GUIDE PPE - Cyprus Organization for the Promotion of Quality

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Guide on PPE Directive EuropeAid /114385/D/SV/CY The NB shall withdraw the certificate if, for example, during the controls according to Article 11 the NB notices that the PPE is not in conformity with the type described in the EC type-approval certificate. In such a case the NB shall inform the Member State which shall then inform the other Member States and the Commission, setting out the reasons for the decision. EC QUALITY CONTROL SYSTEM FOR THE FINAL PRODUCT For category III products the manufacturer shall either take the necessary steps to control the quality of the final product (Article 11A) or he must have a quality-control system for the production (Article 11B). The manufacturer shall plan procedures to ensure that the manufacturing process, including the final inspection of PPE and tests, ensures the homogeneity of production and the conformity of PPE with the type described in the EC type-approval certificate and with the relevant EHSRs of the directive. The manufacturer selects a NB to carry out the necessary checks of the products. Those checks are carried out at random, normally at intervals of less than one year. Some Recommendation for Use sheets produced by the Co-ordination of Notified Bodies describe which tests are relevant for the checking of the products. The NB gives the manufacturer a test report. The manufacturer must be able to present this report on request. The NB must try to find out the reasons if the checks reveal that the product does not fulfil the requirements or is not such as described in the technical file. It shall also inform the Member State in such cases. SYSTEM FOR ENSURING EC QUALITY OF PRODUCTION BY MEANS OF MONITORING The manufacturer must make an application to the NB for the approval of his quality-control system. The application shall include: • all the information relating to the category of PPE concerned, including, when appropriate, documentation relating to the approved model; • documentation on the quality-control system; • the undertaking to maintain the obligations arising from the quality-control system and to maintain its adequacy and efficiency. The directive requires that under this system, each model of PPE shall be examined and the appropriate tests specifically relating to the certification of PPE category III shall be carried out to check their conformity to the relevant EHSRs of the directive. The documentation on the quality-control system shall in particular include an adequate description of: • the quality objectives, the organization chart, the responsibilities of executives and their powers in respect of product quality; • the checks and tests which must be carried out after manufacture; • the means to be employed to check the efficient operation of the quality-control system. The NB shall then assess the quality-control system to determine whether it satisfies the requirements. A quality-control system satisfying the relevant harmonized standard is deemed to be in compliance with these requirements. The PPE Directive does not refer any particular EN ISO 9000 standard when giving requirements to the quality control system for the production of PPE. The guidance given by the Commission is that a system fulfilling the requirements given by EN ISO 9002 is deemed to fulfil the
Guide on PPE Directive EuropeAid /114385/D/SV/CY requirements of the directive. The requirements given in EN ISO 9003 shall be completed with some additional requirements. This guidance is not amended after the publication of the new EN ISO 9001:2000. The European foreword of the standard gives some guidance and there is also a Recommendation for Use sheet (Sheet number 119), describing, which clauses of the standard EN ISO 9001:2000 are relevant. http://www.europa.eu.int/comm/enterprise/mechan_equipment/ppe/clarificationsheets/ tablecontents.pdf The NB carries out audits to evaluate the quality-control system and to make sure that the manufacturer is maintaining and applying the approved quality control. THE EC DECLARATION OF CONFORMITY The manufacturer or his authorised representative must draw up and sign an EC declaration of conformity for each model of PPE whatever its category. In this declaration the manufacturer certifies that the PPE placed on the market is in conformity with the provisions of the PPE Directive. The declaration also contains reference to the harmonized standards applied, to the EC type-examination certificate and to the NB responsible for the 11 A or B procedure, as appropriate. A model of this declaration is given in Annex VI of the directive. CE MARKING The CE marking shall be affixed to each item of PPE placed on the market and on its packaging. If marking on the PPE is impossible (for instance, because it is too small) the marking may be on the packaging only. The marking must be visible, legible and indelible throughout the foreseeable useful life of the PPE. Other marks, which could be confused with the CE marking, may not be affixed to PPE. CE marking is evidence that the product conforms to all the relevant EHSRs and that the product has been subject to the appropriate conformity assessment procedure. The form of CE marking is given in Annex IV of the directive (which has been amended twice, by Directive 93/68/EEC [10] and Directive 96/58/EC). [13] It must have a minimum height of 5 mm except for very small PPE. For category I equipment the CE marking is the letters CE in the given form. The same goes for category II products, which can be identified as Category II products from the information notice supplied by the manufacturer, which must include the name and address of the NB having made the EC typeexamination. For category III products, the CE marking includes the identification number of the NB responsible for the Article 11 A or 11 B procedure.
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GUIDE PPE - Cyprus Organization for the Promotion of Quality

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