intervals not exceeding five years. ( 90 ) This section does not apply <strong>to</strong> <strong>the</strong> Directive on construction products, 31
❝ <strong>Guide</strong> <strong>to</strong> <strong>the</strong> <strong>implementation</strong> <strong>of</strong> <strong>directives</strong> <strong>based</strong> on <strong>the</strong> New Approach and <strong>the</strong> Global Approach ❞ Modules <strong>based</strong> on quality assurance techniques derived from <strong>the</strong> EN ISO 9000 series <strong>of</strong> standards establish a link between <strong>the</strong> regulated and non-regulated sec<strong>to</strong>rs. This should help <strong>the</strong> manufacturers <strong>to</strong> meet simultaneously <strong>the</strong> obligations <strong>based</strong> on <strong>directives</strong> and client needs. Fur<strong>the</strong>r, under certain conditions it allows manufacturers <strong>to</strong> benefit from <strong>the</strong>ir investment in quality systems. It contributes also <strong>to</strong> <strong>the</strong> development <strong>of</strong> <strong>the</strong> quality chain (from <strong>the</strong> quality <strong>of</strong> products <strong>to</strong> <strong>the</strong> quality <strong>of</strong> companies <strong>the</strong>mselves), and promotes awareness <strong>of</strong> <strong>the</strong> importance <strong>of</strong> quality management strategies for improving competitiveness. Table 5/1 • Basic modules • A Internal control <strong>of</strong> production B EC type-examination C Conformity <strong>to</strong> type D Production quality assurance E Product quality assurance F Product verification G Unit verification H Full quality assurance Covers internal design and production control. This module does not require a notified body <strong>to</strong> take action. Covers <strong>the</strong> design phase, and must be followed up by a module providing for assessment in <strong>the</strong> production phase. The EC type-examination certificate is issued by a notified body. Covers <strong>the</strong> production phase and follows module B. Provides for conformity with <strong>the</strong> type as described in <strong>the</strong> EC type-examination certificate issued according <strong>to</strong> module B. This module does not require a notified body <strong>to</strong> take action. Covers <strong>the</strong> production phase and follows module B. Derives from quality assurance standard EN ISO 9002, with <strong>the</strong> intervention <strong>of</strong> a notified body responsible for approving and controlling <strong>the</strong> quality system for production, final product inspection and testing set up by <strong>the</strong> manufacturer. Covers <strong>the</strong> production phase and follows module B. Derives from quality assurance standard EN ISO 9003, with <strong>the</strong> intervention <strong>of</strong> a notified body responsible for approving and controlling <strong>the</strong> quality system for final product inspection and testing set up by <strong>the</strong> manufacturer. Covers <strong>the</strong> production phase and follows module B. A notified body controls conformity <strong>to</strong> <strong>the</strong> type as described in <strong>the</strong> EC type-examination certificate issued according <strong>to</strong> module B, and issues a certificate <strong>of</strong> conformity. Covers <strong>the</strong> design and production phases. Each individual product is examined by a notified body, which issues a certificate <strong>of</strong> conformity. Covers <strong>the</strong> design and production phases. Derives from quality assurance standard EN ISO 9001, with <strong>the</strong> intervention <strong>of</strong> a notified body responsible for approving and controlling <strong>the</strong> quality system for design, manufacture, final product inspection and testing set up by <strong>the</strong> manufacturer. according <strong>to</strong> which <strong>the</strong> Commission specifies <strong>the</strong> conformity assessment procedure for a product, or given family <strong>of</strong> products, <strong>based</strong> on methods laid down in <strong>the</strong> annex <strong>to</strong> this Directive. ( 91 ) The Directive relating <strong>to</strong> pressure equipment has introduced user inspec<strong>to</strong>rates, which operate as a second party. ( 92 ) For manufacturer’s responsibilities, see Section 3.1.1. ( 93 ) According <strong>to</strong> <strong>the</strong> Directive on highspeed rail systems <strong>the</strong> conformity assessment procedures are defined in <strong>the</strong> Technical Specifications <strong>of</strong> Inter-operability, following <strong>the</strong> modules provided for in <strong>the</strong> Decision 93/465/EEC. MANUFACTURER Table 5/2 • Simplified flow chart <strong>of</strong> conformity assessment procedures • DESIGN PHASE PRODUCTION PHASE MODULE A MODULE C MODULE D MODULE B MODULE E MODULE F MODULE G MODULE H 32
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