GUIDE NAWI - Cyprus Organization for the Promotion of Quality

Guide on NAWI DirectiveEuropeAid /114385/D/SV/CYAPPROVAL OF QUALITY SYSTEMSThe manufacturer is to lodge an application for approval of the quality system with a notified body. Theapplication must include an undertaking to carry out the obligations arising from the approved qualitysystem, and an undertaking to maintain the approved quality system to ensure its continuing suitabilityand effectiveness.The manufacturer is to make available to the notified body all relevant information, in particular the qualitysystem’s documentation and the design documentation of the instrument described in Annex III of theDirective.The quality system is to ensure conformity of the instruments with the prototype as described in the ECtype-approval certificate and with the relevant requirement(s) of the Directive. All the elements,requirements and provisions adopted by the manufacturer are to be documented in a systematic andorderly manner in the form of written rules, procedures and instructions. The quality systemdocumentation is to ensure a proper understanding of the quality programmes, plans, manuals andrecords.It is to contain, in particular, an adequate description of:• the quality objectives and the organisational structure;• responsibilities and powers of the management with regard to product quality; the manufacturingprocess, the quality control and assurance techniques and the systematic measures to be used;• the examinations and tests to be carried out before, during and after manufacture, and thefrequency with which they are to be carried out;• and the means to monitor the achievement of the required product quality and the effectiveoperation of the quality system.The notified body is to examine and evaluate the quality system to determine whether it satisfies thoserequirements. It is to presume that quality systems which implement the corresponding harmonisedstandard conform with those requirements. The notified body is to notify the manufacturer of its decisionand inform the other approved bodies thereof. The notification to the manufacturer is to contain theconclusions of the examination and, in the event of refusal, the justification for the decision.The manufacturer or his authorised representative is to keep the notified body that approved the qualitysystem informed of any updating of the quality system in relation to any changes brought about by e.g.new technologies and new quality concepts. Any notified body that withdraws approval of a quality systemis so to inform the other approved bodies through the Member State.Thereafter the manufacturer is to grant the notified body access for inspection purposes to themanufacture, inspection, testing and storage premises, and is to provide it with all necessary information,in particular, the quality system documentation; the design documentation; and the quality records (e.g.the inspection reports and test and calibration data, reports on the qualifications of the personnelconcerned, etc.).The notified body is periodically to carry out audits in order to ensure that the manufacturer is maintainingand applying the quality system; it is to provide the manufacturer with an audit report. They may also carryout unscheduled visits to the manufacturer. During such visits, the notified body may carry out full orpartial audits. It is to provide the manufacturer with a report on the visit and, where appropriate, an auditreport. The notified body shall ensure that the manufacturer maintains and applies the approved qualitysystem.