Directives conformity assessment procedures

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

The publication of BS EN ISO 9001 2000 has implications for Council Decision 93/465/EEC of July 22, 1993 concerning the modules for the various phases of conformity assessment procedures and the mles for affixing and using the CE conformity marking, which are intended to be used in the technical harmonization directives. It is important to note that the modules used in individual technical harmonization directives may vary in some respects compared to those described in Council Decision 93/465/ECC. In all cases, it is the annex of the applicable directive(s) that is legally binding. The principles set out in this foreword remain valid regardless of these variations. 

The Directive classifies the pressure equipment into four categories (I, II, III, IV) dependent on the level of risk presented by the pressure (Figure 4.17). Category IV represents the highest risk. The category of the pressure equipment is established from one of the nine tables in Annex II of the Directive. The categories determine the Conformity Assessment Procedures to be used. 

Directive 93/465/EEC, dated 1993-07-22, gives a survey of the different modules (called A. .. H) for conformity assessment procedures (Fig. 3.2). A short description of these modules is given in Table 3.9. Obviously, module B... 

CE Marking Directive 93/68/EEC states that the choice of conformity assessment procedures must not lead to a lowering of safety standards of electrical equip-ment/products, which have already been established throughout the Community. Alternatives to European standards are possible in the case where no European harmonized standard exists. Conformity to International standards (i.e., lEC) or European national standards (i.e., DIN, BS, NF) is sometimes an acceptable alternative, but in this case the manufacturer must be able to demonstrate conformity with the ERs of the directives and at the same time not fall below the minimum acceptable criteria. The General Product Safety Directive 92/59/EEC allows the use of EU national standards when no European harmonized standards exist. This alternative may be needed as a transitional measure until a European standard is published (see General Product Safety in Chapter 2). This approach is not recommended when European harmonized standards exist, especially if a product becomes suspect, since... 

The objecCive of a conformity assessment procedure is to give users, consumers, and authorities assurance that products conform to the various requirements as expressed in the directives ... 

The essential objective of a conformity assessment procedure is to enable the authorities to ensure that products placed on the market conform to the requirements expressed in the directives and, these products must meet the high level of safety that the directives seek for a given product or product sector. There are seven modules in 93/465/EEC, and the generic directives (LVD, EMC, etc.) or product-specific directives (machinery, etc.) will set the range of choices that may be considered, as follows ... 

The Conformity Assessment Procedures and Rules for CE Marking Directive 93/465/EEC... 

European Harmonized Standards play a key role, not just because they significantly simplify the conformity assessment procedures (Article 10.1 of the directive) if used in full, but also because they provide by consent, a unique, harmonized, technical solution that has been based on an EMC analysis. This means that, even if those standards are not used (they are voluntary) in the design and manufacture of the apparatus, manufacturers should take them into account when performing their analysis. ... 

In demonstrating conformity with the essential requirements, manufacturers may choose whatever conformity assessment procedures are provided for in the directives. 

As discussed earlier, the European Union has adopted two harmonized directives on health and safety, known as ATEX 94/9/EC (also ATEX 95) and ATEX 99/92/EC (also ATEX 137). ATEX Directive 94/9/EC focuses on the essential safety requirements (SRSs) for products and protective systems for use in potentially explosive atmospheres and the respective conformity assessment procedures. ATEX Directive... 

The conformity assessment procedure for the proof of the compliance of explosion-protected equipment and protective systems to be supplied with the regulations of the directive is described in annex 11, article 8 of the directive. 

In accordance with the conformity assessment procedure the protective systems have to be subjected to an EC-type examination according to annex III of the directive by a Notified Body. 

After the conclusion of the conformity assessment procedure and of the tests perhaps required, the manufacturer issues an EC-declaration of conformity for his product. He affixes the explosion protection marking (Ex marking) to the product and if the product fulfills the requirements of other applicable European directives he affixes a CE marking to the product as well. 

Initial consideration of these factors gives a basis for further classification (which can be made by the manufacturer himself) and also determines the relevant conformity assessment procedure that must be followed by the manufacturer. Table 9.4 presents the classification of medical devices according to the European regulation— Directive 93/42/ECC (European Commission, 2012). 

In adopting that New Approach, the European Council was aware that this decision had to be accompanied by a policy on assessment of conformity. The Global Approach to conformity assessment provides for procedures to prove compliance of a product with the essential requirements in New Approach directives. 

Manufacturer is the entity responsible for designing and manufacturing a product that is covered by a directive or directives with a view to placing it on the market. The manufacturer shall follow the appropriate assessment procedures and is responsible for all aspects of the product s conformity. This includes, but is not limited to, the product s design, testing, reports, documentation, declaration, technical file, and CE marking. The manufacturer is ultimately liable for the product s... 

A technical file is required by the primary directives to document the conformity assessment and the product s design. The technical file shall be compiled by the manufacturer or authorized representative and contain design documentation, manufacturing procedures, test reports, and operation information to show conformity as required by the directives. 

The procedures for conformity assessment are chosen from the various modules and in accordance with the criteria set out in the primary directives. Departure from the procedures is allowed only when the specific circumstances of a directive so warrant. Quality is shown in some of the modules, but a common mistake for some ISO 9000 quality-certified companies is to assume that they can select a module that utilizes ISO 9000 when this is not possible unless the primary directive allows it. There is no mention of ISO 9000 quality in the LVD, EMC, and Machinery directives (see Product Quality versus Factory Quality in Chapter 5). ISO 9000 quality may be necessary for some products (i.e., medical products) under the Medical Device Directive (MDD). 

Heavy diesel engines for use in motor vehicles Directive 96/1/EC (amending 88/77/EEC) Introducing a new statistical procedure for the evaluation of conformity of production assessment AND a derogation for smaller engines from the particulate values... 

The two-stage module of the PUF sampler enables determination of suspended particulate matter concentrations by pre- and post-weighing of the four inch glass-fiber filter. Because relative differences in suspended particulate matter are of concern, this evaluation can be performed immediately upon the collection of the samples and can be used to aid site personnel in the assessment of dust suppression techniques and evaluation of meteorological conditions. This technique for the determination of suspended particulate matter concentrations should not be directly compared to national ambient air-quality standard for Total Suspended Particulate (TGP) because the filter size, sample flow rate, and sample volume do not conform to the sampling procedures outlined in the Code of Federal Regulation 0, Part 50.11, Appendix 3 for TSP sampling, however, it does provide accurate re-sult s. ... 

The Council resolution of 7 May 1985 showed the way by accepting that there could be more than one means of proof of conformity to a directive. It provided for presumption of conformity to a directive on the basis of a European harmonized standard, or, during a transition period, of national standards which have submitted and recognized as equivalent under Community control procedure. When the manufacturer complies with these standards, the directives allow him to make use of simplified certification mechanisms. When the product does not conform to a standard, however, either because the standards do not exist or because the manufacturer, for in the case of innovation, prefers to apply other manufacturing criteria of his own choice, the assessment of conformity to the essential requirements must [may] involve a third party either by certification or by third party testing [via notified/competent body]. (OJEC 89/C267/03)... 

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