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

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❝ Conformity assessment procedure ❞ Table 5/3 • Variants <strong>of</strong> basic modules • Additional elements compared <strong>to</strong> basic modules Aa1 and Cbis1 Internal production control, and one Intervention <strong>of</strong> a notified body ei<strong>the</strong>r at design or or more tests on one or more specific production stage regarding testing carried out by <strong>the</strong> aspect <strong>of</strong> <strong>the</strong> finished product manufacturer or on his behalf. The products concerned and <strong>the</strong> applicable tests are specified in <strong>the</strong> directive. Aa2 and Cbis2 Internal production control, and product Intervention <strong>of</strong> a notified body regarding product checks checks at random intervals at production stage. The relevant aspects <strong>of</strong> <strong>the</strong> checks are specified in <strong>the</strong> directive. Dbis Production quality assurance A technical documentation is required. without use <strong>of</strong> module B Ebis Product quality assurance A technical documentation is required. without use <strong>of</strong> module B Fbis Product verification A technical documentation is required. without use <strong>of</strong> module B Hbis Full quality assurance with A notified body analyses <strong>the</strong> design <strong>of</strong> a product or a design control product and its variants, and issues an EC design examination certificate. The modules <strong>based</strong> on quality assurance techniques (modules D, E, H and <strong>the</strong>ir variants) describe <strong>the</strong> elements a manufacturer ● The use <strong>of</strong> quality systems for <strong>the</strong> purpose <strong>of</strong> conformity must implement in his organisation in order assessment procedures in <strong>the</strong> <strong>directives</strong> is described in modules D, E and H and <strong>the</strong>ir variants. <strong>to</strong> demonstrate that <strong>the</strong> product fulfils <strong>the</strong> essential requirements <strong>of</strong> <strong>the</strong> applicable directive. This means that a manufacturer is ● Compliance with standards EN ISO 9001, 9002 and 9003 given <strong>the</strong> possibility <strong>of</strong> using an approved gives a presumption <strong>of</strong> conformity with <strong>the</strong> corresponding quality system for <strong>the</strong> purpose <strong>of</strong> demonstrating compliance with regula<strong>to</strong>ry require- by <strong>the</strong> standard in question, provided that <strong>the</strong> quality system quality assurance modules as regards <strong>the</strong> provisions covered ments, thus having <strong>the</strong> capability <strong>to</strong> design takes in<strong>to</strong> consideration — as necessary — <strong>the</strong> specific (if applicable), manufacture and supply products that fulfil <strong>the</strong> applicable essential requirements <strong>of</strong> <strong>the</strong> products for which <strong>the</strong>y are implemented. ● Compliance with modules D, E, H and <strong>the</strong>ir variants does requirements. A quality system implemented on <strong>the</strong> not require a certified quality system according <strong>to</strong> standards basis <strong>of</strong> <strong>the</strong> EN ISO 9001, 9002 or EN ISO 9001, 9002 or 9003, although it provides a useful means 9003 ( 94 ) standard gives a presumption <strong>of</strong> <strong>of</strong> establishing compliance. The manufacturer is free <strong>to</strong> apply conformity with <strong>the</strong> respective modules with o<strong>the</strong>r quality system models than those <strong>based</strong> on EN ISO 9000 regard <strong>to</strong> <strong>the</strong> provisions in <strong>the</strong> modules that standards for <strong>the</strong> purpose <strong>of</strong> complying with <strong>the</strong>se modules. <strong>the</strong>se standards cover, and provided that ● For <strong>the</strong> purpose <strong>of</strong> complying with <strong>the</strong> applicable <strong>directives</strong> <strong>the</strong> quality system enables <strong>the</strong> manufacturer <strong>to</strong> demonstrate that <strong>the</strong> products fulfil <strong>the</strong> <strong>the</strong> manufacturer shall ensure that <strong>the</strong> quality system is implemented and applied in such a way that it ensures <strong>the</strong> full application <strong>of</strong> <strong>the</strong> essential requirements in question. essential requirements <strong>of</strong> <strong>the</strong> directive in question. This means that <strong>the</strong> manufacturer must specifically address regula<strong>to</strong>ry needs when implementing and applying a quality system for <strong>the</strong> purpose <strong>of</strong> <strong>the</strong> New Approach <strong>directives</strong>, in solutions that will ensure fulfilment <strong>of</strong> <strong>the</strong> essential particular: requirements; ● <strong>the</strong> quality objectives, quality planning, quality manual and ● <strong>the</strong> identified standards or o<strong>the</strong>r technical solutions must control <strong>of</strong> documents must fully take on board <strong>the</strong> objective be used as design input, and as verification that design output ensures that <strong>the</strong> essential requirements will be met; <strong>of</strong> delivering products that conform <strong>to</strong> <strong>the</strong> essential requirements; ● <strong>the</strong> measures taken by <strong>the</strong> organisation <strong>to</strong> control production must ensure that <strong>the</strong> products conform <strong>to</strong> <strong>the</strong> iden- ● <strong>the</strong> manufacturer must identify and document <strong>the</strong> essential requirements that are relevant for <strong>the</strong> product and tified safety requirements; <strong>the</strong> harmonised standards <strong>to</strong> be used or o<strong>the</strong>r technical ● <strong>the</strong> organisation in its measurement and control <strong>of</strong> <strong>the</strong> 5.2. Application <strong>of</strong> quality system standards ( 94 ) EN ISO 9001, EN ISO 9002 and EN ISO 9003 <strong>of</strong> 1994 replaced <strong>the</strong> 1987 versions <strong>of</strong> <strong>the</strong> standards, i.e. EN 29001, EN 29002 and EN 29003. A revision <strong>of</strong> <strong>the</strong> ISO 9000 series <strong>of</strong> standards is underway <strong>to</strong> integrate <strong>the</strong> standards ISO 9001, ISO 9002 and ISO 9003 in<strong>to</strong> <strong>the</strong> standard ISO 9001. The structure and contents <strong>of</strong> <strong>the</strong> revised standard will be different and will include some additional requirements. 33
❝ <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 ❞ ( 95 ) See <strong>the</strong> Directives relating <strong>to</strong> telecommunications terminal equipment and lifts. ( 96 ) For example, <strong>the</strong> quality systems set up according <strong>to</strong> <strong>the</strong> Directives relating <strong>to</strong> active implantable medical devices and medical devices must be supplemented by standard EN 46001, or accordingly by standard EN 46002. ( 97 ) For placing on <strong>the</strong> market, see Section 2.3.1. ( 98 ) According <strong>to</strong> <strong>the</strong> Directives relating <strong>to</strong> active implantable medical devices, medical devices and in vitro diagnostic medical devices <strong>the</strong>se documents must be kept for five years. According <strong>to</strong> <strong>the</strong> Directive relating <strong>to</strong> refrigeration appliances <strong>the</strong> time period is three years. The Directives relating <strong>to</strong> simple pressure vessels, <strong>to</strong>ys, non-au<strong>to</strong>matic weighing instruments, gas appliances and construction products do not define a time period, but <strong>the</strong> general rule should be applied also <strong>to</strong> <strong>the</strong> technical documentation required according <strong>to</strong> <strong>the</strong>se Directives. ( 99 ) For responsibilities <strong>of</strong> <strong>the</strong> manufacturer, <strong>the</strong> authorised representative, <strong>the</strong> importer and person responsible for placing on <strong>the</strong> market, see Sections 3.1 – 3.3. ( 100 ) See <strong>the</strong> Directives relating <strong>to</strong> simple pressure vessels, machinery (for module B), non-au<strong>to</strong>matic weighing instruments, active implantable medical devices, gas appliances, telecommunications terminal equipment, medical devices, potentially explosive atmospheres, lifts (for modules B, C, D, G, H), pressure equipment, in vitro diagnostic medical devices, and radio and production process and finished products must identify and use methods which are identified in standards or o<strong>the</strong>r appropriate methods <strong>to</strong> ensure that <strong>the</strong> essential requirements are met; and ● quality records, such as inspection reports and test data, calibration data, qualification reports <strong>of</strong> <strong>the</strong> personnel concerned, must be suitable <strong>to</strong> ensure <strong>the</strong> fulfilment <strong>of</strong> <strong>the</strong> applicable essential requirements. The manufacturer has <strong>the</strong> responsibility <strong>to</strong> implement and continuously operate <strong>the</strong> quality system in such a way that regula<strong>to</strong>ry needs are respected. The notified body must ensure in its assessment, approval and continued surveillance, that this is <strong>the</strong> case. Very few <strong>directives</strong> refer explicitly <strong>to</strong> <strong>the</strong> quality system standards ( 95 ). However, a general reference can be found in Decision 93/465/EEC. Directives may lay down additional provisions for conformity assessment according <strong>to</strong> modules D, E, H, and <strong>the</strong>ir variants which require that compliance with standards EN ISO 9001, 9002 and 9003 is completed with supplementary elements. This is <strong>to</strong> take in<strong>to</strong> consideration <strong>the</strong> specificity <strong>of</strong> <strong>the</strong> products for which it is implemented ( 96 ). product on <strong>the</strong> Community market must take on this responsibility ( 99 ). The contents <strong>of</strong> <strong>the</strong> technical documentation are laid down, directive by directive, ● The manufacturer must draw up a technical file (technical documentation). in accordance with <strong>the</strong> products concerned. ● The technical documentation is intended <strong>to</strong> provide information on <strong>the</strong> design, manufacture and operation <strong>of</strong> <strong>the</strong> product. <strong>the</strong> design, manufacture and operation <strong>of</strong> As a rule, <strong>the</strong> documentation should cover <strong>the</strong> product. The details included in <strong>the</strong> documentation depend on <strong>the</strong> nature <strong>of</strong> <strong>the</strong> New Approach <strong>directives</strong> oblige <strong>the</strong> manufacturer <strong>to</strong> draw product and on what is considered as necessary, from <strong>the</strong> up technical documentation containing information <strong>to</strong> technical point <strong>of</strong> view, for demonstrating <strong>the</strong> conformity <strong>of</strong> demonstrate <strong>the</strong> conformity <strong>of</strong> <strong>the</strong> product <strong>to</strong> <strong>the</strong> applicable <strong>the</strong> product <strong>to</strong> <strong>the</strong> essential requirements <strong>of</strong> <strong>the</strong> relevant requirements. This documentation may be part <strong>of</strong> <strong>the</strong> quality system documentation where <strong>the</strong> directive provides for a <strong>to</strong> <strong>the</strong>se instead by indicating <strong>the</strong> essential requirements directive or, if <strong>the</strong> harmonised standards have been applied, conformity assessment procedure <strong>based</strong> on a quality system (modules D, E, H and <strong>the</strong>ir variants). This obligation Several <strong>directives</strong> require that <strong>the</strong> technical documenta- covered by <strong>the</strong> standards. begins when <strong>the</strong> product is placed on <strong>the</strong> market, whatever tion is written in an <strong>of</strong>ficial language <strong>of</strong> <strong>the</strong> Member State its geographical origin is ( 97 ). where <strong>the</strong> procedures are <strong>to</strong> be carried out, or in which <strong>the</strong> The technical documentation must be kept for at least notified body is established, or in a language accepted by 10 years from <strong>the</strong> last date <strong>of</strong> manufacture <strong>of</strong> <strong>the</strong> product, it ( 100 ). In order <strong>to</strong> carry out <strong>the</strong> conformity assessment procedures requiring third-party verification in a proper way, <strong>the</strong> unless <strong>the</strong> directive expressly provides for any o<strong>the</strong>r duration ( 98 ). This is <strong>the</strong> responsibility <strong>of</strong> <strong>the</strong> manufacturer or <strong>the</strong> documentation should always be in a language unders<strong>to</strong>od authorised representative established within <strong>the</strong> Community. In some cases <strong>the</strong> importer or <strong>the</strong> person placing <strong>the</strong> tioned in all New Approach by <strong>the</strong> notified body, even if this has not been explicitly men- <strong>directives</strong>. 5.3. Technical documentation New Approach <strong>directives</strong> impose an obligation on <strong>the</strong> manufacturer, or <strong>the</strong> authorised representative established within <strong>the</strong> Community, <strong>to</strong> draw up an EC declaration <strong>of</strong> conformity when <strong>the</strong> product is placed on <strong>the</strong> market. Depending on <strong>the</strong> procedure, <strong>the</strong> EC declaration <strong>of</strong> conformity must ei<strong>the</strong>r ensure that <strong>the</strong> product satisfies <strong>the</strong> essential requirements <strong>of</strong> <strong>the</strong> applicable <strong>directives</strong>, or that <strong>the</strong> product is in conformity with <strong>the</strong> type for which a type-examination certificate has been issued and satisfies <strong>the</strong> essential requirements <strong>of</strong> <strong>the</strong> applicable <strong>directives</strong> ( 101 ). The EC declaration <strong>of</strong> conformity must be kept for at least ten years from <strong>the</strong> last date <strong>of</strong> manufacture <strong>of</strong> <strong>the</strong> product, unless <strong>the</strong> directive expressly pro- 5.4. EC declaration <strong>of</strong> conformity ● The manufacturer or <strong>the</strong> authorised representative established within <strong>the</strong> Community must draw up an EC declaration <strong>of</strong> conformity as part <strong>of</strong> <strong>the</strong> conformity assessment procedure provided for in <strong>the</strong> New Approach <strong>directives</strong>. ● The EC declaration <strong>of</strong> conformity should contain all relevant information <strong>to</strong> identify <strong>the</strong> <strong>directives</strong> according <strong>to</strong> which it is issued, as well as <strong>the</strong> manufacturer, <strong>the</strong> authorised representative, <strong>the</strong> notified body if applicable, <strong>the</strong> product, and where appropriate a reference <strong>to</strong> harmonised standards or o<strong>the</strong>r normative documents. vides for any o<strong>the</strong>r duration ( 102 ). This is <strong>the</strong> responsibility <strong>of</strong> <strong>the</strong> manufacturer or <strong>the</strong> authorised representative 34
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